Roche acquires Telavant Holdings to win TLA1 race

The takeover of Telavant, a 75:25 jont-venture of Roivant Sciences and the US pharmaceutical group Pfizer, however, may cost Roche up to US-$7.25bn. The Basel-based pharma giant cites the excellent Phase IIb data of the anti-TLA1 antibody RVT-3101 in 245 patients with ulcerative colitis, 36% of whom showed clinical remission, as the reason for the investment. A Phase II study in Crohn’s disease is ongoin. Roche sees expansion opportunities in other autoimmune indications in addition to the billion-dollar potential in Crohn’s disease and ulcerative colitis.

RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting tumour necrosis factor-like cytokine 1A (TL1A). It has been shown to modulate the severity of inflammation and fibrosis by stimulating the T_H1 and T_H17 pathways, in addition to activating fibroblasts. As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory and fibrotic pathways. Roche will also obtain an option to enter into a global collaboration with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1.

Under the agreement, Roche is paying US-$7.1bn upfront and a short-term milestone payment of US-$150m for the rights to develop, manufacture and commercialise RVT-3101 in the US and Japan. Roche is committed to starting a global Phase III trial for RVT-3101 as soon as possible to bring this promising therapy to the patients suffering from inflammatory bowel disease. Outside of the US and Japan, Pfizer holds commercialisation rights.

Merck Sharp & Dome in June acquired Prometheus Biosciences for US-$10.8bn, and announced to kick-off a Phase III trial of ts anti-TLA1 antibody PRA-023 (now MK-7240) by end of October in 1,020 patients with ulcerative colitis. At the beginning of October, French Sanofi SA entered an US-$1.5bn partnership – including an upfront paymeTeva’s iPhase IIb-Anti-TLA1 programme TEV’574  to Phase III testing and market approval. A hot race has begun and Roche, which wants to start a Phase III trial as soon as possible, is at least catching up with its competitor Merck who wants to close its Phase III study by December 2026.