FDA grants IND clearance for Servier’s UCART19 to treat relapsed / refractory ALL

The US Food and Drug Administration (FDA) has granted an investigational new drug (IND) clearance to Servier to proceed with the clinical development of UCART19 in the country.

UCART19 is an allogeneic, gene-edited cellular therapy candidate being co-developed by Servier and Pfizer to treat relapsed / refractory acute lymphoblastic leukaemia (ALL).

Pfizer secured exclusive rights from Servier to develop and commercialise UCART19 in the US, while Servier retains rights for all other countries.

Servier clinical development oncology director Dr Patrick Thérasse said: "We are very pleased that Servier’s first IND approval has been granted for such an innovative approach as allogeneic CAR-T therapy.

"B-ALL is a devastating disease and this study is key to gaining greater insight into the efficacy and safety profile of this new immune-oncology approach in patients with B-ALL."

Initially, UCART19 is being developed in ALL and is currently in Phase I.

Servier is sponsoring the CALM Phase I study on UCART19, for which it acquired exclusive rights from Cellectis in 2015.

The open label, dose-escalation CALM study was initiated in the UK in August last year and has been designed to evaluate the safety, tolerability and anti-leukaemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell ALL (B-ALL).

Following the clearance, the study will now be expanded to feature several centres in the US, including the MD Anderson Cancer Center in Houston, Texas.

UCART19 provides an allogeneic, frozen, ‘off-the-shelf’ T-cell based medicinal product and has the potential to overcome the limitation of the current autologous approach.