After an analysis suggested the death was related to aggressive disease progression, not the study drug, the agency agreed to lift the hold in January.
But now it sounds like lacutamab’s PTCL program has run into problems. Despite “objective responses observed,” Innate has decided not to reopen the phase 1b trial evaluating lacutamab as a monotherapy for PTCL. “The prespecified threshold for meaningful clinical activity was not reached,” the biotech explained in a full-year earnings report this morning.
Preclinical data presented at last year’s American Society of Hematology conference showed a “synergistic effect between lacutamab and chemotherapy” that supported the “rationale for combination strategy in this clinical indication,” Innate added. Innate shared phase 2 data for lacutamab in Sézary syndrome, a type of CTCL, at the same conference. The biotech expects to read out mid-stage data on patients with mycosis fungoides, another type of CTCL, later this year. Talking to investors in December 2023, Chief Medical Officer Sonia Quaratino said the plan is to talk to the FDA once the mycosis fungoides data are in. The Marseille-based biotech entered 2024 with cash, equivalents and assets amounting to 102.3 million euros ($111.6 million). This should pave a cash runway to the end of 2025, said interim CEO Hervé Brailly, Ph.D., who also used his statement to highlight the company’s recent Big Pharma collaborations.