On November 11, 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 new clinical data for FATE-NK100, an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy, and provided a regulatory update on the development of FT500, a universal, off-the-shelf NK cell product candidate derived from a master induced pluripotent stem cell (iPSC) line, on November 10, 2018.
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Twenty heavily pre-treated subjects, each presenting with progressive disease at the time of enrollment, have been treated with FATE-NK100 in the dose-escalation phases of three Phase 1 clinical trials. As of a October 22, 2018 data cutoff, one-month follow-up data were available on fourteen subjects1, with clinical benefit indicated in seven of these fourteen subjects:
In the DIMENSION study for the treatment of advanced solid tumors (n=5 in the monotherapy regimen; n=1 in the monoclonal antibody combination regimen1), one subject at the second dose level (1-3×107 cells per kg) and two subjects at the third dose level (3-10×107 cells per kg) treated with a single intravenous infusion of FATE-NK100 in the monotherapy regimen had stable disease at one month. These two subjects at the third dose level were each subsequently treated with a second dose of FATE-NK100 and remain on study (3.1 and 5.0 months, respectively) with ongoing disease control. The study is currently enrolling at the third dose level in the monotherapy regimen, at the second dose level in the cetuximab combination regimen (1-3×107 cells per kg) and at the run-in dose level in the trastuzumab combination regimen (1×106 cells per kg).
In the APOLLO study for the treatment of recurrent ovarian cancer (n=4), one subject treated with a single intraperitoneal infusion of FATE-NK100 at the second dose level (1-3×107 cells per kg) had stable disease at one month. The subject was subsequently treated with a second dose of FATE-NK100 and maintained disease control for 6.2 months. The study is currently enrolling at the third dose level (3-10×107 cells per kg).
In the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia (n=4), all three subjects treated with a single intravenous infusion of FATE-NK100 at the second dose level (1-3×107 cells/kg) showed complete clearance of leukemic blasts in the bone marrow and achieved a morphologic leukemia-free state at Day 14 following treatment. Each of these three subjects received a single dose of FATE-NK100 only, and the anti-leukemic response in each of these subjects was transient. The study is currently enrolling at the second dose level.
No dose limiting toxicities related to FATE-NK100 were reported. One serious adverse event related to FATE-NK100 was reported (Grade 3: abdominal pain) in the APOLLO study.
"The safety and clinical benefit observed with a single infusion of FATE-NK100 as a monotherapy in heavily pre-treated cancer patients, including in refractory AML patients that have high leukemic blast burden in the marrow and in advanced solid tumor patients with progressive disease, are encouraging," said Sarah Cooley, M.D., Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the lead investigator of the VOYAGE study. "We are particularly excited that a repeat dose of FATE-NK100 was well-tolerated and showed persistence. Importantly, all three subjects re-treated with a second dose have demonstrated disease control. These data provide compelling proof-of-concept for FATE-NK100 and support earlier intervention with NK cell therapy using a multi-dose treatment cycle."
In addition, the Company announced that adventitious agents testing of the master iPSC bank for the clinical production of FT500, a universal, off-the-shelf NK cell product candidate, has been completed. The FT500 master iPSC bank was found to be free of adventitious agents as determined by in vivo and in vitro testing. The Company has submitted these results to the U.S. Food and Drug Administration (FDA) in furtherance of the agency’s review of the Company’s FT500 Investigational New Drug (IND) application. Upon allowance by the FDA of the FT500 IND, the Company plans to initiate Phase 1 clinical testing of FT500 as a monotherapy and in combination with checkpoint inhibitor therapy for the treatment of advanced solid tumors. This first-in-human study is expected to evaluate the safety and tolerability of multiple doses of FT500 in multiple dosing cycles.
An updated presentation on the Company’s NK cell cancer immunotherapy franchise can be found under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com.
1 Excludes one subject treated at the run-in dose level in the cetuximab combination regimen (1×106 cells per kg)
About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.