FDA lifts partial hold on Innate Pharma’s lacutamab study

The FDA has lifted partial clinical hold placed on Innate Pharma SA’s (NASDAQ:IPHA) TELLOMAK Phase II clinical trial, evaluating the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas. The company is taking operational measures to re-activate trial in U.S.

The agency’s decision is based on a quality assessment of a new Good Manufacturing Practice (GMP)-certified batch that has been successfully manufactured for the lacutamab program.

The Company can now resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) who have received at least two prior systemic therapies.

The TELLOMAK trial was put on partial hold due to GMP deficiencies at a subcontractor site responsible for fill and finish operations.

Data from the trial for MF are expected in 2021 and for Sézary syndrome in 2022.

https://seekingalpha.com/news/3585614-fda-lifts-partial-hold-on-innate-pharmas-lacutamab-study