Servier and Transgene have established a research collaboration to evaluate the latter’s viral vectorization technologies for use in engineering allogeneic chimeric antigen receptor (CAR) T-cell therapies, including the next generation of Servier’s early clinical-stage CAR T-cell candidate UCART19.
The goal of the initially three-year collaboration is to use Transgene’s viral vector platform to develop vectorization tools that will enable faster, simpler, and more precise CAR T-cell genome modification, with fewer steps and better transgene integration yields. The ultimate aim is to use the technologies to develop more effective anticancer CAR T-cell therapies. Transgene, which is part of Institut Mérieux, could earn more than €30 million ($34.2 million), with Servier retaining rights to use the new vectors for developing its cell immunotherapy portfolio.
“Allogeneic cell therapies using CAR-T open a major field of innovation in the treatment of cancer,” stated Patrick Therasse, M.D., oncology R&D director at Servier. “However, each of the steps in their complex manufacturing process requires specific development and optimization efforts, in order to provide patients with the best possible therapeutic options. And we look for the best partners to move these products forward.”
Servier negotiated exclusive rights to UCART19 from Cellectis in 2015, for development against hematologic cancers. At the same time, Servier confirmed inking an exclusive licensing deal with Pfizer to co-develop and commercialize UCART19. In March this year, the FDA granted IND approval for a Phase I study with UCART19 in patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia (B-ALL). The trial will be carried out by Servier.
Commenting on the research collaboration between Servier and Transgene, Cellectis chairman and CEO, André Choulika, Ph.D., stated, “Transgene stands among the most advanced companies in the world in the development of vector technologies. We are convinced that this collaboration will result in a next generation of UCART19 that will confirm the initial results of this product candidate, but also will lead to ways to optimize production, costs, and potentially explore its use in other leukemia indications.”
Rivals Novartis and Kite Pharma are both vying to win the first FDA approval of a CAR T-cell therapy. In May, Kite Pharma confirmed that the U.S. regulator had accepted for priority review its Biologics License Application (BLA) for lead CAR T-cell therapy axicabtagene ciloleucel (formerly KTE-C19) for treating relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who are ineligible for autologous stem cell transplant. The FDA set a November 29, 2017 prescription drug user fee act target action date. Kite reported positive data from the pivotal ZUMA-1 trial for axicabtagene ciloleucel in patients with chemorefractory aggressive B-cell NHL in February. The firm previously stated that it expects to file a marketing authorization application for axicabtagene ciloleucel with the European Medicines Agency during Q3 2017.
Axicabtagene ciloleucel has been awarded breakthrough therapy designation by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL).
In March, the FDA granted accepted Novartis’ BLA for its lead CAR T-cell therapy CTL019 in relapsed and refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) and granted the application priority review. Breakthrough therapy designation for CTL019 in the treatment of adult patients with relapsed and refractory DLBCL who had failed two or more prior therapies was granted in April. At the time, the firm said it projected filing regulatory submission for the DLBCL indication by the end of the year.