On November 9, 2021 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Communications Committee selected an abstract featuring preclinical data from the Company’s FT538 and FT573 programs for showcase at the SITC (Free SITC Whitepaper) 2021 Annual Meeting Press Conference (Press release, Fate Therapeutics, NOV 9, 2021, View Source [SID1234594878]). The selected abstract entitled "Off-the-shelf, engineered iPSC-derived NK cells mediate potent cytotoxic activity against primary glioblastoma cells and promote durable long-term survival in vivo" will be presented by Jeffrey S. Miller, M.D., Professor of Medicine, University of Minnesota and Deputy Director, Masonic Cancer Center. The press conference is being held on Wednesday, November 10 from 12:30-2 pm ET.
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Dr. Miller’s presentation will describe the anti-tumor activity of the Company’s FT538 clinical product candidate as monotherapy and in combination with an NK cell engager targeting B7-H3, an immune checkpoint transmembrane protein overexpressed on many human cancer cells and commonly associated with poor prognosis. The presentation will also describe the integration of a novel chimeric antigen receptor (CAR) construct targeting B7-H3 into the master induced pluripotent stem cell (iPSC) line of FT538 to create the Company’s preclinical product candidate FT573, a B7-H3-targeted CAR NK cell incorporating multiple anti-tumor modalities.
In a recently published peer-reviewed article in Cell Stem Cell entitled "Harnessing features of adaptive NK cells to generate iPSC-derived NK cells for enhanced immunotherapy", FT538 was shown to share metabolic, transcriptional, and functional features with adaptive NK cells, a rare subset of NK cells with memory-like properties that have a genome-wide epigenetic profile and recall response that parallel cytotoxic effector CD8+ T cells. The published data demonstrate that FT538 exhibits significantly enhanced serial killing and functional persistence compared to peripheral blood NK cells. The superior anti-tumor activity of FT538 was attributable to its novel engineered components, including the knockout of CD38 and the expression of IL-15/IL-15R fusion protein, which were shown to improve metabolic fitness, increase resistance to oxidative stress, and induce a protein expression program that enhanced NK cell activation and effector function. The studies in the Cell Stem Cell publication were conducted as part of a collaboration between scientists at Fate Therapeutics and the laboratory of Dr. Miller, and were led by Frank Cichocki, Ph.D., University of Minnesota.
Investor Event Webcast and Conference Call
The Company will host a live audio webcast on Monday, November 15, 2021 at 4:30 p.m. ET to highlight its emerging pipeline of off-the-shelf, multiplexed-engineered, iPSC-derived NK cell programs for the treatment of solid tumors. In order to participate in the conference call, please dial (877) 303-6235 (domestic) or (631) 291-4837 (international) and refer to conference ID 2793475. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as 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 manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.
About FT538
FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636). FT538 is also being investigated in a multi-dose Phase 1 clinical trial in combination with one of an array of tumor-targeting monoclonal antibodies for the treatment of advanced solid tumors (NCT05069935).