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Magenta Therapeutics Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in Patients with…

Posted: June 6, 2021 at 1:51 am


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today announced additional positive results from a Phase 2 clinical trial of MGTA-145 and plerixafor in patients with multiple myeloma at the American Society of Clinical Oncology (ASCO) Annual Meeting, being held virtually June 4-8, 2021.

We are very pleased to see continued favorable results for MGTA-145 and plerixafor for stem cell mobilization and collection in patients with multiple myeloma, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. These results build on those previously disclosed from this study and the Phase 1 trials to further demonstrate MGTA-145 and plerixafors potential as a rapid, reliable, well-tolerated approach to stem cell mobilization and collection, which has positive implications for patients and donors.

Additional Results MGTA-145 Multiple Myeloma Phase 2 Clinical Trial

The investigator-initiated, 25-patient Phase 2 clinical trial is designed to evaluate the ability of MGTA-145, in combination with plerixafor, to mobilize and collect hematopoietic stem cells for autologous stem cell transplant in patients with multiple myeloma. This study is led by Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy at Stanford University School of Medicine.

Previously reported results from this trial were announced on May 12, 2021, in a published abstract for the European Hematology Association (EHA) Congress and provided preliminary data from the initial cohort of 10 patients.

Summary of cumulative results through data cut-off date:

As indicated previously, this trial has broad and clinically representative inclusion criteria and includes patients that represent the general transplant-eligible population of patients with multiple myeloma. Patients enrolled in this trial included those patients with risk factors that could impact stem cell mobilization and collection, such as myeloma-directed therapies that are known to impact stem cell collection, previous malignancy treated with chemotherapy and/or radiation, and other co-morbid conditions. Mobilization agents may be less effective in patients with multiple risk factors. Final clinical data from this trial are anticipated by the end of 2021. MGTA-145 is also being evaluated for its ability to mobilize and collect stem cells from donors for allogenic transplant in patients with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in a Phase 2 trial, and an additional Phase 2 study is planned to initiate in patients with sickle cell disease in the second half of 2021.

ASCO Poster Presentation

Title: Phase 2 Study of MGTA-145 + Plerixafor for Rapid and Reliable Hematopoietic Stem Cell (HSC) Mobilization for Autologous Stem Cell Transplant in Multiple Myeloma (Abstract #8023)

Author: Surbhi Sidana, M.D., Assistant Professor of Medicine in the Division of Blood and Marrow Transplantation and Cellular Therapy, Stanford University School of MedicinePoster Session: Hematologic Malignancies Plasma Cell DyscrasiaDate/Time: All e-posters are now available in the ASCO Annual Meeting virtual platform

These results will also be presented as an encore at the EHA Virtual Congress, available via the conferences virtual platform on Friday, June 11 at 3:00am EDT / 9:00am CEST.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magentas future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, the anticipated timing of clinical trials and regulatory filings, the development of product candidates and advancement of preclinical programs, the potential benefits of our product candidates, the timing, progress and success of collaborations, as well as other statements containing the words anticipate, believe, continue, could, endeavor, estimate, expect, anticipate, intend, may, might, plan, potential, predict, project, seek, should, target, will or would and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether preliminary results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magentas business, operations, strategy, goals and anticipated timelines, Magentas ongoing and planned preclinical activities, Magentas ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magentas timelines for regulatory submissions and Magentas financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K filed on March 3, 2021, its Quarterly Reports on Form 10-Q and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

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Magenta Therapeutics Announces Additional Preliminary Positive Results from Ongoing Phase 2 Clinical Trial of MGTA-145 and Plerixafor in Patients with...

Antengene Announces Abstracts on Twelve Clinical Studies of Selinexor Selected by EHA 2021 – PRNewswire

Posted: at 1:51 am


SHANGHAI and HONG KONG, June 1, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, announced that results from twelve studies of selinexor, the world's first approved oral selective inhibitor of nuclear export (SINE), were selected for the European Hematology Association (EHA) Annual Congress, taking place in a virtual format on June 9 to 17.

Selected Abstracts:

Phase 2 MARCH study of oral ATG-010 plus low dose dexamethasone in Chinese patients withrelapsed/refractory multiple myeloma previously exposed to an immunomodulatory agent and a proteasome inhibitor.

Abstract #: PB1670

Once weekly selinexor, carfilzomib, and dexamethasone (XKd) in carfilzomib nonrefractory multiple myeloma (MM) patients.

Abstract #: S188

Selinexor containing regimens in patients with multiple myeloma previously treated with anti-CD38 monoclonal antibodies.

Abstract #: EP1002

Oral selinexor, pomalidomide, and dexamethasone (XPd) at recommended phase 2 dose in relapsed/refractory multiple myeloma (MM).

Abstract #: EP1008

Ciltacabtagene Autoleucel versus selinexor + dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) treated with 3 lines of prior therapy: A matching adjusted indirect comparison.

Abstract #: EP1049

Cost effectiveness comparison of belantamab mafodotin and selinexor inrelapsed refractory multiple myeloma.

Abstract #: EP1173

Lymphocyte count effect on efficacy and safety of single agent oral selinexor in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL): A post-hoc analysis from phase 2B SADAL study.

Abstract #: EP530

Genomic correlates of respones to selinexor inmultiple myeloma from the BOSTON study reveal a predictive signature.

Abstract #: EP936

Effects of selinexor on previouslytreated multiple myeloma (MM) with RAS-mutations.

Abstract #: EP966

Efficacy and safety of selinexor, bortezomib, and dexamethasone based on refractory status to lenalidomide in patients with previously treated multiple myeloma: A post-hoc analysis of the BOSTON study.

Abstract #: EP974

Survival among older patients with previously treatedmultiple myeloma treated with selinexor, bortezomib, and dexamethasone (XVd) in the BOSTON study.

Abstract #: EP976

Updated overall survival of eltanexor for the treatment of patients with hypomethylating agent refractory myelodysplastic syndrome.

Abstract #: EP924

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

SOURCE Antengene Corporation Limited

http://www.antengene.com

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Antengene Announces Abstracts on Twelve Clinical Studies of Selinexor Selected by EHA 2021 - PRNewswire

Clinical Trial Results of the BCMA CAR-T Co-developed by Innovent and IASO Biotherapeutics Commented in American Society of Hematology’s Medical…

Posted: at 1:51 am


SAN FRANCISCO, U.S. and SUZHOU, China, June 2, 2021 /PRNewswire/ --Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, together with IASO Biotherapeutics (IASO Bio), today jointly announced that the results of initial clinical studies on treatment of relapsed or refractory multiple myeloma (R/R MMin subjects using fully human BCMA-targeting CAR, an investigational chimeric antigen receptor (CAR) T-cell therapy co-developed by IASO Bio and Innovent (Innovent: IBI326, IASO Bio: CT103A) was published in "Blood", a peer-reviewed medical journal specializing in hematology. The name of the article is "A phase 1 study of a novel fully human BCMA-targeting CAR (CT103A) in patients with relapsed/refractory multiple myeloma." The editors of "Blood" were so impressed by the unique persistence of IBI326 and the authors' exposition on the re-treatment prospects of the disease during the studies that they invited experts from University College London Cancer Institute to write a review entitled "BCMA CARs in multiple myeloma: room for more" (DOI 10.1182/blood.2021010833).

Background and results of IBI326 clinical studies:

Despite recent advances in multiple myeloma (MM) treatment strategies, particularly the emergence and clinical application of immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies that have improved the survival of MM, it remains an incurable plasma cell cancer, and relapse is almost inevitable in all patients. Results from previously published clinical trials showed that; 33% to 88% of patients with relapsed/ refractory MM (R/R MM) had objective antimyeloma responses after treatment with antiB-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells 1-7. However, it remains a great challenge to achieve durable responses, and relapse or disease progression is observed in 28% to 88% of patients at a median follow-up time of 2 to 15 months 1-7.

The clinical study published in "Blood"was conducted in Department of Hematology, Tongji Medical College of HUST in China (ChiCTR1800018137). The results showed IBI326 has favorable safety profile with mild and controllable cytokine release syndrome (CRS). IBI326 shows excellent expansion and longer persistence during transfusion. In addition, subjects relapsed from a prior murine BCMA CAR-T treatment were also benefited from IBI326.

Efficacy:

Safety: No Immune effector cell-associated neurotoxicity syndrome (ICANS) was observed in any of the dose groups. CRS was observed from 94% of the subjects, and there was a comparatively high rate of severe CRS (28% grade 3; 13% would have had grade 3 if the highest dose had been excluded). In dose expansion study, investigator recommended 1X106/kg CAR+ T cells as recommended Phase II dose.

