On December 1, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported the publication in Blood of an abstract providing initial clinical data from the first patient treated at the lowest dose in the ongoing ARDENT Phase 1 clinical trial with SC291, a hypoimmune (HIP)-modified allogeneic CD19-directed CAR T cell therapy (Press release, Sana Biotechnology, DEC 1, 2023, View Source [SID1234638094]). SC291 appeared safe and well tolerated, evaded immune detection, and induced a partial response in a patient with chronic lymphocytic leukemia (CLL). ARDENT is a Phase 1 study evaluating safety and tolerability of SC291 in patients with CLL and non-Hodgkin lymphoma. Treatment in this dose escalation study is ongoing, and the company expects to present more data from this study at a later date in an appropriate venue.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"These are the first clinical data demonstrating that our HIP technology can engineer allogeneic cells to evade adaptive and innate immune detection and rejection in the context of an intact immune system, overcoming the key challenge in unlocking the potential of allogeneic cells," said Gary Meininger, MD, Sana’s Chief Medical Officer. "These data suggest the potential of SC291 to persist and attack cancer cells in a manner consistent with autologous cells, which combined with scaled manufacturing, encourage us about both the opportunity for SC291 and our other HIP-modified cells to provide clinical benefit for patients. The data were published as part of an abstract submitted over the summer, and we look forward to sharing more data from this ongoing clinical trial that we expect will more clearly outline SC291’s profile."
The full abstract is available for online viewing at View Source
About SC291 in B-cell Lymphomas or Leukemias
SC291 is a hypoimmune, CD19-directed allogeneic CAR T cell therapy derived from healthy donor CD4+ and CD8+ T cells that are genetically engineered. SC291 is developed with Sana’s hypoimmune platform, which is designed to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune technology includes disruption of major histocompatibility (MHC) class I and MHC class II expression to allow cells to evade the adaptive immune system, which includes antibody and T cell responses, as well as overexpression of CD47 to evade the innate immune cell system, in particular macrophages and natural killer (NK) cells. The company has presented data across multiple preclinical models highlighting the potential of this platform to cloak cells from immune recognition and the potential of SC291 as a therapeutic for patients with B-cell malignancies. SC291 is being evaluated in a Phase 1 study called ARDENT for patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).
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.