On April 16, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company is presenting new preclinical data on FT819, its off-the-shelf CAR T-cell product candidate, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from April 14-18, 2018 in Chicago, Illinois (Press release, Fate Therapeutics, APR 16, 2018, View Source [SID1234525343]).

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The presentation of FT819 was accepted by AACR (Free AACR Whitepaper) as a late-breaking abstract, and was subsequently selected by AACR (Free AACR Whitepaper) to be featured at the AACR (Free AACR Whitepaper) Annual Meeting press program being held today at 8:30 a.m. CT.
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. Fate Therapeutics is developing FT819 as part of a research collaboration being led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center.

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 (TRAC) locus for enhanced safety and potency and to completely eliminate T-cell receptor (TCR) expression. The line serves as 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. This approach eliminates the need to create a personalized therapy from a patient’s own cells, enables mass production at scale and significantly reduces the cost of, and time to, patient treatment.
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:8:00 a.m. – 12:00 p.m. CT, Monday, April 16, 2018
Location:McCormick Place South (Level 3), Exhibit Hall A, Section 45, Poster LB-108 / 5
Following presentation at the meeting, the AACR (Free AACR Whitepaper) press program and poster presentations will be available on the Company’s website at www.fatetherapeutics.com.