Trevena has carved out a niche in seeking so-called 'biased ligands'--GPCR-binding compounds that selectively activate just one (or a few) of the many biological pathways mediated via a particular GPCR complex. By identifying a ligand that hits the pathways responsible for a medicine's benefits, and avoiding those behind the ill effects, the company hopes to develop safer and more effective therapies, initially in CNS and cardiovascular disease.
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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
The drug boosted overall responses on top of the R-GemOx backbone, but the discussant pointed out that patients in waveLINE-003 were not very heavily pretreated.
In a study intended to show similar benefit in western patients, PD-1/VEGF-targeting ivonescimab met a progression-free survival endpoint, but missed on OS.
One Phase III trial hits but a second study misses by a mile.
