China's National Medical Products Administration (NMPA) has cleared an IND application for a clinical trial of Shanghai Henlius Biotech Inc.'s HLX-60 for the treatment of solid tumors and lymphomas.
Endpoint Health Inc. has announced a new precision immunology program targeting inflammation mediated by tissue factor (TF)-dependent intracellular signaling.
Aqualung Therapeutics Corp. has been awarded two 3-year National Institutes of Health (NIH) Fast Track awards to support development of ALT-100 (enamptcumab), a humanized monoclonal antibody therapy for the chronic indications of pulmonary arterial hypertension (PAH) and inflammatory bowel disease (IBD).
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective.
Immunoprecise Antibodies Ltd.'s subsidiary, Talem Therapeutics LLC, has shared promising results of a new study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) showing continued resilience of Polytope TATX-03 in broadly neutralizing SARS-CoV-2 variants, including two omicron sublineages that had not been previously tested.
Transcenta Holding Ltd. has received IND clearance from the FDA for TST-003, its first-in-class, high-affinity, humanized monoclonal antibody targeting gremlin-1.
Invivyd Inc. (formerly Adagio Therapeutics Inc.) has generated multiple next-generation candidate antibodies for the prevention and treatment of COVID-19, including two molecules designated for near-term clinical development in combination as NVD-200.
Staidson Biopharmaceuticals Co. Ltd. is testing a combination of two monoclonal antibodies (MAb), STSA-1002 and STSA-1005, in China for the potential treatment of people with severe-to-critical COVID-19.
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