Acepodia Announces FDA Clearance

Acepodia Announces FDA Clearance of Investigational New Drug Application for ACE2016, a First-in-Class Allogeneic Anti-EGFR Cell Therapy

Acepodia, a clinical stage biotechnology company developing first-in-class cell therapies with its unique antibody-cell conjugation (ACC) and allogeneic gamma delta 2 (?d2) T cell platforms to address gaps in cancer care, announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for ACE2016, an allogeneic gamma delta 2 (?d2) T cell therapy for the treatment of epidermal growth factor receptor (EGFR)-expressing malignancies in patients with solid tumors.

This clearance enables Acepodia to initiate a phase 1, first-in-human trial evaluating the safety, tolerability and pharmacodynamics of ACE2016 in adults with locally advanced or metastatic EGFR-expressing solid tumors. Acepodia expects to begin the trial in the coming months and treat the first patient 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 (ACC) technology in solid tumors, which remain to be unmet medical needs in the cell therapy field," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "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."

ACE2016 is an off-the-shelf ?d2 T cell therapy candidate developed from Acepodia's proprietary ACC platform. ACE2016 targets EGFR-expressing solid tumors through antibody conjugated ?d2 T cells that target tumors driven by the cancer-causing EGFR gene. Leveraging the advantages of ACC technology and Acepodia's proprietary ?d2 T cell platform, ACE2016 has shown promising cytotoxicity against several EGFR-expressing cancers in various pre-clinical study models. The phase 1 trial will evaluate the safety, tolerability and pharmacodynamics of ACE2016 in patients with locally advanced or metastatic EGFR-expressing solid tumors. The trial is expected to dose its first patient in the second half of 2024

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