Innate Pharma announces regulatory updates for TELLOMAK Phase II study
Category: #health  By Saipriya Iyer  Date: 2020-01-11
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Innate Pharma announces regulatory updates for TELLOMAK Phase II study

Innate Pharma SA, a commercial biopharmaceutical firm involved in the development of immunotherapy drug candidates to treat cancer and inflammatory diseases, has recently announced a regulatory update concerning the TELLOMAK Phase II trial aimed at evaluating the safety and efficacy of lacutamab (IPH4102) found in patients suffering from advanced T-cell lymphomas.

The company has been involved in discussions with the regulatory bodies related to the Good Manufacturing Practice (GMP) deficiencies found at the manufacturing subcontractor site of the company which manages both the fill as well as finish of lacutamab clinical vials.

The US Food and Drug Administration (FDA) has reportedly put the TELLOMAK trial on hold. The patients that have been enrolled can continue their treatment in the trial owing to the unmet medical needs at large after they are re-consented. However, it has been established that no new patients shall enroll in the trial until a batch that is GMP-certified is made available.

The trial has been given approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK with the current available supply. The company has also been waiting for final feedback expected from the National Agency for the Safety of Medicines and Health Products in France (ANSM).

The Independent Data Monitoring Committee (IDMC) has concluded that there are no new and unanticipated safety issues regarding lacutamab, and the products look like it is taken well by the current patients that have been enrolled in the trial.

According to sources, the company has been working on transferring the manufacturing of lacutamab fill and finish to another contract manufacturing organization (CMO). It has been anticipated that a new clinical batch that will be certified by GMP will be made available by the second half of the year 2020.

The company has been able to maintain the partial clinical hold guidance as it has obtained major information from all the regulatory authorities at this point in time.

 

Source Credit- https://www.innate-pharma.com/en/news-events/press-releases/innate-pharma-provides-update-regulatory-agencies-lacutamab-tellomak-trial



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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