So-called off-the-shelf cell therapies may be one of the hotter areas of biotech right now, but that doesn’t mean these companies are immune to the wave of layoffs spreading across the sector. The latest is Sana Biotechnology, which is letting go of 15% of its workforce and discontinuing development of a heart failure drug.
The Seattle-based biotech will end further investment in its SC187 program, which was investigating the use of heart cells called cardiomyocytes to treat heart failure. Sana will also stage-gate certain investments in its other platforms based on how the assets perform in the clinic.
The pared-back workforce and investment strategy should give the company a cash runway to invest in key clinical programs over “the next several years,” Sana said in a post-market release Tuesday.
The focus of Sana’s second allogeneic CAR-T program will now be SC263, which aims to use an off-the-shelf CAR-T therapy to treat the more than 50% of patients whose cancer relapses or isn’t effectively treated with an approved autologous CAR-T therapy that targets the CD19 protein.
SC263, a CD22-directed CAR construct that has been modified using Sana’s HIP platform, has led to a complete response in over 50% of patients whose CD19-targeted CAR-T therapy has failed, the company said. The biotech expects to file a request next year to enter the program into U.S. clinical trials.
All approved CAR-Ts to date are what are called autologous treatments, meaning they are based on donations of a patient’s own cells. An up-and-coming class of CAR-Ts in various stages of clinical testing is known as allogeneic, or off-the-shelf, therapies, because they use engineered cells collected from a third party.
“We are making significant progress with our platforms to address two of the fundamental opportunities to enable greater utilization of cell engineering to treat serious diseases—overcoming immune rejection of allogeneic cells and in vivo delivery of gene modification reagents in a cell-specific manner,” said CEO Steve Harr, M.D. “We look forward to generating human proof-of-concept starting next year and are positioning the company to invest fully based upon the clinical data.”
Sana still plans to file a request this year to enter its SC291 program into clinical trials for a number of B-cell malignancies. The company also remains on track to submit a trial request next year for SG295, an in vivo CAR-T with CD8-targeted fusogen delivery of a CD19-targeted CAR, while a BCMA-targeting allogeneic CAR-T is further back in development.
And while the company has given up on using cardiomyocytes, it still has plans for modifying other cell types. Preclinical work is ongoing on a hematopoietic stem-cell-targeted fusosome to treat sickle cell disease as well as a stem-cell-derived pancreatic islet cell therapy for patients with Type 1 diabetes.
Having gone public with a $587 million IPO only last year, Sana’s latest announcement is a reminder of the straightened financial environment that biotechs are operating in, whatever their specialty. In a common trajectory, the company’s stock was trading at $4.71 at market close yesterday, a steep drop from the almost $40 share price Sana entered the public markets with in February 2021.
Perhaps the company can take comfort in the fact that it isn’t the only T-cell-focused biotech forced to trim its workforce and pipeline this month. Earlier in November, Adaptimmune announced 30% layoffs as well as the culling of its tumor-infiltrating lymphocytes IL-7 program.