Date: 2016-06-20
Type of information: Milestone
Compound: UCART19 and five other product candidates targeting solid tumors
Company: Cellectis (France) Servier (France) Pfizer (USA - NY)
Therapeutic area: Cancer - Oncology
Type agreement: development
commercialisation
Action mechanism: immunotherapy product/cell therapy/gene therapy/CAR-T cell therapy. Cellectis’ CAR-T platform technology provides a proprietary, allogeneic approach to developing CAR-T therapies. Allogeneic CAR-Ts are “off-the-shelf” products which have the potential to be industrialized and thereby standardized, with consistent pharmaceutical release criteria, over time and from batch to batch. Each potential future patient may thus be treated by immediately receiving a single dose of a standard product with consistent quality. In addition, it is expected that such allogeneic products may be shipped in advance and would be accessible to any cancer center in the world without the need to invest in a local CAR-T processing facility.
Disease: chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL)
Details: * On February 17, 2014, Cellectis has announced that it has signed a strategic collaboration agreement with Servier, the first independent French pharmaceutical research company, to develop and commercialize novel product candidates targeting leukemia and solid tumors. The partnership covers the development and potentially the commercialization of Cellectis’ lead product candidate, UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemias and lymphomas. The agreement also included research, development, and potentially the commercialization of five other product candidates targeting solid tumors. Cellectis will be responsible for the R&D of certain product candidates through the end of Phase I. Servier may exercise an exclusive worldwide option for a license on each product candidate developed under the agreement. Upon exercising each option, Servier will be responsible for taking over clinical development, registration and commercialization of each product.
Financial terms: The financial terms of the collaboration include an upfront payment of $10 million and up to $140 million for each of the six product candidates potentially developed, spread over various milestones in the development and commercialization phases. In addition, Cellectis will receive royalties on the sales of commercialized products.
Latest news: * On June 20, 2016, Cellectis announced that the first patient has been treated in the Phase I study of UCART19 in pediatric acute B lymphoblastic leukemia (B-ALL) at the University College of London (UCL). This UCART19 clinical trial is sponsored by Servier in close collaboration with Pfizer. The pediatric Phase I is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT). Cellectis will receive a milestone payment from Servier of an undisclosed amount. * On November 19, 2015, Cellectis and Servier announced that they 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 commercialize UCART19, which is about to enter Phase 1 development for chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL). * On July 8, 2015, Cellectis announced the achievement of a significant milestone under the Company's collaboration agreement with Servier, in the preclinical development of two next-generation product candidates in solid tumors. Under the terms of the collaboration agreement with Servier, Cellectis is eligible to an undisclosed payment.
In addition, Pfizer and Servier have entered into an exclusive global license and collaboration agreement to co-develop and commercialize UCART19. Under the terms of the agreement, Pfizer and Servier will work together on a joint clinical development program for UCART19 and share development costs. Pfizer will be responsible for potential commercialization 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 commercialized products. Financial terms for the Servier agreement with Pfizer were not disclosed.
