On November 13, Acepodia announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ACE1831, its lead candidate targeting IgG4-related disease (IgG4-RD). IgG4-RD is a chronic, systemic autoimmune disease characterized by multi-organ fibrosis. This FDA approval marks Acepodia’s first expansion of its allogeneic cell therapy platform into the autoimmune disease arena.
Acepodia explained that ACE1831 leverages its proprietary Antibody-Cell Conjugation (ACC) technology, using bioorthogonal chemistry to link a CD20-targeting antibody directly to gamma delta T cells. This innovation produces an “off-the-shelf” allogeneic cell therapy that combines the benefits of T cell therapy without the genetic modifications typical of CAR-T therapies, thereby avoiding many of CAR-T’s common side effects and allowing for easier large-scale production. ACE1831 is also undergoing a Phase I clinical trial for non-Hodgkin lymphoma (NHL).
Sonny Hsiao, CEO and co-founder of Acepodia, commented, “Based on CAR-T’s clinical success in autoimmune diseases, we believe ACE1831 can achieve deeper B-cell depletion than antibody therapies, which is crucial for longer-lasting remission in autoimmune disease patients. Acepodia has engaged leading IgG4-RD researchers worldwide, and we are excited about the potential of this novel therapy.”
Dr. Jerry Liu, Acepodia’s Head of Clinical Development, added, “With the FDA’s approval, we can now begin clinical trials and bring this promising therapy to patients.”
The clinical trial will be conducted with support from Pfizer’s Ignite program, which offers resources and technical expertise to help biotech companies accelerate the development of promising new drugs. The study will be led by Dr. John Stone, Chief of Rheumatology at Massachusetts General Hospital and a leading expert in IgG4-RD. Dr. Stone remarked, “B-cell depletion has shown significant efficacy in managing IgG4-RD. I am optimistic that Acepodia’s ACE1831 could achieve even deeper B-cell clearance, and its ease of use and potential for reduced side effects make it an attractive alternative to existing cell therapy options.”
Resource: 育世博異體細胞新藥獲美FDA核准IND 攜手輝瑞展開臨床
