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Fate (FATE) Announces Encouraging Data on Immunotherapies

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Shares of Fate Therapeutics, Inc. FATE surged 41.3% after the company came out with positive data on experimental cancer candidates.

The company announced initial clinical data on its candidates — FT516 and FT500. Both are off-the-shelf, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell product candidates.

FT516 is being investigated in an open-label, multi-dose phase I clinical study as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-directed monoclonal antibodies for the treatment of advanced B-cell lymphoma. The initial findings show the absence of morphologic evidence of leukemia (at day 42) along with complete neutrophil recovery in the first patient treated with FT516 monotherapy for AML following the first dosing cycle.

FT500 is the first iPSC-derived cell product candidate from the iPSC product platform. The study on FT500 is an open-label, multi-dose phase I trial being conducted for the treatment of advanced solid tumors. The dose-escalation stage of the study is designed to assess the safety and tolerability of three once-weekly doses of FT500, without IL-2 cytokine support, as a monotherapy and in combination with one of the three FDA-approved immune checkpoint inhibitor (ICI) therapies in patients who have failed prior ICI therapy.

Initial data showed that there were no dose-limiting toxicities or FT500-related serious adverse events reported in the first 12 patients treated with the candidate for advanced solid tumors.

The safety, tolerability and immunogenicity profile from the phase I dose-escalation stage of FT500 was favorable and provided evidence that multiple doses of iPSC-derived NK cells can be delivered off the shelf and administered without patient matching.

Fate’s stock has soared 50.6% in the year so far compared with the industry's growth of 6.1%.

The company also announced new in vivo preclinical data for FT596, its off-the-shelf, multi-antigen targeting NK cell product candidate derived from a clonal master engineered iPSC line.

FT596 as a monotherapy demonstrates comparable anti-tumor activity to CAR19 T Cells in vivo in the humanized mouse model of lymphoma. The combination of FT596 with rituximab shows durable tumor clearance in the preclinical lymphoma model. The company plans to initiate enrollment of a first-in-human clinical study on FT596 in early 2020.

The data bode well for this clinical-stage biopharmaceutical company.

Cellular immunotherapies promise huge potential. Hence, companies like Gilead Sciences, Inc. GILD, bluebird bio BLUE and Bristol-Myers Squibb Company BMY are currently focusing on the development of cellular immunotherapies for the treatment of cancer.

Fate currently carries a Zacks Rank #3 (Hold) You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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