On September 23, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, reported that it has successfully completed Part 1 of its Ph I/IIa CICILIA study having reached the planned target dose of CyPep-1 while maintaining a favorable safety profile (Press release, Cytovation, SEP 23, 2021, View Source [SID1234590270]).

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To date the trial has recruited 12 patients with a range of solid tumors, each patient having received a minimum of three intra-tumoral injections of CyPep-1. Safety and tolerability in this first part of the study have been encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals are positive and remain consistent with the preclinical proof-of-concept data previously generated.

Based on these results, Cytovation plans to advance and expand the study to include a combination arm with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy manufactured by MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, as previously communicated, as well as two extended monotherapy arms, with one of these including the treatment of visceral tumors.

The study, which is being performed at four renowned cancer centers in The Netherlands (Netherlands Cancer Institute, Erasmus MC Cancer Institute, Leiden University Medical Centre, and University Medical Center Utrecht), will now be expanded to add leading sites in Germany, France, Spain, and UK.

The combination arm with KEYTRUDA is part of a clinical trial collaboration with MSD which is intended to progress to a Phase II program in patients with melanoma, advanced head and neck squamous cell carcinoma (HNSCC) and triple negative breast cancer (TNBC). Initial results from Part 1 of the combination arm safety study are expected early next year with the Phase II combination trial scheduled to start shortly thereafter.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are pleased to report the successful conclusion of the first dose escalation phase of our CICILIA clinical trial. Encouragingly, the early clinical profile of CyPep-1, our proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition, continues to mirror the findings from our pre-clinical studies, demonstrating a promising safety profile and encouraging early signs of efficacy. We look forward to reporting on further progress in this trial, including the planned combination arm with KEYTRUDA, MSD’s anti-PD-1 therapy, which may hold great promise for the treatment of a range of solid tumors."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal 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 is highly synergistic with checkpoint inhibitors.