- Acepodia Receives IND Approval, Paving the Way for First Clinical Trial of Its Autoimmune Program
- ACE1831: A Novel Gamma Delta T Cell Therapy Targeting CD20-Expressing Cells, Under Investigation for Non-Hodgkin Lymphoma (NHL)
- The planned clinical study is part of a strategic collaboration with Pfizer Ignite.
Acepodia, a biotechnology company at the clinical stage, known for pioneering novel cell therapies with its proprietary γδ2 (gamma delta 2) T cell and Antibody-Cell Conjugation (ACC) technologies, has shared the exciting news that it has received FDA approval for its Investigational New Drug (IND) application. This approval enables Acepodia to advance its lead candidate, ACE1831, into clinical trials for IgG4-related disease (IgG4-RD), a multi-organ inflammatory autoimmune condition.
This green light allows Acepodia to evaluate the safety and efficacy of ACE1831 in patients with IgG4-RD, marking an important step in addressing autoimmune diseases. ACE1831 utilizes orthogonal biochemistry to link CD20-targeting antibodies to gamma delta T cells. This approach creates an off-the-shelf, non-genetically modified T cell therapy that is more scalable and potentially reduces side effects commonly associated with CAR-T therapies, such as T-cell malignancies. The therapy is also undergoing a Phase 1 dose-escalation trial for NHL.
Dr. Sonny Hsiao, CEO, President, and Co-Founder of Acepodia, said, “Building on the clinical success of CAR-T therapies in autoimmune diseases, we aim to prove that ACE1831 can achieve deeper B-cell depletion compared to antibody treatments, which is crucial for extending recovery periods in autoimmune conditions.” Dr. Jerry Liu, Head of Clinical Development at Acepodia, added, “We have brought together leading IgG4-RD researchers from around the world, all of whom are excited about our innovative approach. This approval allows us to start the study and offer a promising new treatment to participants.”
The Phase 1b/2a trial for ACE1831 will be conducted in partnership with Pfizer Ignite, a service that provides biotech companies with access to Pfizer’s extensive resources, expertise, and infrastructure to help speed up the development of promising new treatments for patients. The study will be overseen by Dr. John Stone, MD, MPH, from Massachusetts General Hospital, who also serves as Executive Chairman of the IgG4ward! Foundation. Dr. Stone is a leading researcher in IgG4-RD, having pioneered the concept of B-cell depletion with rituximab. Dr. Stone explained that one of the major breakthroughs for people with IgG4-RD has been understanding how effective B-cell depletion is in managing the disease. “I’m really excited about Acepodia’s approach, as it has the potential to achieve deeper B-cell depletion while being easier to use and possibly causing fewer side effects compared to other cell-based therapies.”