Porton Helps Acepodia's Dual-Payload ADC ACE723 Win IND Clearance in Both the US and China
Acepodia announced that IND applications for its dual-payload ADC candidate ACE723 have been approved by both the US FDA and China's NMPA, making it the first candidate from Acepodia's AD2C platform to enter clinical development. As CDMO partner, Porton delivered end-to-end development and GMP IND clinical supply for the dual-payload ADC, spanning payload-linker, antibody and ADC development and manufacturing.
Porton's partner Acepodia biotechnologies, Ltd announced that IND applications for its dual-payload ADC candidate ACE723 have been approved by the US FDA and China's NMPA. ACE723 is the first candidate from Acepodia's Antibody-Dual-Drugs Conjugation (AD2C) platform to enter clinical development, marking the platform's entry into global clinical development.
Porton's Role: End-to-End Delivery for a Dual-Payload ADC
As CDMO partner on the project, Porton completed end-to-end delivery of dual-payload ADC process development and GMP IND clinical supply.
On the technical side, the project team overcame multiple key challenges in dual-payload ADC development, established a stable and reliable manufacturing process, and successfully achieved pilot-scale scale-up. On coordination, the co-located one-stop platform allowed payload-linker synthesis process development and GMP manufacturing to align early with downstream conjugation needs, seamlessly connecting antibody preparation with small-molecule conjugation — an integrated optimization of R&D, manufacturing and downstream application that improved both development efficiency and process robustness.
Porton's one-stop biologics and conjugate CDMO platform delivered the full workflow from process development to release of registration samples, covering payload-linker, antibody, and ADC development and manufacturing. This serves as validation of Porton's technical strength and scale-up capability in complex conjugates, and another example of enabling global innovative-drug partners.
About ACE723: A GPC3-Targeting Therapy for Hepatocellular Carcinoma
ACE723 is a dual-drug ADC targeting GPC3, developed on Acepodia's proprietary AD2C platform. GPC3 is a tumor-associated antigen frequently expressed in hepatocellular carcinoma and a potential target for selectively delivering chemotherapeutic payloads to tumor cells.
Hepatocellular carcinoma (HCC) accounts for more than 70% of all liver cancer cases and is a common and often fatal cancer, with a five-year survival rate of only about 22%. For patients with unresectable or metastatic disease, first-line standard of care relies mainly on immunotherapy combinations; however, many patients have limited options after treatment failure or resistance, leaving significant unmet need.
The planned Phase I trial will evaluate ACE723's safety, tolerability, dose-limiting toxicities (DLTs), pharmacokinetics and preliminary anti-tumor activity in patients with unresectable or metastatic hepatocellular carcinoma. The dose-escalation phase is expected to further characterize its safety profile and determine the recommended dose for subsequent development. ACE723 remains investigational and has not been approved for marketing.
About the Partners
Acepodia biotechnologies, Ltd (6976: TT) is a clinical-stage biotechnology company developing next-generation therapies for cancer and autoimmune diseases using its proprietary drug conjugation platforms. Built on bio-orthogonal click chemistry originating from the laboratory of Nobel laureate Professor Carolyn Bertozzi, its modular platforms link antibodies with immune cells or therapeutic payloads. The company is expanding its portfolio through Antibody-Cell Conjugation (ACC) and Antibody-Dual-Drugs Conjugation (AD2C) platforms.
Porton's Biologics and Conjugates CDMO Services Platform focuses on custom development of antibodies and novel conjugates including ADCs, AOCs, DACs, PDCs and RDCs. With R&D centers and manufacturing sites located close to each other for efficient logistics and coordination, it offers one-stop CMC solutions covering druggability assessment, conjugation technology development, OAR control, process and formulation development, scale-up and manufacturing, analytical and quality studies, IND filing and clinical drug manufacturing.