Fate Therapeutics Announces Successful Completion of Technology Transfer and Initiation of IND-Enabling Manufacture of FT500
SAN DIEGO, Calif., Dec. 11, 2017 (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 IND-enabling production of FT500 has commenced at University of Minnesota, Molecular and Cellular Therapeutics, a state-of-the-art, FDA-registered Good Manufacturing Practice (GMP) facility. Jeffrey S. Miller, M.D., Professor of Medicine, Deputy Director of the Masonic Cancer Center, University of Minnesota presented an overview today at the 59th American Society of Hematology Annual Meeting and Exposition of the clinical translation of FT500, a first-of-kind natural killer (NK) cell cancer immunotherapy generated from a self-renewing clonal master pluripotent cell line (MPCL). The clonal MPCL was created from a single induced pluripotent stem cell (iPSC) using the Company's proprietary iPSC product platform. The Company expects to file an Investigation New Drug (IND) application in the first quarter of 2018 for the clinical testing of multiple dosing cycles of FT500 in combination with FDA-approved checkpoint inhibitor therapies for advanced solid tumors in the outpatient setting.
"Preclinical studies demonstrate that FT500 has direct anti-tumor activity and the capacity to secrete inflammatory cytokines and chemokines upon activation. This enables the cell product to potentially exploit both innate and adaptive immunity and elicit a broad, multi-targeted immune response against tumor cells by engaging a diverse set of stress ligands, recruiting a polyclonal T-cell population to the tumor site and augmenting T-cell activation in the tumor microenvironment," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "While checkpoint inhibitors have transformed the cancer therapy landscape by inducing long term remissions in multiple solid tumor indications, many tumor subtypes are resistant to checkpoint blockade therapy and non-responsiveness remains a significant concern. We thank the FDA for considering the unique therapeutic value of FT500 in combination with checkpoint inhibitors and its supportive feedback on our ongoing clinical translation and planned 1Q18 IND submission."
In November 2017, Fate Therapeutics received a Type B Pre-IND meeting written response from U.S. Food & Drug Administration (FDA) for FT500. The written response and subsequent FDA correspondence aligned the Company's approach to safety testing, product manufacture, quality assessment and clinical trial design in support of IND submission. FT500 is manufactured in a first-of-kind paradigm that uses a clonal MPCL as a renewable cell source for large-scale, cost-effective manufacture of a homogeneous NK cell product that can be reliably administered as a multi-dose, off-the-shelf cell product without patient matching restrictions. The Company estimates that a single manufacturing campaign conducted in one cGMP suite can yield hundreds of doses of up to 1x109 NK cells per dose. This novel approach to cell therapy has the potential to mediate safer, more effective pharmacologic activity, including in combination with cycles of other cancer treatments.
In preclinical studies conducted by the Company, FT500 displays multiple potential mechanisms by which it may synergize with T cells to activate the immune system in patients with tumors that are non-responsive to checkpoint inhibitors alone. FT500 has shown augmented secretion of cytokines and chemokines capable of enhancing T-cell activation in vitro. In addition, localized administration of FT500 into the peritoneal cavity results in the migration of circulating T cells into the peritoneal cavity. Finally, utilizing a three-dimensional tumor spheroid model in vitro, infiltration of activated T cells into tumor spheroids was significantly enhanced in the presence of FT500.
Fate Therapeutics has built an extensive intellectual property portfolio broadly covering the genomic engineering of iPSCs and off-the-shelf NK and T-cell cancer immunotherapies. Its proprietary portfolio includes compositions and methods for engineering iPSCs to modify their biological properties using CRISPR and other nucleases, and for manufacturing cells of all hematopoietic lineages from iPSCs including NK cells. In addition, the Company has an exclusive license from the University of Minnesota covering iPSC-derived NK cells expressing targeting receptors, including modified CD16 Fc receptors and chimeric antigen receptors for human therapeutic use.
About Fate Therapeutics' iPSC Product Platform
The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables large-scale generation of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity. 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 pluripotent cell line (MPCL). Similar to master cell lines used for the manufacture of monoclonal antibodies, clonal MPCLs can serve as a renewable cell source for the consistent and repeated manufacture of homogeneous cell products with the potential to treat many different diseases and many thousands of patients in an off-the-shelf manner. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 90 issued patents and 100 pending patent applications.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company's hematopoietic cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf product candidates derived from engineered induced pluripotent cell lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company's novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding its advancement of and plans related to the Company's research and development programs relating to off-the-shelf NK cell products and iPSC-derived cellular therapies, including the safety and therapeutic potential of iPSC-derived cellular therapeutics and FT500, the Company's progress and plans for its manufacturing of FT500, and the Company's expected product development and regulatory strategy, and associated timelines, for off-the-shelf NK cell products and 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, the risk that the Company may cease or delay development of any of its iPSC-derived product candidates, including any off-the-shelf NK cell products, for a variety of reasons (including requirements that may be imposed by regulatory authorities and requirements for regulatory approval, difficulties or delays in subject enrollment in planned clinical trials, difficulties in manufacturing and supplying any off-the-shelf NK cell products or any of the Company's other iPSC-derived product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that any iPSC-derived cell products developed, including any off-the-shelf NK cell products, may not be suitable for therapeutic applications and may not provide the anticipated therapeutic benefits. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time the Company's 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.
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