Feb 20 2018

Fate Therapeutics Announces First Subject Treated with FATE-NK100 in DIMENSION Study for Advanced Solid Tumors

First Clinical Trial Investigating the Combination of Allogeneic Donor NK Cell Therapy and FDA-Approved Targeted Monoclonal Antibody Therapy for Solid Tumor Malignancies

SAN DIEGO, Feb. 20, 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 that the first subject has been treated in the DIMENSION study of FATE-NK100 for the treatment of advanced solid tumors. The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, allogeneic donor-derived adaptive memory natural killer (NK) cell cancer therapy, when administered as a monotherapy and in combination with trastuzumab or cetuximab, two FDA-approved targeted monoclonal antibody therapies that are widely used today to treat various cancers.

“Patients with cancer often have deficient or dysfunctional natural killer cells. The co-administration of FATE-NK100 alongside a targeted monoclonal antibody therapy is a novel approach to restore a patient’s immune cell function and to selectively recognize and kill antibody-coated tumor cells,” said Manish R. Patel, D.O., Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. “We are excited to have initiated what we believe to be the first clinical investigation of healthy allogeneic donor NK cell therapy in combination with FDA-approved monoclonal antibody therapy for solid tumor malignancies. This new treatment paradigm holds great promise for cancer patients who have progressed on or failed monoclonal antibody therapy and have no other therapeutic options.”

Monoclonal antibodies are a well-established class of cancer immunotherapy agents designed to selectively target and bind to proteins on the surface of tumor cells. Compelling clinical data indicate that NK cells mediate the therapeutic effect of monoclonal antibody therapy by recognizing and efficiently killing antibody-coated tumor cells via a potent immune response mechanism known as antibody-dependent cellular cytotoxicity (ADCC). The combination of FATE-NK100 and monoclonal antibody therapy is designed to enhance ADCC by administering an activated population of healthy allogeneic donor NK cells to augment the killing of antibody-coated tumor cells. It is estimated that the worldwide market for cancer monoclonal antibodies is over $30 billion, and is poised to reach $45 billion by the end of 2020.

DIMENSION is the third clinical trial of FATE-NK100 currently being conducted. FATE-NK100 is also being clinically investigated in the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia and in the APOLLO study for the treatment of ovarian cancer resistant to, or recurrent on, platinum-based treatment.

DIMENSION is a multi-center, open-label, accelerated dose-escalation Phase 1 clinical trial of FATE-NK100 in subjects with advanced solid tumors who have progressed on or failed available approved therapies. The clinical trial is designed to evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 when administered as a monotherapy and in combination with monoclonal antibody therapy after outpatient lymphoconditioning therapy followed by sub-cutaneous IL-2 administration. Other endpoints to be assessed include objective response rates and progression-free and overall survival.

The clinical trial is being conducted across three independent treatment arms: (i) as a monotherapy for advanced solid tumor malignancies, including small cell lung cancer and hepatocellular carcinoma; (ii) in combination with trastuzumab for advanced human epidermal growth factor receptor 2 positive (HER2+) cancers, including breast and gastric cancers; and (iii) in combination with cetuximab for advanced epidermal growth factor receptor 1 positive (EGFR1+) cancers, including colorectal and head and neck cancers. In the combination arms, subjects will receive the monoclonal antibody therapy two days prior to and seven days following administration of FATE-NK100. Subjects with evidence of tumor shrinkage at Day 29 following administration of FATE-NK100 may be considered for retreatment.

Up to three dose levels in the monotherapy arm, and up to four dose levels in the monoclonal antibody therapy arms, of FATE-NK100 are intended to be assessed. In the event a dose limiting toxicity is observed in an arm, the arm will convert to a 3+3 design. Following dose escalation, expansion cohorts of 20 subjects per arm may be enrolled.

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 feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy allogeneic 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 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 generating 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 other NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies. 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 to promote immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

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 cancer, including as a monotherapy and in combination with monoclonal antibody therapy for solid tumor malignancies. 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.