NEW YORK – Acepodia said on Sunday that it will begin a Phase I study of its EGFR-targeted T-cell therapy, ACE2016, in solid tumor patients whose cancers express EGFR.
The US Food and Drug Administration cleared the firm's investigational new drug application, allowing it to launch a Phase I trial of the allogeneic gamma delta 2 (γδ2) T-cell therapy. Acepodia will begin the trial in the coming months and aim to treat the first patient with ACE2016 in the second half of 2024.
In the Phase I trial, Alameda, California-headquartered Acepodia is planning to assess ACE2016's safety, tolerability, and pharmacodynamics in patients with locally advanced or metastatic EGFR-expressing solid tumors.
The firm developed ACE2016 using its antibody cell conjugate platform. The therapy comprises γδ2 cells linked with antibodies that target EGFR-driven tumors. Acepodia believes that it has designed the treatment to have stronger binding against tumors that express low levels of tumor antigens.
According to the firm, ACE2016 has demonstrated promising activity against EGFR-expressing cancers in preclinical models. Acepodia is also evaluating a natural killer cell-based off-the-shelf cell therapy, ACE1702, as treatment for HER2-expressing cancers.