On March 29, 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 initial clinical data from the ongoing APOLLO Phase 1 study of FATE-NK100 as a monotherapy following outpatient chemotherapy for the treatment of women with ovarian cancer resistant to, or recurrent on, platinum-based treatment (Press release, Fate Therapeutics, MAR 29, 2018, View Source [SID1234525382]). No dose-limiting toxicities were reported in either of the two subjects receiving NK100, the Company’s first-in-class, donor-derived adaptive memory natural killer (NK) cell cancer immunotherapy. Additionally, the Day 28 response evaluation for Subject 2 following a single intraperitoneal infusion of NK100 showed stable disease with evidence of tumor reduction.

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"We are very encouraged by our initial clinical observations of FATE-NK100 in heavily pre-treated patients with recurrent ovarian cancer," said Melissa Geller M.D., Associate Professor of Gynecologic Oncology, Department of Obstetrics, Gynecology and Women’s Health at the University of Minnesota and Principal Investigator of the APOLLO clinical trial at the Masonic Cancer Center. "Currently approved single-agent therapies for platinum-resistant ovarian cancer typically have low response rates and short median progression-free survival. The administration of NK100 directly within the peritoneal cavity is a novel therapeutic strategy to potentially improve these dismal outcomes."
Subject 2 enrolled with platinum-resistant stage III fallopian tube carcinoma having been treated with five prior lines of therapy and most recently progressing following three cycles of Avastin (bevacizumab) plus Cytoxan (cyclophosphamide) and 12 cycles of Zejula (niraparib). Stable disease with evidence of tumor reduction was observed at Day 28 following a single intraperitoneal infusion of NK100 (2×107 cells/kg). The subject elected to receive a second infusion of NK100. Both doses were well-tolerated and persistence of each dose was observed in the intraperitoneal cavity at two weeks following infusion.

The data were featured in an oral presentation by Jeffrey S. Miller, M.D., Professor of Medicine, Deputy Director of the Masonic Cancer Center, University of Minnesota at the Innate Killer Summit 2018 being held in San Diego, CA, March 28-29, 2018.

"We continue to be impressed with the safety profile and enhanced persistence of FATE-NK100. These data in ovarian cancer reinforce our experience with NK100 in the VOYAGE study for relapsed refractory AML and strengthen our conviction that NK100 is capable of addressing a broad range of tumors, including those that are known to be unresponsive to current immunotherapies," said Dr. Miller.
Longer-term follow-up assessments of response are pending for Subject 2. Subject 1 enrolled at the first dose level (1×107 cells/kg) with platinum-resistant ovarian cancer having failed five prior lines of therapy, and showed progressive disease at Day 28 follow-up. APOLLO is currently enrolling at the third dose level (≥3×107 cells/kg to 1×108 cells/kg). Ten subjects are expected to be enrolled at the maximum dose level.

About Ovarian Cancer
Ovarian cancer is the fifth leading cause of cancer-related death among women and is the deadliest of gynecologic cancers. The American Cancer Society estimates that in 2017, about 22,440 new cases of ovarian cancer will be diagnosed and 14,080 women will die of ovarian cancer in the United States. While a high proportion of women respond to initial platinum-based chemotherapy, around 70% of patients diagnosed with ovarian cancer will have a recurrence. While recurrent ovarian cancer is treatable, it is rarely curable and there is a significant need for more effective, better-tolerated therapies.

About FATE-NK100
FATE-NK100 is a 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 preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence, enhanced antibody-dependent cellular cytotoxicity and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a seven-day, feeder-free manufacturing process during which NK cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators. 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.
About APOLLO

APOLLO is an ongoing open-label, accelerated dose-escalation, Phase 1 clinical trial of FATE-NK100 in women with ovarian, fallopian tube or primary peritoneal cancer resistant to, or recurrent on, platinum-based treatment. The primary objective of the clinical trial is to assess the safety and determine the maximum dose of a single infusion via intraperitoneal catheter of FATE-NK100 as a monotherapy when administered after outpatient chemotherapy followed by a short course of intraperitoneal IL-2 infusion. Up to three dose levels of FATE-NK100 are intended to be assessed, proceeding in cohorts of one subject per dose level until a dose-limiting toxicity is observed. A total of ten subjects are expected to be enrolled at the maximum dose level. Other endpoints include objective response rates at 28 days and progression-free and overall survival at six months. The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota as an investigator-initiated study.