Sana Biotechnology, Inc. SANA has received clearance from the U.S. Food and Drug Administration (FDA) to commence a study of SC262, marking a significant milestone for the company.
The clearance for SC262, an investigational new drug (IND) application, is intended for use in patients with relapsed or refractory B-cell malignancies, particularly those who have previously undergone CD19-directed CAR T therapy.
Doug Williams, President of Research and Development at Sana, emphasized the urgency of addressing the unmet needs of patients who have failed CD19-directed CAR T therapy, a population which is steadily increasing as more patients receive these treatments.
Williams further stated, “SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T therapy platform.”
In a similar vein, on November 9, the company also announced the FDA clearance of the Investigational New Drug Application for SC291, a hypoimmune-modified, CD19-directed allogeneic CAR T therapy designed for patients with lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis.
In the pipeline, Sana plans to unveil data from multiple studies over the course of the year, including initial proof of concept data for SC262 later this year.
Price Action: SANA shares are trading higher by 2.24% at $5.01 at the time of the last check on Friday.
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