Fate Therapeutics Secures Exclusive Option to Novel Humanized anti-BCMA CAR Constructs for Development of iPSC-derived Cell Products
Agreement with Max Delbrück Center Provides Access to Broad Intellectual Property Portfolio of Humanized Antibody Fragments and Antigen-Binding Domains Targeting BCMA
SAN DIEGO, Dec. 03, 2018 (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, announced today that it has secured an exclusive option to an intellectual property portfolio owned by the Max Delbrück Center for Molecular Medicine (MDC) covering novel humanized chimeric antigen receptor (CAR) constructs that uniquely and specifically bind B-cell Maturation Antigen (BCMA). Under the agreement with MDC, Fate Therapeutics holds an exclusive option to exclusively license the portfolio for all cell products, including CAR NK- and T-cell products, derived from induced pluripotent stem cells (iPSCs).
“BCMA is a validated target for cancer immunotherapy, and we are particularly impressed with the innovative work of MDC in developing superior approaches to engage BCMA with higher affinity and greater specificity,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We look forward to incorporating MDC’s humanized antigen-binding domains into our proprietary CAR constructs for NK cells and T cells, and applying our industry-leading iPSC product platform to develop universal, off-the-shelf cell products for multiple myeloma and other BCMA-positive malignancies.”
Last week, Fate Therapeutics announced that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master iPSC line. The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product. The Company’s iPSC-derived cell product platform overcomes significant challenges that limit both patient- and donor-derived cell therapy, where heterogeneous populations of primary cells are repeatedly sourced, engineered, expanded and characterized on a batch-by-batch basis resulting in cell therapies with substantial variability in quality, consistency and potency.
In a recent publication entitled “CAR T Cells with Enhanced Sensitivity to B Cell Maturation Antigen for the Targeting of B Cell Non-Hodgkin’s Lymphoma and Multiple Myeloma” (doi:10.1016/j.ymthe.2018.06.012), scientists from MDC demonstrated that anti-BCMA CAR T cells equipped with its unique humanized extracellular antigen-binding domains have higher affinity and greater specificity than other anti-BCMA antigen-binding domains. These differentiated properties provided both greater selectivity in recognizing target B cells and more robust killing of target B cells in vitro, including malignant B cells with low expression levels of BCMA. Additionally, in in vivo proof-of-concept studies, its anti-BCMA CAR T cells mediated anti-tumor activity in xenotransplant mouse models of multiple myeloma as well as mature B-cell non-Hodgkin lymphoma, where BCMA surface expression is up to 4-fold lower as compared to multiple myeloma cells.
Fate Therapeutics is applying its iPSC product platform, which utilizes clonal master engineered iPSC lines to mass produce NK- and T-cell products that are uniformly engineered and extensively characterized, to create off-the-shelf cell-based cancer immunotherapies for multiple myeloma. The intellectual property of MDC covered under the exclusive option includes humanized antibody fragments that bind a unique BCMA epitope, humanized CAR constructs with extracellular antigen-binding domains to BCMA, and immune cells, including NK cells and T cells, expressing anti-BCMA CAR constructs.
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate 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 Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single 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 to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 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 is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation 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 .
Fate Therapeutics Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the breadth and scope of the MDC intellectual property and the scope and enforceability of the Company’s intellectual property rights, the advancement of and plans related to the Company’s research and development of iPSC-derived cell products for the treatment of cancer, including the safety and therapeutic potential of such products, and the Company’s plans and timing for its intended clinical investigation of FT500. 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, risks related to the Company’s ability to negotiate and execute a definitive license agreement with MDC, the risk that any patents that may issue from the MDC patent applications will not provide adequate protection for the Company’s product candidates, risks relating to the Company’s ability to protect and maintain its intellectual property position, the risk that any of the patents or patent applications owned or licensed by the Company may be challenged and that such a challenge may be successful, resulting in loss of any such patent claims or loss or reduction in the scope of one or more of the claims of a such patent, the risk of difficulties or delay in the initiation of any planned clinical studies, and 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, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development). For a discussion of other risks and uncertainties, and other important factors, any of which could cause Fate Therapeutics’ actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in Fate Therapeutics’ periodic filings with the Securities and Exchange Commission, including but not limited to Fate Therapeutics’ most recently filed periodic report, and from time to time in Fate Therapeutics’ press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and, except as required by law, 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 Tartaglia
Stern Investor Relations, Inc.
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