Innate Pharma Signs USD 580M Lacutamab Deal with Sobi to Fund CTCL Phase 3 Trial

A USD 75 million upfront payment from Sobi will allow Innate Pharma to initiate TELLOMAK-3, the confirmatory Phase 3 study required to support an accelerated approval filing for lacutamab in Sézary syndrome, a rare, aggressive leukemic form of cutaneous T-cell lymphoma. The deal structure is a direct response to the capital demands of running a registrational trial against a rare-disease indication where patient populations are limited and trial timelines are extended.

Under the agreement, Innate retains conduct of TELLOMAK-3 while Sobi receives exclusive global commercialization rights upon potential accelerated approval. Sobi holds an option to assume full global development rights following positive Phase 3 results, triggering up to an additional USD 465 million in option fees, regulatory, and commercial milestones. Near-term development milestones tied to Sézary syndrome carry a further USD 40 million, with tiered double-digit royalties on net sales applicable thereafter. Closing remains subject to antitrust clearance.

For regulatory affairs leads, the designation stack behind lacutamab is notable. The program holds FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome, Fast Track designation, EMA PRIME designation for Sézary syndrome, and Orphan Drug designation in both the U.S. and EU. That combination positions the accelerated approval pathway as the primary near-term filing strategy, with the TELLOMAK-3 confirmatory cohort in Sézary syndrome designed to convert that conditional approval to full approval, and a separate registrational cohort in mycosis fungoides targeting full approval with progression-free survival as the primary endpoint.

Lacutamab is a first-in-class anti-KIR3DL2 antibody. CTCL encompasses a group of rare non-Hodgkin lymphomas; mycosis fungoides is the most common subtype, while Sézary syndrome represents the aggressive leukemic variant. TELLOMAK-3 is designed as an open-label, multicenter, randomized trial enrolling patients who have failed at least one prior systemic therapy across both subtypes.

For QA and supply chain leads at Sobi, the transition from development-stage asset to commercial readiness will hinge on the confirmatory cohort readout. The accelerated approval filing timeline, and the subsequent full-approval conversion, will define the manufacturing scale-up and GMP compliance window Sobi must plan against before assuming full development rights.

The total potential deal value reaches USD 580 million, with TELLOMAK-3 initiation now the first measurable checkpoint against which both parties' obligations will be tracked.

Source: Innate Pharma via press release, 9 August 2026.