Cellectis, a biopharmaceutical company, and Servier, an independent French-based pharmaceutical company, have signed an amendment to their existing collaboration agreement from February 2014 especially for UCART19, a TALEN gene-edited allogeneic chimeric antigen receptor T-cell (CAR-T) immunotherapy. Under this amendment, Servier early exercises its option to acquire the exclusive worldwide rights to further develop and commercialise UCART19, which is about to enter phase 1 development for chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).

In addition, Pfizer Inc. and Servier have entered into an exclusive global license and collaboration agreement to co-develop and commercialise UCART19. Under the terms of the agreement, Pfizer and Servier will work together on a joint clinical development programme for UCART19 and share development costs. Pfizer will be responsible for potential commercialisation of UCART19 in the United States, and Servier will retain marketing rights in countries outside the United States. Pfizer’s collaboration with Servier on UCART19 is distinct from the collaboration with Cellectis that Pfizer announced in June 2014, which did not include UCART19.

UCART19 utilizes Cellectis’ proprietary, allogeneic approach to develop CAR-T therapies that engineer T-cells from non-patient donors for use in multiple patients. This is different from autologous approaches, which engineer a patient’s own T-cells.

Cellectis will receive from Servier a payment of $38.2 million upon signature. In addition, Cellectis is eligible for over $300 million of milestone payments, R&D financing, and royalties on sales from Servier, based on annual net sales of commercialised products. Financial terms for the Servier agreement with Pfizer were not disclosed.

“Servier’s early option exercise is a strong recognition of the potential value of UCART19 for patients, as the first allogeneic CAR-T therapy expected to move into clinical development that utilizes Cellectis’ TALEN gene editing technologies,” said Dr. André Choulika, Ph.D., chairman and chief executive officer of Cellectis.

“Cellectis aims to provide cancer patients with highly innovative best-in-class allogeneic CAR-T therapies across all geographies, and we are proud to collaborate on this license agreement with Servier and Pfizer to foster access for patients.”

“The partnership between Pfizer and Servier is a major step in the development of UCART19 and our ambition to provide innovative drugs for patients in oncology, as it has been envisioned by Servier’s president, Olivier Laureau,” said Emmanuel Canet, M.D., president, research and development at Servier.

“This collaboration on the development of the UCART19 asset builds on Pfizer’s position in the CAR-T space and our growing portfolio of investigational immuno-oncology assets, which is a major priority for our oncology business,” said Mikael Dolsten, M.D., Ph.D., president, worldwide research and development at Pfizer.

“This work with Servier and Cellectis underscores our companies’ shared commitment to developing unique cancer therapies that may benefit patients around the world.”