The Food and Drug Administration (FDA) has granted Fast Track designation to ADI-001, an investigational therapy for the treatment of relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL).
According to the Company, ADI-001 works by targeting malignant B cells by leveraging the adaptive receptors found on gamma delta T cells, with the added benefit of an engineered anti CD20 chimeric antigen receptor (CAR).
A phase 1 trial (ClinicalTrials.gov Identifier: NCT04735471) is currently evaluating the safety and tolerability of ADI-001 in 76 participants with B cell malignancies who have relapsed or are refractory to at least 2 prior regimens. The trial will escalate dosage and is designed to determine maximum tolerated dose.
The FDA’s Fast Track designation is intended to expedite the review of drugs to treat serious conditions and that fill an unmet medical need.
Commenting on the FDA’s Fast Track decision, Adicet CEO Chen Schor said, “We remain optimistic about the potential of our program and look forward to reporting additional data from the Phase 1 trial of ADI-001 in the first half of 2022.”
Adicet Bio receives FDA Fast Track designation for lead candidate ADI-001. News release. Adicet Bio, Inc. Accessed April 19, 2022. https://www.businesswire.com/news/home/20220419005427/en/Adicet-Bio-Receives-FDA-Fast-Track-Designation-for-Lead-Candidate-ADI-001