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.
Regeneron Pharmaceuticals Inc.’s Inmazeb and Ridgeback Biotherapeutics LP’s Ebanga earned a ringing endorsement from the World Health Organization (WHO) in its first ever guideline on Ebola therapies. In releasing the guideline Aug. 19, WHO officials celebrated the fact that Ebola is no longer “a near certain killer” – provided treatment starts as soon as possible following diagnosis.
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.
Genentech Inc. is paying Kiniksa Pharmaceuticals Ltd. $100 million in up-front and near-term payments for the development and commercialization rights to vixarelimab, a fully human monoclonal antibody. Kiniksa also could receive up to approximately $600 million in certain clinical, regulatory and sales-based milestones, as well as royalties on annual net sales.
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
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