ST. LOUIS & SAN DIEGO–(BUSINESS WIRE)–Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of allogeneic cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation and Rare Pediatric Disease Designation (RPDD) for WU-CART-007, the company’s off-the-shelf CAR-T cell therapy. WU-CART-007 is currently being explored for the treatment of relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (LBL).
“We are very pleased to have received both fast track and rare pediatric disease designations, which re-affirm the great unmet need for new treatment options for people with R/R T-ALL/LBL,” said Dan Kemp, Ph.D., President and Chief Executive Officer of Wugen. “Earlier this year, we dosed the first patient in our ongoing Phase 1/2 trial of WU-CART-007 for R/R T-ALL/LBL and are currently in the dose escalation phase of the study. We look forward to working closely with the FDA as we continue to advance WU-CART-007 through clinical development.”
The FDA’s Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. According to the FDA, the purpose is to get important new drugs to the patient earlier. Features of Fast Track Designation include opportunities for more frequent interactions with the FDA review team and, if supported by clinical data, eligibility for Priority Review.
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