Adagene Offers Clinical Trial Collaboration to Evaluate Roche's Standard-of-Care for First-Line Advanced Liver Cancer

Adagene highlights clinical trial collaboration with Roche to assess Anti-CTLA-4 SAFEbody ADG126 in combination with Roche's standard of care for advanced first-line liver cancer.

FREMONT, CA: “We are excited to initiate this collaboration with Roche and explore the potential of ADG126 as a key component of a triplet combination for treating first-line liver cancer, along with an established standard-of-care doublet pioneered by Roche,” says Peter Luo, Ph.D., Co-founder and CEO of Adagene. Adagene, a company transforming the discovery and development of antibody-based therapies, has clinically collaborated with Roche to assess the triple combination of Adagene's ADG126 with Roche's atezolizumab and bevacizumab in the first-line treatment of advanced hepatocellular carcinoma. The cooperation will employ Roche's MORPHEUS-LIVER technology for efficient and speedy combination creation.

“Given the longstanding safety challenges of combining multiple therapies in this cancer type, we are very excited to bring forth a potential anti-CTLA-4 treatment with an unprecedented safety profile in an immunotherapy-based triplet combination as a promising strategy to treat liver cancer patients, where two first-line therapies have already received FDA approval,” adds  Luo.

Under the terms of the collaboration, Roche will sponsor and execute a randomized phase 1b/2 multi-national trial comparing the effectiveness, safety, and pharmacokinetics of ADG126 in combination with bevacizumab and atezolizumab in an initial cohort of 60 patients. Each company supplies its particular anti-cancer agent(s) to support the experiment. Adagene will retain worldwide commercialization and development rights to ADG126.

Using ADG126 as a component of the first-line combination therapy for HCC, Adagenes expands its global clinical development program into a new setting and tumor type. When combined with anti-PD-1/PD-L treatment, anti-CTLA-4 therapy has shown statistically significant clinical benefits. The safety profile of ADG126 at dosages of up to 20 mg/kg with subsequent dosing as monotherapy and up to 10 mg/kg in conjunction with anti-PD-1 treatment has been proven by ongoing phase 1b/2 clinical trials. ADG126 is ideally suited as a combination treatment to improve patient outcomes due to its remarkable safety profile, promising antitumor activity, and dose repeatability.

SAFEbody technology solves numerous antibody-based treatments' safety and tolerability difficulties by decreasing on-target off-tumor damage in healthy tissues. ADG126 SAFEbody integrates this precision-masking technology into the parental anti-CTLA-4 antibody, ADG116, enabling conditional activation in the tumor microenvironment (TME), thereby expanding the therapeutic index and addressing additional safety concerns with conventional anti-CTLA-4 therapies.

The masked ADG126, which binds to the same distinct and highly conserved epitope as ADG116, is intended to provide improved safety and efficacy profiles due to the combined effect of the potent Treg depletion in the tumor microenvironment and partial ligand blocking by the activated ADG126, which is released steadily for the prolonged tumor-killing effect.