Innate gets a new lacutamab blow

Innate Pharma’s wholly owned lead project lacutamab might now be off clinical hold, but today the company slipped out news of a setback in peripheral T-cell lymphoma, raising questions about the asset’s potential market. Innate said in its fourth-quarter results release that a phase 1 monotherapy trial hadn’t shown sufficient efficacy; it’s now pinning its PTCL hopes on a lacutamab-chemo combo, being tested in an investigator-sponsored study, Kilt. The anti-KIR3DL2 MAb is still in play in the cutaneous T-cell lymphomas Sézary syndrome and mycosis fungoides, but these are much smaller indications than PTCL. Following promising data late-line Sézary data at ASH last year investors had been waiting for details of Innate’s filing strategy; during today’s earnings call the company outlined plans to submit Sézary and mycosis fungoides results simultaneously to regulators. The latter are not yet publicly available, although Innate says it has the "promising" final data in house. Accelerated approval could still be an option, the group added, but it still needs to agree its confirmatory trial design with the FDA. However, Innate didn't give any timelines for filing, and there is another complication: it is looking for a partner for lacutamab.

Lacutamab’s indications

Note: *Innate Pharma estimates Jan 2024, citing SEER Cancer Statistics Review 1975-2017; **investigator-sponsored trial. Source: OncologyPipeline & company releases.