French regulator agrees to partial resumption of Tellomak trial patient recruitment14 Jan 2020
The French National Agency for Medicines and Health Product Safety (ANSM) has agreed that Innate Pharma’s Tellomak (lacutamab) Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) in France, the biotech firm said late Monday.
Lacutamab is an anti-KIR3DL2 antibody being developed for the treatment of the rare cancer cutaneous T-cell lymphoma.
“The ANSM decision to allow new patient recruitment to resume in Sézary syndrome and MF in France is based on an assessment of the unmet medical need and the lack of currently available standard of care options,” Innate Pharma said.
Innate said it would take operational measures to reactivate the Tellomak trial for Sézary and MF patients in France and the UK where regulators have authorized it.
However, due to wider available treatment options, no new T-cell lymphoma patients can enrol in the trial until a new Good Manufacturing Practice (GMP)-certified batch is available.
The Tellomak trial has been on partial clinical hold since December 13 in France and the UK and since January 9 in the US. Innate has been in ongoing discussions with US and European regulators over GMP deficiencies at its manufacturing subcontractor’s site that manages fill and finish operations for Tellomak.
Despite being awarded GMP certification by the Austrian Agency for Health and Food Safety in August 2018, Rentschler Fill Solutions (RFS) unilaterally withdrew the Certificate of Conformity guaranteeing the quality of batches produced at the plant in November last year.
RFS has also filed for bankruptcy, according to Innate.
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