Sana Cuts Workforce, Increases Focus on Four Hypoimmune-Related Programs

Rare Daily Staff

Sana Biotechnology, a company focused on creating and delivering engineered cells as medicines for patients, gave a portfolio update that included an increased focus on its ex vivo cell therapy product candidates and the submission of an application to begin human clinical testing for SC291 in autoimmune diseases.

As part of the company’s pipeline prioritization, which is expected to reduce cash burn moving forward, Sana said it would cut 29 percent of its employees, or about 120 people. The workforce reduction is the second this year for the company, which has raised more than $1 billion in private and public capital.

Sana said the strategic repositioning of the company will focus on generating clinical proof of concept from multiple programs in 2023 and 2024, with a goal of better understanding its allogeneic HIP CAR T programs in blood cancers, allogeneic HIP CAR T program in autoimmune diseases, and HIP pancreatic islet cells in type 1 diabetes. The company will reduce near-term spending on its fusogen platform for in vivo gene delivery, postponing the planned SG299 IND, to decrease its expected forward operating burn.

“The SC291 IND submission for the treatment of autoimmune diseases positions us to move into the rapidly emerging opportunity of utilizing CAR T cells in these large and underserved populations, leveraging the investments we have made to date in the HIP platform, T cell therapeutics, and scaled manufacturing that can produce hundreds of patient doses per run,” said Steve Harr, president and CEO of Sana. “We need to ensure that we have a financeable cost structure with these emerging opportunities factored in, and this strategic repositioning enables us to deliver significant clinical data across multiple drug candidates with the current balance sheet.”

SC291 is currently being evaluated in Sana’s ARDENT phase 1 study for the treatment of B-cell lymphomas and leukemias with clinical data expected in 2023 and 2024. Sana also submitted an IND for SC291 for the treatment of multiple autoimmune diseases, with preliminary clinical data expected across multiple indications in 2024. Sana expects to submit an IND for SC262 by the end of 2023 for the treatment of B-cell lymphomas and leukemias in patients who have failed CD19-directed CAR T therapies, with preliminary clinical data expected in 2024.

The company has submitted a CTA for its HIP-modified primary islet cells for the treatment of type 1 diabetes to begin an 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 with proof-of-concept data expected in 2023 and 2024.

Sana will reduce near-term investment on its fusogen in vivo delivery platform clinical and preclinical programs, including delaying and IND for SG299, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR. Development of other in vivo preclinical assets will be put on hold.

The changes are expected to reduce Sana’s operating cash burn in 2024 to be below $200 million, allowing the current cash position to extend further into 2025. The strategic re-positioning will reduce headcount by 29 percent while allowing the company to invest in clinical capabilities across multiple indications in oncology, autoimmune diseases, type 1 diabetes, and central nervous system disorders. Sana will leverage its existing allogeneic manufacturing expertise and continue development of its GMP manufacturing facility in Bothell, Washington.

Photo: Steve Harr, president and CEO of Sana