Mar 29 2018

Fate Therapeutics Announces Initial Clinical Data of FATE-NK100 for Recurrent Ovarian Cancer at the Innate Killer Summit 2018

Stable Disease with Tumor Shrinkage Reported in Subject 2 Following Single Dose of NK100

SAN DIEGO, March 29, 2018 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today 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. 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.

“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 (2x107 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 (1x107 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 (≥3x107 cells/kg to 1x108 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.

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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell therapies using its proprietary induced pluripotent stem cell (iPSC) product platform. This platform uniquely enables the single-cell selection of a precisely engineered iPSC clone and the subsequent creation and maintenance of a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of many thousands of patients in an off-the-shelf manner. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit

Forward-Looking Statements 
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the safety and therapeutic potential of NK cells including FATE-NK100, the expected clinical development plans for FATE-NK100, and the potential of FATE-NK100 to treat patients with hematologic and solid tumor malignancies, including relapsed refractory acute myeloid leukemia (AML) and recurrent ovarian cancer. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of cessation or delay of planned development and clinical activities for a variety of reasons (including any delay in enrolling patients in clinical trials, or the occurrence of any adverse events or other results that may be observed during development), the risk that results observed in prior preclinical studies and current clinical trials of FATE-NK100 may not be replicated in current or future clinical trials, and the risk that FATE-NK100 may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time the Company’s other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Christina Tartaglia
Stern Investor Relations, Inc.

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Source: Fate Therapeutics, Inc.