Ankyra Therapeutics, a clinical-stage biotechnology company pioneering anchored immunotherapies for cancer treatment, has received approval for its investigational new drug (IND) application from the U.S. Food & Drug Administration (FDA) and a clinical trial application (CTA) from Health Canada for its lead agent, ANK-101. ANK-101 is a groundbreaking tumor-directed anchored immune medicine. The company intends to commence a Phase I clinical trial for ANK-101 as a single agent in early 2024. This trial will be conducted at a limited number of clinical sites in the United States and Canada, focusing on patients with advanced solid tumors who have not responded to standard treatments.

ANK-101 is an interleukin-12 (IL-12) cytokine anchored to aluminum hydroxide, designed for local delivery and retention within the tumor microenvironment for several weeks. In this environment, it facilitates the recruitment and activation of effector immune cells. Ankyra has demonstrated the effectiveness of ANK-101 as a single agent in preclinical studies involving various solid tumors in mice, as well as in canine melanoma (cANK-101), with a manageable safety profile.

Ankyra Therapeutics, explained, "By anchoring ANK-101 to the tumor site and retaining it there, we can overcome the challenges associated with both systemic and intratumoral therapies. This approach prevents the diffusion of cytokines, effectively training the body to aggressively target and eliminate cancer cells. We are thrilled about the clearance of our CTA and IND, as it will enable us to offer ANK-101 to patients who could benefit from this innovative cancer treatment approach."

Ankyra, added, "ANK-101 holds the promise of providing therapeutic benefits without unwanted side effects. Our goal is to see therapeutic activity without systemic toxicity by anchoring IL-12 at the tumor growth site. We are eager to advance this first-in-class asset to make this vision a reality and pave the way for anchored immunotherapy to safely deliver other biologically active agents in the future."

ANK-101 is a specialized drug complex composed of interleukin-12 (IL-12) linked to aluminum hydroxide. It allows for the localized delivery of functional IL-12 to the tumor microenvironment, where it remains biologically active for several weeks without entering the systemic circulation, thus avoiding systemic toxicity. Treatment with ANK-101 in animal models has shown the recruitment and retention of tumor-specific CD8+ T cells, NK cells, and M1 macrophages, activating both innate and adaptive anti-tumor immunity. ANK-101 is under evaluation for the treatment of advanced solid tumors, both as a standalone treatment and in combination with anti-PD-1 agents.

 

Source: businesswire.com

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