Vanda Pharmaceuticals Inc. and AnaptysBio, Inc. are partnering to develop and commercialize imsidolimab (interleukein [IL]-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).
Imsidolimab inhibits the function of the IL-36R, compensating for the deficiency of the endogenous IL-36 regulator in patients with GPP. Imsidolimab has successfully concluded its development program in GPP, including the GEMINI-1 and GEMINI-2 global Phase 3 studies.
In 2025, Vanda intends to initiate and complete the technology transfer activities and will immediately begin preparing the biologic license application (BLA) and marketing authorization application for the US and EU and making preparations for commercialization.
“We are excited to add imsidolimab to Vanda’s product portfolio for rare orphan disorders, as well as explore the potential of this IL-36 signal regulator in the treatment of additional inflammatory conditions where the IL-36 homeostatic balance is dysregulated,” says Mihael H. Polymeropoulos, M.D., Vanda’s President, CEO and Chairman of the Board, in a news release.“Imsidolimab has great synergy with our commercial portfolio, leveraging both our rare disease expertise in the US and EU as well as the anti-inflammatory portfolio that includes Ponvory for multiple sclerosis, psoriasis and ulcerative colitis.”
“GPP is a severely debilitating, life-threatening skin disease in need of novel therapeutic approaches,” adds Johann Gudjonsson, MD, PhD., Arthur C. Curtis Professor of Molecular Skin Immunology and Scholar of the Taubman Medical Research Institute, University of Michigan in Ann Arbor, MI. “The positive Phase 3 data, demonstrating GPP patients achieved rapid disease clearance through Week 4 after a single dose of infused imsidolimab, and maintained clear to almost clear skin for at least 24 weeks, with no clinically meaningful safety signals, represents a promising new option for patients living with this disease. I’m excited imsidolimab is progressing toward a regulatory filing this year.”
“Vanda is an ideal partner for imsidolimab due to their strong regulatory and commercial capabilities in the US and Europe, evidenced by successful recent launches in specialty and rare diseases, and their commitment to invest in label expansion across their therapeutic portfolio, including their growing presence in inflammatory disease,” says Daniel Faga, president and chief executive officer of Anaptys. “Following our productive pre-BLA meeting with FDA in 2024, we look forward to Vanda’s BLA and MAA submissions later in 2025, with the hope that this potentially differentiated therapeutic option will be made available for patients living with GPP, a burdensome, and sometimes life-threatening skin disease.”
Under the terms of the agreement, Vanda will make to Anaptys an upfront payment of $10 million and a $5 million payment for existing drug supply. Anaptys is also eligible to receive up to $35 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales. Vanda will receive an exclusive global license to develop, manufacture and commercialize imsidolimab.
Guggenheim Securities acted as financial advisor and Fenwick & West LLP served as legal counsel to Anaptys on this transaction. Cantor Fitzgerald & Co. acted as financial advisor and Orrick, Herrington & Sutcliffe LLP served as legal counsel to Vanda.
About GEMINI-1 and GEMINI-2 Studies
In the 45-patient GEMINI-1 Phase 3 trial, patients were randomized 1:1:1 to receive a single infusion of 750mg intravenous (IV) imsidolimab, 300mg IV imsidolimab or placebo at Day 0. Of the patients who received a single dose of 750mg IV imsidolimab, 53% achieved a GPP Physician Global Assessment (GPPPGA) score of 0/1 (clear or almost clear skin) at Week 4 (primary endpoint), compared to 13% of the patients on placebo (p=0.0131). Of the patients who received a single dose of 300mg IV imsidolimab, 53% achieved GPPPGA 0/1 at Week 4.
Sixteen GPPPGA 0/1 responder patients from GEMINI-1 were subsequently re-randomized to monthly maintenance dosing of either 200mg subcutaneous (SC) imsidolimab or placebo in the GEMINI-2 Phase 3 trial. Patients were followed for at least 24 weeks and up to a maximum of 92 weeks. Of the eight responding patients from GEMINI-1 who were re-randomized to monthly 200mg SC imsidolimab maintenance therapy, 100% maintained a GPPPGA score of 0/1 and none of them experienced a flare. Of the remaining eight responding patients from GEMINI-1 who were re-randomized to placebo, 25% maintained a GPPPGA score of 0/1 and 63% experienced a flare.
Data from both trials demonstrated a consistent, favorable safety and tolerability profile with no treatment-related serious adverse events (SAEs).
PHOTO CREDIT: DermNet
