Autoantibody

EQS-News: Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

Retrieved on: 
Wednesday, March 13, 2024

Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

Key Points: 
  • Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment
    The issuer is solely responsible for the content of this announcement.
  • Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment
    Berlin Cures, a clinical-stage biotechnology firm, advances innovative treatment aimed at combating Long COVID, currently impacting over 100 million people globally.
  • The ongoing Phase II clinical trial in Long COVID seeks to deliver conclusive and reliable results on the drug's effectiveness and safety for patients.
  • With the ongoing Phase II trial focusing on Long COVID, Berlin Cures continues to seek additional investments and partnerships to advance this groundbreaking opportunity.

Cartesian Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 7, 2024

GAITHERSBURG, Md., March 07, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today reported financial results for the full year ended December 31, 2023, and recent corporate updates.

Key Points: 
  • Enrollment remains ongoing in the Company’s Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG (NCT04146051), with topline results expected in mid-2024.
  • Announced Positive Long-Term Follow-Up Data from Phase 2a Study of Descartes-08 in Patients with MG.
  • In January 2024, Cartesian announced that the FDA cleared its IND application for Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T product candidate.
  • General and administrative expenses were $40.6 million for the year ended December 31, 2023, compared to $23.9 million for the year ended December 31, 2022.

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

Retrieved on: 
Tuesday, February 20, 2024

“Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.

Key Points: 
  • “Today’s announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients,” said Luc Truyen, Chief Medical Officer of argenx.
  • We chose to use a priority review voucher to accelerate review of our submission because CIDP patients have long been waiting for new treatment options.
  • In the open-label Stage A of the study, 67% of patients showed evidence of clinical improvement (ECI) following treatment with VYVGART Hytrulo.
  • VYVGART Hytrulo was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART®.

Lupus Research Alliance Announces Recipients of the Lupus Mechanisms and Targets Award

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).

Key Points: 
  • NEW YORK, Feb. 28, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to announce the recent recipients of the Lupus Mechanisms and Targets Award (LMTA), whose research will investigate molecular pathways or targets that will lead to new or improved therapies for individuals with systemic lupus erythematosus (SLE).
  • The development of targeted treatments is hindered by an incomplete understanding of lupus and its devastating complications.
  • These seven talented investigators will identify targets for new treatments and test novel therapeutic avenues to revolutionize the field and improve the lives of individuals with lupus.
  • Surgical biopsies of the kidneys are often needed to diagnose lupus nephritis (LN), kidney inflammation caused by lupus that can result in severe and sometimes life-threatening organ damage.

Enable Biosciences Publishes Study Revealing ADAP Technology's Improved Accuracy in T1D Risk Prediction

Retrieved on: 
Tuesday, February 13, 2024

Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.

Key Points: 
  • Detailed findings are presented in the article "Advances in risk predictive performance of pre-symptomatic type 1 diabetes via the multiplex Antibody-Detection-by-Agglutination-PCR (ADAP) assay," published in Frontiers of Endocrinology.
  • This pivotal study underscores the ADAP assay's ability to detect islet autoantibodies, which are indicative of a high risk of progression to clinical T1D.
  • Dr. Jason Tsai, PhD, CTO of Enable Biosciences, elaborates on the significance of the findings: "These study results reinforce the strength of our ADAP technology in early T1D detection.
  • For more insights into Enable Biosciences and the impact of their ADAP technology, please visit www.enablebiosciences.com .

JDRF Applauds Usher and NFL Star Noah Gray for Shining a Spotlight on Type 1 Diabetes at Super Bowl LVIII

Retrieved on: 
Monday, February 12, 2024

NEW YORK, Feb. 12, 2024 /PRNewswire/ -- JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, is recognizing Grammy award-winning megastar Usher and NFL Super Bowl Champion Noah Gray of the Kansas City Chiefs for shining a spotlight on T1D during Super Bowl LVIII.

