Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE1831 in IgG4-Related Disease

IND clearance paves the way for Acepodia to enter the clinic for the first time with its autoimmune program

ACE1831 is an allogeneic gamma delta T cell therapy candidate targeting CD20-expressing cells currently being investigated in non-Hodgkin's lymphoma (NHL)

The planned clinical study will be executed as part of strategic clinical collaboration with Pfizer Ignite

ALAMEDA,Calif. and TAIPEI,Nov. 15,2024 -- Acepodia (6976:TT),a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2)T cell platforms,announced today that it has received U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for the company's lead candidate ACE 1831 in IgG4-related disease (IgG4-RD),a multi-organ,fibro-inflammatory autoimmune condition.

This IND clearance allows Acepodia to investigate the safety and efficacy of Acepodia's ACE1831 in patients with IgG4-RD,as its first step in autoimmune disease. ACE1831 utilizes bioorthogonal chemistry to link CD20-targeting antibodies to gamma deltaT cells,creating an off-the-shelf,non-genetically engineered version of T cell therapy that is more easily scaled and may potentially mitigate side effects associated with autologous CAR-T cell therapies,such as T cell malignancies. ACE1831 is also in a Phase 1 dose escalation study for non-Hodgkin's lymphoma (NHL).

"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 SonnyHsiao,PhD,Chief Executive Officer,President and Co-Founder ofAcepodia. "We've engaged accomplished IgG4-RD research physicians worldwide,excited by our innovative approach. This clearance enables us to launch the study,offering participants a promising new treatment," commented Jerry Liu,MD,Head of Clinical Development of Acepodia.

The Phase 1b/2a study of ACE1831 will be executed in collaboration with Pfizer Ignite,a service that offers biotech companies access to Pfizer's significant resources,scale,and expertise to accelerate the progression of potential breakthrough medicines for patients. The study will be led by Dr. John Stone,MPH,of Massachusetts General Hospital,Executive Chairman of The IgG4ward! Foundation and an eminent IgG4-RD researcher whose work identified the potential of targeted B-cell depletion with rituximab. Dr. Stone said,"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's approach,but also about its ease of use and potential for fewer adverse effects than other cell-based approaches."

About Acepodia

Acepodia is a clinical-stage biotechnology company developingfirst-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform technology to address gaps in cancer care. Leveraging its ACC technology,the company links tumor-targeting antibodies to its proprietary immune cells,such as natural killer and gamma deltaT cells,to create novel ACE therapies,which have increased binding strength against tumors that express low levels of tumor antigens as well as pathogenic B cells causing autoimmune disease. Acepodia is composed of seasoned leaders and scientific experts dedicated to advancing its robust pipeline of ACE therapies with the potential to bring innovative,effective,and affordable cell therapies to a broad population of patients across a variety of solid tumors and hematologic cancers. For more information,visitwww.acepodia.comand follow Acepodia onTwitterandLinkedIn.