CAR T-cell expansion: According to ddPCR-based CAR transgene quantification, the median time to reach peak concentration after infusion was 12 days (range, 7-26 days), a strong indication of rapid CAR expansion. No significant difference was observed among 3 dosing groups. For the 4 patients who had participated in prior murine BCMA CAR T-cell trials, low levels of expansions of previously infused murine CAR T cells were observed with short durations compared with IBI326, indicating that the therapeutic response should mainly be attributed to IBI326 expansion.

Immunogenicity: ADA was tested in all 18 subjects and two samples of one subject were validated as positive for ADA.

Comments on the "Blood" article :

In the article, 3 experts from University College London (UCL) Cancer Institute, Lydia Sarah, Hui Lee and Kwee L. Yong commented on the IBI326 studies (as "CT103" in the article). "Wang et al describe clinical outcomes that we have come to expect in the field today and include sufficient details on their trial protocol and subject cohort to allow considered comparison with other trials globally. The authors are candid in their assessment of the trial, and they discuss the possible impact of their comparatively treatment-naive cohort and their lymphodepletion regimen (combining fludarabine with high-dose cyclophosphamide) on response, toxicity, and CAR persistence. Even so, the study is noteworthy for the duration of CAR persistence and its inclusion of subjects previously treated with a murine BCMA CAR."

They also mentioned that both points are significant because it is well known that CARs targeting CD19 in acute lymphocytic leukemia (ALL) can maintain durable responses in 40% of subjects despite therapy being given for refractory disease and multiple relapses8. However, even with initial disease regression, durable responses with CAR T cells have not been achieved in MM9-11. In the first 2 BCMA CAR trials reported, subjects had a median PFS of 1 year. Although the outcomes reported in the CARTITUDE-1 trial were better, it is still not clear whether prolonged remissions can be obtained with existing CAR T-cell products in MM.

The experts subsequently noted and affirmed the in vivo persistence of IBI326. They compared the clinical trial data for CT103 and 2 other CAR-T drugs launched in the market. "In trials assessing the earliest BCMA CARs, bb2121 and LCAR-B38M/JNJ-4528, persistence was typically 6 months. Given this landscape, the reported persistence of CT103 is notable. The maximum concentration of circulating CT103 is lower than other CARs, but it has a median persistence of 308 days, which will likely increase with follow-up. Robust expansion was seen in all subjects, and at last follow-up (median, 13 months), CAR T cells had fallen below 1 X 102 copies per mg of DNA in only 5 subjects."

In addition to relatively high persistence, the experts also noted relative low binding affinity (10 nM) of CT103. "Another unusual feature of CT103 is its relatively low binding affinity (10 nM), which the authors have usefully compared with that of bb2121. CT103 has a slower on-rate, and both binders have similarly fast off-rates compared with the CD19 binder in tisagenlecleucel and axicabtagene ciloleucel (ie, FMC63). The association between binding affinity and clinical outcomes is still uncertain and is likely to be target and context dependent. In CD19, a lower-affinity CAR has been associated with improved persistence in pediatric ALL in which the authors postulated that a faster off-rate may facilitate serial triggering. More work is needed to define the binding kinetics that may influence the efficacy of BCMA CARs."

They also made special mention of the unusual practice of enrolling 4 subjects who had previously been treated with a murine BCMA CAR for CT103 clinical trials. "Unusually, this study enrolled 4 subjects who had previously been treated with a murine BCMA CAR. CT103 expanded in all 4 subjects, and in 3 of them, there was transient and low-level expansion of the murine BCMA CAR construct after lymphodepletion. This indicates that undetectable levels of CAR T cells can remain at disease relapse with antigen-positive disease, but they are likely to be exhausted or terminally differentiated. This further underlines the importance of defining the drivers of disease control in terms of CAR manufacture or in the tumor niche."

The experts from UCL Cancer Institute ended with positive remarks and optimism on the persistence of CT103 and its treatment of MM, "More widely, we are witnessing rapid developments in MM CAR T-cell therapy. We await maturity of promising but early data from an increasing number of MM CARs jostling for a spot on the global landscape, some of which may achieve persistence to rival CT10313. CT103 thus enters a rather crowded field but is a welcome addition for its report of increased persistence and contribution to the discussion surrounding the prospect of retreatment."

About IBI326 (BCMA CAR-T)

IBI326 is an innovative therapy co-developed by Innovent and IASO Bio. Previous studies indicate subjects with relapsed/refractory multiple myeloma (R/R MM) who received high-dose BCMA-targeting CAR-T cells may achieve better remission but have worse adverse events. Moreover, once the disease progresses again, the re-infusion of CAR-T cells will not be effective. To solve this dilemma, IBI326 has been developed, a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3 activation domains. Based on strict selection and screening, utilizing a proprietary in-house optimization platform, the construct of the BCMA CAR-T is potent and persistent. In February 2021, IBI326 was granted breakthrough therapy designation by the NMPA for the treatment of relapsed/refractory multiple myeloma.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 24 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China - TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection) and HALPRYZA (rituximab biosimilar injection), one Biologics License Application (BLA)submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: http://www.innoventbio.com.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput CAR-T drug priority platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. Currently, the company is developing a diversified portfolio of over 10 novel pipeline products, IASO's leading asset, IBI326, an innovative anti-BCMA CAR-T cell therapy under pivotal study for relapsed/refractory (R/R) multiple myeloma (RRMM), was granted Breakthrough Therapeutic Designation by China's National Medical Products Administration (NMPA) in February 2021. For more information on IASO, please visit http://www.iasobio.com.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to the Company, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

REFERENCES:

1. Ali SA, Shi V, Maric I, et al. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016;128(13):1688-1700.

2. Xu J, Wang Q, Xu H, et al. Anti-BCMA CAR-T cells for treatment of plasma cell dyscrasia: case report on POEMS syndrome and multiple myeloma. J Hematol Oncol. 2018;11(1):128.

3.Zhao WH, Liu J, Wang BY, et al. A phase 1, open-label study of LCAR-B38M, a chimeric antigen receptor T cell therapy directed against B cell maturation antigen, in subjects with relapsed or refractory multiple myeloma. J Hematol Oncol. 2018;11(1):141.

4. Brudno JN, Maric I, Hartman SD, et al. T cells genetically modified to express an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of poor-prognosis relapsed multiple myeloma. J Clin Oncol. 2018;36(22): 2267-2280.

5. Raje N, Berdeja J, Lin Y, et al. Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma. N Engl J Med. 2019; 380(18):1726-1737.

6. Xu J, Chen LJ, Yang SS, et al. Exploratory trial of a biepitopic CAR T-targeting B cell maturation antigen in relapsed/refractory multiple myeloma. Proc Natl Acad Sci U S A. 2019; 116(19):9543-9551.

7. Cohen AD, Garfall AL, Stadtmauer EA, et al. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019;129(6):2210-2221.

8.Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with B-cell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439-448

9.Brudno JN, Maric I, Hartman SD, et al. T cells genetically modified to express an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of poor-prognosis relapsed multiple myeloma. J Clin Oncol. 2018;36(22): 2267-2280.

10. Raje N, Berdeja J, Lin Y, et al. Anti-BCMA CAR T-cell therapy bb2121 in relapsed or refractory multiple myeloma. N Engl J Med. 2019; 380(18):1726-1737.

11. Madduri D, Berdeja JG, Usmani SZ, et al CARTITUDE-1: Phase 1b/2 study of ciltacabtagene autoleucel, a B-cell maturation antigendirected chimeric antigen receptor T cell therapy, in relapsed/refractory multiple myeloma [abstract]. Blood. 2020;136(suppl 1). Abstract 177.

12Ghorashian S, Kramer AM, Onuoha S, et al. Enhanced CAR T cell expansion and prolonged persistence in pediatric subjects with ALL treated with a low-affinity CD19 CAR. Nat Med. 2019;25(9):1408-1414.

13. Mailankody S, Jakubowiak AJ, Htut M, et alOrvacabtagene autoleucel (orva-cel), a B-cell maturation antigen (BCMA)-directed CAR T cell therapy for subjects (pts) with relapsed/ refractory multiple myeloma (RRMM): update of the phase 1/2 EVOLVE study (NCT03430011) [abstract]. J Clin Oncol. 2020; 38(suppl 15). Abstract 8504.

SOURCE Innovent Biologics, Inc.

http://www.innoventbio.com

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Clinical Trial Results of the BCMA CAR-T Co-developed by Innovent and IASO Biotherapeutics Commented in American Society of Hematology's Medical...

Medical Research and the COVID Effect – Avera Health

Posted: at 1:51 am


Worldwide, as cases and deaths escalated, it was a race for a cure or at least an effective treatment for COVID-19.

