Biopharmaceutical company Swedish Orphan Biovitrum AB (Sobi) (STO:SOBI) and clinical-stage biotechnology company Innate Pharma SA (Euronext Paris:IPH) (Nasdaq:IPHA) announced on Monday that they have entered into a strategic partnership to advance lacutamab in cutaneous T-cell lymphoma (CTCL).
Under the agreement, Innate will conduct the TELLOMAK-3 confirmatory Phase 3 trial, supporting a potential accelerated approval filing for lacutamab in Sézary syndrome (a subtype of CTCL) and subsequent full-approval applications in Sézary syndrome and mycosis fungoides (the most common subtype).
Sobi will receive exclusive global commercialisation rights upon potential accelerated approval and may assume full global development rights following positive Phase 3 results, subject to transaction closing conditions including antitrust clearance.
Sobi will pay Innate USD75m at closing, with Innate eligible for up to a further USD40m in near-term development milestones related to Sézary syndrome and up to USD465m tied to potential development rights, regulatory and commercial milestones. Innate will also receive tiered double-digit royalties on net sales.
Lacutamab is a first-in-class anti-KIR3DL2 antibody being developed for CTCL, including Sézary syndrome and mycosis fungoides. The programme has received FDA Fast Track and Breakthrough Therapy designations, EMA PRIME designation and US and EU Orphan Drug designation, and is advancing toward the pivotal Phase 3 TELLOMAK-3 study.
Under the terms of the agreement
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