First-in-Human – Tumor membrane immunotherapy trial.

The first patient has been dosed as part of its Phase I/IIa CICILIA clinical trial.

Tumor membrane immunotherapy trial.

Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, announced that the first patient has been dosed as part of its Phase I/IIa CICILIA clinical trial. CyPep-1 will be administered in combination with KEYTRUDA (pembrolizumab), in patients with advanced solid tumors.

Following successful completion of Phase I, the combination trial will move to a three arm, Phase II open-label, multi-center trial of CyPep-1, in combination with KEYTRUDA, to evaluate the efficacy and safety profile of intra-tumoural CyPep-1 in patients with advanced HNSCC (head and neck squamous cell carcinoma), melanoma, or TNBC (triple negative breast cancer), who are receiving poor standard of care.

In Part One of the CICILIA trial, 12 patients were recruited with a range of solid tumors, and each patient received a minimum of three intra-tumoural injections of CyPep-1.

CyPep-1 is engineered to selectively target tumor cell membranes, based on their altered molecular composition relative to normal cells. It eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor specific immune response.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We are very pleased to report the dosing of our first patient with CyPep-1 in combination with MSD’s leading anti-PD-1 therapy KEYTRUDA. This marks a further important milestone in our journey to bring this exciting potential new therapy to patients, where preclinical data suggest its mode of action is highly synergistic with checkpoint inhibitors. We believe CyPep-1 could have broad utility in treating a range of solid tumors and we look forward to reporting further data as we progress this study.”



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