Pfizer and Roivant Launch Another Vant with an Initial Focus on Ulcerative Colitis

Dan Kitwood/Getty Images

Dan Kitwood/Getty Images

Pfizer and Roivant have joined forces to form yet another Vant. The new entity will initially work to commercialize RVT-3101 for ulcerative colitis.

Dan Kitwood/Getty Images

Pfizer and Roivant Sciences have joined forces to form yet another Vant. The new entity will initially work to commercialize a Pfizer compound, now dubbed RVT-3101, for ulcerative colitis (UC), the companies announced Thursday.

In an interview with BioSpace, Roivant CEO Matt Gline said a name for the new Vant hasn’t yet been chosen. He noted that the target of RVT-3101, tumor necrosis factor-like cytokine 1A (TL1A), is “a pretty interesting target...because it affects both inflammatory and fibrotic pathways.”

RVT-3101 (formerly PF-06470605) is a human monoclonal antibody that targets TL1A. TL1A is known to drive inflammatory diseases that affect mucosal tissues, such as those in the gut and lung. Research suggests that inhibiting TL1A can modulate the severity of inflammation and fibrosis.

The drug has been studied in the Phase II TUSCANY trial in 50 patients and is currently being assessed in the ongoing Phase IIb TUSCANY-2 trial in 245 adults with moderate to severe UC. Pfizer and Roivant believe the compound can also be developed for other inflammatory and fibrotic diseases as well.

Gline shared that TUSCANY-2 will possibly wrap up by the end of this year. He called preliminary data “very exciting”, but said it is still too early to talk about Phase III design.

In addition to RVT-3101, the new Vant has an exclusive option to work with Pfizer on a next-generation TL1A-directed antibody currently in Phase I studies.

“These are really tough diseases, really challenging, and a lot of the widely-used therapeutics have disappointing efficacy,” Gline said. “So, there’s a lot of room and opportunities for compounds that can deliver better outcomes for both safety and efficacy.”

Studies suggest that up to 40% of patients with UC and similar illnesses do not respond to biologics such as AbbVie’s Humira or Johnson & Johnson’s Simponi, according to the Crohn’s & Colitis Foundation.

Furthermore, approximately 30% of UC patients don’t respond to biologics long-term. Due to treatment failure rates, about 50% of patients cycle off a specific therapy within six to 12 months, with little likelihood of achieving sustained remission.

The new Vant will be responsible for the global development of RVT-3101 in UC and other inflammatory and fibrotic diseases. It will hold commercial rights in the U.S. and Japan.

Pfizer holds a 25% equity position in the Vant and keeps commercial rights outside the U.S. and Japan. Pfizer also will have a member on the new entity’s board of directors.

“This is a very exciting opportunity, a rare opportunity, to show the world data from a new class of drug in the near future,” Gline said.