Fate Therapeutics announces dose-escalation clinical data of FATE-NK100
Fate Therapeutics announced new clinical data for FATE-NK100, an investigational, first-in-class, allogeneic donor-derived natural killer 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 line, on November 10, 2018. 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 subjects, with clinical benefit indicated in seven of these fourteen subjects: In the DIMENSION study for the treatment of advanced solid tumors, one subject at the second dose level and two subjects at the third dose level 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 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 and at the run-in dose level in the trastuzumab combination regimen. In the APOLLO study for the treatment of recurrent ovarian cancer, one subject treated with a single intraperitoneal infusion of FATE-NK100 at the second dose level 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. In the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia, all three subjects treated with a single intravenous infusion of FATE-NK100 at the second dose level 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 in the APOLLO study. 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 in furtherance of the agency's review of the company's FT500 Investigational New Drug 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.