Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector.
Telum Therapeutics SL has completed an €18 million (US$24 million) series A financing to advance its lead program targeting hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by the multidrug-resistant gram-negative pathogen Acinetobacter baumannii.
A U.S. biotechnology company founded by Deerfield Management Company L.P. licensed exclusive rights to Metis Techbio Co. Ltd.’s preclinical trispecific T-cell engager (TCE) for autoimmune disorders in a potential $1.62 billion deal.
MPM Bioimpact-spawned K2 Therapeutics Inc. inked a license deal plus option agreement, worth $980.5 million apiece, to gain ex-China rights to two of Antengene Corp. Ltd.’s preclinical anticancer bispecific T-cell engager (TCE) assets. The deal, announced June 21, will grant Singapore-based K2 exclusive rights to develop and commercialize Antengene’s ATG-106 outside of mainland China, Hong Kong, Macau and Taiwan.
Lu-AG-22515, also known as velaprumig, is a recombinant fusion protein that targets CD40 ligand (CD40L) and human serum albumin (HSA), thereby blocking the binding between CD40 and CD40L, a known signaling pathway involved in several autoimmune diseases. Researchers at H. Lundbeck A/S evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Lu-AG-22515 in cynomolgus monkeys, as well as the impact of its inhibitory effect in the preclinical setting of thyroid eye disease (TED).
MPM Bioimpact-spawned K2 Therapeutics Inc. inked a license deal plus option agreement, worth $980.5 million apiece, to gain ex-China rights to two of Antengene Corp. Ltd.’s preclinical anticancer bispecific T-cell engager (TCE) assets. The deal, announced June 21, will grant Singapore-based K2 exclusive rights to develop and commercialize Antengene’s ATG-106 outside of mainland China, Hong Kong, Macau and Taiwan.
Modulating G protein-coupled receptors (GPCRs) is one of the major challenges in biomedicine. These are flexible proteins with small, deep binding pockets. The scientific community has explored small molecules, antibodies and nanobodies to develop ligands. Skape Bio Inc. is betting on creating miniproteins, a strategy that brings precise solutions for different functions.
Although CAR T-cell therapy has been highly effective in hematological cancers, its activity in solid tumors is still constrained by inhibitory checkpoints such as PD-1, LAG-3 and TIM-3, together with the lack of locally available cytokines such as IL-2 needed to sustain T-cell function. Anwita Biosciences Inc. and collaborators aimed to overcome these challenges by developing a strategy integrating an immune checkpoint inhibitor (ICI) with a T-cell stimulatory cytokine.
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA.
RSS
