Sobi partners with Innate Pharma to license lacutamab in T-cell lymphoma

Swedish Orphan Biovitrum AB (publ), known as Sobi, has entered a strategic partnership with Innate Pharma SA to support the start of the TELLOMAK-3 confirmatory Phase 3 study of lacutamab in cutaneous T-cell lymphoma, a rare form of non-Hodgkin lymphoma. The companies said the trial is a key step toward a planned accelerated approval filing for lacutamab in Sézary syndrome, with the broader Phase 3 program also intended to support full approvals in key jurisdictions for both Sézary syndrome and mycosis fungoides. Under the agreement, Sobi will obtain exclusive global commercial rights to lacutamab upon potential accelerated approval and may assume full global development rights if Phase 3 results are positive. Innate Pharma will receive $75 million at closing, up to $40 million in near-term development milestones tied to Sézary syndrome, and up to $465 million linked to Sobi's option for full development rights as well as future regulatory and commercial milestones, along with tiered double-digit royalties on net sales. Lacutamab is described as a first-in-class anti-KIR3DL2 antibody and has received Fast Track designation from the FDA (U.S. drug regulator), PRIME designation from the EMA (EU medicines regulator), Orphan Drug designation in the U.S. and EU for CTCL, and Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome.

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