Autoantibody

Zai Lab Partner argenx Announces Positive Phase 3 Data from ADVANCE Trial of VYVGART® (efgartigimod alfa-fcab) in Adults with Primary Immune Thrombocytopenia

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Thursday, May 5, 2022
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SHANGHAI, China and SAN FRANCISCO and CAMBRIDGE, Mass., May 05, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the company’s partner argenx (Euronext & Nasdaq: ARGX) reported positive data from the Phase 3 ADVANCE trial of VYVGART® (efgartigimod alfa-fcab).

Key Points: 
  • In adults with primary ITP, ADVANCE met its primary endpoint demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • ADVANCE is the first Phase 3 clinical trial of a neonatal Fc receptor (FcRn) blocker in ITP.
  • Additional secondary endpoint data from the ADVANCE trial are consistent with primary and secondary platelet-derived endpoints and provide additional context on metrics that often drive treatment decisions.
  • The Phase 3 ADVANCE trial was a randomized, double-blind, placebo-controlled, multicenter, global trial evaluating the efficacy and safety of VYVGART in adult patients with chronic or persistent primary ITP.

Vera Therapeutics Announces Two Oral Presentations at the 59th European Renal Association – European Dialysis and Transplant Association Congress Featuring New Clinical Data on Atacicept in IgA Nephropathy and in Systemic Lupus Erythematosus

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Tuesday, May 3, 2022
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These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis.

Key Points: 
  • These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis.
  • Atacicept showed a dose-dependent effect on key biomarkers and clinical markers in a Phase 2a clinical study in patients with IgAN.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.

Vera Therapeutics Selected to Present Interim Phase 2 Data for MAU868 to Treat BK Virus in Kidney Transplant Patients as Oral Late-Breaker at the American Transplant Congress 2022

Retrieved on: 
Tuesday, May 3, 2022
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MAU868 is currently undergoing a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BKV in kidney transplant patients.

Key Points: 
  • MAU868 is currently undergoing a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BKV in kidney transplant patients.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Vera Therapeutics Announces Appointment of Michael M. Morrissey, Ph.D., as Chairman of its Board of Directors

Retrieved on: 
Tuesday, April 12, 2022
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BRISBANE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, announced today the appointment Michael M. Morrissey, Ph.D., as chairman of its board of directors.

Key Points: 
  • BRISBANE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological disease, announced today the appointment Michael M. Morrissey, Ph.D., as chairman of its board of directors.
  • This is an opportune moment for Mike to join our board, stated Marshall Fordyce, founder and CEO of Vera Therapeutics.
  • I look forward to working with Veras board and leadership team to realize the potential of the Companys product candidates.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.

Vera Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results

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Thursday, March 24, 2022
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ET

Key Points: 
  • ET
    BRISBANE, Calif., March 24, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2021.
  • We believe this initial progress is being recognized by our investors, as Vera finished the year as the top performing biotech IPO in 2021, said Marshall Fordyce, M.D., founder and CEO of Vera Therapeutics.
  • This study is expected to complete enrollment in mid-2022 and announce topline results in the fourth quarter.
  • Veras management team will host a webcast today at 8:00 AM ET to discuss a financial results and recent corporate developments.

Sengenics Expands Autoantibody Biomarker Discovery Capability with the Launch of a New Protein Array Service

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Tuesday, March 22, 2022
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Sengenics announced the launch of a new autoantibody profiling service the Pan-Autoimmune Protein Array 1.0 to expedite the identification and quantitation of autoantibody disease biomarker signatures.

Key Points: 
  • Sengenics announced the launch of a new autoantibody profiling service the Pan-Autoimmune Protein Array 1.0 to expedite the identification and quantitation of autoantibody disease biomarker signatures.
  • The service is a protein microarray-based, multiplexed immunoassay which utilizes Sengenics KREX protein folding technology and optimized computational analysis.
  • The protein microarray comprises 110 known autoantigens reported in the literature to be associated with a wide range of autoimmune diseases.
  • The launch of the Pan-Autoimmune Protein Array 1.0 will expand the breadth of assay options designed to better serve customers.

Vera Therapeutics to Host BK Virus Webinar Featuring Stanley C. Jordan, M.D., World-Renowned Transplant Nephrologist and Pioneering Kidney Transplant Researcher

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Monday, March 21, 2022
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BRISBANE, Calif., March 21, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera”), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it will host a key opinion leader (KOL) webinar discussing BK Virus (BKV) featuring world-renowned transplant nephrologist and pioneering kidney transplant researcher, Stanley C. Jordan, M.D., FASN, FAST. As part of the webinar, management will provide an overview of Vera’s lead asset in the treatment of BKV, MAU868, a first-in-class monoclonal antibody to treat BKV infections.

Key Points: 
  • BK Virus is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant.
  • MAU868 is currently undergoing a randomized, double-blind, placebo-controlled Phase 2 clinical trial to assess the safety, pharmacokinetics, and efficacy for the treatment of BKV in kidney transplant patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Vera Therapeutics to Host Business Update Call

Retrieved on: 
Thursday, March 17, 2022
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A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on Vera Therapeutics website.

Key Points: 
  • A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on Vera Therapeutics website.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Cabaletta Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

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Thursday, March 17, 2022
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PHILADELPHIA, March 17, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on the discovery and development of targeted cell therapies for patients with autoimmune diseases, today reported financial results for the fourth quarter and full year ended December 31, 2021, and provided a business update.

Key Points: 
  • No clear signs of biologic activity were observed in the two lowest cell dose cohorts (20 million and 100 million DSG3-CAART cells).
  • In addition, Cabaletta plans to share additional clinical data updates from the DesCAARTes trial at scientific meetings throughout 2022 and 2023.
  • Received FDA clearance to proceed with manufacturing enhancement at a dose of up to 5.0 to 7.5 billion DSG3-CAART cells.
  • All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Everest Medicines Enters into Agreement with Calliditas Therapeutics, Expanding Territory License to Develop and Commercialize NEFECON in South Korea

Retrieved on: 
Monday, March 14, 2022
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SHANGHAI, March 13, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that it has entered into a license agreement with Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) to develop and commercialize NEFECON for the treatment of primary IgA nephropathy (IgAN) in South Korea, expanding its license in addition to rights held in Greater China and Singapore. The deal signals the Company's latest efforts to further enhance its international commercial footprint.

Key Points: 
  • "South Korea's sophisticated healthcare model enables innovative medicines such as NEFECON to have a higher potential likelihood of healthcare coverage once approved.
  • Under the terms of the agreement, Calliditas receives an initial upfront payment of USD$3 million at signing of the agreement.
  • In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, Hong Kong, Macau, Taiwan and Singapore.
  • The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories.