US FDA accepts Cytovation's IND application for Phase II combination studies of CyPep-1, a first-in-class targeted tumor membrane immunotherapy

BERGEN, Norway I May 19, 2022 I Cytovation ASA, a clinical stage immune-oncology company focused on the development of CyPep-1, its first-in-class targeted tumor membrane immunotherapy, announces that its investigational new drug (IND) application for CyPep-1 has been accepted by the U.S. FDA, allowing the drug to proceed into Phase II studies in combination with MSD's (a tradename of Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in advanced solid tumors.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "The acceptance of our IND application for these combination studies is a major milestone in the clinical development of CyPep-1. With the funds recently raised from our successful Series A round, we are strongly positioned to build on the early encouraging data from our pre-clinical studies and Phase I/II investigations of CyPep-1 as a monotherapy. We look forward to reporting further data from the early clinical program later in 2022 and initiating in the U.S. the series of studies of CyPep-1 in combination with KEYTRUDA in collaboration with MSD, as enabled by this IND."

In the U.S., Cytovation will conduct Phase II studies investigating CyPep-1 in combination with KEYTRUDA® in melanoma, head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer (TNBC). These studies will also be conducted in leading sites across Europe, initially in the Netherlands, France, Spain and Italy.

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer 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 demonstrates increased activity in combination with checkpoint inhibitors.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Cytovation

Cytovation ASA 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.

SOURCE: Cytovation

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