ALLO-316 Demonstrates Antitumor Activity in Advanced ccRCC

• Data Provide Proof-of-Concept for an Allogeneic Anti-CD70 CAR T Candidate in Patients with Renal Cell Carcinoma (RCC) Who Received Prior Immune Checkpoint Inhibitor and VEGF-Targeting Therapy
• Single Infusion of ALLO-316 Demonstrates Promising Anti-Tumor Activity in CD70 Expressing RCC
  • Three of 10 Patients Achieved Partial Response
  • Disease Control Rate of 100% in CD70 Expressing RCC
• Proprietary Dagger™ Technology, a component of Investigational ALLO-316, Is Designed to Confer Resistance to Allogeneic CAR T Cell Rejection and Contributes to Improved Cell Expansion and Persistence in Patients
• Dose Escalation Ongoing with New Investigational Diagnostic Assay In Place

SOUTH SAN FRANCISCO, Calif., April 17, 2023 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today presented interim data from its Phase 1 TRAVERSE trial of ALLO-316, the Company’s first AlloCAR T^TM investigational product candidate for solid tumors, in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida. The presentation follows the release of initial ALLO-316 data reported at the Company’s R&D Showcase event in November 2022.

The ongoing Phase 1 TRAVERSE study is enrolling patients with advanced or metastatic renal cell carcinoma (RCC) who have progressed on standard therapies that include an immune checkpoint inhibitor and a VEGF-targeting therapy. Emerging data from this trial have demonstrated the potential of an AlloCAR T to treat CD70 expressing RCC. In this trial, ALLO-316 showed early anti-tumor activity with deepening responses over time.

“CAR T therapy has revolutionized the treatment of several hematologic malignancies, but its application to solid tumors has been an ongoing industry challenge,” said Zachary Roberts, M.D., Ph.D., Executive Vice President of Research & Development. “Early safety and efficacy data from the ongoing Phase 1 ALLO-316 dose escalation trial suggest the possibility for an off-the-shelf CAR T product to make inroads into solid tumors. Additionally, preliminary translational data confirm preclinical results showing the potential of our Dagger™ technology. This feature of ALLO-316 is designed to prevent premature AlloCAR T cell rejection, allowing marked cell expansion and persistence, even at low CAR T cell doses.”

“I am encouraged by these data highlighting the potential of an allogeneic CAR T as a new and much needed treatment modality for patients with renal cell carcinoma,” said Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center. “Initial data from the TRAVERSE trial provides a proof-of-concept for the successful application of this novel CAR T product in the treatment of advanced renal cell carcinoma.”

As of the March 23, 2023 data cutoff, 19 patients were enrolled in the Phase 1 trial, 10 of whom had RCC confirmed to express CD70. The median time from enrollment to the start of therapy was five days. In the ongoing dose escalation phase of the TRAVERSE trial, patients will receive lymphodepletion followed by ALLO-316 at one of four cell dose levels (DL1= 40M cells, DL2= 80M cells, DL3=120M cells, DL4= 240M cells). The data reported to date is primarily from the DL1 and DL2 cohorts.

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