Pharma Focus Europe

ImmPACT Bio Granted FDA Fast Track Designation for IMPT-314 in Patients with Relapsed or Refractory Aggressive B-cell Lymphoma

Tuesday, May 16, 2023

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 and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-314, a potential first-in-class CD19/CD20 CAR T therapy for the treatment of patients with B-cell mediated malignancies. These include relapsed or refractory (R/R) aggressive B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from follicular lymphoma (FL), after two or more lines of systemic therapy.

"Fast track designation from the FDA underscores the serious unmet medical need in patients with aggressive B cell lymphomas and reinforces the differentiated therapeutic promise of IMPT-314," said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. "Relapsed or refractory B cell lymphomas are aggressive malignancies that despite the availability of multiple treatment options, are limited by high rates of relapse, low survival rates or serious toxicity. IMPT-314 was specifically designed to target two prevalent B cell antigens, CD19 and CD20 to prolong durability and help overcome treatment resistance arising from antigen escape. In a UCLA-led investigator study, the bispecific CAR construct underlying IMPT-314 has also demonstrated unmatched safety that includes no neurotoxicity and only Grade 1 cytokine release syndrome. We believe IMPT-314 has potential to extend duration of response with a safe, well-tolerated profile that may enhance accessibility. We look forward to dosing the first patient with IMPT-314 in our Phase 1/2 trial in aggressive B-cell malignancies in the second quarter of this year."

IMPT-314 is based on research work by Yvonne Chen, Ph.D., associate professor, University of California, Los Angeles (UCLA). In 2019, Sarah Larson, M.D., also at UCLA, initiated an ongoing investigator-led Phase 1 study of IMPT-314 in patients with R/R non-Hodgkin lymphoma. ImmPACT Bio in-licensed the logic-gate-based CAR T-cell platforms from UCLA.

Key safety and efficacy highlights from the Phase 1 UCLA investigator-led study (n = 11):

91% objective response rate, with 73% achieving a durable complete response
18.2 months median progression-free survival with a median follow-up of 20.5 months
No neurotoxicity or immune effector cell-associated neurotoxicity syndrome
No cytokine release syndrome above Grade 1
Fast track designation is designed to help drugs reach patients faster by facilitating the development and expediting the review of drugs with the potential to fill an unmet medical need and treat serious or life-threatening conditions. Programs receiving FTD benefit from early and frequent interactions with the FDA during the clinical development process and, if relevant criteria are met, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application.

ImmPACT Bio will evaluate IMPT-314 in a Phase 1/2 clinical trial for aggressive B-cell lymphoma, including DLBCL. Dosing of the first patient is expected in Q2 2023 with initial Phase 1 safety and efficacy data expected in the second half of 2023.

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