Acepodia Releases Early Phase 1 Data on ACE1831 Therapy for Non-Hodgkin's Lymphoma

Acepodia, a clinical-stage biotechnology firm based in Alameda, California, and Taipei, recently revealed promising preliminary data from its Phase 1 dose escalation clinical trial of ACE1831. This novel therapy involves an anti-CD20 antibody conjugated with allogeneic gamma delta T cells and is being evaluated in patients with non-Hodgkin's lymphoma (NHL).

Key outcomes from the study indicate that one out of five patients exhibited a complete response (CR) and three out of five experienced disease stabilization (SD) after a single dose of ACE1831 at the lowest dose level. Notably, one CR and two SD patients had previously undergone CD19 CAR-T treatment. The clinical response was durable for up to three months following the initial dose. Importantly, the lowest dose of ACE1831 was well-tolerated, with no related severe adverse events or dose-limiting toxicities observed. Dose escalation is continuing.

ACE1831 is Acepodia's inaugural cell therapy to progress into clinical development from its proprietary Antibody-Cell Conjugation (ACC) platform. This platform employs biorthogonal chemistry to conjugate gamma delta T cells with antibodies targeting the CD20 antigen. Based on the pioneering "click chemistry" work by 2022 Nobel Prize winner Dr. Carolyn Bertozzi, the ACC platform creates an off-the-shelf, non-genetically engineered version of CAR-T cell therapy. This version is easier to scale and avoids the severe side effects often associated with CAR-T therapies, such as cytokine release syndrome (CRS) and neurotoxicity.

Preliminary data suggest that ACE1831 can activate both innate and adaptive immune responses. These responses involve direct tumor cell killing, tumor opsonization, and T cell recruitment through cytokine secretion, potentially generating a more comprehensive immune response compared to standard CAR-T therapies. According to Sonny Hsiao, Ph.D., CEO of Acepodia, the trial underscores the potential clinical benefits of using biorthogonal chemistry in cell therapy, offering a powerful new approach that addresses the limitations of current CAR-T treatments and enhances patient accessibility.

The ongoing Phase 1 trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed or refractory non-Hodgkin's lymphoma. The multi-center trial aims to enroll up to 42 patients across sites in the United States and Taiwan.

ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia's ACC platform. It targets CD20-expressing hematological cancers through anti-CD20 antibody conjugated gamma delta T cells. Leveraging the high expression of natural killer (NK) cell-activating receptors on gamma delta T cells, ACE1831 has demonstrated enhanced cytotoxicity against cancer cells in both in vitro and in vivo models. Currently, ACE1831 is under evaluation in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma.

Acepodia is dedicated to advancing its robust pipeline of first-in-class cell therapies. Using its ACC technology, the company links tumor-targeting antibodies to proprietary immune cells, such as natural killer and gamma delta T cells, to create novel ACE therapies. These therapies exhibit increased binding strength against tumors with low antigen expression, aiming to bring innovative, effective, and affordable cell treatments to a broad patient population across various solid tumors and hematologic cancers.