Marseille-based Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) and Swedish Orphan Biovitrum AB (Nasdaq Stockholm: SOBI) announced a strategic licensing partnership covering lacutamab, a first-in-class anti-KIR3DL2 antibody, in cutaneous T-cell lymphoma (CTCL), providing the financing needed to initiate the TELLOMAK-3 confirmatory Phase III trial and support a planned accelerated approval filing in Sézary syndrome (SS).
Lacutamab targets KIR3DL2, a receptor expressed on malignant T-cells in CTCL, enabling antibody-dependent cytotoxic elimination of tumor cells. The program carries US FDA Breakthrough Therapy Designation and Fast Track designation for relapsed or refractory SS, PRIME designation from the European Medicines Agency (EMA) for SS, and Orphan Drug designation in both the US and EU for CTCL. The planned TELLOMAK-3 study is an open-label, multicenter, randomized trial enrolling patients with SS and mycosis fungoides (MF) who have failed at least one prior systemic therapy. The confirmatory SS cohort is intended to support accelerated approval based on existing Phase II TELLOMAK data, which reported a 42.9% objective response rate and a median duration of response of 25.6 months in heavily pretreated SS patients; a separate MF cohort targets full approval, with progression-free survival as the primary endpoint for both cohorts.
Under the terms of the agreement, Sobi will pay Innate USD 75 million on closing, with Innate eligible to receive up to a further USD 40 million in near-term development milestones tied to SS. Sobi receives exclusive global commercialization rights upon potential accelerated approval and an option to assume full global development rights following positive Phase III results, which would trigger up to USD 465 million in additional option, regulatory, and commercial milestones. Innate will also be eligible for tiered double-digit royalties on net sales. The USD 75 million upfront payment is said by the company to extend Innate's projected cash runway through Q3 2027. Closing remains subject to antitrust clearance.