On the 12th, Acepodia-KY announced at its investor conference the development plans for its core clinical candidates, ACE1831 and ACE2016, for the coming year. During the event, the company also showcased research outcomes from its latest technology platform, Antibody-Dual-Drugs Conjugation (AD2C), further solidifying its leadership in cancer and immune disease therapeutics.

Sonny Hsiao, co-founder and CEO of Acepodia-KY, shared that advancements in the treatment strategy for ACE1831, focused on hematologic cancers, are progressing. The company plans to complete modifications to clinical trial protocols, transitioning from single-dose to multi-dose regimens, by the first half of next year.

In the area of autoimmune diseases, the application of ACE1831 is also expanding, particularly in IgG4-related disease (IgG4-RD). In November, Acepodia-KY received approval from the U.S. FDA to conduct a Phase 1b/2a clinical trial for ACE1831 and aims to obtain IND approvals in additional countries and Orphan Drug Designation (ODD) from the U.S. FDA by the first half of next year.

For solid tumor treatments, Acepodia-KY’s other candidate, ACE2016, plans to complete enrollment of a double-digit number of patients next year to explore its therapeutic potential in EGFR-positive solid tumors.

Acepodia-KY also emphasized ongoing breakthroughs in the AD2C technology platform. Anticancer dual-drug conjugates developed using this platform have shown significant cytotoxicity in GPC3-positive HepG2 cancer cell models while demonstrating no notable toxicity to normal cells, highlighting their exceptional anticancer efficacy and safety. This platform will serve as a key technological foundation for future developments in the solid tumor field, with plans to initiate preclinical research and process development for GPC3-positive hepatocellular carcinoma treatments next year.

Resource: 育世博核心候選產品ACE1831和ACE2016 明年臨床試驗進展加速推進