Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced a regulatory update regarding its TELLOMAK Phase II trial, evaluating the efficacy and safety of lacutamab (IPH4102) in patients with advanced T-cell lymphomas. The Company has been in ongoing discussions with regulatory authorities regarding Good Manufacturing Practice (GMP) deficiencies at the Company’s manufacturing subcontractor site that manages the fill and finish operations of the lacutamab clinical vials. Based on these discussions, on December 13, 2019, the Company decided to suspend enrollment of new patients in the TELLOMAK trial, except in Italy where the clinical trial has been suspended.
The Company has received the following new regulatory feedback:
- The US Food and Drug Administration (FDA) has placed the TELLOMAK trial on partial clinical hold. Currently enrolled patients can continue treatment in the trial due to the high degree of unmet medical need, once patients are re-consented. However, no new patients can enroll in the trial until a new GMP-certified batch is available.
- UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed for the trial to continue as planned with current available supply.
To note, the Company is awaiting final feedback from the National Agency for the Safety of Medicines and Health Products in France (ANSM).
The FDA did not cite any safety issues related to the trial medication. This is consistent with the review conducted by the Independent Data Monitoring Committee (IDMC), which concluded there were no new, unexpected safety issues related to lacutamab, and the product appeared to be well-tolerated among current patients enrolled in the trial. In addition, the IDMC determined it would be acceptable to continue recruiting additional patients in the TELLOMAK trial, if agreed by regulatory agencies.
The Company is working to transfer the lacutamab fill and finish manufacturing to another contract manufacturing organization (CMO). At this stage, it anticipates that a new clinical GMP-certified batch should be available in the second half of 2020.
At this point in time, the Company maintains its partial clinical hold guidance globally as it obtains more information from additional regulatory authorities. The Company will provide a further update in due course.
About the GMP Deficiency:
This situation is related to GMP deficiencies put forward by the Company’s manufacturing subcontractor, Rentschler Fill Solutions GmbH or “RFS” (now known as Impletio Wirkstoffabfüllung GmbH). RFS was granted a Good Manufacturing Practice (GMP) certificate by the Austrian regulatory agency in August 2018, which was further confirmed in October 2019 after two on-site inspections. In November, RFS unilaterally withdrew the Certificate of Conformity of batches they have produced, including the lacutamab batch currently used in the TELLOMAK trial. RFS also filed for bankruptcy.
The Company’s utmost priority is to ensure patient safety. An extensive internal and third-party analysis concluded that there was no evidence that the integrity of the product was questioned.