• In animal studies, deep IgG lowering similar to batoclimab with no or minimal impact on albumin and low-density lipoprotein (LDL) was observed. 
  • Plan to submit IND and initiate Phase 1 study in early 2023 with initial data expected in mid-2023. 
  • Previously announced programs for lead asset batoclimab continue at full speed.
  • Two asset anti-FcRn franchise offers multiple potential development and commercial synergies, with composition of matter patent protection expected for IMVT-1402 through at least 2042.

NEW YORK, Sept. 28, 2022 (GLOBE NEWSWIRE) —  Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company committed to enabling normal lives for people with autoimmune diseases, today announced a new anti-FcRn, IMVT-1402, at Roivant’s Investor Day at 11:00am on September 28, 2022. The presentation can be accessed at the Investor Relations section of the Company’s website, located at www.immunovant.com.

“We are excited to unveil IMVT-1402, which has a combination of features that we believe could make a significant impact in the lives of people with autoimmune diseases,” said Pete Salzmann, M.D., Chief Executive Officer at Immunovant. “As with batoclimab, IMVT-1402 may offer deep, potentially best-in-class IgG reduction formulated for the same simple subcutaneous route of administration delivered in a matter of seconds. Additionally, IMVT-1402 has been observed to have minimal or no impact on levels of albumin and LDL in animal studies. With these encouraging preclinical results, we are pursuing an accelerated development plan to bring IMVT-1402 to the clinic, with a Phase 1 study planned to start in early 2023 contingent on IND clearance. Importantly, our cash runway guidance into calendar year 2025 remains unchanged, as expected Phase 1 development costs for IMVT-1402, have been included,” Dr. Salzmann added.   

The combined franchise of batoclimab and IMVT-1402 may enable multiple paths to enhanced value creation for Immunovant. From a development perspective, proprietary patient level data from batoclimab complements the general strength of IgG as a biomarker, and these data together may allow us to accelerate the development of IMVT 1402 from our planned Phase 1 trial directly to planned pivotal studies.  IMVT-1402 may also create an expanded opportunity for Immunovant in therapeutic areas such as Rheumatology, Hematology, and others, where chronic, maximal IgG reduction may be required to deliver the most robust clinical efficacy. From a commercial standpoint, if approved, the two-asset franchise may offer a range of synergies in addition to faster cash flow from batoclimab’s potential launches.  IMVT-1402 is also expected to have composition of matter patent protection through at least 2042, assuming issuance of the pending patent.   

Immunovant’s previously announced programs studying batoclimab in Myasthenia Gravis, Thyroid Eye Disease, Chronic Inflammatory Demyelinating Polyneuropathy and Graves’ Disease continue at full speed. The trial design and lead asset for Warm Autoimmune Hemolytic Anemia will be determined based on an expected engagement with the FDA in calendar year 2022.

About Immunovant, Inc.  
Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, the Company is boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. For additional information on the Company, please visit www.immunovant.com.

SOURCE: Immunovant