First Patient With NHL Receives γδ T-Cell Therapy in Phase 1 Trial

Acepodia has dosed the first patient in the phase 1 trial (NCT05653271) evaluating ACE1831 for the treatment of non-Hodgkin lymphoma (NHL).¹

"As we continue to validate our Antibody-Cell Conjugation (ACC) technology in humans, this trial marks the beginning of a new chapter in the field of allogeneic cell therapy," Sonny Hsiao, PhD, chief executive officer,Acepodia, said in a statement.¹ "Currently available cell therapies still present challenges in effectively engaging cancer cells due to immunosuppression caused by the tumor microenvironment. By utilizing potent gamma delta T cells with our novel tumor-targeting mechanisms, we are committed to identifying a safe and therapeutic dose in this Phase 1 trial and to advancing this study in larger patient cohorts."

ACE1831 is a γδ T-cell therapydeveloped with the use of Acepodia’s AAC platform and is the company’s first therapy of this kind to enter clinical trials. The therapy targets CD20-expressing hematological cancers and has demonstrated enhanced cytotoxicity against cancer cells both in vitro and in vivo in animal models.

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The multicenter, dose escalation trial is evaluatingthe safety and tolerability of intravenous infusion of ACE1831 in patients with NHL alongside cyclophosphamide and fludarabine lymphodepletion and in combination with obinutuzumab in treatment group B, as measured by adverse events and dose-limiting toxicities. Other primary outcomes of the trial are assessing maximum tolerated dose and changes from baseline in ECOG status, physical examination results, clinical laboratory tests results, urinalysis results, vital signs results, andelectrocardiogram results. Secondary outcomes include ACE1831 persistence,anti-ACE1831 antibodies, and Objective Response Rate. The study will also measure pharmacodynamics of ACE1831.

Acepodiaexpects to enroll up to 42 patients in the United States for the trial. The FDA cleared Acepodia’s investigational new drug application for ACE1831 in June 2022.²

"The FDA clearance of our IND application for ACE1831 is a significant milestone for Acepodia as we move into the clinic with a first antibody armed allogeneic gamma delta T cell product candidate through our unique ACC platform. Based on ACE1831's encouraging preclinical data, we believe that our antibody ­armed gamma delta T cell therapy has the potential to provide additional treatment options for patients with NHL," Hsiao said in a statement at that time.² "The ACC approach allows us to circumvent the limitations of current T cell engager therapies. Meanwhile, we can also significantly reduce manufacturing costs and have the potential to generate a cost-effective cancer treatment for patients. We look forward to advancing ACE1831 into its first clinical trial.”

REFERENCES

1. Acepodia announces first patient dosed in phase 1 clinical trial of ACE1831, an anti-CD20 armed allogeneic gamma delta T-cell therapy in development to treat patients with non-Hodgkin's lymphoma. News release. Acepodia. May 22, 2023. https://www.prnewswire.com/news-releases/acepodia-announces-first-patient-dosed-in-phase-1-clinical-trial-of-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-in-development-to-treat-patients-with-non-hodgkins-lymphoma-301830957.html
2. Acepodia announces FDA clearance of IND application for ACE1831, an anti-CD20 armed allogeneic gamma delta T-cell therapy candidate to treat patients with non-Hodgkin's lymphoma. News release. Acepodia. https://www.prnewswire.com/news-releases/acepodia-announces-fda-clearance-of-ind-application-for-ace1831-an-anti-cd20-armed-allogeneic-gamma-delta-t-cell-therapy-candidate-to-treat-patients-with-non-hodgkins-lymphoma-301570711.html