Fate Therapeutics Inc. (NASDAQ: FATE) shares jumped on Monday after the firm announced new preclinical data for its off-the-shelf, multi-antigen targeting natural killer cell product candidate derived from a clonal master engineered induced pluripotent stem cell (iPSC) line at the American Society of Hematology (ASH) annual meeting.
FT596 is the first cellular immunotherapy engineered with three active antitumor components to be cleared for clinical investigation by the FDA.
New preclinical data presented at ASH showed that FT596 administered as a monotherapy exhibited durable tumor clearance and extended survival in vivo similar to primary CAR T cells in a humanized mouse model of CD19+ lymphoma.
Additionally, when combined with the anti-CD20 monoclonal antibody rituximab, FT596 showed enhanced killing of CD20+ lymphoma cells in vivo as compared to rituximab alone. These results confirm previously presented positive in vitro findings.
Bob Valamehr, Ph.D., chief development officer of Fate Therapeutics, commented:
Current patient- and donor-specific CAR T-cell immunotherapies recognize only one antigen and fail to address the significant risk of relapse due to antigen escape. FT596 is ground-breaking in that it is designed to be available off-the-shelf for timely patient access and to promote deeper and more durable responses by targeting multiple tumor-associated antigens. Additionally, since FT596 is manufactured from a renewable master engineered iPSC line, the complexities of patient-by-patient genetic engineering and production are greatly reduced and, for the first time, we are able to mass produce multi-functional cellular immunotherapies in a uniform and cost-effective manner.
Looking ahead, the company plans to initiate enrollment of a first-in-human clinical trial of FT596 in early 2020.
Shares of Fate Therapeutics traded up about 38% to $18.88 on Monday, in a 52-week range of $11.00 to $22.82. The consensus price target is $24.80.