Biopharmaceutical company Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI) and clinical-stage biotechnology company Innate Pharma SA (Euronext Paris:IPH) (Nasdaq:IPHA) confirmed on Wednesday that their previously announced strategic partnership is now effective, following the expiration of applicable antitrust waiting periods and completion of other conditions.

This partnership enables initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T cell lymphoma (CTCL), a key step toward filing for accelerated approval of lacutamab in Sézary syndrome, a subtype of CTCL, with first patient expected Q1 2027.

Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in CTCL to support a planned accelerated approval filing for Sézary syndrome. The planned study will support applications for full approvals in key jurisdictions in Sézary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialise lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results.

Under the terms of the agreement, Sobi will pay Innate Pharma USD75m upon the partnership becoming effective. Innate will be eligible to receive up to a further USD40m in respect of near-term development milestones connected to Sezary syndrome. Additionally, Innate will be eligible to receive up to USD465m related to the option for Sobi to get full development rights and to future regulatory and commercial milestones. Innate will be eligible to receive tiered double-digit royalties on net sales.