On March 14, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will present interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR T candidate for solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in April in Orlando, Florida (Press release, Allogene, MAR 14, 2023, View Source [SID1234628642]). The AACR (Free AACR Whitepaper) conference presentation follows the release of preliminary ALLO-316 data reported at the Company’s R&D Showcase event in November 2022.
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"We are excited to present ALLO-316 data for the first time at a medical conference," said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development. "There is an urgent need for innovation for patients with renal cell carcinoma who have failed immune checkpoint inhibitors and targeted therapy. Initial data from this trial shared at our R&D Showcase in November 2022 demonstrated the potential of ALLO-316 in patients with CD70 expressing advanced or metastatic RCC, and we look forward to further exploring the potential of this AlloCAR T product candidate in RCC and potentially other CD70-expressing tumors."
Dagger technology is a proprietary platform designed to control rejection of AlloCAR T cells by the host immune cells and is an intrinsic property of ALLO-316. The results from this trial indicate that ALLO-316 possesses antitumor activity as well as the anti-rejection effect.
"The Dagger technology has been shown preclinically to counter premature rejection of AlloCAR T cells via the elimination of CD70 positive, alloreactive host T cells," said Barbra Sasu, Ph.D., Chief Scientific Officer of Allogene. "The demonstration of this novel mechanism of action in the clinic opens the possibility of combining the CD70 Dagger receptor with other anti-tumor CARs to create dual-targeting, rejection-resistant next generation products that may be less dependent on lymphodepletion."
Allogene presentation at the 2023 AACR (Free AACR Whitepaper) Annual Meeting:
A phase 1 multicenter study (TRAVERSE) evaluating the safety and efficacy of ALLO-316 following conditioning regimen in pts with advanced or metastatic clear cell renal cell carcinoma (ccRCC)
Presenter: Dr. Samer Srour, MB ChB, MS, Assistant Professor, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Session Title: Promising Novel Antitumor Strategies in Early Phase Clinical Trials
Abstract #: CT011
Session Date and Time: Monday April 17, 2023 10:15 AM – 12:15 PM ET
Clear cell renal cell carcinoma is the most common type of RCC in adults, making up about 80% of all cases in the U.S., according to the National Cancer Institute (NCI). The five-year survival rate for patients with metastatic kidney cancer is less than 15%.1
The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. The Company is testing the need to prospectively assess CD70 expression levels in tumors to enhance patient selection using a new investigational in vitro companion diagnostic (IVD) assay. TRAVERSE will continue to explore varying cell dose and lymphodepletion regimens.
ALLO-316 for the treatment of advanced or metastatic RCC was granted Fast Track Designation (FTD) by the U.S. FDA in March 2022.