US-based biotechnology company Ankyra Therapeutics has entered a clinical trial supply agreement with Regeneron to assess ANK-101 in combination with Regeneron’s anti-PD-1 therapy Libtayo (cemiplimab) in cutaneous squamous cell carcinoma (CSCC) patients.

The companies plan to evaluate the combination treatment study following Ankyra’s Phase I clinical trial.

This first-in-human Phase I trial is due to begin in the first quarter of next year.

ANK-101 is an intratumoral drug complex comprising interleukin-12 (IL-12) cytokine linked to aluminium hydroxide.

The drug allows functional IL-12 to be delivered to the tumour microenvironment, where it remains biologically active for several weeks but does not diffuse into the systemic circulation.

It is currently being analysed to treat advanced solid tumours both as a monotherapy and in combination with anti-PD-1 treatments.

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By GlobalData

Ankyra chief medical officer Dr Joe Elassal said: “We are excited to expand our clinical collaborations to evaluate the combination of ANK-101 with cemiplimab in cutaneous squamous cell carcinoma.

“Cemiplimab has been a major step forward for patients with advanced CSCC and we believe that this is a tumour where combination therapeutic effects are highly likely.”

ANK-101 has been proven to remain in the tumour microenvironment for up to 28 days in preclinical studies. 

The immunotherapy also demonstrated substantial anti-tumour activity in multiple murine tumour models and a Phase I trial in canine melanoma.

Preclinical data from PD-1-refractory tumour models also showed that ANK-101 offered enhanced therapeutic activity when offered in combination with the PD-1 blockade.

Ankyra president and CEO Dr Howard Kaufman said: “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.”

Earlier this year, Regeneron worked with the US Biomedical Advanced Research and Development Authority to clinically develop a monoclonal antibody vaccine for Covid-19.