FDA lifts partial hold on cancer drug after Innate resolves manufacturing issue
Innate Pharma has smoothed over a bump on a Phase II for lacutamab, resuming enrollment in the US as the FDA lifts its partial hold.
The hold, which was issued in January, came after the French biotech stopped treating new patients following discussions with regulators in Europe. Its manufacturing subcontractor, Rentschler Fill Solutions, had abruptly filed for bankruptcy and withdrawn a certificate of conformity on the lacutamab batches they produced.
With a new clinical batch now greenlighted, the US portion of TELLOMAK will now be re-activated, following France and the UK earlier this year. Decisions are still pending in Spain, Italy and Germany.
Lacutamab is an anti-KIR3DL2 antibody designed to treat cutaneous T-cell lymphoma. In the US, it’s specifically being targeted for patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies — two subtypes of the orphan disease.
“We’re confident in our ability to supply lacutamab in this important trial moving forward, and look forward to reactivating the trial globally as quickly as possible,” Pierre Dodion EVP and CMO of Innate, said in a statement.