Acepodia, a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ACE1831 in IgG4-related disease (IgG4-RD). This clearance allows Acepodia to begin clinical trials for its lead candidate in this multi-organ, fibro-inflammatory autoimmune condition. The planned Phase 1b/2a study will be executed as part of a strategic clinical collaboration with Pfizer Ignite.
ACE1831 is an allogeneic gamma delta T cell therapy designed to target CD20-expressing cells. It leverages bioorthogonal chemistry to link CD20-targeting antibodies to gamma delta T cells, creating an off-the-shelf, non-genetically engineered T cell therapy. This approach aims to improve scalability and potentially reduce the side effects often associated with autologous CAR-T cell therapies, such as T cell malignancies. ACE1831 is also currently in a Phase 1 dose escalation study for non-Hodgkin's lymphoma (NHL).
Rationale and Clinical Development
Acepodia's CEO, Sonny Hsiao, PhD, stated, "Based on the observation of clinical benefits of CAR-T in autoimmune diseases, we hope to prove that ACE1831 can deliver 'deeper' B cell depletion than antibody drugs, critical for longer remission in autoimmune diseases." Jerry Liu, MD, Head of Clinical Development of Acepodia, added that the company has engaged leading IgG4-RD research physicians worldwide who are enthusiastic about this innovative approach.
The Phase 1b/2a study will be led by Dr. John Stone, MD, MPH, of Massachusetts General Hospital, who also serves as Executive Chairman of The IgG4ward! Foundation. Dr. Stone's previous research has highlighted the efficacy of targeted B-cell depletion with rituximab in managing IgG4-RD. He expressed enthusiasm about the potential of ACE1831, noting the possibility of deeper B cell depletion, ease of use, and potentially fewer adverse effects compared to other cell-based approaches.
IgG4-Related Disease and ACE1831's Potential
IgG4-RD is a systemic fibro-inflammatory condition that can affect multiple organs. Current treatments often involve B-cell depletion strategies. ACE1831 aims to improve upon these strategies by providing a more effective and scalable T cell therapy that can achieve deeper B cell depletion, potentially leading to longer remission periods for patients.
Acepodia's Antibody-Cell Conjugation (ACC) platform links tumor-targeting antibodies to immune cells, such as natural killer and gamma delta T cells. This technology enhances the binding strength against tumors expressing low levels of tumor antigens, as well as pathogenic B cells causing autoimmune disease. Acepodia is focused on advancing its pipeline of ACE therapies to provide innovative, effective, and affordable cell therapies for a broad range of patients with solid tumors, hematologic cancers, and autoimmune diseases.
