FDA Clears Acepodia's IND for ACE1831 in IgG4-Related Disease

Acepodia, a biotechnology company focused on cell therapies, has announced the FDA clearance of its Investigational New Drug (IND) application for their lead candidate, ACE1831, for the treatment of IgG4-related disease (IgG4-RD). This autoimmune condition affects multiple organs and is characterized by fibro-inflammatory symptoms. This clearance marks a pivotal moment for Acepodia as it allows them to proceed with clinical trials to evaluate the safety and effectiveness of ACE1831 in patients suffering from IgG4-RD.

ACE1831 is an allogeneic gamma delta T cell therapy designed to target CD20-expressing cells. This innovative approach combines CD20-targeting antibodies with gamma delta T cells through bioorthogonal chemistry, resulting in an off-the-shelf T cell therapy that is not genetically engineered. This method is expected to be easier to scale and may reduce the side effects often associated with autologous CAR-T cell therapies, such as T cell malignancies. ACE1831 is also being tested in a Phase 1 dose escalation study for non-Hodgkin's lymphoma (NHL).

Sonny Hsiao, PhD, CEO, President, and Co-Founder of Acepodia, expressed optimism about the potential of ACE1831 to provide deeper B cell depletion than current antibody drugs, which could lead to longer remission periods for patients with autoimmune diseases. Jerry Liu, MD, Head of Clinical Development at Acepodia, highlighted the global collaboration with IgG4-RD research physicians and the promising new treatment approach that this IND clearance allows them to pursue.

The upcoming Phase 1b/2a study will be conducted in partnership with Pfizer Ignite. This service offers biotech companies access to Pfizer's resources, expertise, and scale to advance potential breakthrough medicines. The study will be led by Dr. John Stone, MD, MPH, of Massachusetts General Hospital. Dr. Stone is also the Executive Chairman of The IgG4ward! Foundation and a leading IgG4-RD researcher. His work has demonstrated the potential of targeted B-cell depletion using rituximab in managing the disease. Dr. Stone expressed enthusiasm about ACE1831, noting its potential for deeper B cell depletion and fewer adverse effects compared to other cell-based therapies.

Acepodia is known for its unique Antibody-Cell Conjugation (ACC) platform technology, which links tumor-targeting antibodies to proprietary immune cells, including natural killer and gamma delta T cells. This approach creates advanced ACE therapies with increased binding strength against tumors with low antigen levels and pathogenic B cells causing autoimmune diseases. The company is committed to advancing its pipeline of ACE therapies to provide innovative, effective, and affordable cell therapies to patients with various types of solid tumors and hematologic cancers.

With seasoned leaders and scientific experts at the helm, Acepodia aims to address significant gaps in cancer care and autoimmune disease treatment. The FDA clearance for ACE1831 is a significant milestone for the company, positioning it to contribute valuable new therapies to the clinical landscape. The planned study in collaboration with Pfizer Ignite reflects a strategic effort to bring these innovations to patients in need, potentially transforming treatment paradigms in oncology and autoimmune diseases.