Ankyra Therapeutics will be working with Regeneron to evaluate ANK-101 in combination with Regeneron’s anti-PD-1 therapy, Libtayo (cemiplimab) in patients with cutaneous squamous cell carcinoma (CSCC) via a new a clinical trial supply agreement.

ANK-101 is a novel first-in-class anchored IL-12 immunotherapy designed for limited anchored delivery to increase immune cell infiltration into tumors and may further increase responses to immune checkpoint inhibitors.

Preclinical studies of ANK-101 have demonstrated retention within the tumor microenvironment for up to 28 days with limited systemic diffusion or toxicity. Significant monotherapy anti-tumor activity has been seen in multiple murine tumor models and in a Phase I clinical trial of canine melanoma. Further studies have shown that ANK-101 drives expression of local PD-L1 and pre-clinical combination studies with PD-1 blockade demonstrated improved therapeutic activity in PD-1-refractory tumor models.

“We are excited to expand our clinical collaborations to evaluate the combination of ANK-101 with cemiplimab in cutaneous squamous cell carcinoma (CSCC),” says Dr. Joe Elassal, Chief Medical Officer at Ankyra, in a news release. “Cemiplimab has been a major step forward for patients with advanced CSCC and we believe that this is a tumor where combination therapeutic effects are highly likely.”

The combination study will proceed following Ankyra’s first-in-human phase I clinical trial, which is starting in the first quarter of 2024.

Dr. Howard L. Kaufman, President and Chief Executive Officer at Ankyra adds, “We are especially pleased to be working with Regeneron, leaders in the CSCC space, and look forward to building a strong relationship with Regeneron to improve the lives of patients with this common form of skin cancer.”