On December 11, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported preclinical data supporting the anti-tumor and immune evasion capabilities of allogeneic CAR T cells engineered with Sana’s proprietary hypoimmune (HIP) technology were presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, CA (Press release, Sana Biotechnology, DEC 11, 2023, View Source [SID1234638436]).
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"These data, indicating that HIP-modified CAR T cells are consistently able to avoid detection by the immune system while retaining their functionality and eliciting an anti-tumor effect, add to our learnings about and the opportunities for our allogeneic CAR T cell platform," said Terry Fry, MD, Sana’s Senior Vice President and Head of T Cell Therapeutics. "HIP-modified allogeneic CAR T cells remain well-tolerated in preclinical models. We look forward to initiating several additional clinical studies with our promising therapeutic candidates, with proof-of-concept data from multiple trials expected next year, including from SC291, our CD19-targeted HIP-modified CAR T cell therapy, and SC262. We also continue to develop our allogeneic CAR T cell pipeline, including our fully-human GPRC5D-targeted CAR T cell therapy."
On Sunday, December 10, abstract #3437 titled "Hypoimmune, Allogeneic CD22-Directed CAR T Cells That Evade Innate and Adaptive Immune Rejection for the Treatment of Large B Cell Lymphoma Patients That Are Relapsed/Refractory to CD19-Directed CAR T Cell Therapy" detailed preclinical data supporting the advancement of SC262, a CD22-directed HIP CAR T cell therapy, into human clinical studies. The results demonstrated that CD22 HIP CAR T cells evaded adaptive immune cell recognition and cytolysis through B2M and CIITA gene disruption and innate immune cell recognition through the overexpression of CD47. Furthermore, CD22 HIP CAR T cells elicited robust tumor control that produced cytokine/effector analytes and expanded in a dose- and antigen-dependent manner in vitro, with consistent effect across lots manufactured from different donors. CD22 HIP CAR T cells were well tolerated with no signs of graft-versus-host disease (GvHD). Sana submitted the investigational new drug (IND) application and intends to begin human testing of SC262 in early 2024.
On Sunday, December 10, abstract #3290 titled "Development of a Novel, Allogeneic GPRC5D-Directed CAR for Treatment of Multiple Myeloma Patients" outlined preclinical data demonstrating the characterization and candidate selection of fully-human GPRC5D-specific CARs for use in combination with HIP technology to develop an allogeneic GPRC5D CAR T cell therapy. The data showed that candidate GPRC5D CARs elicited in vitro cytotoxicity and effector cytokine production that is comparable to clinically validated benchmark control CARs. Additionally, these GPRC5D CAR T cells controlled multiple myeloma tumor cells both in vitro and in vivo, demonstrating efficacy that is on par with clinical benchmark GPRC5D CAR T cells.
About Hypoimmune Platform
Sana’s hypoimmune platform is designed to create cells ex vivo that can evade the patient’s immune system to enable the transplant of allogeneic cells without the need for immunosuppression. We are applying the hypoimmune technology to both donor-derived allogeneic T cells, with the goal of making potent and persistent CAR T cells at scale, and pluripotent stem cells, which can then be differentiated into multiple cell types at scale. Preclinical data published in peer-reviewed journals demonstrate across a variety of cell types that these transplanted allogeneic cells are able to evade both the innate and adaptive arms of the immune system while retaining their activity. Our most advanced programs utilizing this platform include an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program targeting CD22+ cancers, and stem-cell derived pancreatic islet cells for patients with type 1 diabetes.