Dr. Yvonne Chen’s Work with ImmPACT Bio Approved by FDA

ImmPACT Bio USA, Inc. (“ImmPACT Bio”), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer, today announced clearance of its first Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for IMPT-314, a bispecific “OR-Gate” autologous CAR T-cell therapy targeting the B-cell antigens CD19 and CD20. IMPT-314 will be studied in a Phase 1/2 clinical trial in patients with aggressive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL).

Based on the pioneering work of Yvonne Chen, Ph.D., associate professor at the University of California, Los Angeles (UCLA), this CD19/CD20-directed bispecific CAR has demonstrated clinically meaningful and differentiated results in an ongoing investigator-led study at UCLA. Principal investigator Sarah Larson, M.D., studied patients with non-Hodgkin lymphoma (NHL), including various subtypes of aggressive B-cell lymphoma, DLBCL, non-indolent or refractory follicular lymphoma (FL), and mantle cell lymphoma (MCL). Data from the study demonstrated 90 percent of patients (9/10) had an objective response with 70 percent (7/10) of patients achieving a durable complete response (CR). Of note, no patients had neurotoxicity, also known as immune effector cell-associated neurotoxicity syndrome (ICANS). Patients had Grade 1 or no cytokine release syndrome (CRS). Median follow-up was more than 20 months and median progression-free survival (PFS) is 18.2 months. These results from the first 10 evaluable patients were recently published in Cancer Discovery. The UCLA study continues to enroll additional patients.

"Dr. Chen designed this bispecific CAR to address antigen escape, which is a key challenge for current approved CD19 therapies for hematological malignancies,” said Dr. Larson. “We tested this anti-CD19/CD20 CAR-T cell therapy in patients with relapsed or refractory NHL and are encouraged about the potential of this therapy for patients.”

To read more about this news, please see PR Newswire article: ImmPACT Bio Announces FDA Clearance of IND for Novel Bispecific CAR to Treat Aggressive B-cell Lymphoma