Acepodia Announces 2025 Clinical Development Milestones and Comprehensive Growth Strategies

Acepodia (The Company, 6976.TT) announced today at the investor conference the clinical trial progress for its core product candidates ACE1831 and ACE2016, along with a detailed roadmap for 2025 and strategic plans to unlock future value. The Company also showcased groundbreaking developments in its Antibody-Dual-Drugs Conjugation (AD2C) technology platform, further solidifying its leadership in the fields of oncology and autoimmune diseases.

Advancing Hematological Cancer Treatments
Acepodia is actively optimizing the therapeutic strategy for ACE1831. The Company plans to complete a clinical protocol amendment by H1 2025, transitioning from single-dose to multi-dose regimens to enhance treatment outcomes for patients. This innovative approach underscores the potential of ACE1831 in advancing hematological cancer therapies.

Expanding into Autoimmune Diseases
The therapeutic applications of ACE1831 continue to expand, particularly in the treatment of IgG4-related disease (IgG4-RD). In November 2024, the Company obtained FDA clearance for a Phase 1b/2a clinical trial and is planning to obtain Investigational New Drug (IND) approvals in additional countries by H1 2025. Additionally, Acepodia aims to apply Orphan Drug Designation (ODD) from the FDA to further support its development in this field by H1 2025.

Exploring Solid Tumor Therapies and breakthroughs in the AD2C Technology Platform
Acepodia’s candidate ACE2016 is set to complete enrollment of a double-digit number of patients in 2025, focusing on its application in EGFR-positive solid tumors.

Acepodia is also expanding its innovation capabilities with breakthroughs in its AD2C technology platform. The anti-GPC3 dual-drug conjugate developed through this platform has demonstrated significant cytotoxicity against GPC3-positive HepG2 cancer cells while sparing normal cells, highlighting its safety profile and therapeutic potential. This platform will serve as a cornerstone for Acepodia’s future programs targeting solid tumors, with preclinical studies for GPC3-positive hepatocellular carcinoma (HCC) planned to commence in 2025.

“We are thrilled with the clinical progress of ACE1831, ACE2016, and our AD2C platform,” said Sonny Hsiao, Ph.D., Co-Founder and CEO of Acepodia. “These advancements not only demonstrate our capabilities in developing innovative therapies for cancer and autoimmune diseases but also represent a pivotal step toward fulfilling our mission to deliver breakthrough solutions for patients.”
As its clinical trials advance, Acepodia remains committed to technological innovation and global expansion. The Company strives to bring hope and transformative solutions to patients while driving progress in the biotech industry.