Closer to home, Avera researchers were on the lookout for opportunities to participate in clinical trials that could offer patients options and ultimately, hope.

This journey started with giving convalescent plasma to patients diagnosed with COVID-19. Individuals who recovered from COVID-19 were asked to donate plasma and these antibodies were transferred to hospitalized patients in the hopes this would help convey additional protections. This treatment seemed to help some patients, but the data was unclear as to how well it worked. As physicians and scientists continued to learn more about the virus, numerous other experimental therapeutic options became available.

One experimental therapeutic option is the Regeneron monoclonal antibody cocktail, known as REGEN-COV. This is a cocktail of two lab-developed synthetic antibodies that specifically target and neutralize the virus by attaching to the spike protein of COVID thus preventing the spikes from latching onto healthy cells.

As COVID cases began appearing in the region, Avera research experts began working with their contacts to find opportunities. Our physicians learned all that was available about the virus and reviewed many clinical trial protocols trying to target the ones with the most promise, said Amy Elliott, PhD, Chief Clinical Research Officer of Avera Research Institute. Regeneron emerged as being highly recommended. Avera underwent a competitive process and was selected by Regeneron for these studies due to its integrated hospital structure and strong background in clinical research, Elliott added.

In August, Avera started by enrolling patients in three Regeneron studies for hospitalized COVID patients, non-hospitalized COVID patients, and people who were exposed to COVID-19. Enrolling patients were made aware that they would either receive the study drug or a placebo.

Enrollment in these trials went exceptionally well and we were considered by Regeneron to be a high enrolling site, Elliott said.

Regeneron went on to receive emergency use authorization (EUA) in November at the height of the COVID surge in the Midwest. Patients could receive Regeneron only if they met certain criteria, so the ongoing clinical studies continued to give people options.

Bamlanivimab, another monoclonal antibody treatment, also received EUA in November.

At Avera, an analysis of patients from mid-November of 2020 to January 2021 followed 356 patients who received monoclonal antibody treatment. A 4.5% hospitalization rate was noted compared to a projection of 9-11% for this group of patients.

Regeneron recently announced results that indicate that the cocktail is effective in preventing the onset of symptoms and lessening the severity of symptoms in someone who tests positive for COVID.

Avera McKennan Hospital & University Health Center was also a clinical collaborator with Totient and Ginkgo Bioworks to identify antibodies against COVID-19 for further development.

And, early on, Avera treated hospitalized patients with the antiviral drug remdesivir which received EUA in May and FDA approval in October 2020. Avera participated in a clinical trial with Gilead to look at the efficacy of using remdesivir with patients not requiring hospitalization. This study recently ended patient recruitment with results coming.

Most often with research, it takes a long time to see effects reach a large patient population, Elliott said. It was very inspirational to know we played an important role in helping to bring Regeneron to EUA. Our physicians were ahead of the curve when it came to embracing that research, and they could see first-hand the impact it was making.

Even before the EUA was granted for Regeneron, it was motivating to caregivers to be able to offer their patients some hope through participating in the clinical studies, even though they knew that half the patients participating would receive a placebo, said Jyoti Angal, MPH, CIP, Director of Clinical Research at Avera Research Institute.

Clinical trials provided options to patients as physicians considered how to treat their disease based on the available science of the time. We were honored to take part in the Regeneron study and help bring that drug to our region earlier than anyone else did, Elliott said.

COVID has had its effect on how we work, play, travel and relate to other people. Its also had its effect on research.

One of the things the pandemic caused us to do was to look at non-traditional data collection methods. Researchers will continue to be motivated to reach out to people who cant come to us, Angal said.

People from many aspects of the organization came together to allow Avera to set up its research clinic very quickly. COVID also intensified physician interest in research and provided learning opportunities for medical residents from the University of South Dakota COVID research not only brought about effective treatments for the virus research brought about vaccines, all of which are having a worldwide impact for the greater good. Because of that, theres increasing interest for people going into the field of medical research, Angal said.

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Medical Research and the COVID Effect - Avera Health

Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease -…

Posted: at 1:51 am


Protalix will host a conference call today, June 2, 2021, at 8:30 am Eastern Daylight Time, to review regulatory matters related to the development of PRX-102. To participate in the conference call, please dial the following numbers prior to the start of the call:

Conference Call Details:

Wednesday, June2, 2021, 8:30am Eastern Daylight Time (EDT)Domestic:1-877-423-9813International: 1-201-689-8573Conference ID: 13720271

The conference call will also be webcast livefrom the Protalix website and will be available via the following links:

Webcast Details:

Company Link: https://protalixbiotherapeutics.gcs-web.com/events0 Webcast Link: https://tinyurl.com/42857k4w Conference ID: 13720271

Please access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software.

PRX-102Development Program Update

PRX102 is currently being studied in the pivotal PhaseIII BALANCE clinical trial and in two ongoing long-term extension studies, all of which are part of the overall clinical development of PRX102 for the proposed treatment of Fabry disease. The BALANCE study is a 24month, randomized, double-blind, active control study of PRX102 in Fabry patients with impaired renal function and is designed to evaluate the safety and efficacy of 1mg/kg of PRX102 dosed every two weeks compared to agalsidase beta (Fabrazyme). The study enrolled 78 patients who were randomized on a 2:1 scheme. The BALANCE study is ongoing and assignment to treatment arm remains blinded.

The primary endpoint of the interim analysis is the comparison of mean annualized changes (slope) of the eGFR (CKD-EPI) after completion of at least 12 months of treatment between the two treatment arms. The interim efficacy analysis was conducted on two pre-defined analysis sets: Intention to Treat (ITT), consisting of all randomized patients who received at least one dose (77patients), considered as the primary analysis for this interim review; and the Per Protocol (PP), consisting of all patients who completed at least 12 months of treatment with no major protocol violations (74 patients). The patient population (ITT analysis set) of the study is comprised of 47 males (61%) and 30 females (39%) with a mean age of 44.3 years.

The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments was below the non-inferiority margin pre-specified for this interim analysis in the ITT analysis set and above such limit in the PP analysis set. At the time of this analysis, two patients discontinued participation due to treatment emergent adverse events (TEAEs). Of these two patients, one discontinued participation due to a related adverse event. No deaths were registered. Overall, safety data appears favorable and consistent with what was observed in previous clinical studies with PRX-102. Unblinded final data is anticipated to be released in the second quarter of 2022 after all remaining patients have completed the 24-month treatment period.

Based on the interim analysis of the 12-month data generated from the BALANCE study, and in combination with previously reported positive data from the PhaseIII BRIGHT and BRIDGE clinical trials of PRX102, Protalix and Chiesi intend to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the review of PRX102 for the proposed treatment of Fabry disease.

"We look forward to submission of the MAA to EMA for the European Union and to continuing to work with the FDA toward approval in the United States," said Dror Bashan, Protalix's President and Chief Executive Officer. "These regulatory milestones are currently our primary focus."

"The BALANCE study continues as planned through its 24-month treatment duration to support its final analysis. Based on the entire clinical development program, which includes the BRIGHT and BRIDGE studies, we believe that PRX102 has the potential to become an important treatment option for both male and female Fabry patients. The BRIGHT and BRIDGE studies have been completed and the studies met the defined endpoints," continued Mr. Bashan.

In addition to the BALANCE study, the PRX-102 clinical program currently includes extension studies for patients who completed the BRIDGE, BRIGHT and BALANCE studies, as well as a PhaseI/II clinical trial of PRX102. Currently, more than 100 patients who participated in such studies continue to be treated in the extension studies, and additional patients completing the BALANCE study are expected to join the extension studies.

"We thank the patients and clinicians participating in our completed and ongoing clinical studies evaluating PRX-102. As we plan for MAA submission in the EU, we remain committed to advancing our development program for PRX-102 in the United States while also making access to therapy available to eligible patients through our U.S. expanded access program," said Giacomo Chiesi, head of Chiesi Global Rare Diseases.

Regarding the regulatory process in the United States, Protalix and Chiesi plan to submit a TypeA meeting request with the FDA to discuss the path for approval of PRX102.

About Pegunigalsidase Alfa (PRX102)

Pegunigalsidase alfa (PRX102) is an investigational, plant cell culture-expressed, and chemically modified stabilized version of the recombinant a-Galactosidase-A enzyme. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. In clinical studies, PRX102 has been observed to have a circulatory half-life of approximately 80 hours. Protalix designed PRX102 to potentially address the continued unmet clinical need in Fabry patients.

About Protalix BioTherapeutics, Inc.

Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. Protalix was the first company to gain U.S.Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. Protalix's unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner.

Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved by the FDA in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.

Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: pegunigalsidase alfa, a modified stabilized version of the recombinant human a-GalactosidaseA protein for the treatment of Fabry disease; alidornase alfa or PRX110, for the treatment of various human respiratory diseases or conditions; PRX115, a plant cell-expressed recombinant PEGylated uricase for the treatment of refractory gout; PRX119, a plant cell-expressed long action DNase I for the treatment of NETs-related diseases; and others. Protalix has partnered with Chiesi Farmaceutici S.p.A., both in the United States and outside the United States, for the development and commercialization of pegunigalsidase alfa, and with SarcoMed USA, Inc. for the worldwide development and commercialization of PRX110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery.

About Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused on research and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works in collaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative new treatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit is also a dedicated partner with global leaders in patient advocacy, research and patient care. For more information visit http://www.chiesiglobalrarediseases.com.

About Chiesi Group

Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, and markets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, and Sweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people.

Chiesi Group is a certified Benefit corporation. For more information, please visit http://www.chiesi.com.

Protalix BioTherapeutics Forward-Looking Statements Disclaimer

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. The terms "expect," "anticipate," "believe," "estimate," "project," "may," "plan," "will," "would," "should" and "intend," and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the timing and progress of the preparation of an updated BLA addressing the complete response letter; risks related to the timing, progress and likelihood of final approval by the FDA of a resubmitted BLA for PRX102 and, if approved, whether the use of PRX102 will be commercially successful; failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and inability to monitor patients adequately during or after treatment; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities, and other risks relating to the review process; risks associated with the novel coronavirus disease, or COVID19, outbreak, which may adversely impact our business, preclinical studies and clinical trials; risks related to any transactions we may effect in the public or private equity markets to raise capital to finance future research and development activities, general and administrative expenses and working capital; the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy, or that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to our ability to maintain and manage our relationship with our collaborators, distributors or partners; risks related to the amount and sufficiency of our cash and cash equivalents; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S.Securities and Exchange Commission. The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.

Protalix BioTherapeutics Investor Contact

Chuck Padala, Managing DirectorLifeSci Advisors+1-646-627-8390[emailprotected]

Chiesi Global Rare Diseases Media Contact

Jenna UrbanBerry & Company Public Relations +1-212-253-8881[emailprotected]

SOURCE Protalix BioTherapeutics, Inc. and Chiesi

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Protalix Biotherapeutics and Chiesi Global Rare Diseases Provide Update Regarding Clinical Development of PRX-102 for Treatment of Fabry Disease -...

Adaptive Phage Therapeutics Initiates Phase 1/2 Trial of PhageBank in Urinary Tract Infections – Business Wire

Posted: at 1:51 am


GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the first patient has been dosed in a Phase 1/2 study of bacteriophage therapy (PhageBank) to evaluate the safety, tolerability, and efficacy of targeted, personalized, bacteriophage (phage) treatments in patients with urinary tract infection (UTI).

This multi-center clinical trial represents the first study of an expanding phage library for intravenous administration and/or bladder instillation of phage therapy. PhageBank is APTs continually expanding phage library that functions as an integrated logistics platform to dispense phage on demand. The phage distributed are selected via a PhageBank Susceptibility Test (PST) that is being advanced and commercialized by APT in collaboration with Mayo Clinic Laboratories. The PST enables rapid, automated identification of individual phage to be included in patient-specific therapy to treat bacterial infections.

Im delighted to announce the initiation of APTs first PhageBank clinical trial, which is being funded in part by the U.S. Department of Defense through an advanced development contract intended to accelerate clinical progression of PhageBank therapy to more effectively treat multidrug-resistant infections, said Greg Merril, CEO and co-founder, Adaptive Phage Therapeutics. This Phase 1/2 UTI trial is the first of several initial indications in which APT plans to study PhageBank, following the success achieved in PhageBank treatment of more than 40 emergency INDs for individual patients. APT recently received IND clearance for PhageBank treatment of prosthetic joint infection (PJI) and diabetic foot osteomyelitis (DFO), and plans to initiate clinical studies for these two indications. Initial data readouts in PJI and DFO are expected in 2022.

The UTI Phase 1/2 study, evaluating the safety and efficacy of bacteriophage therapy, is being conducted at the James J. Peters VA Medical Center in Bronx, New York, as well as multiple other U.S. clinical study sites, and is supported in part by the U.S. Department of Defense (DoD) under a $14.2 million advanced development contract.

This interventional, randomized, placebo-controlled, open label study is designed to enroll approximately 156 patients. Patients enrolled have urinary tract infections due to either E. coli or K. pneumoniae. The trial will use pre-specified criteria to determine phage regimens for evaluation. Results from an initial cohort will be used to confirm or modify the phage dosing regimen and route, before progressing to patients with symptomatic infection at a higher risk of recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection. Clinical results from this trial are expected to lead to regulatory approval to advance directly into pivotal trials for chronic and recurrent urinary tract infections.

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been fixed, while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.

APTs PhageBank approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.

APTs technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

For more information, visit http://www.aphage.com.

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Adaptive Phage Therapeutics Initiates Phase 1/2 Trial of PhageBank in Urinary Tract Infections - Business Wire

Helping families deal with another pandemic: Alzheimer’s disease – Morning Journal News

Posted: at 1:50 am


By CATHY BROWNFIELD

Family Recovery Center publicist

Mr. Bidens recent remarks about Alzheimers has gained public attention. Conspiracy theorists have jumped on it. But the concept is not a new one. The need for answers was as great 20, 30 years ago or longer. We know more now, but there is still so much that we dont know.

Mom has been gone for nearly 10 years. It is when you are looking back that you see the red flags and question how you could have missed them. The answer: The signs are subtle. And you dont realize you should be looking for them.

My mother said she came out of work and found her car. But her surroundings did not look familiar to her. She wasnt sure how to get home from that parking lot.

So, how did you find your way home? I asked.

I followed all the other cars until I got where I recognized things, she answered.

Dad called me on the phone. Your mother went to Alliance by herself. Im worried she might get lost.

My mother knew her way around. She was the navigator when our family traveled in the truck and camper, the map reader. Shed gotten us well into Canadas Algonquin Park and back again. She had gotten us to so many destinations and back home again. How could she get lost between home and Salem or Alliance or anywhere else in Columbiana County?

The Alzheimers Association reports that more than 6 million Americans age 65 and older are living with Alzheimers right now. The disease kills more people than breast cancer and prostate cancer combined. In fact, deaths from other chronic conditions like heart disease, diabetes and kidney disease, have declined while the number of deaths attributed to Alzheimers has increased 145 percent! One in three seniors dies with Alzheimers or other dementias.

People with Alzheimers or other dementias have twice as any hospital stays as other older people. They have more skilled nursing facility stays and home health care visits per year than other people and are more likely to receive adult day care services and nursing home care, says Alzheimers Association.

Ohio statistics show that the number of people with Alzheimers in the state for 2020 is 220,000. By 2025 it is expected to be 250,000. There are 442,000 caregivers providing 590,000,000 hours of unpaid care.

The Alzheimers Association says that, On average, people age 65 and older survive four to eight years after diagnosis yet some live as long as 20 years with Alzheimers

One in three caregivers is age 65 or older. Most are women, specifically daughters. Many of them are the sandwich generation, caring for elderly parents and children under age 18. There are many challenges for caregivers.

Black Americans are twice as likely to have Alzheimers as older White Americans, but more than half believe that future care will not be equally shared. Older Hispanics are one and a half times as likely as White Americans to have dementia, but many of them do not believe they will live long enough to develop dementia.

The disease is an emotional wrecking ball, awful for the person who has it, but perhaps worse for those who provide the care for them and watch the decline of their loved one. You learn to lie to them, I was once advised. I couldnt lie to my mother, but I did learn ways to word things that she accepted easily. (Well, I am a wordsmith.) The disease is difficult for families to navigate. When you add in trauma from other family issues, it becomes easy to be overwhelmed. You will get to the other side of things eventually, but in the meantime the struggle is real. And there are people who can help you find ways to cope.

Family Recovery Center helps families to find ways to navigate through the challenges we face. For more information about the agencys treatment and education programs, contact FRC at 964 N. Market St., Lisbon; phone, 330-424-1468, or email, info@familyrecovery.org. FRC is funded in part by the Columbiana County Mental Health and Recovery Services Board.

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Helping families deal with another pandemic: Alzheimer's disease - Morning Journal News

Mouse study suggests that repairing brain protein production could counteract Alzheimer’s disease – National Institute on Aging

Posted: at 1:50 am


Restoring protein production in the brain could help treat Alzheimers disease, according to a recent study using mouse models. In the study, researchers showed that a substance that jump-starts protein synthesis helped mice with cognitive problems do better on memory-associated behavior tests. The study was led by researchers at the Federal University of Rio de Janeiro and New York University and was published in Science Signaling on Feb. 2.

