The Food and Drug Administration (FDA) has granted Fast Track designation to ALLO-316, an allogeneic chimeric antigen receptor (CAR) T-cell candidate, for the treatment of advanced or metastatic clear cell renal cell carcinoma (RCC).
The investigational product targets CD70, which is highly expressed in RCC with limited normal tissue expression. The Company is currently evaluating the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC in the phase 1 TRAVERSE trial (ClinicalTrials.gov Identifier: NCT04696731). Patients enrolled in the study must have received a checkpoint inhibitor and a vascular endothelial growth factor (VEGF) inhibitor in the advanced and/or metastatic setting, have at least 1 measurable lesion as defined by RECIST version 1.1, and Eastern Cooperative Oncology Group Performance Status of 0 or 1.
“Metastatic solid tumors have historically been a challenge to treat regardless of treatment modality, creating a large unmet need for patients and a necessity for scientific innovation,” said Rafael Amado, MD, Executive Vice President of Research and Development and Chief Medical Officer. “We remain optimistic for the potential of our AlloCAR T platform to address the challenge and we look forward to generating data from our ongoing phase 1 trial.”
According to the Company, ALLO-316 is being developed for a variety of hematologic malignancies and solid tumors as CD70 is selectively expressed in several cancers.
The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.
Allogene Therapeutics receives FDA Fast Track designation for its first solid tumor candidate, ALLO-316 in the treatment of renal cell carcinoma. News release. Allogene Therapeutics, Inc. March 10, 2022. Accessed March 11, 2022. https://www.globenewswire.com/news-release/2022/03/10/2400941/0/en/Allogene-Therapeutics-Receives-FDA-Fast-Track-Designation-for-its-First-Solid-Tumor-Candidate-ALLO-316-in-the-Treatment-of-Renal-Cell-Carcinoma.html