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Acepodia Cleared to Begin Phase 1 Trial for Liver Cancer Drug ACE723

Acepodia Cleared to Begin Phase 1 Trial for Liver Cancer Drug ACE723

The U.S. Food and Drug Administration has cleared Acepodia to initiate clinical testing of ACE723, a dual-payload antibody-drug conjugate. This regulatory green light marks the first time the company’s proprietary AD2C platform has transitioned a candidate into human trials, specifically targeting patients suffering from unresectable or metastatic hepatocellular carcinoma.

ACE723 functions by delivering two distinct cytotoxic payloads to tumor cells expressing GPC3, an antigen frequently found in liver cancer. By employing this dual-action mechanism, developers aim to overcome the limitations of traditional single-payload therapies, which often struggle against tumor heterogeneity and drug resistance. The upcoming Phase 1 study will focus on establishing safety, pharmacokinetics, and initial anti-tumor activity, with a dose-escalation phase designed to determine the optimal regimen for future cohorts.

Hepatocellular carcinoma accounts for over 70% of global liver cancer cases, and while immunotherapy has improved first-line outcomes, patients often face few options once initial treatments fail. Acepodia, based in Alameda and Taipei, is also seeking approval from China's National Medical Products Administration to support its global development strategy. The company utilizes bio-orthogonal click chemistry, a technology rooted in the work of Nobel laureate Carolyn Bertozzi, to build modular platforms that integrate antibodies with therapeutic payloads.

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