Ankyra Therapeutics have announced a clinical trial collaboration and supply agreement with MSD to evaluate the combination of ANK-101 and KEYTRUDA® in patients with advanced solid tumours.
Following the completion of a first-in-human phase I study of ANK-101 in patients with advanced solid tumours, a clinical trial collaboration will now take place to evaluate the efficiency of using both ANK-101 and KEYTRUDA® (pembrolizumab).
The study is anticipated to begin enrollment in 2024.
‘ANK-101 has demonstrated therapeutic activity’
The Ankyra platform uses an inert scaffolding composed of aluminium hydroxide – a well-known vaccine adjuvant – to link bioactive immune agents to the anchor. The technology platform expands the therapeutic window of cytokine drugs by forming a stable depot in the tumour after local administration.
Preclinical studies of ANK-101 revealed retention within the tumour micro-environment for up to 28 days with limited diffusion and systemic toxicity.
Monotherapy anti-tumour activity has also been seen in multiple murine tumour models and in a Phase I clinical trial of canine melanoma.
Further studies have demonstrated that ANK-101 drives the expression of local PD-L1. Pre-clinical combination studies with a PD-1 blockade have shown improved therapeutic activity in PD-1-refractory tumour models.
“ANK-101 has demonstrated therapeutic activity in several preclinical models and has been shown to strongly induce expression of PD-1 within the tumour microenvironment,” said Robert Tighe, CSO at Ankyra.
“We have also seen significant improvement in tumour responses and abscopal activity in the preclinical models when murine ANK-101 is combined with PD-1 blockade without increased toxicity.”
Combining ANK-101 and KEYTRUDA® may have significant benefits
Dr Joe Elassal, CMO at Ankyra, said: “We are especially excited about evaluating our drug in combination with pembrolizumab in the KEYNOTE-E56 trial.
“Pembrolizumab has changed the clinical landscape for many different cancers, and we anticipate that the combination of ANK-101 and pembrolizumab may allow more patients to benefit from immunotherapy.”
About ANK-101 and KEYTRUDA®
ANK-101 is a first-in-class anchored IL-12 immunotherapy designed for limited intratumoural delivery to increase immune cell infiltration into tumours. It has the potential to improve the outcomes of patients treated with immune checkpoint inhibitors.
ANK-101 is being evaluated for the treatment of advanced solid tumours alone and in combination with KEYTRUDA®.
KEYTRUDA®, or pembrolizumab, is MSD’s anti-PD-1 therapy. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
