Ankyra Therapeutics Doses First Visceral Tumor Patient in Phase 1 ANCHOR Trial of ANK-101

Ankyra Therapeutics, a biotechnology company specializing in cancer treatments, has reported the dosing of the first patient with a visceral tumor in the second part of their dose escalation Phase 1 study. The ANCHOR study, Ankyra's first human clinical trial, is divided into two segments. Part 1, currently enrolling patients with superficially accessible tumors, is expected to conclude by December 2024. Meanwhile, Part 2 has now begun, targeting patients with solid tumors deep within the body that are accessible via interventional radiologic or endoscopic methods.

The company is using a novel approach called "anchored therapy," which aims to retain drugs within the tumor microenvironment for extended periods. This method focuses on local anti-tumor activity, comparable to antibody drug conjugates, and minimizes systemic toxicity. ANK-101, the company's leading compound, is an interleukin-12 (IL-12) molecule anchored to aluminum hydroxide. Once administered, ANK-101 stays within the tumor microenvironment for several weeks, where it works to recruit and activate effector immune cells. In preclinical trials, a version of ANK-101 adapted for mice showed increased immune cell infiltration and activation, displaying significant therapeutic effects across different tumor types. Additionally, a canine version of ANK-101 was tested in an exploratory phase I study on dogs with advanced melanoma. Human trials for ANK-101 are currently underway in the U.S. and Canada for solid tumors.

Dr. Joe Elassal, MD, MBA, commented on this development, stating that the progression to Part 2 of the Phase 1 study represents a significant milestone in their efforts to provide new cancer treatments. This segment of the ANCHOR study aims to evaluate the safety of ANK-101 and establish the recommended dose for further trials involving patients with viscerally injected solid tumors. Secondary objectives include assessing the pharmacokinetics, immunogenicity, and initial clinical activity of the treatment. Part 1 of the study is still actively enrolling participants.

Dr. Jong Chul Park, MD, an Assistant Professor at Harvard Medical School and attending physician at Mass General Cancer Center, expressed his appreciation for ANK-101's performance in the initial phase of the study. He highlighted the importance of expanding the trial to include visceral lesions, which would allow a broader range of cancer patients to receive ANK-101. He also expressed anticipation for the continued progress of this trial phase, focusing on the safety and therapeutic potential of ANK-101 for patients with advanced cancer.

ANK-101 is a drug complex composed of human interleukin-12 (IL-12) bound to aluminum hydroxide. This formulation allows for the localized delivery of IL-12 to the tumor microenvironment, where it remains active for several weeks without spreading into the systemic circulation, thus avoiding systemic toxicity. In animal models, ANK-101 treatment has been linked to the recruitment and retention of CD8+ T cells, NK cells, and M1 macrophages, activating both innate and adaptive anti-tumor immune responses. ANK-101 is currently being evaluated for the treatment of advanced solid tumors, both as a standalone therapy and in combination with anti-PD-1 agents. The Phase 1 clinical trial (NCT:06171750) includes dose escalation phases for both superficial and visceral lesions to assess the safety and tolerability of ANK-101, followed by dose expansion cohorts.

Ankyra Therapeutics is dedicated to revolutionizing cancer treatment through their anchored therapy approach, which aims to provide sustained local delivery and retention of therapeutics within the tumor microenvironment, thereby reducing systemic exposure and side effects. Their lead program, ANK-101, shows promise in treating a variety of cancers.