Marseille, France-based Innate first flagged up problems with its Phase II cutaneous T-cell lymphoma trial of anti-KIR3DL2 antibody lacutamab late last year. At that time, Innate stopped enrollment in the study but continued to treat existing participants at all sites outside of Italy.
The suspension of patient enrollment stemmed from the withdrawal of the Certificate of Conformity for lacutamab batches handled by aseptic filling service provider Rentschler Fill Solutions (RFS). RFS’ action created potential concerns with the conformance of the batches to quality specifications.
Now, Innate has received feedback from two key regulators on its response to the problems at its contract manufacturing organization (CMO).
The US Food and Drug Administration (FDA) placed the trial on partial clinical hold, meaning investigators will be able to continue treating existing participants once they provide consent again. This compromise reflects the high unmet medical need in cutaneous T-cell lymphoma, a rare cancer, and the fact the US FDA did not cite any safety issues related to lacutamab.
Separately, the Independent Data Monitoring Committee (IDMC) also found no new, unexpected safety issues related to lacutamab. The IDMC ruled it will be acceptable to enroll new patients in the trial if regulators permit Innate to do so.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is allowing the trial to continue as planned using the currently available supplies of lacutamab.
According to the ClinicalTrials.gov entry for the lacutamab study, the trial features one site in MHRA’s jurisdiction and two centers overseen by the US FDA.
Innate’s home country of France has the most sites enrolling patients in the trial. The French National Agency for the Safety of Medicines and Health Products is yet to provide final feedback on how it wants Innate to proceed.
While gathering the regulatory feedback, Innate has been working to put a new CMO in place. The transfer of fill and finish manufacturing to a new CMO is underway, putting Innate on track to have a new good manufacturing practice-certified batch ready for use in the second half of the year.