Senti Bio (NASDAQ: SNTI) has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the company’s potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, currently in development for the treatment of relapsed/refractory (R/R) hematologic malignancies, including Acute Myeloid Leukemia (AML).
SENTI-202 is Senti Bio’s lead asset. The FDA granted the RMAT designation based on data from the company’s ongoing Phase 1 clinical trial of SENTI-202 in adult patients with R/R CD33 and/or FLT3 expressing hematologic malignancies, including AML.
In a statement, Timothy Lu, MD, PhD, co-founder and CEO of Senti, commented, “This significant FDA designation validates both the tremendous need for better treatments for R/R AML and the promise of SENTI-202 to transform the therapeutic landscape for this notoriously aggressive cancer. We are incredibly pleased with the exciting clinical progress we recently shared at the ASH conference on SENTI-202.”
Kanya Rajangam, MD, PhD, CMO of Senti, remarked, “Leveraging our Logic Gate technology, SENTI-202 has continued to demonstrate its ability to aggressively kill cancer cells while protecting normal cells for hard-to-treat cancers such as AML, a central challenge in oncology. We view the FDA’s decision to grant RMAT and Orphan Drug designations to SENTI-202 as major milestones for the AML patient community and we look forward to working with regulators to develop this potentially first-in-class treatment as quickly as possible and to accelerate a paradigm shift in how we treat other difficult cancers.”
