• First dosing cohort was completed with complete response and disease stabilization identified at three months at the lowest dose level in the Phase 1 study
  • No ACE1831-related serious adverse events, including GvHD, neurotoxicity, high-grade CRS or dose limiting toxicities were observed
  • Results shared during a fireside chat hosted by William Blair & Company on May 7th, 2024. An archived recording will be available for 7 days following the event at https://www.acepodia.com/newsroom/media/.

ALAMEDA, CA, USA and TAIPEI, Taiwan I May 8, 2024 I 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 to address gaps in cancer care, today 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 bioorthogonal chemistry to conjugate gamma delta 2 (γδ2) 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. 

“This ongoing trial is the first to demonstrate potential clinical benefit to patients using bioorthogonal chemistry and opens the door to a powerful, new approach for cell therapy that overcomes limitations of current CAR-T cell therapies and is more accessible to patients,” said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. “We are encouraged to see a robust and durable effect after a single treatment at the lowest dose, and remain focused on the continued development of this first-of-its kind treatment option.”

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.

About ACE1831

ACE1831 is an off-the-shelf gamma delta T cell therapy candidate developed from Acepodia’s proprietary ACC platform. ACE1831 targets CD20-expressing hematological cancers using anti-CD20 antibody conjugated gamma delta T cells. Taking advantage of the high expression of NK cell activating receptors of the gamma delta T cells to scavenge the malignant blood cells, ACE1831 has demonstrated in models enhanced cytotoxicity against cancer cells both in vitro and in vivo. ACE1831 is currently being evaluated in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin’s lymphoma.

About Acepodia

Acepodia is a clinical-stage biotechnology company developing first-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 delta T cells to create novel ACE therapies, which have increased binding strength against tumors that express low levels of tumor antigens.

Acepodia is made up 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, visit www.acepodia.com and follow Acepodia on Twitter and LinkedIn.

SOURCE: Acepodia