Sana Biotechnology has become the latest cell therapy biotech to shift resources from cancer to autoimmune diseases as part of a strategic refocus that sounds likely to include a side order of layoffs.
Under plans to extend the company’s cash runway into 2026, Sana said it has halted development of its CD19-directed allogeneic CAR T-cell therapy, dubbed SC291, in cancer and will instead focus the asset on B-cell mediated autoimmune diseases.
A phase 1 trial of the hypoimmune platform (HIP)-modified SC291in B-cell-mediated autoimmune diseases is due to read out some initial clinical data either later this year or in 2025. The changes mean the company will halt an early-stage study in B-cell malignancies, which it claimed in the summer had demonstrated SC291’s “desired immune evasion profile and early clinical efficacy.”
In a post-market release Oct. 4, Sana’s chief scientific officer Dhaval Patel, M.D., Ph.D., said the decision to prioritize SC291 in autoimmune diseases over oncology was based on data from both of those trials.
“Early clinical data … show that therapy 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,” Patel added.
Sana also blamed “increased competition within blood cancers and uncertainty about the best path to regulatory and commercial success” as reasons for stopping the SC291 oncology trial.
The strategic restructuring will see Sana end work on its pluripotent stem cell-derived glial progenitor cell product, dubbed SC379, which was in preclinical development for central nervous system disorders.
The biotech said it would seek partners for both programs and also alluded to the possibility of spinning out the glial progenitor cell work into a separate company.
A top funding priority for the rejigged company will be UP421, HIP-modified cells currently being evaluated in a phase 1 study in Type 1 diabetes that is due to read out proof-of-concept data either later this year or in 2025.
Sana isn’t giving up on cancer completely, though. The company said it will continue with SC262, a CD22-directed allogeneic CAR T currently in a phase 1 study for patients with refractory B-cell malignancies who have failed a previous CD19-directed CAR T therapy. Data are due next year.
Sana also sees potential for the preclinical SG299, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR, to be used against both autoimmune diseases and oncology.
“Early clinical data with our hypoimmune platform suggest HIP-modified cells evade immune detection, giving us confidence in the potential of the platform across multiple therapeutic areas,” Sana’s CEO Steve Harr said in the release.
“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 12 to 18 months,” Harr added. “This modified strategy will also help us reduce our cash burn but comes with the necessity of parting with some talented and valued colleagues.”
When asked by Fierce Biotech for details of how many employees are likely to be impacted by the changes, a spokesperson for Sana said the company is “working on the exact number and timing of exits” with “all functions affected.”
Sana is no stranger to tweaking its pipeline and head count to conserve cash, including on two occasions last year that saw the Seattle-based biotech pulling back from its in vivo delivery platform among other assets.