On December 12, 2023 Ankyra Therapeutics, an emerging clinical-stage biotechnology company pioneering anchored immunotherapies to treat cancer, reported results from a preclinical study demonstrating potent anti-tumor activity of its lead program ANK-101 were published in the December issue of the Journal of Clinical Investigation Insight (JCI Insight) (Press release, Ankyra Therapeutics, DEC 12, 2023, View Source [SID1234638518]). The research paper is titled "Intratumoral aluminum hydroxide-anchored IL-12 drives potent antitumor activity by remodeling the tumor microenvironment."
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ANK-101 is a novel tumor-directed anchored immune medicine (AIM) composed of interleukin-12 (IL-12) linked to aluminum hydroxide.
"One of the key challenges of intratumoral administration is retention within the tumor, both for efficacy and to limit systemic exposure," said Howard L. Kaufman, M.D., President and Chief Executive Officer of Ankyra Therapeutics. "Our pre-clinical data indicates that anchored immunotherapy retains active IL-12 at the tumor site for weeks, versus just hours with unanchored recombinant IL-12. This results in potent immune activation with limited systemic exposure, indicating the potential to improve patient outcomes while reducing side effects. We are excited to continue to advance this program and look forward to initiating our Phase 1 clinical study in humans in early 2024."
Data published in JCI showed:
Ankyra’s anchored immunotherapy platform achieves retention of the drug ANK-101 at the injected site for approximately four weeks
One or two intratumoral injections of a murine ANK-101 analogue induced single-agent anti-tumor activity across a diverse range of syngeneic mouse models
Local treatment with the drug induced tumor regressions of distant, non-injected lesions demonstrating abscopal effects, which were enhanced when combined with systemic checkpoint blockade
Anti-tumor activity mediated by the drug was associated with recruitment of immune cells and remodeling the tumor microenvironment
Human ANK-101, when tested in cynomolgus macaques, was well tolerated
About ANK-101
ANK-101 is an anchored drug complex composed of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables local delivery of functional IL-12 to the tumor microenvironment where it remains biologically active for several weeks, but does not diffuse into the systemic circulation, thereby avoiding systemic toxicity. Treatment with ANK-101 in animal models has been associated with recruitment of CD8+ T cells, NK cells and M1 macrophages activating innate and adaptive anti-tumor immunity. ANK-101 is being evaluated for the treatment of advanced solid tumors alone and in combination with anti-PD-1 agents.