Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease.
LONDON – A fourth COVID-19 vaccine is on the road to approval in Europe, with Novavax Inc. announcing positive interim data from the phase III U.K. trial of NVX-CoV2373. The vaccine was 89.3% effective at a time when there was a high rate of infection in the country, and in the face of the newly identified variant, B 1.1.7, which is more transmissible. There also was positive data, though slightly less sparkly, from a phase IIb study in South Africa, where NVX-CoV2373 showed 60% efficacy in preventing mild, moderate and severe COVID-19 disease.
In light of its ongoing restructuring of priorities, Medigene AG, of Planegg/Martinsried, Germany, is now discontinuing its MDG-1021 development program. The company was planning a phase I study of the T-cell receptor-modified T-cell (TCR-T) therapy that targets the antigen HA-1 in patients with relapsed or persistent blood cancers after allogeneic hematopoietic stem cell transplantation.
Using Rhythm AI Ltd.'s stochastic trajectory analysis of ranked signals (STAR) mapping system with pulmonary vein isolation terminated and eliminated recurrence of persistent atrial fibrillation (AF) at much higher rates than other ablation procedures in a study published in the Journal of Cardiovascular Electrophysiology. The artificial intelligence-driven STAR mapping process collects and analyzes thousands of heart signals to precisely identify the areas of the heart responsible for the errant electrical signals causing atrial fibrillation, enabling more thorough and accurate ablation.
A Swiss diagnostics company is looking to tap into China’s vast patient pool to validate its diagnostic test for prostate cancer. Schlieren-based Proteomedix AG inked a partnership with Zhengzhou University Henan Cancer Hospital in China to validate its Proclarix diagnostics test in the local population.
Marking the first time monoclonal antibodies developed by separate companies will be tested in combination against COVID-19, Vir Biotechnology Inc.’s VIR-7831 will be added to Eli Lilly and Co.’s bamlanivimab in the ongoing phase II BLAZE-4 study in low-risk patients with mild to moderate disease. The collaboration comes as early research indicates some antibodies in development appear to lose activity when pitted against emerging SARS-CoV-2 variants. VIR-7831 (also known as GSK-4182136), partnered with Glaxosmithkline plc, is designed to bind to a different epitope of the SARS-CoV-2 spike protein than bamlanivimab. A dual-action antibody, VIR-7831 is designed to both block viral entry into healthy cells and clear infected cells.
Phase II data with San Diego-based Heron Therapeutics Inc.’s pain drug HTX-011 (Zynrelef) graced the online pages of the Journal of the American Podiatric Medical Association in early January, whetting investor thirst for an FDA decision regarding approval, slated by May 12. And the agency’s go-ahead, if it comes, could have special meaning for Pacira Biosciences Inc. with competing analgesic Exparel (bupivacaine).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Briacell, Dr. Reddy's, Glaxosmithkline, Immutep, Lead Discovery Center, Lilly, Nervgen, Oncosec, Pfizer, Pharvaris, Qurient, Sorrento, Surface Ophthalmics, Theralase, VBL, Vir.
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