BERGEN, Norway, July 30, 2021 /PRNewswire/ -- Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD to evaluate the safety and efficacy of CyPep-1 in combination with KEYTRUDA ® (pembrolizumab), MSD's anti-PD-1 therapy.
Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort. Subsequently, clinical evaluation will proceed into a Phase II trial that will evaluate the efficacy and safety of the combination in up to 90 patients with advanced head and neck squamous cell carcinoma (HNSCC), melanoma, or triple-negative breast cancer (TNBC). Initial results from the safety study are expected early next year with the Phase II trial scheduled to start shortly thereafter.
Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "Early clinical data for CyPep-1 monotherapy have shown a strong safety profile and encouraging anti-tumor activity that are consistent with our preclinical data, where we have also seen a highly synergistic effect of CyPep-1 with checkpoint inhibitor therapy. We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."
KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 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 by in situ vaccination.
Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.
Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells. The company is a spin-off from the University of Bergen ( Norway), the city where it is headquartered. For more information, please visit www.cytovation.com.
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SOURCE Cytovation AS