Ankyra Therapeutics to Present at 2024 ASCO and Announces ANK-101 Phase 1 Protocol Amendment Approval

Ankyra Therapeutics, a clinical-stage oncology firm, has announced its participation in the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, occurring from May 31 to June 4 in Chicago, IL. The company will present a poster detailing the ongoing Phase 1 ANCHOR clinical trial, which focuses on its lead therapy, ANK-101.

Ankyra has pioneered a drug delivery platform that enhances immunotherapy by anchoring drugs to aluminum hydroxide. This approach allows localized delivery to tumors, retaining the compounds for several weeks and promoting anti-tumor activity while minimizing systemic toxicity. ANK-101, the company’s leading drug, combines interleukin-12 with an alum-binding peptide, enabling its attachment to aluminum hydroxide.

The ANCHOR trial, a multi-institutional, first-in-human Phase 1 study, began in February 2024. It targets patients with superficially accessible solid tumors that have not responded to standard treatments. The main goals are to establish the safety, tolerability, and recommended dosage of ANK-101 for future studies. Five clinical sites are participating: Massachusetts General Hospital in Boston, MA; Providence Cancer Institute in Portland, OR; University of Pittsburgh in Pittsburgh, PA; Princess Margaret Hospital in Toronto, ON; and the National Cancer Institute (NCI) in Bethesda, MD.

The upcoming poster presentation at ASCO will provide insights into the clinical trial’s rationale, objectives, design, and patient enrollment status. Additionally, the study will assess pharmacokinetics, immune biomarkers, and quality of life.

Ankyra Therapeutics has recently received approval from both the U.S. Food and Drug Administration (FDA) and Health Canada to amend the Phase 1 study. This amendment includes an additional dose-escalation and expansion phase to test ANK-101 on patients with solid tumors in visceral organs. This part of the study will proceed once patients in the superficial tumor group have completed a 21-day dose-limiting toxicity (DLT) observation period.

Howard L. Kaufman, MD, CEO of Ankyra Therapeutics, expressed optimism about the trial’s progress. He highlighted that the study is essential for establishing the initial safety profile and dosing parameters for ANK-101. Dr. Kaufman noted that anchored immunotherapy could allow the delivery of high doses of immunotherapy without systemic toxicity, representing a significant advancement in cancer treatment. Joe Elassal, MD, Chief Medical Officer at Ankyra, echoed this sentiment, emphasizing the excitement around extending ANK-101 to treat visceral tumors, which broadens the potential patient population and indications for the therapy.

ANK-101 is a complex drug formulation that includes interleukin-12 (IL-12) linked to aluminum hydroxide. This configuration ensures that IL-12 remains active in the tumor microenvironment for several weeks without entering the systemic circulation, thus preventing systemic toxicity. Preclinical studies in animal models have shown that ANK-101 facilitates the recruitment and retention of immune cells like CD8+ T cells, NK cells, and M1 macrophages, stimulating both innate and adaptive anti-tumor responses.

The Phase 1 clinical trial for ANK-101 is open-label and aims to assess the drug’s safety and tolerability through a dose-escalation phase, followed by dose expansion cohorts. ANK-101 is also being evaluated for its effectiveness in combination with anti-PD-1 agents for treating advanced solid tumors.

Ankyra Therapeutics, founded in 2019 and headquartered in Cambridge, Massachusetts, has developed a unique technology platform. This platform enhances the therapeutic window for cytokine drugs by creating a stable depot in tumors after local administration. This approach results in prolonged immune activation and robust local and systemic immunity with reduced systemic toxicity.

The poster presentation at the ASCO meeting will comprehensively cover the trial's design and interim findings, marking a significant milestone in Ankyra Therapeutics’ mission to revolutionize cancer treatment through anchored immunotherapies.