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IND Cleared for γδ T-Cell Therapy in Non-Hodgkin Lymphoma

ACE1831 will soon be evaluated in a phase 1, first-in-human, clinical trial.

The FDA has cleared the investigational new drug application (IND) for Acepodia’s ACE1831, a γδ T-cell therapy, for the potential treatment of non-Hodgkin lymphoma (NHL).1

"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 Antibody-Cell Conjugation (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," Sonny Hsiao, PhD, chief executive officer, Acepodia, said in a statement.1 "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," said the chief executive officer.

ACE1831 is an allogeneic, anti-CD20 γδ T-cell therapy developed with Acepodia’s ACC platform. The therapy will be evaluated in a phase 1, first-in-human, multi-center clinical trial in patients with NHL. γδT cells

READ MORE: Allogeneic CAR T-Cell Therapy Yields 100% CR Rate in B-NHL

“In an in vivo model, ACE1831 showed prolonged survival compared to treatment groups utilizing the same antibody and effector cells separately. In addition, ACE1831 is shown to trigger the release of interferon gamma but not interleukin-6 while engaging target tumor cells in vivo, suggesting that ACE1831 may activate the immune system without the risk of cytokine release syndrome,” Hsiao previously told CGTLive.

Acepodia’s lead program, ACE1702, is an allogeneic, amplified natural killer (NK) cell therapy also developed with the ACC platform.2 ACE1702 is currently being evaluated in a phase 1 trial (NCT04319757) in HER2-positive tumors.

The study is primarily evaluating safety and tolerability via the incidence and severity of adverse events (AEs) and dose-limiting toxicities as well as the maximum tolerated dose and the phase 2 recommended dose. Secondary endpoints include pharmacokinetics and pharmacodynamics such as NK cell persistence and immune function. Other outcomes evaluate preliminary efficacy by measuring tumor response via RECIST 1.1, radiographic assessments, and serum tumor marker values.

“The trial will continue to enroll patients with advanced HER2-expressing tumors. Dose escalation is continuing up to 15 billion cells per cycle with updated clinical data to be provided in the first half of 2022,” Thorsten Graef, MD, PhD, chief medical officer, Acepodia, previously told CGTLive.

1. 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
2. Acepodia Presents Positive Interim Phase 1 Feasibility Data for Antibody Cell Effector Therapy, ACE1702, in Advanced HER2-Positive Tumors. News release. Acepodia. September 16, 2021. https://www.globenewswire.com/news-release/2021/09/16/2298101/0/en/Acepodia-Presents-Positive-Interim-Phase-1-Feasibility-Data-for-Antibody-Cell-Effector-Therapy-ACE1702-in-Advanced-HER2-Positive-Tumors.html