Acepodia's ACE1831 Receives FDA IND Clearance for IgG4-Related Disease Trial

Key Insights

• Acepodia's ACE1831, an allogeneic gamma delta T cell therapy, has received FDA IND clearance for investigation in IgG4-related disease, marking Acepodia's entry into autoimmune disease treatment.
• ACE1831 targets CD20-expressing cells and is designed as an off-the-shelf therapy, potentially reducing side effects associated with autologous CAR-T cell therapies.
• A Phase 1b/2a study, in collaboration with Pfizer Ignite, will assess the safety and efficacy of ACE1831 in IgG4-RD patients, led by Dr. John Stone of Massachusetts General Hospital.

Acepodia, a clinical-stage biotechnology company, has announced FDA clearance of its Investigational New Drug (IND) application for ACE1831 in IgG4-related disease (IgG4-RD). This clearance allows Acepodia to initiate clinical trials for its lead candidate in this multi-organ, fibro-inflammatory autoimmune condition.

ACE1831: A Novel Approach to B Cell Depletion

ACE1831 is an allogeneic gamma delta T cell therapy candidate that targets CD20-expressing cells. It employs bioorthogonal chemistry to link CD20-targeting antibodies to gamma delta T cells, creating an off-the-shelf T cell therapy. This approach aims to improve scalability and reduce the risk of 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).

Clinical Trial Details and Collaboration

The Phase 1b/2a study of ACE1831 will be conducted in collaboration with Pfizer Ignite. Dr. John Stone, MD, MPH, of Massachusetts General Hospital, a leading IgG4-RD researcher, will lead the study. The trial will evaluate the safety and efficacy of ACE1831 in patients with IgG4-RD.

Dr. Stone emphasized the importance of B cell depletion in managing IgG4-RD, noting the efficacy of rituximab in disease control. He expressed enthusiasm for ACE1831's potential for deeper B cell depletion, ease of use, and potentially fewer adverse effects compared to other cell-based approaches.

Rationale for ACE1831 in Autoimmune Disease

Acepodia's CEO, Dr. Sonny Hsiao, stated the hope that ACE1831 can deliver deeper B cell depletion than antibody drugs, which is critical for longer remission in autoimmune diseases. This approach is based on observations of clinical benefits of CAR-T in autoimmune diseases.

About IgG4-Related Disease

IgG4-RD is a systemic fibro-inflammatory condition that can affect multiple organs, leading to significant morbidity. Current treatments often involve B cell depletion strategies, but there remains a need for more effective and less toxic therapies.