Acepodia's ACE1831 Receives FDA IND Clearance for IgG4-Related Disease
核心洞察
Acepodia (搜索)'s ACE1831, an allogeneic gamma delta T cell therapy, has received FDA IND clearance for IgG4-related disease (搜索), marking Acepodia's entry into autoimmune disease therapeutics.
ACE1831 targets CD20 (搜索)-expressing cells using Antibody-Cell Conjugation (ACC) technology, offering a potentially scalable and safer alternative to autologous CAR-T cell therapies.
A Phase 1b/2a study of ACE1831 will be conducted in collaboration with Pfizer Ignite, focusing on the safety and efficacy in IgG4-RD patients.
Acepodia (搜索), a clinical-stage biotechnology company, has announced FDA clearance of its Investigational New Drug (IND) application for ACE1831 in IgG4-related disease (搜索) (IgG4-RD), a multi-organ, fibro-inflammatory autoimmune condition. This clearance allows Acepodia to initiate clinical trials to evaluate the safety and efficacy of ACE1831 in patients with IgG4-RD.
ACE1831 is an allogeneic gamma delta T cell therapy candidate that targets CD20 (搜索)-expressing cells. The therapy utilizes Acepodia (搜索)'s proprietary Antibody-Cell Conjugation (ACC) technology, which links CD20-targeting antibodies to gamma delta T cells. This approach creates an off-the-shelf, non-genetically engineered T cell therapy, potentially offering scalability and reduced side effects compared to autologous CAR-T cell therapies.
Clinical Trial and Collaboration
The Phase 1b/2a study of ACE1831 will be executed in collaboration with Pfizer Ignite. This collaboration provides Acepodia (搜索) with access to Pfizer's resources and expertise to accelerate the development of ACE1831. Dr. John Stone, MD, MPH, of Massachusetts General Hospital, a leading IgG4-RD researcher, will lead the study.
"A crucial finding for people living with IgG4-RD now has been the efficacy in disease control exerted by B cell depletion. I’m enthusiastic now not only about the possibility of deeper B cell depletion with Acepodia (搜索)’s approach, but also about its ease of use and potential for fewer adverse effects than other cell-based approaches," said Dr. Stone.
Mechanism of Action and Potential Benefits
ACE1831 aims to achieve deeper B cell depletion than traditional antibody drugs, which is considered critical for achieving longer remission in autoimmune diseases. By targeting CD20 (搜索), a protein expressed on B cells, ACE1831 seeks to eliminate pathogenic B cells that contribute to the inflammation and fibrosis characteristic of IgG4-RD.
"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," said Sonny Hsiao, PhD, Chief Executive Officer, President and Co-Founder of Acepodia (搜索).
About IgG4-Related Disease
IgG4-RD is a systemic fibro-inflammatory condition characterized by elevated serum IgG4 concentrations and infiltration of IgG4-positive plasma cells into various organs. The disease can affect multiple organ systems, leading to a variety of clinical manifestations, including pancreatitis, cholangitis, sialadenitis, and retroperitoneal fibrosis. Current treatment options include corticosteroids and B cell-depleting agents like rituximab. However, there remains an unmet need for more effective and durable therapies.