License Covers First-in-class Alloimmune Defense Receptors Designed to Protect Allogeneic Cells from Rejection in Immunocompetent Recipients

Preclinical Data Published in the Journal Nature Biotechnology Demonstrate Allogeneic CAR T Cells Overcome Immune Rejection and Exhibit Durable Tumor Eradication

SAN DIEGO, July 14, 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 that the Company entered into an exclusive license agreement with Baylor College of Medicine covering alloimmune defense receptors, a first-in-class approach that renders off-the-shelf allogeneic cell products resistant to host immune rejection. Preclinical studies published in the journal Nature Biotechnology (https://www.nature.com/articles/s41587-020-0601-5) demonstrate that allogeneic cells engineered with a novel alloimmune defense receptor (ADR) are protected from both T- and NK-cell mediated rejection, and provide proof-of-concept that ADR-expressing allogeneic cell therapies can durably persist in immunocompetent recipients.

Allogeneic cell therapy requires a patient to endure systemic lympho-conditioning to suppress the immune system and mitigate cellular rejection, often resulting in severe blood cell deficiencies and related toxicities. There is great interest in strategies that enable allogeneic cells to overcome host immunity and evade immune rejection while maintaining a patients functional hematopoietic system, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. The published preclinical data provide compelling evidence that allogeneic cell therapies armed with novel alloimmune defense receptors can effectively abrogate both T- and NK-cell rejection responses and can persist and remain functional in immunocompetent patients.

ADRs are synthetic receptors that selectively recognize cell surface receptors, such as 4-1BB, that are uniquely expressed on activated lymphocytes, which are responsible for host immune rejection. The published preclinical findings show that the arming of allogeneic T cells with an ADR selectively eliminates alloreactive T and NK cells, while sparing resting lymphocytes. Importantly, in in vivo preclinical models of cancer, allogeneic T cells expressing both an ADR and a CD19-targeted chimeric antigen receptor (CAR) demonstrated increased expansion and persistence, resulting in sustained tumor eradication and a long-term survival benefit compared to conventional CD19-targeted CAR T cells.

There is tremendous promise for the use of off-the-shelf allogeneic cells as replacement therapy. One of the most significant barriers to overcome is host immunity, which can prevent the engraftment of allogeneic cells and the long-term replacement of a patients damaged or dysfunctional cells, said Maksim Mamonkin, Ph.D., Assistant Professor, Center for Cell and Gene Therapy, Baylor College of Medicine and the senior author on the Nature Biotechnology publication. We are excited for Fate Therapeutics to explore the use of alloimmune defense receptors in the development of rejection-resistant, iPSC-derived cellular therapies.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, 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 a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Companys NK and T-cell product candidates and preclinical research and development programs, and the scope and enforceability of the Companys intellectual property portfolio. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of its product candidates may not be replicated in ongoing or future clinical trials or studies, the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that any of the patents owed or licensed by the Company may be challenged and that such a challenge may be successful, resulting in loss of any such patent or loss or reduction in the scope of one or more of the claims of a challenged patent. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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Fate Therapeutics Announces Exclusive License Agreement with Baylor College of Medicine for Rejection-resistant iPSC-derived Cellular Therapies -...