Sana Biotechnology, Inc. (NASDAQ:SANA) announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to begin a study of SC262 in patients with relapsed or refractory B-cell malignancies (initially in patients who have received prior CD19-directed CAR T therapy).
“Patients who have failed a CD19-directed CAR T therapy represent a significant unmet need, and this population is growing as more patients receive these therapies,” said Doug Williams, Sana’s President of Research and Development.
“SC262 represents an important potential option for these patients and is the next step in building Sana’s hypoimmune CAR T therapy platform,” Williams added.
On November 9, the company announced the FDA Clearance of Investigational New Drug Application for SC291, a Hypoimmune-modified, CD19-directed allogeneic CAR T therapy, for patients with lupus nephritis, extrarenal lupus, and ANCA-associated vasculitis.
The company plans to present data from multiple studies this year, including initial proof of concept data for SC262 later this year.
Price Action: SANA shares are trading higher by 2.24% to $5.01 on the last check Friday.
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