Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.
Extending its cash runway into 2026, Sana Biotechnology Inc. is prioritizing certain autoimmune assets and punting an oncology program and a central nervous system diseases program to a potential licensing partner or spinout company.
It has been hypothesized that allogeneic, hypoimmune (HIP) iPSC-derived or donor-derived islet grafts could provide a new and safe therapeutic alternative for the treatment of type 1 diabetes mellitus (T1DM). Researchers from Sana Biotechnology Inc. and affiliated organizations have published preclinical data from studies further assessing this novel strategy in nonhuman primates (NHPs).
Sana Biotechnology Inc. has obtained FDA clearance of its IND application to conduct a study of SC-262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed chimeric antigen receptor (CAR) T therapy.
It is known that CD19-directed CAR T-cell therapy is useful in the treatment of large B-cell lymphoma, but about 60% of patients relapse after treatment, and about 30% of these are CD19-negative patients with poor survival. Sana Biotechnology Inc. is developing a hypoimmune CD22-directed CAR T-cell therapy, named SC-262, for the potential treatment of large B-cell lymphoma.
The Swedish Medical Products Agency has authorized Uppsala University's clinical trial application to initiate an investigator-sponsored, first-in-human study of UP-421, an allogeneic, primary islet cell therapy engineered with Sana Biotechnology Inc.'s hypoimmune technology, in patients with type 1 diabetes.
Transplanted human glial cells could outcompete human glia in a chimeric mouse model of Huntington’s disease, inducing apoptosis. And younger health cells could outcompete older ones. The findings, which appeared online in Nature Biotechnology on July 17, 2023, help pave the way for testing glial cell transplantation as a therapeutic strategy in neurodegenerative disorders.
Venture firm Flagship Pioneering Inc. and Pfizer Inc. are each investing $50 million in a pact that could result in the development of 10 programs, each worth a potential $700 million in milestones. Altogether, if all products are successfully commercialized, the deal could be worth $7 billion, with milestone money going to Flagship and some of its 45 bioplatform companies.
Type 1 diabetes mellitus (T1DM) is an autoimmune disease in which the person’s immune system destroys its own pancreatic islet cells that leads to complete loss of insulin production. Allogeneic pancreatic islet cell transplantation has been shown to replenish the vanished β-cell population and provide glycemic control, restoration of hypoglycemia awareness, and protection from severe hypoglycemic events. However, with allogeneic transplantation, there is a need for life-long immunosuppression to protect the islet grafts from allo- and autoimmunity.
Sana Biotechnology Inc. has received FDA clearance of its IND application to initiate a first-in-human study of SC-291 in patients with various B-cell malignancies. Initial clinical data from the study are expected later this year. SC-291 is a CD19-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy developed using Sana's hypoimmune platform.
