Ankyra Therapeutics has announced the dosing of the first patient with a visceral tumor in Part 2 of the Phase 1 ANCHOR clinical trial, evaluating ANK-101. This milestone marks a significant step in the development of a novel anchored Interleukin-12 (IL-12) therapy for advanced solid tumors. The ANCHOR study (NCT:06171750) is a first-in-human Phase 1 trial conducted across multiple sites in the United States and Canada.
ANCHOR Study Design and Objectives
The ANCHOR study is divided into two parts. Part 1 focuses on patients with superficially accessible tumors and is expected to complete enrollment by December 2024. Part 2 is now enrolling patients with solid tumors located in deep viscera, accessed via interventional radiologic or endoscopic procedures for injection. The primary objective of Part 2 is to assess the safety and tolerability of ANK-101 and determine the recommended dose for expansion in patients with viscerally injected solid tumors. Secondary objectives include the evaluation of pharmacokinetics, immunogenicity, and preliminary clinical activity.
ANK-101: Anchored Therapy Approach
ANK-101 represents a novel approach to cancer immunotherapy, utilizing what Ankyra Therapeutics refers to as "anchored therapy." This strategy involves physically anchoring IL-12 to aluminum hydroxide, enabling local delivery and prolonged retention of the drug within the tumor microenvironment. This localized approach aims to maximize anti-tumor activity while minimizing systemic toxicity, a common challenge with systemic immunotherapies.
Preclinical and Clinical Evidence
Preclinical studies of a murine-adapted ANK-101 have demonstrated increased immune cell infiltration and activation, leading to significant therapeutic activity across multiple tumor types. Furthermore, a canine version of ANK-101 has been evaluated in an exploratory Phase 1 study in dogs with advanced melanoma, showing promising results. The ongoing Phase 1 clinical trial in humans is evaluating ANK-101 as a monotherapy for advanced solid tumors.
Expert Commentary
"I have been impressed with ANK-101 in Part 1 of the Phase 1 study and expansion of the trial to include visceral lesions will enable us to deliver ANK-101 to a broader group of cancer patients," said Jong Chul Park, MD, Assistant Professor at Harvard Medical School and attending physician at Mass General Cancer Center. "We look forward to advancing this part of the trial and exploring the safety and therapeutic potential of ANK-101 for patients with more advanced disease."
Mechanism of Action
ANK-101 is designed to deliver functional IL-12 locally to the tumor microenvironment, where it remains biologically active for several weeks without diffusing into systemic circulation. This localized delivery is intended to recruit and retain CD8+ T cells, NK cells, and M1 macrophages, activating both innate and adaptive anti-tumor immunity. Ankyra Therapeutics is also exploring the potential of ANK-101 in combination with anti-PD-1 agents.
