Ankyra Initiates Phase 1 Trial of ANK-101, Targeted Immunotherapy for Solid Tumors, with First Patient Dosed

Ankyra Therapeutics, a biotech firm at the forefront of developing anchored immunotherapies for cancer treatment, has reached a pivotal moment with the commencement of patient dosing in a Phase 1 clinical trial for their drug candidate, ANK-101. This drug is designed to target solid tumors with a localized delivery system that minimizes side effects.
The Phase 1 study, which will be conducted across up to 10 sites in the US and Canada, will evaluate the safety and optimal dosage of ANK-101. The drug candidate is an innovative interleukin-12 (IL-12) cytokine attached to aluminum hydroxide, which is intended to be retained in the tumor microenvironment for an extended period, thereby stimulating the immune system's response against the tumor without causing systemic toxicity.
Howard L. Kaufman, Ankyra's President and CEO, emphasized the significance of this trial, stating, "This marks a critical step in our mission to develop a first-in-class asset, ANK-101, and our broader commitment to delivering effective, anchored immunotherapies to patients."
Preclinical studies have shown that ANK-101 can enhance immune cell infiltration into tumors without causing systemic toxicity. The trial's dose escalation phase aims to establish the drug's safety profile and determine the appropriate dosage for further trials, focusing on patients with advanced solid tumors who have exhausted standard treatment options.
Joe Elassal, Ankyra's Chief Medical Officer, highlighted the importance of the data generated from this study, which will guide the future clinical development of ANK-101 and identify suitable indications for its use. He expressed confidence in the drug's potential to provide effective immunotherapy while reducing significant side effects.
Jong Chul Park, an assistant professor at Harvard Medical School and an investigator in the trial, praised ANK-101's novel delivery mechanism and its potential to positively impact various cancer treatments. He stressed the importance of patient well-being throughout the treatment process.
ANK-101 is a complex of the IL-12 cytokine linked to aluminum hydroxide, designed for local delivery to the tumor site where it remains active for weeks without entering systemic circulation. It has shown to attract and activate immune cells like CD8+ T cells, NK cells, and M1 macrophages, enhancing both innate and adaptive anti-tumor responses. The Phase 1 clinical trial (NCT:06171750) will assess the drug's safety and tolerability, followed by dose expansion cohorts.
Ankyra Therapeutics is dedicated to transforming cancer treatment with its anchored immunotherapy platform, which includes a pipeline of novel therapeutics aimed at sustained local delivery and retention within the tumor microenvironment. The company's lead program, ANK-101, holds promise for treating a wide spectrum of cancers. 

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