Polaris Group's Phase II candidate is a microbial enzyme that degrades arginine, an amino acid crucial to tumor cell metabolism and growth. Depleting arginine from the blood can control tumor growth, but normal cells retain their ability to synthesize arginine so should not be harmed by the enzyme's effects.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Plus deals involving Lilly/Gate Bioscience, Concentra/iTeos, Nicox/Kowa, Ajax/Schrodinger, I-Mab/Bridge Health, Otsuka/Cantargia, JCR/Acumen and more.
Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.
Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.
