Anaptys and Vanda Announce Global Licensing Agreement of Imsidolimab for GPP

Image Credit: © dermnetnz.org

Vanda Pharmaceuticals and AnaptysBio announced today that an exclusive, global license agreement has been reached to develop imsidolimab for the treatment of generalized pustular psoriasis (GPP).¹

"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," said Mihael H. Polymeropoulos, MD, President and CEO of Vanda. "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."¹

With this agreement, Anaptys will receive $15 million from Vanda in the form of an upfront payment worth $10 million and a $5 million payment for the existing drug supply. Anaptys will also receive a 10% royalty on global net sales of imsidolimab and is eligible to receive up to $35 million for future regulatory approval and other sales milestones.

Imsidolimab works by inhibiting the function of the IL-36R, which compensates for the deficiency of the endogenous IL-36 regulator in patients with GPP. The fully humanized IgG4 antibody and IL-36R antagonist mAb has been successfully evaluated for safety and efficacy in global GEMINI-1 and GEMINI-2 phase 3 clinical trials.²

As announced in May 2024, patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin with no treatment-related serious adverse events. Over half of GEMINI-1 participants receiving a single dose of 750mg IV imsidolimab achieved a GPP Physician Global Assessment (GPPPGA) score of 0/1 at Week 4, compared to 13% of the patients on placebo. Similar results were seen in the patients who received a single dose of 300mg IV imsidolimab. Those who were rerandomized to monthly maintenance dosing in GEMINI-2 maintained a GPPPGA score of 0/1 with no flares.

Johann Gudjonsson, MD, PhD, commented on the success of the phase 3 trials in a press release. Gudjonsson is an Arthur C. Curtis Professor of Molecular Skin Immunology and Scholar of the Taubman Medical Research Institute at the University of Michigan.

"GPP is a severely debilitating, life-threatening skin disease in need of novel therapeutic approaches,” Gudjonsson said. “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."¹

The technology transfer activities will be initiated in 2025 in hopes of preparing for the commercialization of imsidolimab. Vanda also expects to begin preparing BLA and MAA applications for the US and Europe 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," said Daniel Faga, president and chief executive officer of Anaptys. "Following our productive pre-BLA meeting with the 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."¹

References

1. Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist. News release. AnaptysBio. February 3, 2025. Accessed February 3, 2025. https://ir.anaptysbio.com/news-releases/news-release-details/vanda-pharmaceuticals-and-anaptys-announce-exclusive-global

2. Anaptys announces positive top-line GEMINI-2 phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP). News release. AnaptysBio. May 9, 2024. Accessed February 3, 2025. https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-positive-top-line-gemini-2-phase-3-clinical