Cytovation ASA, a Norwegian clinical stage immune-oncology company focused on the development of CyPep-1, its first-in-class targeted tumor membrane immunotherapy, announces that the first patient has been dosed in its phase 2a study.
The trial is investigating CyPep-1 monotherapy in patients with advanced melanoma refractory to checkpoint inhibitors (CPIs).
The study is an expansion arm of its ongoing phase 1/2 CICILIA trial in solid tumors, which is being conducted in The Netherlands, France, and Spain. The phase 2a study builds on encouraging data from the first phase of the trial, which has demonstrated a favorable safety profile for CyPep-1 monotherapy along with strong early signals of efficacy in several tumor types.
Cytovation’s CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer cells. Administered by intratumoral injection, 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 systemic, tumor-specific immune response.
A synthetic peptide, CyPep-1 has been designed for easy and scalable manufacturing and is highly stable – an uncommon feature in these molecules.
Other indications for Cytovation’s CyPep-1
Melanoma is the first of several indications that will be explored in phase 2 expansion studies, which will investigate CyPep-1 both as a monotherapy and in combination with the immune checkpoint inhibitor KEYTRUDA (pembrolizumab). Some of these indications, including melanoma subgroups, are orphan indications with few currently available treatments, which could allow for accelerated approval.
Lars Prestegarden, CEO of Cytovation, said: “We continue to be very pleased with the clinical development progress of CyPep-1, and are excited to be launching this phase 2a expansion arm, building upon our strong phase 1 monotherapy data. Patients with metastatic melanoma that is refractory to checkpoint inhibitors currently have few treatment options and a high unmet need.”
Preclinical data has also shown CyPep-1’s mechanism of action is amenable to combination with other immunotherapies. Cytovation has an ongoing clinical research collaboration with MSD to explore CyPep-1 in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), and melanoma.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.