Key Points: 
  • NEW YORK, Feb. 12, 2024 /PRNewswire/ -- JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, is recognizing Grammy award-winning megastar Usher and NFL Super Bowl Champion Noah Gray of the Kansas City Chiefs for shining a spotlight on T1D during Super Bowl LVIII.
  • As Usher prepared for his highly anticipated Super Bowl Halftime Show and the release of his forthcoming album, he also prioritized raising awareness for T1D and the importance of screening.
  • "Usher's advocacy has played a crucial role in raising awareness about type 1 diabetes and the importance of early detection through screening," said Aaron Kowalski, CEO of JDRF.
  • Noah Gray, a standout tight end for the NFL Kansas City Chiefs, was diagnosed with T1D during his freshman year at Duke University.

Lupus Research Alliance 2023 Dr. William E. Paul Distinguished Innovator Award Granted to Yale School of Medicine Researcher Akiko Iwasaki, Ph.D.

Retrieved on: 
Tuesday, January 30, 2024

NEW YORK, Jan. 30, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to grant the 2023 Dr. William E. Paul Distinguished Innovator Award (DIA) to Akiko Iwasaki, Ph.D., Sterling Professor of Immunobiology at the Yale School of Medicine. Dr. Iwasaki will investigate a possible cause of lupus – remnants of ancient viruses that have been integrated into our genome called endogenous retroviruses. The DIA provides investigators up to $1 million over four years to explore bold, paradigm-shifting ideas that could lead to groundbreaking discoveries in lupus research.

Key Points: 
  • NEW YORK, Jan. 30, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA) is pleased to grant the 2023 Dr. William E. Paul Distinguished Innovator Award (DIA) to Akiko Iwasaki , Ph.D., Sterling Professor of Immunobiology at the Yale School of Medicine.
  • Dr. Iwasaki will investigate a possible cause of lupus – remnants of ancient viruses that have been integrated into our genome called endogenous retroviruses.
  • The DIA provides investigators up to $1 million over four years to explore bold, paradigm-shifting ideas that could lead to groundbreaking discoveries in lupus research.
  • With this award, we will probe the link between the immune system reacting to viruses within us as a possible trigger of lupus disease," commented Dr. Iwasaki.

The Mark Foundation for Cancer Research Announces 2024 Emerging Leader Awards; $3.75 Million Awarded to Outstanding Early-career Scientists

Retrieved on: 
Thursday, January 18, 2024

NEW YORK, Jan. 18, 2024 /PRNewswire/ -- The Mark Foundation for Cancer Research announced the recipients of the 2024 Emerging Leader Awards. Five outstanding early-career investigators will receive a total of $3.75 million for their projects aimed at addressing urgent needs in cancer research. The Mark Foundation Emerging Leader Award (ELA) empowers these scientists to take on innovative, high-risk/high-reward projects that have significant potential to improve outcomes for cancer patients.

Key Points: 
  • NEW YORK, Jan. 18, 2024 /PRNewswire/ -- The Mark Foundation for Cancer Research announced the recipients of the 2024 Emerging Leader Awards.
  • Five outstanding early-career investigators will receive a total of $3.75 million for their projects aimed at addressing urgent needs in cancer research.
  • The Mark Foundation Emerging Leader Award (ELA) empowers these scientists to take on innovative, high-risk/high-reward projects that have significant potential to improve outcomes for cancer patients.
  • Since launching the ELA program in 2018, The Mark Foundation has awarded more than $34 million to 39 early-career scientists.

Cartesian Therapeutics Highlights Progress and 2024 Strategic Priorities Across Innovative Pipeline of mRNA Cell Therapies for Autoimmunity

Retrieved on: 
Monday, January 8, 2024

The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.

Key Points: 
  • The Company’s RNA-engineering approach is designed to expand the reach of cell therapy to autoimmunity with potent therapies that can be dosed more reliably and safely in an outpatient setting without lymphodepletion.
  • Cartesian’s proprietary technology platform, RNA Armory®, is designed to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, including autologous, allogeneic, and in situ transfection.
  • Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T.
  • Cartesian continues to anticipate the initiation of Phase 2 basket studies in additional autoimmune indications in the second half of 2024.

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

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Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised