Clinical updates, including trial initiations, enrollment status and data readouts and publications: Active Biotech, Aeromics, Angion, Beigene, Carrick, Clene, Eucure, Gilead, Immunic, Moderna, Obseva, Roche, Simcere, UCB, Vifor.
Core presentations at the 63rd meeting of the annual American Society of Hematology (ASH) began Saturday morning with the presentation of three studies focused on non-Hodgkin lymphomas and one on multiple myeloma (MM). Each approach used the immune system as a cancer fighter but employed different mechanisms of action. Two of them successfully used CAR T therapies as treatment.
Angion Biomedica Corp. CEO Jay Venkatesan said his firm is ransacking phase II data for “a clear and consistent trend” toward benefit with ANG-3777 before going to the next stage of development with the hepatocyte growth factor mimetic for patients undergoing cardiac surgery involving cardiopulmonary bypass who are at risk for developing acute kidney injury. A decision is due early next year.
LONDON – New figures underline the devastating effect the pandemic is having on cancer clinical research, with recruitment to U.K. studies falling by 60%. A total of 27,734 patients were recruited in 2020/21, compared to an average of 67,057 in the three years previously. Over those three years, recruitment had been on the rise, going from 61,810 in 2017/18 to 71,709 in 2019/20, according to figures compiled by the Institute of Cancer Research in London.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia. The company had reported in December 2020 that the allogeneic mesenchymal cell therapy failed to meet the primary endpoint of a reduction in hospitalizations in its DREAM-HF phase III trial.
There is now more clarity on the Omicron variant of SARS-CoV-2, as serum antibodies produced by three doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine have been shown to neutralize it. The data arrived a day after Glaxosmithkline plc and Vir Biotechnology Inc. said the monoclonal antibody sotrovimab retains activity against key mutations of the Omicron variant, including those found in sotrovimab’s binding site.
PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
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