Newly-public Immunovant announces first proof-of-concept success
Immunovant announced its first batch of proof-of-concept data for its antibody against a rare autoimmune disease, a month after its biggest rival slid one of its dogs out of the race.
In a tiny study of thyroid eye disease, 4 out of 7 patients given IMVT-1401 saw their clinical activity score improve by 2 or more points and 3 out of 7 saw their proptosis — eye protrusion — improve. There was a 65% reduction in IgG, the protein IMVT-1401 is meant to block, which was “nearly identical to modeled predictions for dosing regimen” in the trial.
Crucially, the trial showed no adverse events and no headaches.
“We see these data as a near best-case scenario,” SVB Leerink’s Thomas Smith wrote to investors this morning. “Expect strength in IMVT shares this morning.”
With their blank-check merger in October, Immunovant — Vivek Ramaswamy’s 12th Vant — is newly public. The company, like many of the other Vants, is based solely around a single asset: IMVT-1401, a monoclonal antibody licensed from HanAll Biopharma. It targets FcRn-Immunoglobulin G. The protein has been implicated in several rare auto-immune disorders. Immunovant hopes that the antibody will stop the body from recycling immunoglobulin G, lowering protein levels and potentially treating those disorders.
The idea was enough to earn the company a deal with a $115 million blank check company sponsored by RTW Investments and a couple other investors. Between thyroid eye disease and the two other auto-immune diseases Immunovant is testing — myasthenia gravis and warm autoimmune hemolytic anemia — Smith has projected $2.7 billion in peak sales for the antibody.
There is competition, though, even if some if it is waning. Alexion has recently invested in the FcRn pathway, most notably with the ALXN-1830 antibody they acquired in 2018, part of a $1.2 billion buyout of Syntimmune. But last month, Alexion dropped ABY-039, an FcRn antibody they picked up from a Swedish biotech in 2019. At the time, Baird’s Brian Skorney sent a note calling the news “an incremental positive” for Immunovant.
“We continue to believe that IMVT-1401 possesses best-in-class potential as a rapidly administered and highly efficacious FcRn inhibitor,” he wrote.
Immunovant now has a larger and randomized Phase II study underway for thyroid eye disease, a Phase II underway in myasthenia gravis and a Phase II in warm autoimmune hemolytic anemia set to get underway.
IMVT-1401 would be the second antibody developed for thyroid eye disease, after Horizon Pharma’s Tepezza won approval earlier this year.
