Biotechnology company Innate Pharma SA (Euronext Paris: IPH) (Nasdaq: IPHA) announced on Monday that it has received FDA clearance to proceed with its confirmatory Phase 3 TELLOMAK 3 trial evaluating lacutamab in patients with Sézary syndrome (SS) and Mycosis fungoides (MF) who have failed at least one prior systemic therapy.

TELLOMAK 3 is an open-label, randomized study comprising two cohorts: patients with Sézary syndrome previously treated with mogamulizumab will be randomized 1:1 to receive lacutamab or romidepsin, while Mycosis fungoides patients will be randomized 1:1 to receive lacutamab or mogamulizumab. Progression-free survival assessed by blinded central review is the primary endpoint for both cohorts.

Phase 2 TELLOMAK data demonstrated durable activity, a favourable safety profile, and improvements in quality of life. FDA feedback supports Innate Pharma's proposed regulatory pathway, which could include accelerated approval for Sézary syndrome. The Company plans to initiate TELLOMAK 3 in H1 2026.

Lacutamab is a first-in-class anti-KIR3DL2 antibody developed for cutaneous and peripheral T-cell lymphomas. The program holds FDA Fast Track designation, EMA PRIME designation for Sézary syndrome, Orphan Drug designation in the US and EU for CTCL, and Breakthrough Therapy designation for Sézary syndrome.

Innate Pharma specialises in immunotherapies for cancer, including antibody-drug conjugates, monoclonal antibodies and multi-specific NK cell engagers via its ANKET platform. Its portfolio includes IPH4502, lacutamab and monalizumab, developed in collaboration with AstraZeneca. Headquartered in Marseille, France, with a US office in Rockville, Maryland, Innate Pharma partners with companies including Sanofi and AstraZeneca.