On November 4, 2024 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported it will prioritize future development activity for SC291, the company’s CD19-directed allogeneic CAR T cell therapy, in B-cell mediated autoimmune diseases (AID) (Press release, Sana Biotechnology, NOV 4, 2024, View Source [SID1234647669]). The company will suspend development of both SC291 in oncology and of SC379, its glial progenitor cell program, as it seeks partnerships for these programs. Sana will increase its investment in its type 1 diabetes program with the cash savings from these changes.

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"Early clinical data with our hypoimmune platform (HIP) suggest HIP-modified cells evade immune detection, giving us confidence in the potential of the platform across multiple therapeutic areas. At the same time, we need to ensure that we are directing our investments into the areas where we believe we can have the greatest impact for patients," said Steve Harr, Sana’s President and Chief Executive Officer. "Greater focus on type 1 diabetes, SC291 in AID, and SC262 in refractory blood cancers will enhance our ability to present robust clinical data over the next twelve to eighteen months. This modified strategy will also help us reduce our cash burn but comes with the necessity of parting with some talented and valued colleagues. We thank them for their contributions toward building Sana and thank the patients who have been treated in the SC291 oncology study."

With these changes, Sana extends its expected cash runway into 2026. Payments related to ongoing activities combined with the reduction in force may increase the 2024 operating cash burn above prior guidance of less than $200 million.

"Since joining Sana, I have actively engaged with the team to understand both Sana and competitor data and believe it is the right time to prioritize where we believe we have the most differentiated therapeutic candidates and the highest probability of success for patients," said Dhaval Patel, M.D., Ph.D., Chief Scientific Officer of Sana. "Type 1 diabetes is a significant unmet need, and we are optimistic that our program is novel and has the potential to offer patients meaningful benefit. The decision to prioritize SC291 in B-cell mediated autoimmune diseases is based on early clinical data with this drug in both oncology and autoimmune diseases, which show that therapy with SC291 can predictably lead to the deep B cell depletion that appears to drive an immune "reset" and significant clinical benefit in patients with B-cell mediated autoimmune diseases such as lupus. We look forward to generating and sharing more data from across our portfolio."

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UP421 (HIP-modified primary pancreatic islet cells) in type 1 diabetes: The investigator-sponsored trial exploring the potential of HIP modifications to allogeneic primary islet cells to enable immune evasion and overcome transplant rejection in type 1 diabetes is active; Sana expects to share proof of concept data in 2024 and/or 2025.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases: Sana continues enrollment in the Phase 1 GLEAM trial for SC291 for the treatment of B-cell mediated autoimmune diseases and expects to share clinical data in 2024 and/or 2025.

SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology: Sana continues enrollment in the Phase 1 VIVID study for patients with refractory B-cell malignancies who have failed a previous CD19-directed CAR T therapy and expects to share data in 2025.

SC451 (HIP-modified stem cell-derived pancreatic islet cells) in type 1 diabetes: Sana continues preclinical development of this HIP-modified, stem-cell derived therapy for patients with type 1 diabetes.

SG299 (in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR): Sana is continuing its preclinical development of this program, with potential in both B-cell mediated autoimmune diseases and oncology.

SC291 (HIP-modified CD19-directed allogeneic CAR T) in oncology: Given alternative opportunities within its pipeline as well as increased competition within blood cancers and uncertainty about the best path to regulatory and commercial success, Sana is halting enrollment and further internal investment in the Phase 1 ARDENT trial. It is actively seeking a licensing partner to support advancement.

SC379 (stem-cell derived glial progenitor cells) in various CNS diseases: Sana will actively seek a partner or opportunity to spin out this program into a new company.