Cytovation Announces Dosing of First Patient in its Phase I/II CICILIA Trial Investigating CyPep-1 in Patients with Solid Cancers

Cytovation AS ("Cytovation"), a clinical-stage biotechnology company focused on developing CyPep-1, a next-generation lytic immunotherapy, is pleased to announce that the first patient has today been successfully dosed in its Phase I/II CICILIA clinical trial. The CICILIA trial will investigate CyPep-1 in patients with advanced solid cancers (ClinicalTrials.gov Identifier: NCT04260529).

The aim of the open-label, dose-escalation Phase I/II trial is to evaluate the safety, efficacy and pharmacokinetics of CyPep-1 given as intratumoral injection. Up to 21 patients with advanced (unresectable Stage III) or metastatic (Stage IV) solid tumor malignancies will be recruited. Two renowned clinical centers in the Netherlands are currently open for recruitment: the Netherlands Cancer Institute (NKI) in Amsterdam and Erasmus MC (EMC) in Rotterdam. Three additional university medical centers in the Netherlands will be opened shortly: the UMCU in Utrecht, the LUMC in Leiden and the MUMC in Maastricht.

This marks the first time a patient suffering from an advanced solid tumor will be dosed in a clinical trial with a lytic agent specifically targeting and lysing tumor cell membranes based on their altered molecular composition compared to healthy cells. CyPep-1's mode of action enables it to selectively bind to and disrupt cancer cells by forming pores that destabilize and rupture the membrane to kill the cell. Upon lysis, tumor antigens are released into the circulation and induce a systemic, tumor-specific immune response by in-situ immunization, which offers the possibility of long-lasting immunity against the tumor.

Mr. Kjell-Inge Arnevig, CEO of Cytovation said: "We are thrilled about the progress we are making enrolling the first patient into the CICILIA trial. Treatment strategies that aim at recruiting the immune system to attack and kill tumor cells hold great promise and are currently a main focus in global oncology research. CyPep-1 may represent a unique, dual, tumor-agnostic approach that has a direct tumor-killing effect and boosts the effect of established immunotherapies across multiple tumor types. CICILIA is our first clinical trial in malignant tumors and we have an ongoing clinical trial investigating CyPep-1 in benign tumors, which is expected to read out in the coming months. We expect the result from this study to provide important support for the clinical proof-of-concept of this novel candidate. We look forward to providing updates on the clinical development of CyPep-1 in due course."

"Today's announcement defines the first major milestone in the clinic for CyPep-1." commented Veroni Baas, Project Director of the CICILIA trial at CATO SMS, the CRO supporting Cytovation in this trial. "Our dedicated team supported the start-up of Cytovation's first-in-human trial. Given these COVID-19 times, this encouraging start is extraordinary. We are glad to closely support Cytovation and to see how CyPep-1 progresses in the upcoming months."