Fate Therapeutics Announces Exclusive License Agreement with Baylor College of Medicine for Rejection-resistant iPSC-derived Cellular Therapies
License Covers First-in-class Alloimmune Defense Receptors Designed to Protect Allogeneic Cells from Rejection in Immunocompetent Recipients
Preclinical Data Published in the Journal Nature Biotechnology Demonstrate Allogeneic CAR T Cells Overcome Immune Rejection and Exhibit Durable Tumor Eradication
“Allogeneic cell therapy requires a patient to endure systemic lympho-conditioning to suppress the immune system and mitigate cellular rejection, often resulting in severe blood cell deficiencies and related toxicities. There is great interest in strategies that enable allogeneic cells to overcome host immunity and evade immune rejection while maintaining a patient’s functional hematopoietic system,” said
ADRs are synthetic receptors that selectively recognize cell surface receptors, such as 4-1BB, that are uniquely expressed on activated lymphocytes, which are responsible for host immune rejection. The published preclinical findings show that the arming of allogeneic T cells with an ADR selectively eliminates alloreactive T and NK cells, while sparing resting lymphocytes. Importantly, in in vivo preclinical models of cancer, allogeneic T cells expressing both an ADR and a CD19-targeted chimeric antigen receptor (CAR) demonstrated increased expansion and persistence, resulting in sustained tumor eradication and a long-term survival benefit compared to conventional CD19-targeted CAR T cells.
“There is tremendous promise for the use of off-the-shelf allogeneic cells as replacement therapy. One of the most significant barriers to overcome is host immunity, which can prevent the engraftment of allogeneic cells and the long-term replacement of a patient’s damaged or dysfunctional cells,” said Maksim Mamonkin, Ph.D., Assistant Professor,
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 cycles of 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 300 issued patents and 150 pending patent applications.
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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 advancement of and plans related to the Company’s NK and T-cell product candidates and preclinical research and development programs, and the scope and enforceability of the Company’s intellectual property portfolio. 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 that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of its product candidates may not be replicated in ongoing or future clinical trials or studies, the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that any of the patents owed or licensed by the Company may be challenged and that such a challenge may be successful, resulting in loss of any such patent or loss or reduction in the scope of one or more of the claims of a challenged patent. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s 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.