Ankyra Therapeutics Doses First Patient in Visceral Tumor Study with ANK-101

• Ankyra Therapeutics has dosed the first patient in the Phase I clinical trial of ANK-101, an anchored interleukin-12 (IL-12) therapy, for visceral tumors.
• The ANCHOR trial is evaluating ANK-101 in two parts, focusing on both superficially accessible and deep-seated solid tumors accessible via interventional procedures.
• ANK-101 aims to enhance local anti-tumor activity while minimizing systemic toxicity by anchoring IL-12 to aluminum hydroxide, stimulating local immune responses.
• Preclinical models of ANK-101 have demonstrated increased immune cell infiltration and activation, showing significant anti-tumor activity across various tumor types.

Ankyra Therapeutics has announced the dosing of the first patient with a visceral tumor in the second part of its Phase I clinical trial of ANK-101, an anchored interleukin-12 (IL-12) therapy. This open-label, first-in-human ANCHOR trial is designed to evaluate the safety, tolerability, and preliminary efficacy of ANK-101 in patients with solid tumors.

Trial Design and Objectives

The ANCHOR trial is being conducted in two parts to comprehensively assess ANK-101. Part 1 focuses on patients with superficially accessible tumors and is on track to complete enrollment by December 2024. Part 2 has now expanded to include patients with deep-seated solid tumors, which are accessible through interventional radiologic or endoscopic procedures for injection. The trial's secondary objectives include assessing immunogenicity, pharmacokinetics, and preliminary clinical activity of the medicine.

Mechanism of Action

ANK-101 is designed to harness the power of IL-12 by physically anchoring it to aluminum hydroxide. This approach aims to stimulate local anti-tumor responses, similar to antibody-drug conjugates (ADCs). By ensuring prolonged drug retention in the tumor microenvironment, ANK-101 potentially enhances local anti-tumor activity while minimizing systemic toxicity.

Preclinical Evidence

Preclinical models have demonstrated the therapeutic potential of ANK-101. A murine-adapted version of the therapy showed increased immune cell infiltration along with activation, resulting in significant activity across several tumor types. Specifically, treatment with ANK-101 in animal models has led to the recruitment and retention of CD8+ T cells, natural killer (NK) cells, and M1 macrophages, which are crucial for activating both innate and adaptive anti-tumor immunity.

Executive Perspective

Ankyra Therapeutics' chief medical officer, Joe Elassal, stated, "The first patient dosed in part two of our Phase I study advances our lead asset into visceral solid tumors and marks a key milestone in our mission to bring novel medicines to patients with cancer."

The human version of ANK-101 is currently undergoing Phase I clinical trials in the US and Canada.