The brain converts short-term memories into long-term memories through molecular changes in the nervous system. Protein production in a region of the brain called the hippocampus is a critical part of this process. A group of proteins called the eukaryotic initiation factor 2 (eIF2) complex helps guide protein production in cells. However, when the cell encounters stress, it reduces protein production by adding a small chemical group called a phosphate onto eIF2.

Studies from multiple research groups suggest that the mechanism that controls the addition of a phosphate onto eIF2 goes awry in Alzheimers and other diseases. In this recent study, funded in part by NIA, researchers found that compared with controls, brain tissue from deceased people who had Alzheimers disease had higher levels of phosphate-modified eIF2, which reduces protein production. The researchers tested whether a substance called ISRIB (integrated stress response inhibitor), which is known to restore protein production after cellular stress, would increase protein production and help improve memory in mice that had symptoms similar to Alzheimers disease.

The researchers tested the effectiveness of ISRIB in three mouse models of Alzheimers disease: mice that were injected with a molecule that impairs long-term memory, mice that were given beta-amyloid oligomers (memory-impairing protein toxins that build up in the brains of people with Alzheimers disease), and mice that were genetically engineered to have hallmarks of Alzheimers disease. The researchers tested the memory of these mice by using behavior tests. In all three models, mice that received daily ISRIB injections over several days performed better on the memory tests and had higher levels of protein production in the brain than they had prior to the injections. A control group of mice had no noticeable effects from the treatment, suggesting that ISRIB could repair protein production when needed but not have an effect when conditions in the brain are normal.

The researchers note that two previous studies suggested that ISRIB had no benefits against the symptoms of Alzheimers in mouse models. However, the prior studies used a single, high dose of the drug. The new study used lower doses of ISRIB daily for several days, which might have helped improve its effectiveness. Future studies to explore the details of how ISRIB works to improve memory could help researchers develop drugs that restore protein synthesis in the brain as effective treatment options for Alzheimers disease.

This research was supported in part by NIA grants AG04469, AG055581, and AG056622.

These activities relate to NIHs AD+ADRD Research Implementation Milestone 6.C, Identify, characterize, and complete early validation for at least 6 novel therapeutic targets for AD and AD-related dementias.

Reference: Oliveira MM, et al. Correction of eIF2-dependent defects in brain protein synthesis, synaptic plasticity, and memory in mouse models of Alzheimers disease. Science Signaling. 2021;14:eabc5429. doi: 10.1126/scisignal.abc5429.

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Mouse study suggests that repairing brain protein production could counteract Alzheimer's disease - National Institute on Aging

Alzheimer’s Disease Pipeline Report: Current Therapies, Emerging Drugs, and Treatment Outlook – GlobeNewswire

Posted: at 1:50 am


Los Angeles, USA, May 31, 2021 (GLOBE NEWSWIRE) -- Alzheimers Disease Pipeline Report: Current Therapies, Emerging Drugs, and Treatment Outlook

Alzheimers Disease pipeline shows progress in the clinical trials with the upcoming therapies such as BAN2401, Gantenerumab, Bryostatin-1, INB03, AZT-211, and others.

DelveInsights Alzheimer's Disease Pipeline Insight report provides comprehensive insights about 150+ companies and 150+ pipeline drugs in the Alzheimer's Disease pipeline landscapes. It comprises Alzheimer's Disease pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Alzheimer's Disease therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Alzheimer's Disease pipeline products.

Some of the key takeaways of the Alzheimer's Disease Pipeline Report

Get an overview of pipeline landscape @ Alzheimer's Disease Clinical Trials Analysis

Alzheimer's Disease is a progressive neurologic disorder, which causes the brain to shrink and brain cells to die. The disease is the most common cause of dementia that affects a person's ability to function independently.

Alzheimer's Disease Emerging Drugs

NE3107 is a small molecule, orally-administered, anti-inflammatory, insulin-sensitizing agent with a novel mechanism of action targeting multiple mechanisms of pathology in Alzheimer's disease. It is currently in the phase III stage of development.

BAN2401 is the humanised IgG1 version of the mouse monoclonal antibody mAb158, which selectively binds to large, soluble A protofibrils. BAN2401 selectively binds to neutralise and remove toxic A protofibrils that are considered to be a causative factor for Alzheimers Disease. Eisai secured the global rights to study, develop, manufacture and market BAN2401 for Alzheimer's Disease treatment.

Gantenerumab is an investigational therapy designed to bind more specifically to aggregated forms of beta-amyloid and eliminate beta-amyloid plaques. Gantenerumab was formerly developed by Chugai Pharmaceuticals, which is currently part of Hoffmann-La Roche. This treatment is administered as an injection under the skin, and is currently being developed by Hoffmann-La Roche in collaboration with MorphoSys.

AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. AXS-05 is currently being developed for the treatment of Major Depressive Disorder (MDD), Alzheimers Disease agitation, and Smoking Cessation. The drug is in Phase III clinical studies for the treatment of Alzheimer Disease. Axsome Therapeutics have received breakthrough therapy designation for AXS-05 from the FDA for both Major Depressive Disorder and Alzheimers Disease agitation.

Anavex2-73 is an investigational oral therapy that activates the sigma-1 receptor (SIGMAR1). Anavex2-73 targets protein misfolding and oxidative stress by binding to a protein called sigma-1. Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. The drug is in Phase III clinical studies for the treatment of Alzheimer Disease.

For further information, refer to the detailed report @ Alzheimer's Disease Pipeline Therapeutics

Scope of Alzheimer's Disease Pipeline Drug Insight

Key Questions regarding Current Alzheimer's Disease Treatment Landscape and Emerging Therapies Answered in the Pipeline Report

Table of Contents

Get a customised pipeline report @ Alzheimer's Disease Drugs Pipeline Report

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About DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

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Alzheimer's Disease Pipeline Report: Current Therapies, Emerging Drugs, and Treatment Outlook - GlobeNewswire

Hoag to Participate in Groundbreaking Study Aiming to Help Prevent Memory Loss Due to Alzheimer’s Disease – PRNewswire

Posted: at 1:50 am


NEWPORT BEACH, Calif., June 3, 2021 /PRNewswire/ -- Hoag's Pickup Family Neurosciences Institutehas started recruiting volunteers for a study testing an investigational treatment that aims to help prevent the earliest stages of memory loss due to Alzheimer's disease.

Funded by the National Institutes of Health (NIH) and Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo), the AHEAD Study is the first Alzheimer's disease research study to recruit people as young as 55 years old who are at risk of developing symptoms of Alzheimer's disease as they get older. It introduces apersonalized approach that will tailor treatment dosing levels to a participant's particular risk of memory loss related to Alzheimer's disease.

The AHEAD Study consists of two different clinical trials testing the same investigational treatment (known as BAN2401 (lecanemab)). Participants are enrolled in one of the two trials based on the level of amyloid in their brain. Amyloid is a protein that builds up in people who can go on to have memory problems and develop Alzheimer's disease.

"The tailored approach of this study, starting treatment years before memory loss has begun, has the potential to be a breakthrough step in our aim to prevent Alzheimer's disease," said William R. Shankle, M.S., M.D., F.A.C.P., program director of Memory & Cognitive Disorders at Hoag and The Judy and Richard Voltmer Chair in Memory and Cognitive Disorders at the Pickup Family Neurosciences Institute, who is serving as the principal investigator of the study at Hoag. "It can potentially serve as a model to improve future clinical trials in Alzheimer's research and other diseases."

The AHEAD Study will be conducted in the US, Japan, Canada, Australia, Singapore, and Europe. Hoag was selected to participate in the parallel, 216-week study in part because of its renowned Orange County Vital Brain Aging Programand our track record of successfully conducting complex clinical studies.

"Hoag's Pickup Family Neurosciences Institute has pioneered a comprehensive program to maintain cognitive health as we age, and to combat the community's fear of Alzheimer's disease and related disorders, through the Orange County Vital Brain Program," said Michael Brant-Zawadzki, M.D.,F.A.C.R., Hoag's senior physician executive and the Ron & Sandi Simon Executive Medical Director Endowed Chair of the Pickup Family Neurosciences Institute. "As a result, we are able to offer our community unique opportunities to participate in studies like the AHEAD Study. This is well-aligned with the mission of our Institute, and we are very excited to be a part of this pioneering effort to help identify ways to prevent Alzheimer's disease."

People may be eligible to enroll in the trial if they are between the ages of 55 and 80 and meet certain eligibility criteria. For more information on the study and the study participation, please email [emailprotected].

