Fate Therapeutics Announces First Subject Treated with FATE-NK100 in DIMENSION Study for Advanced Solid Tumors
“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
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
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.
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
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
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Source: Fate Therapeutics, Inc.