Acepodia announced preliminary data from its Phase 1 dose escalation clinical trial of ACE1831, an anti-CD20 antibody conjugated allogeneic gamma delta T cell therapy being evaluated in patients with non-Hodgkin's lymphoma (NHL). Key Results From Preliminary Clinical Data One out of five patients demonstrated complete response (CR) and three out of five patients experienced disease stabilization (SD) with single dose of ACE1831 at the lowest dose level. Among those patients, one CR and two SD patients were previously treated with CD19 CAR-T. Durability of clinical response was observed for three months after a single dose of ACE1831.

The lowest dose of ACE1831 was well tolerated with no ACE1831-related serious adverse events or dose limiting toxicities. Dose escalation is ongoing. ACE1831 is Acepodia's first cell therapy to enter clinical development from its proprietary ACC platform, which uses biorthogonal chemistry to conjugate gamma delta 2 (?d2) T cells with antibodies targeting CD20.

The platform, based on the pioneering work of 2022 Nobel Prize laureate Dr. Carolyn Bertozzi that applied click chemistry to living systems, creates an off-the-shelf, non genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxity and other side effects associated with CAR-T cell therapies. The preliminary data demonstrates that ACE1831 activates both an innate and adaptive immune response by direct killing of tumor cells, tumor opsonization, and recruitment of T cells through cytokine secretion, and may therefore generate a more comprehensive immune response than standard CAR-T cell therapies. The first-in-human, phase 1 trial is an open-label, dose escalation study that aims to evaluate the safety and tolerability, pharmacokinetics, and efficacy of ACE1831 in patients with relapsed/refractory non-Hodgkin's lymphoma.

The multi-center trial is expected to enroll up to 42 patients in the United States and Taiwan.