Allogene Therapeutics, Inc. (Nasdaq: ALLO) is making significant strides in its allogeneic CAR T (AlloCAR T™) pipeline, targeting both cancer and autoimmune diseases. The company recently reported corporate updates and financial results for the third quarter of 2024, highlighting progress in key clinical trials and preclinical development programs.
Cema-Cel: Pivotal ALPHA3 Trial in Large B-Cell Lymphoma
The pivotal Phase 2 ALPHA3 trial, initiated in June 2024, is evaluating cemacabtagene ansegedleucel (cema-cel) as a first-line (1L) treatment consolidation for patients with large B-cell lymphoma (LBCL) at high risk of relapse. This randomized trial aims to enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event-free survival (EFS) in patients treated with cema-cel compared to the current standard of care (observation). The trial utilizes Foresight CLARITY™ powered by PhasED-Seq™, a novel test for minimal residual disease (MRD) to identify high-risk patients. Enrollment is expected to complete in the first half of 2026, with efficacy analyses anticipated by the end of 2026 and a potential biologics license application (BLA) submission targeted for 2027.
ALLO-316: TRAVERSE Trial in Renal Cell Carcinoma
Updated data from the Phase 1 TRAVERSE trial, evaluating ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) patients who have progressed following treatment with an immune checkpoint inhibitor and VEGF-targeting therapy, demonstrates promising anti-tumor activity. As of the October 14, 2024, data cutoff, 26 patients with CD70 positive RCC were evaluable for efficacy outcomes. Following a single infusion of ALLO-316, the trial demonstrated a best overall response rate (ORR) of 50% and a confirmed response rate of 33% in patients with CD70 Tumor Proportion Score (TPS) of ≥50% who received the Phase 1b expansion regimen. Notably, 76% (16/21) of patients with a TPS ≥50% experienced a reduction in tumor burden. The most common all-grade adverse events included cytokine release syndrome (CRS) (with only one grade ≥3), fatigue (59%), neutropenia (56%), and anemia (51%).
On October 29, 2024, the company announced that it had received Regenerative Medicine Advanced Therapy (RMAT) designation for ALLO-316 for adult patients with advanced or metastatic RCC based on Phase 1 clinical data.
ALLO-329: CD19/CD70 Dual CAR for Autoimmune Disease
Allogene is advancing ALLO-329, a next-generation AlloCAR T candidate for autoimmune indications. This product is the first allogeneic CD19/CD70 dual CAR T specifically designed to target CD19+ B-cells and CD70+ activated T-cells, both of which are key players in autoimmune diseases. ALLO-329 incorporates CRISPR-based site-specific integration and the company’s clinically validated Dagger® technology, which aims to reduce or eliminate the need for lymphodepletion. The company plans to file an investigational new drug (IND) application in Q1 2025 and expects to have proof-of-concept data by the end of 2025. Pre-clinical data for ALLO-329 will be presented at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, on November 18, 2024, in Washington, D.C.
Financial Update
Allogene reported research and development expenses of $44.7 million for the third quarter of 2024 and a net loss of $66.3 million, or $0.32 per share. The company had $403.4 million in cash, cash equivalents, and investments as of September 30, 2024, which is expected to fund operations into the second half of 2026. The company continues to expect a decrease in cash, cash equivalents, and investments of approximately $200 million in 2024. GAAP Operating Expenses are expected to be approximately $300 million, including estimated non-cash stock-based compensation expense of approximately $60 million. These estimates exclude any impact from potential business development activities.
