Innate has secured FDA’s fast track designation and PRIME designation from the European Medicines Agency for lacutamab. Credit: Stock-Asso/Shutterstock.

Innate Pharma has secured US Food and Drug Administration (FDA) breakthrough therapy designation for lacutamab to treat adults with relapsed or refractory Sézary syndrome.

Lacutamab is a first-in-class antibody designed to target killer cell immunoglobulin-like receptor 3DL2 (KIR3DL2) and induce cytotoxicity. It is being tested in clinical trials for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma.

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The FDA’s designation follows positive results from the Phase I study and the Phase II TELLOMAK trial, which showed lacutamab’s efficacy and safety in patients who had previously undergone at least two systemic therapies, including mogamulizumab.

TELLOMAK is a global Phase II clinical trial for patients with Sézary syndrome and mycosis fungoides in the US and Europe. It is an open-label, multi-cohort study.

The trial’s primary endpoint is an objective global response rate, with key secondary endpoints including progression-free survival, overall survival, duration of response and quality of life.

Innate Pharma previously received fast track designation from the FDA in 2019 and PRIME designation from the European Medicines Agency in 2020 for lacutamab.

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The company is currently aligning with regulatory agencies for a confirmatory Phase III trial in CTCL and is seeking a partner.

Lacutamab also holds orphan drug status in both the European Union (EU) and the US for the treatment of CTCL.

Innate Pharma chief medical officer Sonia Quaratino stated: “There is a high unmet medical need for patients with Sézary syndrome.

“In this aggressive and rare form of cutaneous T-cell lymphoma, patients in advanced disease often experience very poor quality of life and are in strong need of new, targeted treatment options.”

In March 2024, Innate dropped plans to assess lacutamab as a monotherapy in KIR3DL2-expressing refractory/relapsing peripheral T-cell lymphoma following disappointing data from a Phase Ib trial.