Pfizer Partners with Cellectis in ImmunotherapyBy
Pfizer Inc. and Cellectis, a French company specializing in immunotherapy, have entered into a global strategic collaboration to develop Chimeric Antigen Receptor T-cell (CAR-T) immunotherapies in the field of oncology directed at select targets. Cellectis' CAR-T platform technology provides a proprietary, allogeneic approach (using engineered T-cells from a single donor for use in multiple patients) to developing CAR-T therapies that is distinct from other autologous approaches (engineering a patient's own T-cells to target tumor cells).
Under the agreement, Pfizer has exclusive rights to pursue development and commercialization of CAR-T therapies, in the field of oncology, directed at a total of 15 targets selected by Pfizer. Both companies will work together on preclinical research, and Pfizer will be responsible for the development and potential commercialization of any CAR-T therapies for the Pfizer-selected targets. In addition, the agreement provides for a total of 12 targets selected by Cellectis. Both companies will work together on preclinical research on four Cellectis-selected targets, and Cellectis will work independently on eight additional targets. Cellectis will be responsible for clinical development and commercialization of CAR-T therapeutics for the Cellectis-selected targets. Pfizer has right of first refusal to the four Cellectis-selected targets.
Cellectis will receive an upfront payment of $80 million, as well as funding for research and development costs associated with Pfizer-selected targets and the four Cellectis-selected targets within the collaboration. Cellectis is eligible to receive development, regulatory and commercial milestone payments of up to $185 million per Pfizer product. Cellectis is also eligible to receive tiered royalties on net sales of any products that are commercialized by Pfizer.
Additionally, Pfizer will be entering into an equity agreement to purchase approximately 10% of the Cellectis capital through newly issued shares at EUR 9.25 ($12.55) per share, pending Cellectis shareholder approval. Approval by two-thirds of the votes cast by voting Cellectis shareholders is required for the issuance. Shareholders of Cellectis representing 52.8% of its voting rights have already undertaken to vote in favor of the issuance. In the event the sale of equity is not approved by the Cellectis shareholders, Pfizer has the option to terminate the collaboration agreement.
Cellectis expects to open a site in the United States to work more closely with scientists at Pfizer.
In its release, Pfizer explains that 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.
Earlier this moth, Cellectis formed an agreement with CELLforCure, a subsidiary of the biopharmaceutical group LFP Group, for the cGMP manufacturing of clinical batches of Cellectis’ allogeneic CART Cells. CELLforCure provides industrial development of cell and gene therapy processes, contract manufacturing services for clinical trials and regulatory and pharmaceutical services. It operates in a large-scale facility in Les Ulis, France and currently employs 35 people. CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for candidates from Cellectis' UCART product family. The candidates from UCART (for Universal Chimeric Antigen Receptor â€“ T cells) product family are allogeneic cell therapy products based on the CAR (Chimeric Antigen Receptor) technology combined with genome engineering. Engineered allogeneic T-lymphocytes bearing a CAR directed at a tumor antigen are directed for treating various forms of leukemias, lymphomas, and solid tumors.
See related story, “Immunotherapies: The Next Wave in Biologic-Based Oncology Drugs.”