Fate Therapeutics Announces Off-the-Shelf CAR T-cell Cancer Immunotherapy to be Featured at 2018 AACR Annual Meeting Press Program
Off-the-Shelf CAR T-cell Product Candidate Designed to Target CD19-positive Tumor Cells and to Overcome Antigen Escape
Manufacture from Master iPSC Line Enables Mass Production and Broad Accessibility without Patient Restriction
AACR Press Program to Begin Today at
The presentation of FT819 was accepted by AACR as a late-breaking abstract, and was subsequently selected by AACR to be featured at the AACR Annual Meeting press program being held today at
FT819 is an off-the-shelf CAR T-cell product candidate produced from a master induced pluripotent stem cell (iPSC) line. FT819 has two targeting receptors, a chimeric antigen receptor (CAR) targeting CD19-positive tumor cells and a CD16 Fc receptor that can engage other proven cancer therapies, such as tumor antigen-targeting monoclonal antibody (mAb)-based treatments, to overcome antigen escape.
In preclinical studies, FT819 exhibited an efficient cytotoxic T-cell response in vitro when challenged with CD19-positive tumor cells, displaying robust production of effector cytokines, including INF-gamma and TNF-alpha, and cytolytic proteins, including perforin and granzyme B. The product candidate’s activity was also found to be target-specific in vitro, attacking only CD19-positive tumor cells and sparing CD19-negative tumor cells. Additionally, when combined with a mAb-based treatment targeting CD20, FT819 was shown to elicit antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro against CD19-negative, CD20-positive tumor cells through CD16 engagement.
The master iPSC line used for the production of FT819 is engineered in a one-time event to insert CAR19 into the T-cell receptor α constant (
The data is also being presented by the Company in a poster session.
Presentation: Generation of off-the-shelf TCR-less CAR-targeted cytotoxic T cells from renewable pluripotent cells for cancer immunotherapy
Session: Late-Breaking Poster Session – Immunology
Time and Date:
Following presentation at the meeting, the AACR press program and poster presentations will be available on the Company’s website at www.fatetherapeutics.com.
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 consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of 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.
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s advancement of and plans related to its research and development of iPSC-derived cellular immunotherapies and off-the-shelf CAR T-cell products, including the safety and therapeutic potential of such therapies, the Company’s progress and plans for the manufacture and development of FT819, and the Company’s expected product development and regulatory strategy, and associated timelines, for its iPSC-derived cellular immunotherapies and off-the-shelf CAR T-cell products, including FT819. 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 results observed in prior preclinical studies of any of its iPSC-derived cellular immunotherapies, including any off-the-shelf CAR T-cell products, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay development of any of its iPSC-derived cellular immunotherapies, including any off-the-shelf CAR T-cell products, 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 any of the its iPSC-derived cellular immunotherapies, including any off-the-shelf CAR T-cell products, for preclinical or clinical testing, difficulties or delays in subject enrollment in planned clinical trials, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that any of its iPSC-derived cellular immunotherapies, including any off-the-shelf CAR T-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 the Company’s 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
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Source: Fate Therapeutics, Inc.