FDA Clears Acepodia's ACE1831 Drug for IgG4-Related Disease

Acepodia, a biotechnology firm in its clinical stage focusing on pioneering cell therapies, has announced its recent U.S. FDA approval for an Investigational New Drug (IND) application. This approval concerns their lead candidate, ACE1831, aimed at treating IgG4-related disease (IgG4-RD), an autoimmune condition characterized by multi-organ fibro-inflammatory responses.

This IND clearance is significant as it allows Acepodia to initiate clinical investigations into the safety and efficacy of ACE1831 for IgG4-RD patients. ACE1831 is an allogeneic gamma delta T cell therapy candidate that employs bioorthogonal chemistry, enabling the linkage of CD20-targeting antibodies to gamma delta T cells. This results in a non-genetically engineered, off-the-shelf T cell therapy, which potentially offers easier scalability and reduced side effects compared to autologous CAR-T cell therapies, such as T cell malignancies. ACE1831 is also being examined in a Phase 1 dose escalation study for non-Hodgkin's lymphoma (NHL).

Dr. Sonny Hsiao, Acepodia's CEO, President, and Co-Founder, expressed hope that ACE1831 could achieve deeper B cell depletion than existing antibody drugs, which is vital for prolonged remission in autoimmune diseases. He noted the involvement of distinguished IgG4-RD research physicians globally, who are enthusiastic about Acepodia's innovative approach. Dr. Jerry Liu, Acepodia's Head of Clinical Development, remarked that this FDA clearance is a significant milestone, allowing the company to launch the clinical study and offer patients a promising new treatment option.

The planned Phase 1b/2a clinical study of ACE1831 will be carried out in strategic collaboration with Pfizer Ignite. Pfizer Ignite provides biotech companies access to Pfizer's extensive resources, scale, and expertise to expedite the development of potential breakthrough treatments. The study will be led by Dr. John Stone from Massachusetts General Hospital, an eminent IgG4-RD researcher. Dr. Stone, who also serves as the Executive Chairman of The IgG4ward! Foundation, has played a key role in identifying the potential of targeted B-cell depletion with rituximab. He highlighted the critical role of B cell depletion in controlling IgG4-RD and expressed enthusiasm about the potential of Acepodia's approach for deeper B cell depletion and its ease of use with potentially fewer adverse effects compared to other cell-based therapies.

Acepodia is known for developing first-in-class cell therapies using its unique Antibody-Cell Conjugation (ACC) platform technology. This technology couples tumor-targeting antibodies with proprietary immune cells, such as natural killer and gamma delta T cells, to create novel therapies. These therapies show increased binding strength against tumors with low levels of tumor antigens and pathogenic B cells involved in autoimmune diseases. The company's team comprises experienced leaders and scientific experts committed to advancing a robust pipeline of therapies that aim to deliver innovative, effective, and affordable treatments for a wide range of solid tumors and hematologic cancers.