Innate Pharma announced that the U.S. Food and Drug Administration has cleared the confirmatory Phase 3 protocol for lacutamab in cutaneous T‑cell lymphoma (CTCL). The trial, named TELLOMAK 3, is an open‑label, randomized study that will enroll patients with Sézary syndrome and mycosis fungoides who have failed at least one prior line of systemic therapy.
Phase 2 data from the TELLOMAK trial showed an overall response rate of 42.9 % in Sézary syndrome and 19.6 % in mycosis fungoides, with median durations of response of 25.6 months and 13.8 months, respectively. The study also reported meaningful improvements in health‑related quality of life, supporting the drug’s therapeutic potential.
Innate Pharma’s strategy centers on three high‑value assets—IPH4502, lacutamab, and monalizumab—while maintaining a partnership with AstraZeneca on monalizumab. The company reported a cash balance of €70.4 million as of June 30 2025, providing a runway through the end of Q3 2026, and has reduced staffing by roughly 30 % to align resources with its focused pipeline.
The market reacted positively to the FDA clearance, reflecting investor confidence that the regulatory approval of the Phase 3 trial removes a critical barrier and accelerates the path to potential accelerated approval for Sézary syndrome. Analysts noted that, if lacutamab captures 20 % of the estimated $995 million CTCL market, annual revenue could exceed $200 million by 2030.
The clearance de‑risks the lacutamab program, positions the company for accelerated approval, and supports the company’s plan to secure financing for the confirmatory trial. It also strengthens Innate Pharma’s pipeline and reinforces its partnership with AstraZeneca, underscoring a commitment to antibody‑based therapies for rare cancers.
Chief Medical Officer Sonia Quaratino said, “We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study. The efficacy and safety data from the Phase 2 trial suggest that lacutamab has the potential to be a game‑changer in the treatment of CTCL, an orphan disease with a high unmet medical need.” CEO Jonathan Dickinson added, “This milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway.”
The FDA clearance of TELLOMAK 3 marks a significant advance for Innate Pharma, positioning lacutamab as a promising candidate to address a critical unmet need in CTCL and potentially generate substantial revenue once approved.
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