Ankyra Therapeutics Enters Clinical Trial Collaboration and Supply Deal with Merck to Assess ANK-101 Alongside KEYTRUDA® in Advanced Solid Tumor Patients
Thursday, October 05, 2023
Ankyra Therapeutics, a clinical biotechnology company specializing in the development of a unique form of localized immunotherapy known as "anchored immunotherapy," has announced a collaboration and supply agreement for a clinical trial with Merck (known as MSD outside of the US and Canada). The purpose of this collaboration is to assess the effectiveness of ANK-101 when used in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). This announcement comes following the successful completion of a phase I study involving ANK-101 as a monotherapy for patients with advanced solid tumors.
Pending the successful completion of the initial phase I study, ANK-101 is expected to advance to the KEYNOTE-E56 clinical trial, which is designed to evaluate the combination of ANK-101 and pembrolizumab in patients with advanced solid tumors. This clinical trial is anticipated to commence enrollment in 2024.
Ankyra's platform utilizes an inert scaffolding made of aluminum hydroxide, a well-known vaccine adjuvant, to link bioactive immune agents, resulting in the creation of ANK-101. Preclinical investigations of ANK-101, a functional human interleukin-12 (IL-12) cytokine, have demonstrated its ability to remain within the tumor microenvironment for up to 28 days. Importantly, it exhibits limited diffusion into the systemic circulation, thus minimizing systemic toxicity. ANK-101 has shown significant anti-tumor activity when used as a monotherapy in various murine tumor models, as well as in a Phase I clinical trial involving canine melanoma. Furthermore, studies have indicated that ANK-101 promotes the expression of local PD-L1, and preclinical combination studies with PD-1 blockade have demonstrated improved therapeutic efficacy in PD-1-refractory tumor models.
Dr. Robert Tighe, Chief Scientific Officer at Ankyra, remarked, "ANK-101 has exhibited therapeutic activity in several preclinical models and has been shown to strongly induce expression of PD-1 within the tumor microenvironment. We have also observed significant improvement in tumor responses and abscopal activity in preclinical models when murine ANK-101 is combined with PD-1 blockade, all without increased toxicity."
Dr. Joe Elassal, Chief Medical Officer at Ankyra, expressed excitement about evaluating their drug in combination with pembrolizumab in the KEYNOTE-E56 trial, stating, "Pembrolizumab has revolutionized the clinical landscape for numerous cancer types, and we anticipate that the combination of ANK-101 and pembrolizumab could potentially expand the benefits of immunotherapy to a larger patient population."
Please note that KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
ANK-101 is an intratumoral drug complex consisting of interleukin-12 (IL-12) linked to aluminum hydroxide. ANK-101 enables the localized delivery of functional IL-12 to the tumor microenvironment, where it remains biologically active for several weeks without diffusing into the systemic circulation, thus avoiding systemic toxicity. In animal models, treatment with ANK-101 has been associated with 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 currently under evaluation for the treatment of advanced solid tumors, both as a standalone therapy and in combination with pembrolizumab.
