Cytovation & SMS-oncology Sign Agreement on Conduct of Phase 1/2 Trial


Cytovation AS and Specialized Medical Services-oncology BV recently announce that SMS-oncology has been selected as the CRO to conduct the Phase 1/2 clinical trial with CyPep-1 in patients with advanced solid cancers.

In recent months, Cytovation has progressed through preclinical and toxicology studies with its lead candidate CyPep-1, a first-in-class lytic agent. Through its unique pharmacological properties, CyPep-1 selectively targets and lyses tumor cell membranes based on their altered molecular composition. This mode of action kills cancer cells, releases tumor antigens, and potentially induces a tumor-specific immune response by in-situ immunization.

Cytovation is currently initiating a first-in-human trial with intratumoral injection of CyPep-1 and aims to reach first in patient (FPI) milestone by the end of 2019. An agreement is now concluded with the oncology dedicated CRO SMS-oncology in Schiphol, the Netherlands.

The study is designed as an open-label, dose escalation Phase 1/2 trial to evaluate the safety, efficacy and pharmacokinetics of intratumoral CyPep-1 in patients with advanced solid cancers. The multicenter trial in Europe will enroll approximately 18 patients. SMS-oncology is developing the protocol and giving guidance regarding patient inclusion criteria and investigational sites for a best-fit and seamless transition to clinic. This will be followed by full conduct of the trial, expected to commence in Q4 2019.

Mr. Kjell-Inge, CEO of Cytovation, said “We are excited CyPep-1 is now progressing to the next phase of development, which is an important step for our company. We are pleased with selecting SMS-oncology as our partner in this transition to clinic. From the initial discussions, they lived up to their reputation as experts in the field of early phase and immuno-oncology trials. Preparations of the trial are moving forward in a fast pace, and we feel confident our trial will be conducted in an optimal and valuable matter with our goals is mind.”

Ms. Philine van den Tol, CEO of SMS-oncology, added “We are delighted to support Cytovation and look forward to jointly make the CyPep-1 trial a great success. It is exactly these type of innovative projects SMS-oncology leverages great experience in, and beyond all, is passionate about. The enthusiasm of Cytovation is catching and our team can’t wait to see results of this promising first-in-class lytic compound.”

CyPep-1, in a cream formulation for topical application, is currently being evaluated in a phase I trial in patients with HPV-induced cutaneous tumors (warts).

Cytovation builds on over 15 years of cutting-edge research from two leading Norwegian institutions; University of Bergen and Haukeland University Hospital. Led by a highly experienced management team and world-renowned experts in tumor biology, an extensive research program has focused on engineering synthetic peptides with unique properties. CyPep-1, the company’s lead candidate, is being developed as a first-in-class lytic agent for the treatment of solid tumors in both injectable and cream formulations.

SMS-oncology is one of the few full-service contract research organizations (CROs) in the world solely dedicated to oncology. With our unique business model of integrating oncology drug development affairs and clinical operations, we cover the whole value chain from trial design to the setup, management and completion of Phase 1 to 4 oncology trials. We specialize in early phase, pediatric and immuno-oncology trials.

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