Alumis and Kaken partner in Japan to develop ESK-001

Alumis has recently forged a strategic partnership and licensing agreement with Kaken Pharmaceutical to further the development, manufacturing, and commercialization of ESK-001 in Japan for dermatological conditions. This agreement also presents opportunities to extend ESK-001's application to gastrointestinal and rheumatological indications. As part of this partnership, Kaken Pharmaceutical will make an initial payment of $40 million to Alumis, with additional co-development payments planned from 2025 to 2026.

The collaboration grants Alumis the potential to earn up to $140 million in milestone payments, contingent on meeting specific developmental and commercial milestones. Additionally, Alumis stands to gain tiered royalties based on the net sales of ESK-001 within Japan. Kaken Pharmaceutical will spearhead the clinical development, regulatory approvals, and marketing efforts for ESK-001 in Japan, while also contributing to some global development costs. Meanwhile, Alumis will retain rights to ESK-001 outside Japan.

Martin Babler, CEO and president of Alumis, expressed optimism about the partnership, noting its foundation on the promising Phase II clinical outcomes of ESK-001. He emphasized the goal of leveraging this next-generation oral TYK2 inhibitor to maximize its therapeutic capabilities and broaden its availability to patients suffering from immune-mediated disorders globally.

ESK-001, an oral tyrosine kinase 2 inhibitor, is specifically designed to address immune dysregulation associated with diseases characterized by proinflammatory mediators like interleukin-23, IL-17, and type 1 interferon. The therapy is currently under evaluation through the Phase III ONWARD clinical program, which includes two concurrent global Phase III trials, named ONWARD1 and ONWARD2. These trials aim to determine the safety and efficacy of ESK-001 in adults who have moderate-to-severe plaque psoriasis, with numerous trial sites established in Japan.

The announcement of this collaboration comes on the heels of significant news from February 2025 regarding a merger agreement between Alumis and Acelyrin. This merger is set to result in the creation of a new, late-stage clinical biopharmaceutical company, achieved through an all-stock transaction. This move signifies a concerted effort by both companies to combine their strengths and resources to advance the development and distribution of innovative therapeutic solutions.