On November 1, 2017 Servier, Pfizer Inc. (NYSE: PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), reported that preliminary results from 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 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held in Atlanta on December 9-12 (Press release, Cellectis, NOV 1, 2017, View Source [SID1234521420]).
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Results from the CALM (UCART19 in Advanced Lymphoid Malignancies) study will be shared as an oral presentation by Reuben Benjamin, principal investigator and consultant hematologist at King’s College Hospital, United Kingdom, on December 11 at 7.15 pm (EST). The CALM study is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). The study was initiated in the UK in August 2016.
The abstract for this presentation is available on the ASH (Free ASH Whitepaper) website: View Source
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. Waseem Qasim, principal investigator of the PALL study and consultant in pediatric immunology and reader in cell and gene therapy at Great Ormond Street Hospital for Children, United Kingdom, will present results from the trial during a poster session on December 9 from 5.30 pm to 7.30 pm.
The abstract for this presentation is available on the ASH (Free ASH Whitepaper) website: View Source
Servier is a 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.