"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."
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.
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The Company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA)Technology Development Group, address key biological challenges in treating cancer. ImmPACT Bio's technologies are specifically designed to prevent antigen escape and overcome the immunosuppressive tumor microenvironment. The Company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA. In addition, another logic-gate-based CAR T-cell technology is based on the work of Gideon Gross, Ph.D., from the MIGAL-Galilee Research Institute, to address the prevention of 'on-target, off-tumor' toxicities. For more information, visit www.immpact-bio.com.
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