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Fate Therapeutics Inc (FATE)

  • Event
  • June 30, 2022, 20:06 UTC

(10% Negative) FATE THERAPEUTICS, INC. (FATE) Announces Delay in innovation Trials for Solid Tumors San Diego Due to Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Oct. 2, 2025, 11:13 a.m.

    📋 FATE THERAPEUTICS, INC. (FATE) - Clinical Trial Update

    Filing Date: 2022-06-30

    Accepted: 2022-06-30 16:06:42

    Event Type: Clinical Trial Update

    Event Details:

    Fate Therapeutics Inc (FATE) Announces Clinical Trial Update Fate Therapeutics Inc (FATE) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: innovation, Pharmaceutical
    • Diseases/Conditions: Solid Tumors San Diego, solid tumors
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Regulatory Process
    • Collaboration: Fate Therapeutics, Inc.
      • targeting an initial solid tumor antigen, and Fate is currently conducting preclinical development of a multiplexed-engineered, iPSC-derived CAR T-cell product candidate for solid tumors. “Our collaboration with ONO has focused on driving innovation in the field of cell therapy for solid tumors, and we are excited by the preclinical data we have observed with our first iPSC-derived CAR T-cell product candidate,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “We are impressed with the differentiated antigen binders that ONO has contributed to the partnership, and we are pleased to expand our collaboration to initiate preclinical development of collaboration products targeting a second solid tumor antigen.” Under the terms of the amended Collaboration and Option Agreement, Fate will advance iPSC-derived CAR NK and CAR T-cell product candidates to a pre-defined preclinical milestone, at which point ONO has an option to assume responsibility for worldwide development and commercialization with Fate retaining the right to jointly develop and commercialize in the United States and Europe. Fate retains all rights of manufacture of collaboration products on a global basis. “The first multiplexed-engineered, iPSC-derived CAR T-cell product candidate under our collaboration with Fate Therapeutics incorporates multiple mechanisms of action designed to specifically address solid tumors and is successfully advancing toward clinical development,” said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of ONO. “Based on the collaboration progress and Fate’s proven ability to develop innovative product candidates, we are excited to expand our collaboration to include a second solid tumor target and to continue our work with Fate in developing first-in-class, off-the-shelf CAR NK and CAR T-cell therapies for cancer patients.” Fate will continue to receive committed research funding from ONO during the preclinical option period, and is eligible to receive a preclinical option exercise fee as well as clinical, regulatory and commercialization milestone payments from ONO in connection with the development and commercialization of each product candidate. In addition, Fate is eligible to receive tiered royalties on net sales by ONO of each product candidate in the ONO territory. 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 are designed to 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 designed to overcome 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 Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Fate Therapeutics Forward-Looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995
      • targeting a second solid tumor antigen. Under the original Collaboration and Option Agreement entered into between Fate and ONO in September 2018

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Fate Therapeutics Inc
    • CIK: 0001434316
    • Ticker Symbol: FATE
    • Period End Date: 2022-06-28
    • Document Type: 8-K

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