Sobi and Innate Pharma Enter Strategic Partnership to Advance Lacutamab Toward Accelerated Approval in Sézary Syndrome
核心洞察
Sobi (搜索) and Innate Pharma announced a strategic partnership to enable the TELLOMAK-3 confirmatory Phase 3 study of lacutamab in cutaneous T-cell lymphoma (搜索).
Sobi (搜索) receives exclusive global commercialization rights to lacutamab upon potential accelerated approval and may assume full global development rights following positive Phase 3 results.
Innate will receive USD 75 million upfront, up to USD 40 million in near-term milestones, and up to USD 465 million in additional regulatory and commercial milestones, plus tiered double-digit royalties.
Sobi (搜索) and Innate Pharma have entered a strategic partnership to advance lacutamab, a first-in-class anti-KIR3DL2 (搜索) antibody, toward a potential accelerated approval filing in Sézary syndrome (搜索), a rare and aggressive leukemic form of cutaneous T-cell lymphoma (搜索) (CTCL). The collaboration, announced on August 10, 2026, will enable the initiation of the TELLOMAK-3 confirmatory Phase 3 study, a pivotal step in the drug's regulatory pathway.
"This agreement is an important step in strengthening our portfolio and reflects our strategy of partnering with leading innovators to bring differentiated therapies to patients with rare diseases," said Guido Oelkers, President and CEO of Sobi (搜索). "We look forward to working with Innate Pharma to advance lacutamab and, subject to regulatory approvals, make it available to patients globally."
Jonathan Dickinson, Chief Executive Officer of Innate Pharma, described Sobi (搜索) as "the ideal partner to help unlock the full potential of lacutamab," citing the company's expertise in rare diseases, proven commercial capabilities, and global reach.
TELLOMAK-3: A Pivotal Confirmatory Trial
Under the terms of the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in CTCL. The study is designed as an open-label, multicenter, randomized trial enrolling patients with Sézary syndrome (搜索) and mycosis fungoides (搜索) — the most common CTCL subtype — who have failed at least one prior systemic therapy.
The trial includes two distinct cohorts: a confirmatory cohort in Sézary syndrome (搜索) intended to support a potential accelerated approval, with full approval anticipated upon study completion, and a registrational cohort in mycosis fungoides (搜索) intended to support full approval. Progression-free survival (PFS) will serve as the primary endpoint. The planned TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions for both Sézary syndrome and mycosis fungoides.
Regulatory Momentum and Designations
Lacutamab has already secured significant regulatory recognition. The program has received Fast Track designation from the U.S. Food and Drug Administration (FDA), PRIME designation from the European Medicines Agency (EMA) for Sézary syndrome (搜索), Orphan Drug designation in both the U.S. and EU for CTCL, and Breakthrough Therapy Designation from the FDA for relapsed or refractory Sézary syndrome. These designations underscore the high unmet medical need in this patient population and the potential of lacutamab to address it.
Transaction Structure
The financial terms of the partnership are substantial. Sobi (搜索) will pay Innate Pharma USD 75 million upfront, payable on closing. Innate is eligible to receive up to an additional USD 40 million in near-term development milestones connected to Sézary syndrome (搜索). Furthermore, Innate may receive up to USD 465 million related to the option for Sobi to obtain full development rights and to future regulatory and commercial milestones. Innate will also be eligible to receive tiered double-digit royalties on net sales.
Sobi (搜索) will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following positive Phase 3 results. The closing of the transaction is subject to closing conditions, including the receipt of transaction-related antitrust clearance.
Disease Background and Unmet Need
Cutaneous T-cell lymphoma (搜索) is a group of rare non-Hodgkin lymphomas. Sézary syndrome (搜索), the more aggressive leukemic form, and mycosis fungoides (搜索), the most common subtype, represent areas of significant unmet medical need. Lacutamab, as a first-in-class anti-KIR3DL2 (搜索) antibody, represents a novel therapeutic approach targeting a receptor expressed on malignant T cells in these diseases.