Allogene Therapeutics Receives FDA Fast Track Designation for its First Solid Tumor Candidate, ALLO-316 in the Treatment of Renal Cell Carcinoma
- ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which Has Broad Potential Application Across a Variety of Solid Tumors and Hematologic Malignancies
- Phase 1 TRAVERSE Trial of ALLO-316 for the Treatment of Renal Cell Carcinoma (RCC) ongoing
RCC is a disease in need of innovation as current therapies are based on a few mechanistic targets and complete response rates are low. The five-year survival rate for patients with advanced kidney cancer is less than 15%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
ALLO-316 targets CD70, which is highly expressed in RCC with limited normal tissue expression, making it an attractive CAR T. CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. 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.
Fast Track designation is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may be better than what is currently available.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the timing and ability to progress the TRAVERSE trial; the ability of ALLO-316 to address RCC and other solid tumor and hematological malignancies; the ability to manufacture AlloCAR T™ products; and the potential benefits of AlloCAR T products. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
AlloCAR T™ is a trademark of
Allogene’s AlloCAR T™ programs utilize Cellectis technologies. The anti-CD70 AlloCAR T programs are licensed exclusively from Cellectis by Allogene and Allogene holds global development and commercial rights to these AlloCAR T programs.
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1 Survival rates for kidney cancer.
Source: Allogene Therapeutics, Inc.