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FATE

Fate Therapeutics

$16.33

-0.83 (-4.84%)

08:11
09/03/19
09/03
08:11
09/03/19
08:11

Fate Therapeutics announces FDA clearance of IND application for FT596

Fate Therapeutic announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for FT596, the Company's first off-the-shelf chimeric antigen receptor natural killer cell cancer immunotherapy which targets multiple tumor-associated antigens. FT596 is derived from a clonal master induced pluripotent stem cell line engineered with three functional modalities designed to optimize anti-tumor activity: a proprietary CAR targeting B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 Fc receptor; and an interleukin-15 receptor fusion. The Company plans to initiate clinical investigation of FT596 as a monotherapy and in combination with CD20-directed monoclonal antibodies for the treatment of B-cell lymphoma and chronic lymphocytic leukemia. FT596, which is the first cellular immunotherapy engineered with three active anti-tumor components cleared for clinical investigation by the FDA, is uniquely designed to overcome CD19 antigen escape. In addition to a proprietary CAR targeting CD19, FT596 expresses a novel hnCD16 Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity, enabling coincident targeting of CD19 and additional antigens such as CD20. FT596 also expresses IL-15RF, a potent cytokine complex that promotes survival, proliferation and trans-activation of NK cells and CD8 T cells without the need for systemic cytokine support. Together, these features of FT596 are intended to maximize potency and minimize toxicity in treated patients. FT596 is the third off-the-shelf, iPSC-derived NK cell product candidate from the Company's proprietary iPSC product platform cleared for clinical investigation by the FDA in less than one year. The Company is conducting first-in-human clinical trials of FT516, an off-the-shelf NK cell cancer immunotherapy engineered to express hnCD16, for the treatment of acute myeloid leukemia and B-cell lymphoma, and FT500, an off-the-shelf NK cell cancer immunotherapy, for the treatment of advanced solid tumors.

  • 04

    Sep

FATE Fate Therapeutics
$16.33

-0.83 (-4.84%)

07/22/19
CANT
07/22/19
INITIATION
Target $32
CANT
Overweight
Fate Therapeutics initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young started Fate Therapeutics with an Overweight rating and $32 price target. Fate is "pioneering a highly scalable" next-generation cell-therapy manufacturing process using induced pluripotent stem cells that could potentially be first in class, Young tells investors in a research note. She believes the company's off-the-shelf iPSC-based approach could be the "holy grail" of cell therapy.
08/07/19
WEDB
08/07/19
NO CHANGE
Target $26
WEDB
Outperform
Fate Therapeutics price target raised to $26 from $21 at Wedbush
Wedbush analyst David Nierengarten raised his price target for Fate Therapeutics to $26 from $21 as he sees the company's iPSC-derived, engineered cell therapy platform as increasingly de-risked, noting reported evidence of patients receiving multiple FT500 cell doses over consecutive treatment cycles in the outpatient setting without any dose-limiting toxicities, treatment-related SAEs, or early disease progression. The analyst reiterates an Outperform rating on the shares.
08/09/19
BTIG
08/09/19
INITIATION
BTIG
Buy
Fate Therapeutics initiated with a Buy at BTIG
08/09/19
BTIG
08/09/19
INITIATION
Target $27
BTIG
Buy
Fate Therapeutics initiated with a Buy at BTIG
BTIG analyst Amanda Murphy initiated Fate Therapeutics with a Buy rating and a price target of $27 as part of her broader research note on CAR-T cell therapy names developing "off-the-shelf" engineered cell therapeutics for oncology. The analyst is positive on the company's "decades of experience in iPS cell generation and cell derivation" as well as its licensed IP serving as a "competitive moat" as the industry matures.

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