Fate Therapeutics (NASDAQ: FATE) is developing clinical-stage cellular immunotherapies for cancer and immune disorders, with an opportunity in 2017 to broadly establish the leading NK (natural killer) cell clinical franchise
Fate Therapeutics (“FATE”) is a clinical‐stage biopharmaceutical company dedicated to the development of cellular immunotherapies for cancer and immune disorders. The Company’s product pipeline is comprised of NK‐ and T‐cell immuno‐oncology programs, including off‐the shelf product candidates derived from engineered induced pluripotent cell lines, and immunoregulatory programs, including product candidates to prevent life‐threatening complications in patients undergoing hematopoietic cell transplantation (HCT) and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company’s novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells.
FATE is advancing two clinical‐stage programs:
ProTmune. The Company is currently conducting a randomized, controlled, double blinded clinical trial of ProTmune, a next‐generation hematopoietic cell graft for the prevention of severe acute graft‐versus‐host disease (GvHD), in subjects with hematologic malignancies undergoing HCT. GvHD is the leading cause of early morbidity and mortality in patients undergoing HCT, and there are currently no FDA‐approved therapies for its prevention. The FDA has granted Fast Track designation, and the FDA and the European Medicines Agency have granted Orphan Drug Designation and Orphan Medicinal Product Designation, respectively, for ProTmune.
FATE‐NK100. The Company is executing a multi‐pronged clinical development strategy for FATE‐ NK100, a first‐in‐class adaptive memory natural killer cell cancer immunotherapy for the treatment of hematologic and solid tumor malignancies. FATE‐NK100 has safely advanced through the first two dose cohorts in the ongoing VOYAGE Phase 1 study for the treatment of refractory or relapsed acute myelogenous leukemia (AML). FATE is also enrolling patients in the APOLLO study of FATE‐NK100 for the treatment of women with ovarian cancer resistant to, or recurrent on, platinum‐based treatment and is initiating the DIMENSION study of FATE‐NK100 in combination with monoclonal antibody therapy for the treatment of advanced solid tumors.
In addition, FATE is advancing a preclinical pipeline of off‐the‐shelf cellular immunotherapies created from induced pluripotent stem cell (iPSC) lines for the treatment of cancer. Similar to the manufacture of therapeutic antibodies using master cell lines, the Company’s revolutionary iPSC platform utilizes master pluripotent cell lines to create off‐the‐shelf product candidates that are well‐defined and uniform in composition, can be renewably and reproducibly manufactured, and are capable of treating a large number of patients. FATE has formed key collaborations in support of this ‘one cell, many patients’ cancer immunotherapy approach, including with Dr. Jeffrey S. Miller at the University of Minnesota for the development of NK cell therapies and Dr. Michel Sadelain at Memorial Sloan Kettering Cancer Center for the development of T cell therapies.
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