Initial Phase 1 Results of ACE1831: First Anti-CD20 Linked Allogeneic Gamma Delta T Cell Therapy for Non-Hodgkin's Lymphoma

Acepodia, a biotech firm in the clinical phase that is pioneering unique cell therapies through its proprietary Antibody-Cell Conjugation and allogeneic gamma delta 2 T cell technologies, has recently released initial data from the Phase 1 dose-escalation study of ACE1831. This investigational therapy, which consists of anti-CD20 antibody conjugated allogeneic gamma delta T cells, is currently under evaluation for its efficacy in treating individuals diagnosed with non-Hodgkin’s lymphoma.

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In a recent clinical trial, 20% of participants showed a complete response, while 60% achieved disease stability after receiving a minimal dose of ACE1831. Out of these participants, one exhibiting a complete response and two who achieved stable disease had been treated with CD19 CAR-T previously.

Developed by Acepodia, ACE1831 marks the inaugural use of the company's ACC platform in clinical trials. This platform utilizes bioorthogonal chemistry for attaching antibodies against CD20 to gamma delta 2 T cells. Originating from Dr. Carolyn Bertozzi's innovative research in click chemistry on living systems — which garnished the Nobel Prize in 2022 — this approach offers a ready-to-use, non-genetically modified alternative to CAR-T cell therapies, potentially reducing severe side effects like cytokine release syndrome, neurotoxicity, and more.

Initial findings suggest that ACE1831 triggers a proximate and prolonged immune attack against cancer, involving direct cancer cell destruction, coating of the tumor cells (opsonization), and attracting additional T cells via cytokine release, potentially offering broader immune engagement compared to conventional CAR-T treatments.

Sonny Hsiao, Ph.D. and CEO of Acepodia, remarked, "This ongoing trial showcases the therapeutical promises of bioorthogonal chemistry, positioning it as a transformative, inclusive method in cell therapy, particularly when juxtaposed with existing limitations in CAR-T therapies. The encouraging outcomes from the minimal dose point to a significant, enduring effect, emphasizing our commitment to advancing this novel therapeutic strategy."

The initial human, phase 1 assessment of ACE1831 is designed as an open-label, dose-increasing examination to investigate its safety, pharmacokinetics, and effectiveness in individuals with resistant or recurring non-Hodgkin’s lymphoma. This trial, expanding across multiple centers, seeks to include up to 42 participants across the U.S. and Taiwan.

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According to the data provided by the Synapse Database, As of May 11, 2024, there are 227 investigational drugs for the CD20 targets, including 213 indications, 306 R&D institutions involved, with related clinical trials reaching 3534, and as many as 49676 patents.

ACE-1831 targets CD20 and is primarily focused on treating neoplasms, immune system diseases, and hemic and lymphatic diseases. The drug is currently in Phase 1 of development and has shown promise in treating various lymphomas. Further research and clinical trials will be necessary to determine its safety and efficacy in larger patient populations.