Research reported in this press release was supported by the NIH's National Institute on Aging under award numbers R01AG054029 and R01AG061848. The AHEAD Study (Clinical Trial number NCT04468659) received funding from NIH and from nongovernmental sources. The content is solely the responsibility of the researchers and does not necessarily represent the official views of the National Institutes of Health.

ABOUT PICKUP FAMILY NEUROSCIENCES INSTITUTECompassionate Care, Clinical Excellence, Creative IntelligenceHoag and the Pickup Family Neurosciences Institute were ranked by U.S. News & World Report as the No. 1 hospital in Orange County and No. 27 nationally in Neurology & Neurosurgery, placing it in the top 1% of neuro-specialist programs across the U.S., and the only one in the top 30 without a formal university residency curriculum. Delivering a personalized, integrated approach using best-practice guidelines, the most advanced technology, and integration of medical specialists in the most appropriate facilities, thePickup Family Neurosciences Institute (PFNI) at Hoagprovides world class care for patients with specific conditions of the brain and spine such as stroke, aneurysms and vascular malformations, brain tumors, epilepsy, movement disorders, memory and cognitive disorders, pain, minimally invasive spine surgery, multiple sclerosis, addiction medicine and sleep disorders, as well as the mind-body interface of mental health. Many of Hoag's PFNI programs have received high acclaim.The Hoag Stroke Program was the first in Orange County and the second in California to be named a Certified Comprehensive Stroke Center by DNV GL Healthcare and was awarded the American Stroke Association's Get With The Guidelines Stroke Gold Plus Performance Achievement for stroke care. And as one of the first centers in the U.S. to offer the most advanced radiosurgical treatment system available, Leksell Gamma Knife Perfexion, the PFNI brain tumor program is the largest in Orange County and is also among the top volume programs in the western United States. Hoag has been recognized as a designated Level 4 Comprehensive Epilepsy Center by the National Association of Epilepsy Centers. The PFNI's memory and cognitive disorders program is nationally recognized.

ABOUT HOAGHoag is a nonprofit, regional health care delivery network in Orange County, California, that treats more than 30,000 inpatients and 480,000 outpatients annually. Hoag consists of two acute-care hospitals Hoag Hospital Newport Beach, which opened in 1952, and Hoag Hospital Irvine, which opened in 2010 in addition to nine health centers and 13 urgent care centers. Hoag has invested $261 million in programs and services to support the underserved community within the past five years, including areas like mental health, homelessness, transportation for seniors, education, and support for single mothers. Hoag is a designated Magnethospital by the American Nurses Credentialing Center (ANCC). Hoag offers a comprehensive blend of health care services that includes five institutes providing specialized services in the following areas:cancer,heart and vascular,neurosciences,women's health, and orthopedics through Hoag's affiliate,Hoag Orthopedic Institute,which consists of an orthopedic hospital and two ambulatory surgical centers. In the 2020 - 2021U.S. News & World Report Best Hospitals Rankings, Hoag is the highest ranked hospital in Orange County and the only OC hospital ranked in the Top 10 in California. For an unprecedented 23 years, residents of Orange County have chosen Hoag as one of the county's best hospitals in a local newspaper survey. Visitwww.hoag.orgfor more information.

SOURCE Hoag Memorial Hospital Presbyterian

https://www.hoag.org

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Hoag to Participate in Groundbreaking Study Aiming to Help Prevent Memory Loss Due to Alzheimer's Disease - PRNewswire

The Startling New Side Effect of High Blood Pressure, Says Study | Eat This Not That – Eat This, Not That

Posted: at 1:49 am


According to the American Heart Association, nearly half of Americans have high blood pressure. When left untreated, an elevated blood pressure can damage your circulatory system, and can be a significant contributing factor to heart attack, stroke and other health threats. However, one new study from researchers at Uppsala University, now published in the journal Hypertension, has linked the health condition to a startling side effect. Read onand to ensure your health and the health of others, don't miss these 19 Ways You're Ruining Your Body, Say Health Experts.

It is normal for blood pressure to vary throughout the day, with lower readings at night, known as "dipping." According to the latest study, which involved observational data from 1,000 Swedish men followed for up to 24 years, older men who suffer from higher blood pressure at night than in daytimesomething researchers refer to as "reverse dipping"may be at a higher risk for Alzheimer's disease.

"The night is a critical period for brain health. For example, in animals, it has previously been shown that the brain clears out waste products during sleep, and that this clearance is compromised by abnormal blood pressure patterns. Since the night also represents a critical time window for human brain health, we examined whether too high blood pressure at night, as seen in reverse dipping, is associated with a higher dementia risk in older men," Christian Benedict, Associate Professor at Uppsala University's Department of Neuroscience, and senior author of the study, explained in a press release accompanying the study.

"The risk of getting a dementia diagnosis was 1.64 times higher among men with reverse dipping compared to those with normal dipping. Reverse dipping mainly increased the risk of Alzheimer's disease, the most common form of dementia," Xiao Tan, postdoctoral fellow from the same department and first author of this research, added.

RELATED: The Surprising Reason Why You Could Get a Stroke

Researchers did point out that their study group was only older men, in their early seventies at the start of the study. "Our cohort consisted only of older men. Thus, our results need to be replicated in older women," concluded Benedict.

The next step? Researchers hope to investigate whether taking blood pressure lowering drugs at night would lower the risk of developing Alzheimer's disease. In the meantime, since COVID-19 can endanger your heart, wear a face mask, social distance, avoid large crowds, don't go indoors with people you're not sheltering with (especially in bars), practice good hand hygiene, get vaccinated when it becomes available to you, and to get through life at your healthiest, Don't Take This Supplement, Which Can Raise Your Cancer Risk.

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The Startling New Side Effect of High Blood Pressure, Says Study | Eat This Not That - Eat This, Not That

Betcha Haven’t Heard These: A Biochemist’s 3 Surprising Tips For Longevity – mindbodygreen.com

Posted: at 1:48 am


According to Wolf, maintaining muscle mass is the No. 1 thing you can do to optimize longevity. "There's this guarantee of losing muscle mass, losing the ability for maximum power production, as we age that begins in our 30s," he explains. (Specifically, you lose 3 to 8% of muscle mass per decade after you turn 30, and at an even higher rate after 60.) It's a process called sarcopenia, or age-related muscle mass loss, that happens as you age; between the ages of 20 and 80, research has found you can actually lose 40% of your muscle mass.

The key, says Wolf, is to delay sarcopenia as long as you can: "If you want to avoid a rest home, if you want to avoid neurodegenerative disease... All of that plays favorably to maintaining adequate muscle mass into aging," he says.

In terms of how to maintain muscle mass, Wolf is quick to sing the praises of strength training. "That's where the real return on investment lies with the longevity-healthspan story," he explains. While any physical activity will do, says Wolf, he especially loves workouts with basic strength training mechanics (read: pressing, pulling, squatting, hinging, lunging, etc.)just make sure you switch it up from time to time.

"Your body gets super efficient at the things that you do," Wolf explains. "The real key in this [longevity] story is a novel load, a novel experiencesomething you haven't really done before or is achieved in a different way. And a very minimal dose can go a long way."

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Betcha Haven't Heard These: A Biochemist's 3 Surprising Tips For Longevity - mindbodygreen.com

The 2 fruits and 3 vegetables per day diet for longevity: Harvard study shows the way – Times Now

Posted: at 1:48 am


The fruits and vegetables path to longevity  |  Photo Credit: iStock Images

So, heres the formula that we had been searching for high and low. Eating the right mix of fruits and vegetables can help us live longer, according to a new study.

Released by the American Health Association in March 2021 and conducted by researchers at Harvard TH Chan School of Public Health, the new study found that eating two servings of fruit and three servings of vegetables is associated with lower mortality rates.

Eating more than that was not associated with additional benefits, the study said.CNBC quotes the lead study author Dong D. Wang, M.D., Sc.D., an epidemiologist, nutritionist and a member of the medical faculty at Harvard Medical School and Brigham and Womens Hospital in Boston, who says that This amount likely offers the most benefit in terms of prevention of major chronic disease and is a relatively achievable intake for the general public.

So, does that mean we can eat any and every fruit and vegetable, and expect the 5-a-day combo to enhance our longevity? Not all fruits and vegetables were considered equal, alerts Dr Wang.

Vegetables and fruits that showed benefits:

Not recommended for 5-a-day regimen:

How the study was conducted:

What ifone eats more servings of fruits or veggies?Eating more than five servings per day of fruits and vegetables was not linked with additional health benefits, the researchers found.

