Fate Therapeutics Announces Global Collaboration With


ꟷ The collaboration leverages the company’s iPSC product platform and Janssen’s proprietary tumor targeting antigen binders to create new CAR NK and CAR T-Cell product candidates ꟷ

ꟷ Destiny will receive an upfront payment of $ 50 million and a capital investment of $ 50 million, as well as full funding for the research and development of candidates for collaboration through the IND deposit ꟷ

ꟷ Collaborative candidates to be developed against up to four tumor associated antigens for hematologic malignancies and solid tumors ꟷ

ꟷ Fate is eligible to receive payments of up to $ 1.8 billion in development and regulatory milestones and up to $ 1.2 billion in commercial milestone payments, plus double-digit royalties ꟷ

SAN DIEGO, April 02, 2020 (GLOBE NEWSWIRE) – Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today announced a global collaboration and option agreement with Janssen Biotech, Inc. (Janssen), one of the Janssen pharmaceutical companies of Johnson & Johnson.

As part of the multi-year collaboration agreement, Janssen will provide exclusive antigen-binding domains for up to four tumor-associated antigen targets. The Company will apply its iPSC product platform to the research and preclinical development of new product candidates for chimeric antigen receptor (CAR) NK and CAR T cells derived from iPSCs. The Company will receive $ 50 million in cash and $ 50 million from the purchase by Johnson & Johnson Innovation – JJDC, Inc. of newly issued common shares of the Company at a price per share of $ 31.00. Janssen will also reimburse the Company for all activities carried out within the framework of the collaboration.

“We are delighted to enter this strategic collaboration, which brings together Janssen’s scientific and global marketing leadership, in-depth oncology domain expertise and proprietary technologies for targeting and binding of certain tumors and our platform. Forms industry-leading iPSC products to develop new out-of-the-box products. CAR NK and T cell cancer immunotherapies, ”said Scott Wolchko, President and CEO of Fate Therapeutics. “The collaboration strengthens our financial and operational position through a focused effort to develop anti-cancer cellular immunotherapies using Janssen’s proprietary antigen-binding domains, while allowing us to continue to exploit our extensive pipeline of proprietary product candidates. proprietary and to further develop our off-shelf, iPSC-derived cellular immunotherapies.

The Company will advance the candidates as part of the collaboration to the filing of an Investigational New Drug Application (IND), after which Janssen will have the right to exercise its option for an exclusive license for the development and commercialization of collaborative candidates. targeting antigens associated with tumors. . The Company will be primarily responsible for manufacturing collaboration candidates, the cost of which will be borne by Janssen. The Company is eligible to receive payments of up to $ 1.8 billion upon completion of development and regulatory milestones and up to $ 1.2 billion upon completion of commercial milestones, as well as double-digit royalties on worldwide commercial sales of products targeting antigens. In addition, the Company has the right to elect to co-market each candidate for collaboration in the United States and to share equally the profits and losses in the United States, subject to its payment of certain clinical development costs. and adjustments to milestone and royalty payments.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables the mass production of homogeneous, ready-to-use cellular products that can be administered in multiple doses to provide more effective pharmacological activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique properties of unlimited self-renewal and differentiation potential in all cell types in the body. The company’s novel approach is to design human iPSCs as part of a one-time genetic modification event and select a single designed iPSC for maintenance as the iPSC clonal master line. Analogous to master cell lines used to make biopharmaceutical pharmaceuticals such as monoclonal antibodies, iPSC clonal master lines are a renewable source for the manufacture of cell therapy products that are well defined and uniform in composition, can be mass produced at large scale in a cost-effective manner, and can be delivered off the shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming the many limitations associated with the production of cell therapies using cells from patients or donors, which is logistically complex and expensive and is subject to batch processing. batch and cell to cell variability that may affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of more than 250 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of world-leading cellular immunotherapies for cancer and immune disorders. The Company has established a leading position in the clinical development and manufacture of ready-to-use universal cellular products using its proprietary Induced Pluripotent Stem Cell (iPSC) product platform. The Company’s immuno-oncology product candidates include natural killer cell (NK) and T cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including endpoint inhibitors. immune control and monoclonal antibodies, and to target tumor-associated antigens with antigen receptors (CARs). The Company’s immunoregulatory product candidates include ProTmune â„¢, a pharmacologically modulated donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft versus host disease, and cellular immunotherapy. myeloid-derived suppressive to promote immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, California. For more information, please visit www.fatetherapeutics.com.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expected benefits of the Company’s collaboration with Janssen, the Company’s expectations regarding future milestone payments and potential royalties in connection with the collaboration, the objectives, plans and goals of the collaboration, the rights and obligations of the parties under the collaboration, and the safety and therapeutic potential of the Company’s iPSC product platform . These forward-looking statements and all other forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially. and unfavorably from those stated or implied by such forward-looking statements. forward-looking statements. These risks and uncertainties include, without limitation, the risk that the Company will not comply with its obligations under and otherwise maintain its collaboration agreement with Janssen on the agreed terms, the risk that the Company will cease or delay development planned and clinical trials of any of its product candidates for a variety of reasons (including any delay in the Company’s ability to conduct and complete preclinical studies and enroll patients in ongoing and planned clinical trials, requirements that may be imposed by regulatory authorities on the conduct of clinical trials or to support regulatory approval, difficulties in manufacturing or supplying the Company’s product candidates for clinical trials, or the occurrence of adverse events or other negative results that may be observed during development), the risk that Janssen or the Company will terminate the collaboration agreement for d For a variety of reasons, the resulting risk observed in preclinical studies of its product candidates may not be replicated in ongoing or future clinical trials or studies, and the risk that its product candidates may not produce therapeutic benefits or may cause other unexpected side effects. For a discussion of other risks and uncertainties, and other important factors, each of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the periodic filings. from the Company to the Securities and Exchange Commission, including, but not limited to, the latest periodic report filed by the Company, and from time to time in Company press releases and other communications with investors. Fate Therapeutics is providing the information contained in this press release as of this date and assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Contact:
Christina tartaglia
Stern Investor Relations, Inc.
212.362.1200
[email protected]


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