The US Food and Drug Administration (FDA) has given the green signal to Servier and Pfizer to carry out the clinical development of their UCART19 lymphoblastic leukemia drug for relapsed/refractory acute lymphoblastic leukemia treatment.
In this regard, the FDA granted the pharmas with the Investigational New Drug (IND) clearance for the allogeneic, gene-edited cellular therapy candidate.
UCART19 Lymphoblastic Leukemia Drug
UCART19 is being developed for the treatment of CD19-expressing hematological malignancies, gene edited with Talen.
The allogeneic CAR T-cell product candidate is initially being developed for acute lymphoblastic leukemia treatment and is presently undergoing a phase 1 trial.
As per its co-developer Pfizer, the UCART19 lymphoblastic leukemia drug’s present approach is on the grounds of preliminary positive results from clinical studies which had seen autologous products based on the chimeric antigen receptor technology.
Dr Patrick Thérasse, Director of Clinical Development Oncology at Servier 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.”
French pharmaceutical company Servier, the sponsor of the CALM phase 1 trial on the UCART19 lymphoblastic leukemia drug, had acquired the cellular therapy candidate’s exclusive rights in 2015 from Cellectis.
Lymphoblastic Leukemia Treatment Trial
In August 2016, the CALM trial had commenced in the United Kingdom. It is an open label, dose-escalation study to evaluate safety, tolerability and also antileukemic activity of UCART19 in CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) whose disease had either relapsed or in the refractory stage.
Following the IND clearance of the UCART19 lymphoblastic leukemia drug for lymphoblastic leukemia treatment, Servier can expand the clinical study of UCART19 to additional centers including the Houston-located MD Anderson Cancer Center.
While American pharma giant Pfizer had acquired exclusive rights to develop and market the UCART19 lymphoblastic leukemia drug in the US from Servier, the latter has the exclusive rights for the lymphoblastic leukemia treatment in the rest of the world.
Barbara Sasu, Vice President, CAR T Research at Pfizer on the IND clearance of the lymphoblastic leukemia drug said: “Pfizer is excited by the potential of this investigational CAR T approach to treating ALL and other B-Cell malignancies.
“We are looking forward to having the opportunity to investigate this approach in the U.S.”