The nutty way to longevity:According to a report in the Boston Globe, nuts may help us live longer, healthier lives. New research shows that people who eat a daily handful of nuts have improved longevity, lower risk for chronic illnesses like heart disease, and are generally leaner than those who do not eat nuts.

The report says that this research in 2013, by the Harvard School of Public Health, Brigham and Women's Hospital, and the Dana-Farber Cancer Institute suggests consuming nuts regularly promotes health.

Critics say partial funding by a nut research group raises credibility questions.Walter Willett, professor of epidemiology and nutrition, chair of the department of nutrition at Harvard's School of Public Health, was one of the study's authors.

The nutritional profile of nuts, which includes unsaturated fats, antioxidants, protein, fibre, vitamins, minerals, and phytosterols, maybe what's responsible for the protective effects. Professor Willett says, "Like most good things it's a package."

Researchers saw similar results for both peanuts (which are legumes), and tree nuts such as almonds, cashews, and pecans. The family of tree nuts also includes Brazil nuts, hazelnuts, macadamia nuts, pine nuts, pistachios, walnuts, and others.

Professor Willett cautions against eating too many nuts, though. He suggests using them to replace cheese or meat on salads, tossing some into your yogurt, and mixing them with legumes for protein-rich vegetarian dishes.

Mediterranean diet linked to longer life:The Mediterranean diet, already considered one of the healthiest diets because of its link to reduced risk of heart disease, cancer, and other chronic diseases, has a new feather in its cap. A study by Harvard School of Public Health (HSPH) and the Harvard-affiliated Brigham and Womens Hospital (BWH) researchers found women who regularly consumed this diet rich in olive oil, nuts, beans, fish, fruits, vegetables, and wine in moderation may live longer. The study was published on December 2, 2014, online in The BMJ (British Medical Journal).The researchers studied nutritional data from 4,676 women participating in the Nurses Health Study. They found that those who ate mostly a Mediterranean diet had longer telomeres, a biomarker linked to longevity.

Disclaimer: Tips and suggestions mentioned in the article are for general information purposes only and should not be construed as professional medical advice. Always consult your doctor or a professional healthcare provider if you have any specific questions about any medical matter.

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The 2 fruits and 3 vegetables per day diet for longevity: Harvard study shows the way - Times Now

Longevity and Anti-Senescence Therapy Market Study (2021): Industry trends, Evaluation of Market status, Projected growth by 2027 The Manomet Current…

Posted: at 1:48 am


The recent study of the Global Longevity and Anti-Senescence Therapy Market provides the market size information and market trends along with the factors and parameters affecting it in both the short and long term. The report researches into the Longevity and Anti-Senescence Therapy market to evaluate its current and future potential. The report on Longevity and Anti-Senescence Therapy Market also offers the market players along with the new entrants a complete view of the market landscape. This market report is an analytical consideration of the key challenges that may disembark in the market in terms of sales, revenue, export, or import.

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Longevity and Anti-Senescence Therapy Market Competitive Landscape

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The Cognitive Clock Is a New Tool Scientists Use To Measure Brain Longevity – Well+Good

Posted: at 1:48 am


Theres a new tool in town thats supposed to help measure longevity, cognition, and the risk of long-term memory problems. (And no, its not just brain games.) The cognitive clock was developed by researchers at Rush University Medical Center in Chicago to assess brain health based on current cognitive performance in hopes of identifying individuals who might be at risk for Alzheimers and cognitive decline.

Alzheimers disease, which is of the most common cause of dementia, and other diseases of the brain accumulate slowly over time as people get older, said Patricia Boyle, PhD, professor at Rush Medical College and lead author of the study, in an original report by SciTechDaily. Age is widely recognized as the main risk factor for Alzheimers disease, but its a very imperfect predictor, since not everyone develops dementia as they age.

The theory behind the cognitive clock is fairly simple: Brain age might not match actual, chronological age. Brain function typically changes the older we get. But if theres a significant gap in brain age and our chronological age, this might be a red-flag for issues down the line.

Our new cognitive clock provides a measure of brain health that tells us more about how well a persons brain is functioning than chronological age. In this way, the clock can help us detect who is at highest risk of developing cognitive impairment in the coming years, Boyle said.

The teams results were published in the latest edition of The Journal of the Alzheimers Association.Using data from a population of 1,057 participants from previous cognitive impairment-related studies, results from a widely used mental cognition test, and other metrics from neurological evaluations, researchers were able to create a profile of cognitive aging, also known as the cognitive clock. From there, the team explored how core functions, like memory, attention, and language changed over time. Using this cognitive clock, researchers could estimate an individuals cognitive agetheir position on the clockat any given point in time.

We found that, on average, cognition remains stable until a cognitive age of around 80 years of age, then declines moderately until 90, then declines more rapidly until death, Boyle said. Further, we found that cognitive age is a much better predictor than chronological age of dementia, mild cognitive impairment and mortality. It also is more strongly associated with other aspects of brain health.

To test the clocks accuracy, the team applied the methodology to an independent sample of almost 2,600 participants to predict Alzheimers dementia, mild cognitive impairment, and mortality. Once again, they found cognitive age was a better predictor of these results than chronological age.

Essentially, what we did is use cognitive data collected over many years to create a single, easy-to-understand metric that may be used to predict health outcomes with good accuracy, Boyle said.

Fear not if youre worried that your brain might be aging faster than the rest of you. There are some science-backed ways to stay mentally sharp. Yoga can help jog your memory and improve your concentration. As can eating a brain-boosting meal thats loaded with healthy fats and antioxidants. Whatever you do, avoid falling into a mental rut, which can be the downfall of mental cognition. Instead, keep an open mind and cultivate curiosity whenever you can to keep your brain in tip-top shape.

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The Cognitive Clock Is a New Tool Scientists Use To Measure Brain Longevity - Well+Good

Why On-Chain Governance Is Critical for Blockchain Growth and Longevity Op-Ed Bitcoin News – Bitcoin News

Posted: at 1:48 am


The decentralized properties that make blockchain architecture unique can also be its Achilles heel, demonstrating the importance of bringing network governance on-chain to promote a more inclusive and democratized consensus on network upgrades.

There are many bitter arguments over blockchains, whether involving how they should be run, the consensus mechanisms, implementing changes, or upgrading the frameworks. These debates have often put network communities at odds, creating schisms that eventually unfolded in hard forks. Despite the success of these consensus systems as evidenced by rising transactions and valuations, Bitcoin and Ethereums future could be in doubt.

The term consensus has to do with everything enshrined in code for the two largest networks, like transfers of value, how much miners get paid, smart contract operations, and other basic network-coded functionality. Unfortunately, that means that network consensus is not a part of addressing any severe problems or implementing even the tiniest upgrades. This parallel governance process often occurs exclusively off-chain in a highly politicized manner.

For evidence to support this very point, just look at the aftermath of the Ethereum Classic debacle. Or consider the amount of time it has taken Ethereum to update its consensus mechanism from proof-of-work to proof-of-stake. Implementing any network upgrades in this manner is arduous, time-consuming, and not a function of on-chain consensus.

You can think of consensus as a parallel economic system whereby participants worldwide can operate under the same economic framework without any legal oversight or geographical constraints. Still, without any connection between governance and consensus, attempting any major upgrades can theoretically happen without the communitys consent or blessing.

Fortunately, other networks are capably demonstrating that on-chain governance is possible and also effective when adapting to a constantly changing digital environment.

When evaluating the scope of the problem through the lens of Ethereum, its Ethereum Classic hard fork was over a serious disagreement whether code is law or can be broken to protect the community. At present, both networks are compatible thanks to network upgrades mirrored in Ethereum Classic.

However, the disagreement effectively split the community down the middle because Ethereums original structure didnt provide an on-chain governance mechanism to facilitate this dialogue. Solidarity will be the key to longevity for blockchain, and the breakdown of such can cause unnecessary infighting and distractions.

Networks like Tezos and Polkadot have responded to these events with a much more community-oriented approach. The networks communities can vote on proposals and upgrades by employing an on-chain governance model instead of more centralized off-chain governance measures. Besides improving overall participation, it gives every stakeholder skin in the game.

The success of these measures is evident, with Tezos able to upgrade itself just as seamlessly as a computer or phone periodically installs software updates. In the last two years alone, Tezos has undergone multiple major upgrades, each of which has added value to the overall network while developing the infrastructure and setting the stage for future updates.

By comparison, it has taken Bitcoin four hard forks to simply implement minor changes. The more straightforward approach of on-chain governance makes other competing networks like Polkadot much more flexible and adaptive to changes that can unfold, not to mention improving overall blockchain democratization by decentralizing control over a networks future.

