Servier and Pfizer Announce Results of UCART19 First-in-Human Trials to Be Presented at the 44th EBMT (European Society for Blood and Marrow Transplantation) Annual Meeting

March 8, 2018 – Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), today announced that results from the two phase 1 trials with UCART19, the allogeneic anti-CD19 CAR T-cell product being developed by Servier and Pfizer, will be presented during the European society for Blood and Marrow Transplantation (EBMT) Annual Meeting to be held from March 18 to 21, 2018 in Lisbon, Portugal.

 

Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be presented during an oral session by Reuben Benjamin, MD, PhD, Principal Investigator and consultant hematologist at King’s College Hospital, London, United Kingdom, on March 21, 2018 at 9:30 am (Room 5A). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in adult patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).

 

Presentation title: First-in-human study with UCART19, an allogeneic anti-CD19 car T-cell product, in high-risk adult patients with CD19+ R/R B-cell ALL: preliminary results of CALM study[1]

 

The PALL (Pediatric Acute Lymphoblastic Leukemia) study is a phase 1, open label, study to evaluate the safety and the ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory B-ALL. PALL was initiated in the UK in June 2016. Paul Veys, MD, PhD, Director of the Bone Marrow Transplant Unit at Great Ormond Street Hospital (GOSH), London, United Kingdom, will share data during an oral session on March 21, 2018 at 11:40 am (Auditorium IV).

 

Presentation title: Gene-edited allogeneic CAR19 T-cells (UCART19) induce molecular remission ahead of allo-sct in high risk pediatric patients with CD19+ relapsed/refractory B-cell Acute Lymphoblastic Leukemia²

 

Servier is the sponsor of both studies. In 2015, Servier acquired exclusive rights from Cellectis for UCART19, which is being codeveloped by Servier and Pfizer.

 

About UCART19

UCART19 is an allogeneic CAR T-cell product candidate being developed for treatment of CD19-expressing hematological malignancies, gene edited with TALEN®. UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. The current approach with UCART19 is based on the preliminary positive results from clinical trials using autologous products based on the CAR technology.  UCART19 has the potential to overcome the limitation of the current autologous approach by providing an allogeneic, frozen, “off-the-shelf” T cell based medicinal product.

In November 2015, Servier acquired the exclusive rights to UCART19 from Cellectis. Following further agreements, Servier and Pfizer began collaborating on a joint clinical development program for this cancer immunotherapy. Pfizer has been granted exclusive rights by Servier to develop and commercialize UCART19 in the United States, while Servier retains exclusive rights for all other countries.