Immunovant’s decision to prioritize a next-gen FcRn antibody over phase 3 myasthenia gravis (MG) prospect batoclimab means Vyvgart’s crown remains secure for the time being, analysts have concluded.
The Roivant spinout has been studying the anti-FcRn monoclonal antibody batoclimab in late-stage trials including as a continuous long-term therapy for MG. With the study due to read out at some point by the end of March 2025, the biotech is now prioritizing its up-and-coming compound IMVT-1402 as a lead asset.
Batoclimab isn’t being scrapped altogether—at least, not yet. But running alongside the phase 3 MG trial for batoclimab, Immunovant is now planning to “initiate a potentially registrational program for IMVT-1402 in MG.” A final decision will be made once Immunovant gets a glimpse of the batoclimab data.
Immunovant is also expected to have a clinical update for batoclimab in Graves’ disease this fall and will provide an overview of a development program for IMVT-1402 at that time.
The next-gen asset also looks set to usurp batoclimab’s role in a study Immunovant is running in another autoimmune disorder called chronic inflammatory demyelinating polyneuropathy (CIDP). In the same release, the biotech pointed out that several patients in the CIDP trial have experienced rapid clinical deteriorations during the study’s washout period or within the first two weeks of receiving batoclimab.
“To ensure that we can optimize the level of disease activity and patient population for an IMVT-1402 clinical trial we have decided to run the batoclimab CIDP trial approximately two quarters longer prior to unblinding period,” the company explained.
All told, Immunovant is preparing to launch IMVT-1402 programs in four to five indications by March 2025, with ambitions to stretch to 10 in total by the following year.
“We are very excited about the immunology market evolution that we believe positions the anti-FcRn mechanism to be the leading therapeutic class across a broad range of autoantibody-driven indications,” Immunovant CEO Pete Salzmann, M.D., said in the company’s latest earnings results.
“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,” Salzmann added. “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 a number of indications.”
Immunovant has designed IMVT-1402 to bind to the Fc receptor in a different orientation to batoclimab. The theory is that it can still lower IgG to the same level but avoid a reduction in albumin that batoclimab causes. This albumin reduction in turn leads to an increase in LDL cholesterol.
Analysts at William Blair said Immunovant’s decision made sense but pointed out that it provided a further lead to argenx’s Vyvgart, which was approved for generalized MG in 2021 and is being eyed up for an FDA nod in CIDP this summer.
“Given the liabilities of LDL lowering with batoclimab, which have not been observed to date with IMVT-1402, this does seem like the prudent decision but further delays the company’s time to commercialization, providing additional runway for argenx,” the analysts wrote in their note.
The failure of Biohaven’s BHV-130 to get close to investors’ expectations of a 60% reduction of IgG in phase 1 results announced yesterday further cemented the analysts’ view that argenx remains in “pole position in the FcRn/IgG lowering field.”