Sana’s cell therapy may be ‘transformative cure’ for type 1 diabetes: analysts

Sana Biotechnology has shared early data for its investigational allogeneic cell therapy being studied in one patient with type 1 diabetes, sending the company’s share price up by about 200%.

The data “pave the way for a potentially transformative cure,” for a disease that affects more than 1.7 million Americans, Citi analysts wrote in a Jan. 8 note.

The Seattle-based biotech is evaluating UP421, a donor-derived allogeneic primary islet cell therapy, as a type 1 diabetes treatment that doesn’t require the use of any immunosuppression. Four weeks after the cells were transplanted into the patient’s arm, the therapy had avoided immune rejection and was tied to consistent levels of c-peptide expression—a biomarker that indicates if the transplanted beta cells are producing insulin, according to a Jan. 7 release.

The cell dose was under the threshold of islet cells needed to reach insulin independence, which is par for the course since the cells were harvested from one donor, as opposed to two or more donors required for most patients to achieve insulin independence in previously published studies.

C-peptide levels also rose with a mixed meal tolerance test—a liquid meal designed to demonstrate how much insulin is being generated—which aligns with insulin secretion in response to a meal. MRI scans also revealed a sustained signal at the site of transplanted cells, which is consistent with graft survival.

No safety issues were identified, according to Sana. 

“As far as we are aware, this is the first study showing survival of an allogeneic transplant with no immunosuppression or immune-protective device in a fully immune competent individual,” Sana CEO and president Steve Harr, M.D., said in the release. “Safe cell transplantation without immunosuppression has the potential to transform the treatment of type 1 diabetes and a number of other diseases.”

Investors and analysts alike were bullish on the prospects of the new data, with Citi writing that the drop validates Sana’s hypoimmune platform and was worth the wait. In November 2024, Harr hinted at the phase 1 data findings as the company rolled back investments in other programs.

“While we acknowledge data from a single patient may raise questions of reproducibility for some, we highlight the consistency between Sana’s preclinical and clinical datasets as particularly encouraging,” Citi analysts wrote Jan. 8. “Bottom line, today’s initial proof-of-concept data strongly suggest that Sana’s hypoimmune edits are capable of mediating immune evasion for transplanted allogenic cells.”

Sana expects to keep following the patient transplanted with hypoimmune-edited islet cells and will share additional data at a future medical meeting.

Since Sana released the data yesterday after market close, the biotech’s stock price has skyrocketed from $1.75 per share to $4.92 as of 10:30 a.m. ET today.