Sobi and Innate Pharma partner to advance lacutamab in T-cell lymphoma, with TELLOMAK-3 Phase 3 designed to support potential accelerated approval in Sézary syndrome.
Written By: Rishabh Sonawane, PharmD
Reviewed By: Pharmacally Editorial Team
Swedish Orphan Biovitrum AB (Sobi) and Innate Pharma SA have entered a strategic partnership to advance lacutamab in cutaneous T-cell lymphoma (CTCL), with the collaboration designed to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study. The partnership enables initiation of the TELLOMAK-3 confirmatory Phase 3 study, a key step toward a potential accelerated approval filing for lacutamab in Sézary syndrome, a rare and aggressive subtype of CTCL.
Under the agreement, Innate Pharma will conduct the TELLOMAK-3 Phase 3 study, while Sobi will receive exclusive global commercialisation rights following potential accelerated approval. Sobi will be eligible to assume full global development rights following positive Phase 3 results. Completion of the transaction remains subject to customary conditions, including transaction-related antitrust clearance.
TELLOMAK-3 Phase 3 Study Targets Confirmatory Evidence
The planned TELLOMAK-3 study is an open-label, multicenter, randomized Phase 3 trial evaluating lacutamab in patients with Sézary syndrome or mycosis fungoides who have failed at least one prior systemic therapy. The study includes two independent cohorts. In the Sézary syndrome cohort, patients who have received mogamulizumab will be randomized 1:1 to lacutamab or romidepsin. In the mycosis fungoides cohort, patients will be randomized 1:1 to lacutamab or mogamulizumab.
The Sézary syndrome cohort is intended to provide confirmatory evidence to support a potential accelerated approval and, upon study completion, a full approval. The mycosis fungoides cohort is intended to support full approval. Progression-free survival, assessed by blinded independent central review, is the primary endpoint in both cohorts.
Cutaneous T-Cell Lymphoma and Sézary Syndrome
CTCL comprises a group of rare non-Hodgkin lymphomas involving the skin. The disease spectrum includes Sézary syndrome, a rare and aggressive leukemic form, and mycosis fungoides, the most common CTCL subtype.
The TELLOMAK-3 program is being developed for patients with Sézary syndrome and mycosis fungoides who have failed at least one prior systemic therapy, addressing a patient population with significant unmet treatment needs.
Lacutamab
Innate Pharma describes Lacutamab as a first-in-class anti-KIR3DL2 antibody under development for CTCL. Its clinical development is focused on Sézary syndrome and mycosis fungoides, with the program progressing toward a pivotal Phase 3 evaluation.
The program has received FDA Fast Track designation, EMA PRIME designation for Sézary syndrome, Orphan Drug designation in the United States and European Union for CTCL, and FDA Breakthrough Therapy Designation for relapsed or refractory Sézary syndrome.
Mechanism of Action: KIR3DL2-Targeted Antibody Approach
Lacutamab targets KIR3DL2 through an antibody-based therapeutic approach. The supplied announcement identifies lacutamab specifically as an anti-KIR3DL2 antibody but does not provide detailed pharmacological or cellular mechanism-of-action data. Therefore, the current regulatory announcement supports describing lacutamab as a KIR3DL2-targeted antibody but does not establish a more detailed downstream mechanism or clinical efficacy effect.
Regulatory Designations Support Potential Accelerated Approval
Lacutamab’s existing FDA Fast Track and Breakthrough Therapy designations, together with EMA PRIME and Orphan Drug designations in the U.S. and EU, provide regulatory-development support for the program. However, these designations do not constitute regulatory approval and do not guarantee a positive Phase 3 outcome or future authorisation.
Lacutamab remains an investigational therapy and is not currently approved for any indication.
Sobi President and CEO Guido Oelkers said the partnership strengthens the company’s rare-disease portfolio, while Innate Pharma CEO Jonathan Dickinson described TELLOMAK-3 as the pivotal next step toward potential accelerated approval in Sézary syndrome.
Partnership Economics and Commercial Rights
Sobi will pay Innate Pharma $75 million at closing. Innate may receive up to $40 million in near-term development milestones related to Sézary syndrome and up to $465 million associated with Sobi’s potential acquisition of full development rights and future regulatory and commercial milestones.
Innate will additionally be eligible for tiered double-digit royalties on net sales. Sobi’s exclusive global commercialisation rights would become effective upon potential accelerated approval, with the company eligible to assume full global development rights following positive Phase 3 results.
Expected Regulatory Timeline
TELLOMAK-3 initiation is the immediate clinical-development milestone. The Sézary syndrome confirmatory cohort is intended to support a potential accelerated approval filing, while completion of the study is intended to support full approval applications for Sézary syndrome and mycosis fungoides in key jurisdictions.
The announcement does not specify a Phase 3 start date, regulatory submission date, or anticipated approval date. Consequently, the timing of any future filing or authorisation will depend on TELLOMAK-3 execution, clinical results, regulatory interactions, and agency review.
Reference
Sobi enters strategic partnership with Innate Pharma to license lacutamab in T-cell lymphoma | Sobi
About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.