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, May 19, 2022 /PRNewswire/ — 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.

Contact Information

Cytovation
Federico Grego, Chief Business Officer: [email protected]

MEDiSTRAVA Consulting
Frazer Hall / Mark Swallow / George Underwood: [email protected]
Tel: +44 (0)20 3928 6900

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

PR Newswire Science News

World Reviewer Staff
World Reviewer Staffhttps://weeklyreviewer.com/
The first logical thought has to be "no way". I'm the World Observer! Ill find and share important news all day.

Latest articles

Earnings Disclosure

WeeklyReviewer earns primarily through affiliates and ads. We don’t encourage anyone to click on ads for any other purpose but your own. We recommend products and services often for our readers, and through many we will earn commissions through affiliate programs.

Related articles