Ankyra Therapeutics has announced the dosing of the first patient with a visceral tumour in part two of its Phase I clinical trial of anchored interleukin-12 (IL-12), ANK-101.
The open-label, first-in-human ANCHOR trial is being conducted in two parts to evaluate the new ‘anchored therapy’.
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Part 1 of the trial, which focuses on patients with superficially accessible tumours, is on track to complete enrolment by December 2024.
Part 2 has now expanded to include patients with deep-seated solid tumours, which are accessible through interventional radiologic or endoscopic procedures for injection.
This approach utilises a method that ensures prolonged drug retention in the tumour microenvironment, potentially enhancing local anti-tumour activity while minimising systemic toxicity.
ANK-101 is designed to harness the power of IL-12 by physically anchoring it to aluminium hydroxide. This aims to stimulate local anti-tumour responses, akin to antibody drug conjugates (ADCs).
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By GlobalDataIts therapeutic potential has been demonstrated in various preclinical models, where a murine-adapted version of the therapy showed increased immune cell infiltration along with activation, resulting in significant activity across several tumour types.
The human version of ANK-101 is currently undergoing Phase I clinical trials in the US and Canada.
In animal models, treatment with ANK-101 has led to the recruitment and retention of a cluster of differentiation 8+ (CD8+) T cells, natural killer (NK) cells, and M1 macrophages, which are crucial for activating both innate and adaptive anti-tumour immunity.
Ankyra Therapeutics chief medical officer Joe Elassal said: “The first patient dosed in part two of our Phase I study advances our lead asset into visceral solid tumours and marks a key milestone in our mission to bring novel medicines to patients with cancer.”
Secondary objectives include assessment of immunogenicity, pharmacokinetics and preliminary clinical activity of the medicine.