If blockchain truly endeavors to challenge the status quo, network governance should reflect that notion by upending the role of gatekeepers and shunning the politics that have divided communities. By combining consensus, governance, and the protocol in one package, these divisive hard fork events can be avoided outright, all while solidifying the outlook and securing the longevity of these systems.

The flexibility of on-chain governance by design means the ability to respond to external technology changes that other, more rigid architectures will find difficult to adopt. Although code may be law in the blockchain universe, its still comprised of a network of humans, and governance should absolutely be a mirror reflection of that reality.

Do you think the Bitcoin and Ethereum chains will follow the example of Tezos and Polkadot to expand on-chain governance? Let us know in the comments section below.

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Disclaimer: This article is for informational purposes only. It is not a direct offer or solicitation of an offer to buy or sell, or a recommendation or endorsement of any products, services, or companies. Bitcoin.com does not provide investment, tax, legal, or accounting advice. Neither the company nor the author is responsible, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any content, goods or services mentioned in this article.

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Why On-Chain Governance Is Critical for Blockchain Growth and Longevity Op-Ed Bitcoin News - Bitcoin News

The limits of life – The Indian Express

Posted: at 1:48 am


A curious side-effect of sentience is the awareness of death. Medicine, wellness, meditation, philosophy, neural transfers, even literature and the arts a great deal of human endeavour is tasked with either trying to prolong life, or deal with the reality of its end. It turns out that even the best efforts at least those that aim at corporeal immortality and longevity are bound to be futile.

According to a study published in the journal Nature Communications, the human body cannot survive beyond the age of 150 years, eating right and exercising notwithstanding. Researchers used a combination of data from blood tests from over five lakh people as well as mathematical modelling to conclude what we all know already: Everyone is going to die. The body will deteriorate to such an extent that it will not be able to fight disease or recover from even minor injuries. Despite the obviousness of the finding, its implications are serious. Prolonged old age already, human beings are, on average, living longer than ever before means that the burden on the working population is bound to increase, and that retirement will have to wait for many. After all, if youre going to live to 150, its hardly possible to stop earning at 60. And, to make matters worse, there is no guarantee that the quality of life at 150 will really be something worth living for.

The fear of death, and the futility of life, is of particular resonance now the pandemic has made people confront their own mortality on a scale not seen since World War II. In the aftermath of that war, the absurdity of social norms and ambition was articulated by the existentialists. This time, perhaps, the lessons that are drawn will be a little more hopeful: At the end of it all, people may simply give up the race against death and see that theres more in the moment than planning for a future that can be robbed by a microbe.

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The limits of life - The Indian Express

Apple resolved M1 Mac SSD wear reporting issue in macOS 11.4 – AppleInsider

Posted: at 1:48 am


Previous issues surrounding reporting tools reporting heavy wear on SSDs in Apple Silicon Macs now appear to be fixed in macOS 11.4

Solid State Drives (SSDs) can only be written to so many times before they can become unusable, but it takes many years. A series of reports in February 2021 about the SSDs in M1 Macs, however, appeared to show that their lifespan was considerably reduced.

At the time, an AppleInsider source within Apple, not authorized to speak on behalf the company, told us that it was a data reporting error within the tools used to report SSD wear. According to that source, it was not believed to be an actual hardware issue with the SSD, nor were the SSDs aging notably faster than prior because of RAM swap or other reasons.

Now that same source has told AppleInsider that the issue has been fixed in the latest release of macOS. AppleInsider can also now independently confirm that macOS 11.4 is reporting proper uptime statistics as well, where it was not previously.

Separately, users on Twitter including one of the developers working on the Linux port to Apple Silicon, developer Hector Martin, have now also reported that the issue is resolved.

Follow all the details of WWDC 2021 with the comprehensive AppleInsider coverage of the whole week-long event from June 7 through June 11, including details of all the new launches and updates.

Update: The fix was originally implemented in betas of macOS 11.4. It was made available to the public in the macOS 11.4 release.

Stay on top of all Apple news right from your HomePod. Say, "Hey, Siri, play AppleInsider," and you'll get latest AppleInsider Podcast. Or ask your HomePod mini for "AppleInsider Daily" instead and you'll hear a fast update direct from our news team. And, if you're interested in Apple-centric home automation, say "Hey, Siri, play HomeKit Insider," and you'll be listening to our newest specialized podcast in moments.

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Apple resolved M1 Mac SSD wear reporting issue in macOS 11.4 - AppleInsider

Cristiano Ronaldo on The Key to His Longevity: "Consistency Takes You to Perfection" – Men’s Health

Posted: at 1:48 am


"It's consistency and hard work with the use of all the ingredients that are available to me, like the Theragun for example, that helps keep my body in the best shape," he explains to us over email. "Its critical to work hard and at the same time to recover well. Not just the day after a match, but during the weeks, the months, and the years later."

"Longevity is the most important thing, and as you can see my longevity is great. I'm 36 years old and I can still compete with the best players and can still maintain the shape I was in when I was 20 years old. It's not easy, but consistency takes you to perfection."

Perfection is exactly right - the five-time Ballon d'Or has scored 22 goals in 27 games, he's reported to have 7% of body fat, an astounding 50% muscle mass, and ultimately a physique that literally is comparable to a 20-year old.

This morning, it was revealed that Ronaldo has partnered with creators of the Theragun, Therabody, with plans to use the platform to amplify the importance of whole-body wellness.

"I remember the first time I used a Thergaun was in 2017. The first feeling I had was cool or different because it's nothing like other things available on the market," he explains. "I use it almost every day. Before each game, I have to use the Theragun. I like to use it on my feet because it makes me feel very relaxed the day before a game."

"My body is the most important thing to me; it's my weapon. Your mind and body control everything, so you have to take care of the best things that you have and I do-- consistently," he adds. "I work hard everyday to take good care of my body and mind."

As part of his own personal focus on whole-body wellness, the renowned Juventus striker eats up to six meals and take five naps in a single "typical" day.

He is known to start his days with ham and cheese and a side of yogurt for breakfast. When he gets hungry a little later in the day, Ronaldo likes to snack on avocado toast.He then typically eats two lunches and two dinners to fuel the rest of his day - the first lunch of chicken and salad followed by fish of some variety accompanied by salad, eggs, and olives. And In the evening, he'll either stick with fish swordfish, tuna, or braised cod or switch to some type of meat.

"In football you have basic points - from training well to eating properly to drinking properly and so on, but recovery for me and from my point of view is the most important thing. If you prioritise recovery after training, you will be much better for the next training session and for the next game. I list recovery as the second or third most important thing to me."

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Cristiano Ronaldo on The Key to His Longevity: "Consistency Takes You to Perfection" - Men's Health

How to live longer: Waking up an hour earlier may be linked to a longer life – here’s how – Daily Express

Posted: at 1:48 am


Research into longevity invariably lands on the importance of eating well and engaging in regular exercise. Less resources have been devoted to assessing the impact your mental health can have on your overall life expectancy. That is not to say studies haven't been conducted in this area. In an influential Canadian study, depression was associated with an increased risk of premature death.

To further test this hypothesis, and determine the optimal time for rising, lead author Iyas Daghlas, M.D., turned to data from the DNA testing company 23 and Me and the biomedical database UK Biobank.

Daghlas then used a method called "Mendelian randomization" that leverages genetic associations to help decipher cause and effect.

"Our genetics are set at birth so some of the biases that affect other kinds of epidemiological research tend not to affect genetic studies," said Daghlas, who graduated in May from Harvard Medical School.

More than 340 common genetic variants, including variants in the so-called "clock gene" PER2, are known to influence a person's chronotype, and genetics collectively explains 12-42 percent of our sleep timing preference.

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Chronotype is the natural inclination of your body to sleep at a certain time, or what most people understand as being an early bird versus a night owl.

Researchers assessed de-identified genetic data on these variants from up to 850,000 individuals, including data from 85,000 who had worn wearable sleep trackers for seven days and 250,000 who had filled out sleep-preference questionnaires.

This gave them a more granular picture, down to the hour, of how variants in genes influence when we sleep and wake up.

In the largest of these samples, about a third of surveyed subjects self-identified as morning larks, nine percent were night owls and the rest were in the middle.

This suggests that if someone who normally goes to bed at 1am, goes to bed at midnight instead and sleeps the same duration, they could cut their risk by 23 percent; if they go to bed at 11pm, they could cut it by about 40 percent.

It's unclear from the study whether those who are already early risers could benefit from getting up even earlier.

But for those in the intermediate range or evening range, shifting to an earlier bedtime would likely be helpful.

If you're struggling to wake up in the morning, try keeping regular sleeping hours.

"This programmes the brain and internal body clock to get used to a set routine," explains the NHS.

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How to live longer: Waking up an hour earlier may be linked to a longer life - here's how - Daily Express

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