The Roivant spinout is shifting its attention away from batoclimab to anti-FcRn candidate IMVT-1402, which will target autoimmune disorders, while allowing argenx’s Myasthenia Gravis drug Vyvgart to maintain its lead position for now.
Immunovant, a spinout of Roivant Sciences, announced Wednesday that it is shifting its priority away from batoclimab, which is aimed at treating the autoimmune disorder myasthenia gravis, and is instead focusing on another anti-FcRn asset.
IMVT-1402, an FcRN inhibitor unveiled at Roivant’s 2022 Investor Day, has been designated as the lead asset and is being targeted at Graves’ disease and other autoimmune disorders, based on “positive in-class data.” The company is planning to start IMVT-1402 in four to five registrational studies in endocrinology, neurology and other areas within the fiscal year, which ends on March 31, 2025. Immunovant also intends to initiate 10 studies for the candidate by March 31, 2026.
As for batoclimab, Immunovant said that the topline results for the drug in myasthenia gravis (MG) will be released sometime within its fiscal year, with Immunovant giving its final decision on the drug. At the same time, the company said that MG is an “anchor indication” for IMVT-1402 and will start a program for the chronic autoimmune disorder.
“Within the class, we see tremendous opportunity for IMVT-1402, which we believe has a combination of potentially best-in-class features not seen with any other FcRn inhibitor,” Immunovant CEO Pete Salzmann said in a statement. “Based on these convictions, as well as significant progress made with IMVT-1402, we are prioritizing the development of IMVT-1402 as our lead asset going forward given its broad potential across several indications.”
With Immunovant’s shift, William Blair analysts in a note to investors said that argenx’s drug Vyvgart, which was approved in MG by the FDA in 2021, will maintain its lead position for now. The analysts noted that “given the liabilities” of LDL lowering with batoclimab, which has not been noted with IMVT-1402, the company’s reprioritization is “prudent.” However, they also said Immunovant’s decision delayed its commercialization efforts and gave argenx a further lead in the MG space.
“We believe the batoclimab timing setbacks highlight the challenges of clinical trial design in autoimmune populations beyond just developing an effective IgG lowering agent,” the William Blair analysts wrote.
Immunovant is not just looking to target MG. The company said it may transition batoclimab’s immunochronic inflammatory demyelinating polyneuropathy (CIDP) study to a registrational program with IMVT-1402. Immunovant also expects to announce results from the batoclimab study in Graves’ disease and an overview of IMVT-1402 in the autoimmune disorder in the fall of this year.
In December 2023, the company announced results from a Phase II trial of batoclimab in Graves’ disease, revealing that the drug had “meaningfully exceeded” a 50% of response rate.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
