Acepodia’s innovative Antibody-Cell Conjugate (ACC) new drug, ACE1831, has shown promising initial results in a Phase I clinical trial for non-Hodgkin lymphoma, underscoring its potential in treating autoimmune diseases. CEO Shih-Chia Hsiao announced plans to expedite applications for expanded therapeutic indications, maintaining the company’s goal of introducing a new drug into clinical trials each year.
Hsiao explained that Acepodia’s two major technology platforms are Antibody-Cell Conjugate (ACC) and γδ2T cell-based immunotherapy. The ACC technology, derived from Nobel laureate Carolyn Bertozzi’s click chemistry, boasts high reproducibility and enhances the functionality of cellular new drugs by equipping immune cells with targeted capabilities. This next-generation T-cell engager technology significantly strengthens cell-based new drugs.
The initial data from the lowest dose cohort of ACE1831’s Phase I clinical trial for non-Hodgkin lymphoma was recently released. Among the five participants, four who completed the treatment showed promising results: three had stable disease (SD) and one achieved complete response (CR). These participants had relapsed after first-line treatment with Rituximab and other standard second-line therapies, with several having undergone more than five lines of treatment. Notably, three participants who completed the treatment had relapsed after CAR-T therapy, including the patient who achieved CR.
Regarding durability, one participant with SD experienced no disease progression for one month, while the other three saw no disease progression for three months, indicating no tumor growth or new tumor formation.
In terms of safety and tolerability, there were no occurrences of ACE1831-related cytokine release syndrome (CRS) or acute graft-versus-host disease (GvHD). Pharmacokinetically, ACE1831 was detectable in patients for 21-28 days and demonstrated B-cell clearance efficacy.
Hsiao highlighted that the clinical trial confirmed ACE1831's preliminary safety data, its presence in patients for 21-28 days, and the initial response in patients who relapsed after CAR-T therapy. These findings validate the ACC platform’s potential and ACE1831's applicability in autoimmune disease treatments. Acepodia is actively advancing clinical trial applications for autoimmune diseases.
Currently, Acepodia has three new drugs approved for human clinical trials (IND) in breast cancer, hematologic tumors, and lung cancer. The hematologic tumor trial has enrolled over 30 participants, the breast cancer trial has enrolled 8-10 participants, and the newly approved lung cancer trial is expected to begin enrollment shortly.
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