Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
After announcing that lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD), Opthea has now decided to close the Coast trial as well as the Shore trial. As reported by BioWorld, Opthea announced last week that it was considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet AMD.
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
It was a mixed day for Daewoong Pharmaceutical Co. Ltd., which disclosed separately on March 28 both the termination of a $336 million licensing deal with CS Pharmaceuticals Ltd. and upbeat plans to unveil three new oncology assets at the upcoming American Association for Cancer Research in April.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.
Boehringer Ingelheim GmbH terminated its second metabolic dysfunction-associated steatohepatitis (MASH) alliance on March 6, ending an $870 million license agreement inked with Yuhan Corp. for dual GLP-1/FGF21 agonist, BI-3006337 (YH-25724). Yuhan said March 7 that Boehringer, of Ingelheim, Germany, returned rights to YH-25724, a dual-acting glucagon-like peptide-1 and fibroblast growth factor 21 receptor agonist, based on the counterparty’s “strategic judgement” on developing MASH therapeutics.
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
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