Cytovation Initiates Clinical Development Program for First-in-Class Agent for Tumor Immunotherapy

Cytovation AS recently announced the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts. The initiation of this clinical trial marks the start of the clinical development of CyPep-1 in dermatology and oncology applications, with a Phase I trial of CyPep-1 in malignant tumors planned to start in the second half of 2019.

CyPep-1 has been designed and developed by Cytovation. It is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep-1 selectively targets tumor cells, forming pores that destabilise and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. The release of neoantigens enables cytotoxic CD8 positive T-cells to mount a systemic immune response offering the possibility of long-lasting immunity against the tumor and, in the case of warts, HPV infection. For more information about the mode of action, click here.

Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Cytovation’s Chief Scientific Officer, Lars Prestegarden, said “We are very pleased to achieve this first clinical milestone with CyPep-1 and to begin its formal clinical development. We have designed CyPep-1 to exploit key differences between healthy and tumor cells and have seen strong evidence of its efficacy in preclinical tumor models. We are excited to see if these results can be translated to humans both with this new trial in warts and the future trial in cancer. Both trials are expected to start during 2019 and we are looking forward to reporting first findings later in the year.”

The clinical trial with CyPep-1 is a randomized, placebo-controlled, double-blind Phase I study. The study is being conducted at the Centre for Human Drug Research (Leiden, the Netherlands) and will enrol 58 patients with cutaneous warts. Results are expected in the late 2019. (ClinicalTrials.gov Identifier: NCT03846648).

Warts are benign skin tumors caused by Human Papilloma Virus (HPV). There are over 100 strains of HPV which can cause several types of warts (common, flat, plantar, genital). Warts are highly contagious and affect up to 12% of the population and up to 20% of children. Traditionally wart elimination occurs through dermal abrasion via cutting, freezing or different OTC products, but there is no cure and reoccurrence is common. There is a large medical need and commercial opportunity in excess of $4 billion per year for a safe and effective treatment that eliminates warts and cures the HPV infection.

Cytovation AS is a privately held biotech company developing CyPep-1, a first-in-class lytic agent, as a novel immunotherapy for benign and malignant tumors. For more information, visit www.cytovation.com.