Innate Pharma SA (IPHA) News & EventsIPHAInnate Pharma SA

Sobi and Innate Pharma Enter Strategic Partnership

Sobi and Innate Pharma announced that they have entered a strategic partnership to enable initiation of the TELLOMAK-3 confirmatory Phase 3 study in cutaneous T cell lymphoma, a key step toward filing for accelerated approval of lacutamab in Sezary syndrome, a subtype of CTCL. Under the agreement, Innate will conduct the TELLOMAK-3 Phase 3 confirmatory trial in cutaneous T-cell lymphoma, supporting a planned accelerated approval filing in Sezary syndrome. The planned TELLOMAK-3 study will subsequently support applications for full approvals in key jurisdictions in Sezary syndrome and mycosis fungoides, the most common subtype. Sobi will receive exclusive global rights to commercialize lacutamab upon potential accelerated approval and will be eligible to assume full global development rights following Phase 3 results. Closing of the transaction is subject to closing conditions, including the receipt of transaction related anti-trust clearance.

Innate Pharma Appoints Markus Jensen as Chief Medical Officer

Innate also announced the appointment of Markus Jensen as chief medical officer and member of the executive leadership team, effective September 1, succeeding Sonia Quaratino. Jensen joined Innate Pharma in 2024 as head of clinical pharmacology and has served as global clinical lead for the company's key programs, including IPH4502.

Innate Pharma receives FDA approval to advance TELLOMAK 3 trial

Innate Pharma announced that the FDA has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas, with no further comments, clearing the trial to proceed. The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sezary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sezary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival evaluated by blinded central review. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients' quality of life. With this feedback from FDA, the company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma's proposed regulatory pathway, which could potentially include accelerated approval for Sezary syndrome, once the Phase 3 trial is underway.