Roivant to Shutter MDS-Focused ‘Vant’ After Disappointing Phase I/II Trial Results
14 Feb 2024
Phase 1Clinical ResultAcquisitionPhase 2Immunotherapy
Pictured: Doctor aspirating a patient's bone marrow/iStock, Vadym Terelyuk
Roivant Sciences announced Tuesday during its third-quarter financial report that it will discontinue the development of its investigational SF3B1 modulator RVT-2001, following an interim analysis of a Phase I/II study in myelodysplastic syndromes.
“Unfortunately, the data generated in the Phase I/II study did not meet our bar for progressing,” Roivant CEO Matt Gline said during Tuesday’s investor call. “And so, we’ve decided to discontinue development of RVT-2001 after an interim analysis of that data.”
Roivant had invested a “reasonable modest low double-digit million-dollar sum” on RVT-2001, Gline added. “I think just sometimes these things don’t work out the way you want scientifically, and so, we’re trying to be efficient in making those decisions.”
Roivant first formed Hemavant two years ago to the day. Launched in February 2022, Hemavant’s main goal was to advance RVT-2001 as a potential first-in-class treatment for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS).
MDS are a group of cancers in which immature blood cells in the bone marrow do not mature or become healthy blood cells. Medications or bone marrow transplants may lessen transfusion needs and slow or prevent progression to leukemia.
RVT-2001, which Roivant licensed from Eisai in January 2022, was a potentially first-in-class orally available small molecule modulator of the splicing factor 3B subunit 1 (SF3B1). Eisai had conducted an 84-participant Phase I study of RVT-2001—which was previously dubbed H3B-8800—and found “no complete or partial responses.”
Tuesday’s decision to discontinue RVT-2001 breaks a winning streak for Roivant. In July 2023, The Wall Street Journal reported that Roche was looking to snap up Roivant’s late-stage anti-TL1A antibody RVT-3101, which had aced it Phase IIb study just a month earlier. At 56 weeks, 36% of ulcerative colitis patients treated with RVT-3101 achieved clinical remission.
Roche confirmed the reports in October 2023. For $7.1 billion upfront and the promise of $150 million in near-term milestones, the pharma acquired Roivant subsidiary Televant Holdings, which was principally responsible for advancing RVT-3101 in inflammatory bowel diseases.
Aside from RVT-3101, Roivant’s Immunovant also secured a Phase I victory in September 2023. In the early-stage study, its investigational autoimmune antibody IMVT-1402 led to dose-dependent reductions in IgG levels; IMVT-1402 either matched or outperformed Immunovant’s other experimental asset batoclimb.
IMVT-1402 elicits the degradation of IgG auto-antibodies by binding to FcRn, which makes it a potential treatment for the more than two million people with conditions driven by IgG auto-antibodies, Immunovant said at the time.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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