A2 Bio Updates CAR T-Cell Trials at ASCO 2024

A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company, will share significant updates on clinical trials during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The company will present findings from three ongoing clinical trials, including two first-in-human (FIH) Phase 1/2 studies named EVEREST-1 and EVEREST-2, and highlight the impact of expanded biomarker prescreening on improving the diversity of clinical trial participants.

The EVEREST-1 study (NCT05736731) is evaluating A2B530 in patients with solid tumors expressing carcinoembryonic antigen (CEA) and loss of heterozygosity (LOH) in the HLA-A*02 gene. The trial started in May 2023, and thus far, ten patients have been treated as part of the dose-escalation phase. Similarly, the EVEREST-2 study (NCT06051695) is assessing A2B694 in patients with tumors expressing mesothelin (MSLN) and HLA-A*02 LOH. The first patient in this trial was dosed in May 2024.

Both therapies utilize A2 Bio’s proprietary Tmod™ platform, which features a dual-receptor system. This system includes an activator that targets and destroys tumor cells and a blocker that protects normal cells, thereby minimizing the risk of on-target, off-tumor toxicity. The Tmod™ mechanism ensures that the therapy specifically attacks cancer cells while sparing healthy tissues.

Julian R. Molina, M.D., Ph.D., a Professor of Oncology at Mayo Clinic, emphasized the importance of diversity in clinical trials to ensure that precision medicine is effective across different racial and ethnic groups. A2 Bio has made strides in this area through its BASECAMP-1 master prescreening study (NCT04981119). This study initially screened patients with the HLA-A*02:01 allele but later expanded to include all HLA-A*02 alleles. The expansion significantly increased the representation of Hispanic, African-American, and Asian or Pacific Islander patients.

BASECAMP-1 is a pre-screening study designed to identify eligible patients with unresectable, advanced, or metastatic solid tumors who have HLA-A*02 LOH. After identifying suitable patients through next-generation sequencing, their T cells are collected, processed, and stored for future Tmod™ CAR T cell therapy. This approach aims to optimize patient outcomes by enabling the use of patients' immune cells in their healthiest state during earlier cancer treatment stages.

William Go, M.D., Ph.D., the Chief Medical Officer of A2 Bio, expressed optimism regarding the progress in their clinical trials. He highlighted that A2 Bio is not only advancing innovative CAR T-cell therapies but also pioneering methods to enhance safety, efficiency, and diversity in their trials.

A2 Bio’s Tmod™ platform represents a breakthrough in cancer treatment, addressing the critical challenge of distinguishing between tumor and normal cells. The platform's dual-receptor design allows precise targeting of cancer cells while protecting healthy cells, thereby offering a promising new approach to cancer immunotherapy.

The poster presentations on these studies are scheduled for June 1, 2024, from 9:00 am to 12:00 pm CT at the ASCO Annual Meeting. A2 Bio continues to recruit patients for these ongoing trials, targeting specific cancer types including non-small cell lung, colorectal, pancreatic, ovarian, and mesothelioma cancers.

A2 Biotherapeutics is dedicated to developing first-in-class logic-gated cell therapies to address high unmet needs in cancer treatment. The company's innovative Tmod™ cell therapy platform aims to revolutionize cancer treatment by enabling precise and personalized T cell targeting.