Collaboration to Utilize Cellectis’ Proprietary Allogeneic CAR-T Platform Technology to Develop Immunotherapies Against Select Targets in the Field of Oncology
Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) today announced that they 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 (utilizing 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 terms of 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 fifteen 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 twelve 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 9.25 Euro 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.
“We believe our CAR-T platform technology has the potential to offer a real advantage over other approaches to T-cell receptor engineering and this collaboration with Pfizer is an important step towards realizing the full potential of this technology in harnessing the body’s own immune system to fight cancer,” said Andre Choulika, PhD, Chairman and Chief Executive Officer at Cellectis. “This alliance provides access to Pfizer’s state-of-the-art therapeutic development capabilities and provides a unique opportunity to advance this innovative work with the goal of developing best-in-class CAR-T therapeutics. We look forward to working closely with the team at Pfizer on researching and developing novel CAR-T therapies that could potentially change the way cancer is treated.”
“This leading immuno-oncology collaboration aimed at delivering immunotherapies is built upon Cellectis’ advanced genome editing and cell engineering capability and Pfizer’s cutting-edge biotherapeutic cancer therapy platform," said Mikael Dolsten, MD, PhD, President of R&D at Pfizer. "Combining the innovation and scientific expertise of Cellectis with Pfizer’s deep oncology and immunology experience creates a world-class partnership designed to deliver a new generation of CAR-T immunotherapies for cancer patients with urgent medical needs."
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.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
Cellectis is a biopharmaceutical company focused on oncology. The company's mission is to develop a novel generation of therapy based on engineered T-cells to treat cancer. Cellectis capitalizes on its 14 years of expertise in genome engineering, based on TALEN(TM), meganucleases and the state-of-the-art electroporation technology Pulse Agile, to create a new generation of cancer immunotherapy for treating leukemias and solid tumors. Cellectis adoptive cancer immunotherapy for chronic and acute leukemias is based on the first allogeneic T-cell chimeric antigen receptor (CAR) technology. CAR technologies are designed to target surface antigens expressed on cells. These treatments reduce toxicities associated with current chemotherapeutics and have the potential for curative therapy. The Cellectis Group is focused on life sciences and uses leading genome engineering technologies to build innovative products in various fields and markets. Cellectis is listed on the NYSE Alternext market (ticker: ALCLS). To find out more about us, visit our website: www.cellectis.com
PFIZER DISCLOSURE NOTICE
The information contained in this release is as of June 18, 2014. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties about CAR-T technology and a collaboration between Pfizer and Cellectis to develop CAR-T immunotherapies, including their potential benefits. Such risks and uncertainties include, among other things, whether and when Cellectis’ shareholders will approve the equity purchase by Pfizer; the uncertainties inherent in research and development, including the ability to meet pre-clinical and clinical study commencement and completion dates as well as the possibility of unfavorable study results; whether and when drug applications may be filed for any product candidates that may be developed as part of the collaboration; whether and when any such applications may be approved by regulatory authorities, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such product candidates; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and in its subsequent reports on Form 10-Q and Form 8-K.
This press release and the information contained herein do not constitute an offer to sell or subscribe, or a solicitation of an offer to buy or subscribe for shares in Cellectis in any country. This press release contains forward-looking statements that relate to the Company's objectives based on the current expectations and assumptions of the Company's management only and involve unforeseeable risk and uncertainties that could cause the Company to fail to achieve the objectives expressed by the forward-looking statements.