Acepodia Gains FDA IND Clearance for ACE723 ADC

Alameda, California, USA, September 4, 2026

Acepodia Advances Dual-Payload ADC Technology

ACE723 is designed to target glypican-3 (GPC3), a tumor-associated antigen frequently expressed in hepatocellular carcinoma. The investigational ADC uses a GPC3-targeting antibody to selectively deliver two cytotoxic payloads with different mechanisms of action to tumor cells. Acepodia is developing this dual-payload strategy with the goal of addressing tumor heterogeneity and potential resistance that can emerge when cancer cells are exposed to a single cytotoxic mechanism. The program is based on Acepodia’s proprietary AD2C™ platform, or Antibody-Dual-Drugs Conjugation technology. The platform integrates expertise in antibody engineering, medicinal chemistry and tumor biology and is designed to enable site-selective conjugation of multiple linker-payload configurations. According to the company, the technology provides flexibility in combining different payloads while preserving antibody-binding characteristics, potentially creating ADC architectures that can be tailored to specific therapeutic objectives. The development approach is particularly relevant to the rapidly evolving ADC field, where researchers are exploring ways to improve tumor selectivity, overcome resistance and increase the therapeutic window of targeted cancer therapies. While ACE723 remains an investigational candidate, its progression into clinical development provides an opportunity to determine whether the dual-payload concept can translate the platform’s preclinical rationale into a meaningful clinical benefit.

Phase 1 Trial to Evaluate ACE723 in Liver Cancer

Following the FDA IND clearance, Acepodia plans to initiate a Phase 1 clinical trial in patients with unresectable or metastatic HCC. The study’s dose-escalation component is expected to assess safety, tolerability and dose-limiting toxicities, while also characterizing the pharmacokinetic profile of ACE723. Investigators will additionally evaluate preliminary signs of antitumor activity and establish a recommended dose for subsequent clinical development and potential expansion cohorts. HCC represents a major global cancer burden and accounts for more than 70% of liver cancer cases worldwide, according to Acepodia. Although immunotherapy-based combinations have improved first-line treatment options for advanced disease, patients whose cancers progress or develop resistance continue to face substantial therapeutic challenges. This creates a significant need for new treatment mechanisms and targeted therapies capable of addressing disease after existing approaches fail. The company’s development strategy is therefore focused on evaluating whether ACE723 can provide a differentiated approach for patients with advanced HCC. Importantly, the FDA IND clearance does not represent marketing approval or proof of clinical efficacy. The candidate must first demonstrate an acceptable safety profile and provide clinical evidence of therapeutic activity through human studies.

ACE723 Expands Acepodia’s Global Oncology Pipeline

The FDA milestone follows Acepodia’s submission of ACE723 IND applications in the United States and China in August 2026. The company said the global regulatory strategy is intended to support broader development of the program across major markets. ACE723 is currently identified within Acepodia’s AD2C oncology pipeline, while the company’s broader portfolio also includes antibody-cell conjugation programs designed to target cancer and autoimmune diseases. For the biopharmaceutical industry, ACE723’s advancement highlights continued interest in next-generation ADC technologies, particularly approaches that use multiple payloads to address biological complexity within tumors. Acepodia’s platform is designed to provide flexibility in payload selection and conjugation, potentially enabling developers to investigate combinations of cytotoxic mechanisms within a single targeted therapeutic. With FDA IND clearance now secured, ACE723 becomes the first AD2C-generated candidate to enter clinical development. The upcoming Phase 1 program will provide the first opportunity to evaluate the technology in patients and determine whether its GPC3-targeted dual-payload strategy can deliver a favorable balance of safety, pharmacokinetics and antitumor activity in advanced hepatocellular carcinoma.

Source: Acepodia press release