FDA Grants Senti Bio RMAT Designation for AML Therapy

Rare Daily Staff

The U.S. Food and Drug Administration has granted Senti Biosciences’ experimental cell therapy SENTI-202 Regenerative Medicine Advanced Therapy designation for acute myeloid leukemia.

SENTI-202 is the first Logic Gated, off-the-shelf CAR-NK cell therapy product designed to selectively target and eliminate CD33- and/or FLT3-expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 is designed to effectively kill both leukemic blasts (which largely express CD33) and leukemic stem cells (which predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease.

The FDA established the RMAT designation to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases in which early clinical evidence indicates the potential to address an unmet medical need. The designation provides benefits similar to the FDA’s breakthrough therapy and fast track programs, including enhanced and frequent interactions with the agency throughout development, and eligibility for expedited review mechanisms such as rolling and priority review.

Senti Bio is currently enrolling adult patients with relapsed or refractory CD33- and/or FLT3-expressing hematologic malignancies in a phase 1 clinical trial of SENTI-202, which has the potential to be a first-in-class allogeneic treatment for patients with AML or MDS.

Earlier this year, the FDA granted orphan drug designation to SENTI-202 for the treatment of relapsed or refractory hematologic malignancies, including AML.

“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,” said Kanya Rajangam, chief medical officer of Senti Biosciences. “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.”