FDA Clears IND for Acepodia's Dual-Payload ADC ACE723

FDA has cleared Acepodia's investigational new drug (IND) application for ACE723, a GPC3-targeted dual-payload antibody-drug conjugate (ADC), enabling the company to begin a phase 1 trial in patients with unresectable or metastatic hepatocellular carcinoma (HCC), the company announced September 4, 2026.¹ ACE723 is the first candidate generated from Acepodia's proprietary Antibody-Dual-Drugs Conjugation (AD2C) platform to enter clinical development, according to the US-headquartered clinical-stage biotechnology company.¹

"The FDA clearance of ACE723 marks an important milestone for our AD2C platform and brings our first AD2C-generated candidate into clinical development," said Sonny Hsiao, PhD, CEO and chairman, Acepodia, in a company press release.¹ "ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumor cells, with the goal of addressing tumor heterogeneity and potential resistance to single-payload therapies. We look forward to evaluating its safety, pharmacokinetics and preliminary anti-tumor activity in patients with unresectable or metastatic HCC."

How does ACE723 work?

ACE723 is built on Acepodia's AD2C platform, which uses bioorthogonal click chemistry, derived from Nobel laureate Carolyn Bertozzi's research, to conjugate 2 distinct cytotoxic payloads to a single antibody without requiring antibody engineering.¹ The candidate targets GPC3, a tumor-associated antigen frequently expressed in HCC, and is designed so that its dual-payload mechanism can address tumor heterogeneity and reduce the likelihood of resistance associated with single-payload ADCs. In preclinical studies presented at the 2025 American Association for Cancer Research Annual Meeting, the anti-GPC3 AD2C candidate showed binding affinity and internalization comparable to the parental antibody, supporting its advancement toward clinical testing.²

Why is a new treatment option needed for HCC?

HCC accounts for more than 70% of liver cancer cases worldwide.¹ Although immunotherapy-based combination regimens have improved first-line treatment for patients with unresectable or metastatic disease, significant unmet need remains for patients whose disease progresses or becomes resistant to treatment.

What will the phase 1 trial evaluate?

The planned phase 1 study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics, and preliminary anti-tumor activity of ACE723 in patients with unresectable or metastatic HCC. Its dose-escalation portion is expected to characterize the drug's safety profile and establish a recommended dose for subsequent development and potential expansion cohorts. Acepodia also submitted an IND application for ACE723 to China's National Medical Products Administration in August 2026 as part of the program's global development strategy.¹

How does this fit into Acepodia's broader pipeline?

"Acepodia's dual-payload ADC approach is designed to address key limitations of current single-payload therapies," Dr Hsiao said when the underlying preclinical data were first presented in April 2025.³ "By combining targeted delivery with enhanced cytotoxicity, this platform holds promise for more effective treatment of liver cancer and other solid tumors."

Beyond the AD2C platform, Acepodia is also advancing 2 cell therapy candidates built on its Antibody-Cell Conjugation platform. The candidates are ACE1831, which targets CD20 for B-cell malignancies, and ACE2016, which targets epidermal growth factor receptor for solid tumors. Both are currently in phase 1 trials.⁴

What are the limitations?

Although IND clearance means FDA has reviewed the application and determined it is reasonable to proceed to human testing, its clearance does not indicate that a candidate is safe or effective in patients.⁵ No clinical data for ACE723 in humans yet exist. The preclinical data supporting this program come from a single conference abstract and have not been published in a peer-reviewed journal, and enrollment timelines for the phase 1 trial were not disclosed.

References

1. Acepodia. Acepodia announces FDA clearance of IND application for ACE723, a novel dual-payload antibody-drug conjugate. Press release. Published September 4, 2026. Accessed September 4, 2026. https://www.acepodia.com/newsroom-detail/Acepodia_ACE723_IND_Clearance_en/
2. Li HK, Lai CW, Lin CY, et al. Abstract 1785: development of dual-payload anti-GPC3 antibody-drug conjugate by dual-payload antibody conjugation (AD2C) platform for hepatocellular carcinoma treatment. Cancer Res. 2025;85(8_Suppl_1):1785. doi:10.1158/1538-7445.AM2025-1785
3. Acepodia. Acepodia presents preclinical data on Antibody-Dual-Drugs Conjugation (AD2C) technology at AACR Annual Meeting 2025. Press release. Published April 21, 2025. Accessed September 4, 2026. https://www.prnewswire.com/news-releases/acepodia-presents-preclinical-data-on-antibody-dual-drugs-conjugation-ad2c-technology-at-aacr-annual-meeting-2025-302433216.html
4. Acepodia. Pipeline. Accessed September 4, 2026. https://www.acepodia.com/pipeline/
5. US Food and Drug Administration. Investigational new drug (IND) application. Updated June 17, 2026. Accessed September 4, 2026. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application