Sana Biotechnology, a leader in cell therapy innovation, has announced a major shift in its strategic priorities, reallocating resources from cancer research to autoimmune disease treatments. This shift includes halting its cancer-focused work on SC291, a CD19-directed allogeneic CAR-T cell therapy, to prioritize its application in autoimmune diseases—a decision expected to impact the company’s workforce.
In its latest update, Sana explained the move as part of a broader effort to stretch its cash reserves through 2026. The reallocation includes launching a phase 1 trial for SC291 as a treatment for B-cell-mediated autoimmune diseases, with initial data anticipated either later this year or in 2025. However, this change means pausing early-stage studies on SC291’s use for B-cell malignancies, despite promising early clinical data showing immune evasion and efficacy.
Sana’s Chief Scientific Officer, Dr. Dhaval Patel, explained that early clinical findings demonstrate SC291’s capacity to deplete B cells—a key factor in resetting the immune system for patients with conditions like lupus. This “immune reset” has shown meaningful clinical benefits, influencing the company’s choice to prioritize autoimmune applications over oncology.
The company cited growing competition in blood cancer therapies and uncertainties surrounding regulatory pathways as factors that contributed to its shift away from cancer for SC291.
As part of its restructuring, Sana is also discontinuing SC379, a glial progenitor cell therapy for central nervous system (CNS) disorders, and plans to seek partners or potentially spin off the program. The company’s new primary focus areas will include UP421, a promising treatment for Type 1 diabetes currently in phase 1 trials, with proof-of-concept data expected in late 2024 or 2025.
While Sana will scale back certain cancer programs, the company remains committed to cancer therapies with SC262, a CD22-directed allogeneic CAR-T treatment for patients with refractory B-cell malignancies, which is in a phase 1 trial. Additionally, Sana sees preclinical potential in SG299, an in vivo CAR-T therapy aimed at both autoimmune diseases and oncology, which uses CD8-targeted fusogen delivery of a CD19 CAR.
CEO Steve Harr underscored the promise of Sana’s hypoimmune platform, which has shown immune evasion capabilities across multiple therapeutic areas. Harr highlighted that this focused strategy, concentrating on Type 1 diabetes, SC291 in autoimmune diseases, and SC262 in refractory blood cancers, will allow Sana to present comprehensive clinical data over the next 12 to 18 months while helping to conserve resources.
However, Harr acknowledged the difficult realities of the pivot: “This adjusted strategy will also help reduce our cash burn but comes with the necessity of parting with some talented and valued colleagues.” Sana has not yet disclosed specific numbers on potential layoffs but hinted that further headcount reductions may be on the horizon.
This restructuring marks another phase in Sana’s journey of refining its pipeline and operations to ensure longevity and adaptability amid a competitive and evolving biotech landscape.