FDA Clears IND for ACE2016 in EGFR-Expressing Solid Tumors


The allogeneic gamma delta 2 T-cell therapy ACE2016 will undergo investigation in a phase 1 trial for the treatment of patients with locally advanced or metastatic EGFR-expressing solid tumors.

  • ACE2016 is an allogeneic gamma delta 2 (γδ2) T-cell therapy intended for the treatment of patients with solid tumors.

  • With the investigational new drug (IND) application cleared by the FDA, a phase 1 clinical trial of ACE2016 may begin.

  • Preclinical models demonstrated in vitro and in vivo efficacy of ACE2016 against EGFR-expressing cancer cells.

The FDA has granted clearance to the IND application for ACE2016, an allogeneic γδ2 T-cell therapy for the treatment of patients with solid tumors that express epidermal growth factor receptor (EGFR).1

With the IND cleared, a phase 1, first-in-human trial to assess the safety, tolerability, and pharmacodynamics of ACE2016 in adult patients with locally advanced or metastatic EGFR-expressing solid tumors may begin.

The trial is anticipated to start in the coming months with the first patient expected to be treated in the second half of 2024.

"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 technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," said Sonny Hsiao, PhD, chief executive officer of Acepodia, in a press release.

ACE2016, an off-the-shelf therapy, aims to target solid tumors expressing the EGFR protein. Developed by Acepodia using their antibody-cell conjugation platform, it harnesses the power of gamma delta 2 T cells equipped with targeted antibodies. These T cells specifically attack tumors driven by the EGFR gene.

In pre-clinical models, the agent demonstrated promising results, including potent cytotoxicity against various EGFR-expressing cancers.2 Specifically, nearly all γδ2T cells were successfully equipped with antibodies that bind to EGFR. This boosted their ability to kill EGFR-expressing cancer cells in the lab vs unmodified γδ2T cells. Both versions of the cells showed similar effectiveness against cancer cells lacking EGFR, suggesting the antibody modification specifically enhances targeting.

Findings also showed ACE2016 to become highly active when encountering target cells, and ACE2016 successfully suppressed the growth of EGFR-expressing breast cancer cells without causing weight loss or other toxic effects.

Now, ACE2016 will be evaluated in a phase 1 trial for the treatment of locally advanced or metastatic solid tumors harboring the EGFR protein.1

"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,” said Hsiao in the press release.

  1. Acepodia announces FDA clearance of investigational new drug application for ACE2016, a first-in-class allogeneic anti-EGFR cell therapy. News release. Acepodia. February 4, 2024. Accessed February 5, 2024. http://tinyurl.com/yuuk59ar
  2. Li HK, Wu TS, Leng PR, et al. ACE2016: an off-the-shelf EGFR-targeting γδ2 T cell therapy against EGFR-expressing solid tumors. Cancer Res. 2023;83(Suppl 8):LB089. doi:10.1158/1538-7445.AM2023-LB089
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