The US Food and Drug Administration (FDA) has granted clearance for Acepodia’s investigational new drug (IND) application to commence a Phase I clinical trial of ACE2016 for solid tumours.

An allogeneic gamma delta 2 (γδ2) T cell therapy, ACE2016 is developed using the company’s Antibody-Cell Conjugation (ACC) platform.

ACE2016 acts on epidermal growth factor receptor (EGFR)-expressing solid tumours through antibody conjugated γδ2 T cells that are directed at tumours caused by the cancer-causing EGFR gene.

The first-in-human trial will analyse the tolerability, safety and pharmacodynamics of the cell therapy in adult patients with locally advanced or metastatic EGFR-expressing solid tumours.

Acepodia is preparing to launch the trial in the near future, with the first patient expected to be treated in the second half of 2024.

In pre-clinical studies, ACE2016 demonstrated significant cytotoxicity against a range of EGFR-expressing cancer cells, indicating potential for the upcoming clinical trials.

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Acepodia CEO Sonny Hsiao said: “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 tumours, which remain to be unmet medical needs in the cell therapy field.

“The rapid progression of obtaining the third IND approval within 18 months highlights the team’s remarkable efficiency and dedication to advancing innovative programmes swiftly.

“With our third programme 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.”

In June last year, the company raised $100m in its Series D funding to advance its cell therapy pipeline for treating solid tumours and hematologic cancers, including ACE1831 and ACE2016.

Digital Mobile Venture led the financing round with other current investors taking part.

The company has so far secured a total of $259m, including a $109m Series C round concluded in December 2021.

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