EGFR-Targeting γδ2T-Cell Cleared for Solid Tumor Trial


Acepodia is also evaluating a CD20-targeted γδ2T-cell therapy in patients with non-Hodgkin lymphoma.

The FDA has cleared Acepodia’s investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (γδ2) T-cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.1

"This milestone is a key step as we advance our pipeline of next generation cell therapies and explore the potential of our novel Antibody-Cell Conjugation (ACC) technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," Sonny Hsiao, PhD, chief executive officer, Acepodia, said in a statement.1

Following the clearance, Acepodia plans to initiate a phase 1, first-in-human clinical trial evaluating the safety, tolerability, and pharmacodynamics of ACE2016 in the coming months. The company expects to dose the first participant with locally advanced or metastatic EGFR-expressing solid tumors in the second half of 2024.

"The rapid progression of obtaining the third IND approval within 18 months highlights the team's remarkable efficiency and dedication to advancing innovative programs swiftly. With our third program in the clinic, we are proud to continue progressing the field of cell therapy with the goal of delivering powerful, accessible treatments for patients through a first-of-its-kind approach,” Hsiao continued.1

READ MORE: First Patient With Esophageal Cancer Receives TAC101-CLDN18.2 Cell Therapy

ACE2016 is developed using Acepodia’s Antibody-Cell Conjugation (ACC) platform and its γδ2T-cell platform. The ACC technology is designed to link tumor-targeting antibodies to the cmopany’s proprietary immune cells, such as natural killer and γδ2T-cells. It is based off the work of 2022 Nobel Laureate Carolyn Bertozzi, PhD, in applying click chemistry to living cells. Bertozzi currently serves as chief scientific advisor to Acepodia.2

The company’s lead candidate, also developed with these platforms, is the CD20-targeting ACE1831 γδ2T-cell therapy currently being evaluated in patients with non-Hodgkin lymphoma in a phase 1 trial, and is the first of the company’s therapies to reach the clinical stage.

The trial, which expects to enroll around 42 participants in the United States, dosed its first patient in May 2023. The trial is aiming to determine the maximum tolerated dose of a single infusion of ACE1831 after lymphodepleting chemotherapy. Both ACE2016 and ACE1831 have showed cytotoxicity in previous preclinical studies conducted by Acepodia.3

"As we continue to validate our ACC technology in humans, this trial marks the beginning of a new chapter in the field of allogeneic cell therapy," Hsiao said when the first patient received ACE1831.2 "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."

Also in Acepodia’s pipeline is ACE1708, a PD-L1-targeted ACC-γδ2T-cell therapy currently in preclinical studies exploring potential efficacy against PD-L1-ecpressing solid tumors.

1. Acepodia Announces FDA Clearance of Investigational New Drug Application forACE2016, a First-in-Class Allogeneic Anti-EGFR Cell Therapy. News release. Acepodia. February 4, 2024.
2. Acepodia Announces Nobel Laureate Carolyn Bertozzi, Ph.D., as Chief Scientific Advisor. News release. Acepodia. September 18, 2023.
3. 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.
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