Roivant Sciences and Pfizer Inc. announced formation of a new Vant to develop and commercialize PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal antibody targeting TL1A, which is currently in Phase 2b development in ulcerative colitis (UC). The Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered Phase 1. RVT-3101 is a potential first-in-class agent that targets both inflammatory and fibrotic pathways by inhibiting TL1A, which has been shown to modulate the location and severity of inflammation and fibrosis by stimulating TH1 and TH17 pathways, in addition to activating fibroblasts.

As such, RVT-3101 has the potential to provide greater efficacy by hitting multiple inflammatory pathways as well as fibrotic pathways. RVT-3101 has been evaluated in an earlier Phase 2 study (TUSCANY) in 50 patients, and is being evaluated in a large global Phase 2b study (TUSCANY-2) in 245 adult participants with moderate to severe ulcerative colitis. The induction portion of TUSCANY-2 is complete, and the maintenance portion remains ongoing.

Inflammatory bowel diseases are chronic inflammatory diseases of the gastrointestinal tract. It is estimated that up to 2 million US adults suffer from inflammatory bowel diseases, which include ulcerative colitis and Crohn's disease. There is significant unmet treatment need for patients with inflammatory bowel disease.

High rates of treatment failure mean that approximately 50% of patients are cycling off a given therapy within 6 to 12 months and are unlikely to achieve sustained remission. The commercial markets for these diseases for advanced therapies is nearly $15 billion per year in the US alone and growing. Available treatments have very low remission rates, and thus there is a large need for an efficacious and safe therapy.

Terms of Collaboration: A new Vant or Roivant subsidiary has been created to develop and fund these programs. The Vant will be fully responsible for funding global development of RVT-3101 in UC and in additional inflammatory and fibrotic diseases and holds commercial rights in the US and Japan. Pfizer owns a 25% equity position in the Vant and maintains commercial rights outside of the US and Japan as well as representation on the company's Board of Directors. In addition, the Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered Phase 1. The Vant will have the right to enter into an agreement for global development with a 50/50 cost share as well as co-commercialization rights with Pfizer prior to Phase 2 (expected in 2025).