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Cytovation begins patient dosing in phase I/IIa CICILIA trial of CyPep-1 in combo with Keytruda in patients with a range of solid tumors

Bergen, Norway
Tuesday, November 16, 2021, 09:00 Hrs  [IST]

Cytovation AS, a clinical stage immune-oncology company, announces that the first patient has been dosed in the expansion phase of its phase I/IIa CICILIA clinical trial. In this phase of the trial, CyPep-1 is being administered in combination with Keytruda (pembrolizumab) in patients with a range of solid tumors.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "We are very pleased to report the dosing of our first patient with CyPep-1 in combination with MSD's leading anti-PD-1 therapy Keytruda. This marks a further important milestone in our journey to bring this exciting potential new therapy to patients, where preclinical data suggest its mode of action is highly synergistic with checkpoint inhibitors. We believe CyPep-1 could have broad utility in treating a range of solid tumors and we look forward to reporting further data as we progress this study."

This new part of the planned expansion phase follows the successful conclusion of the initial monotherapy trial (Part 1) previously announced on September 23rd, 2021 and aims to evaluate the safety of CyPep-1 in combination with Keytruda in 15 patients with a variety of advanced solid tumors.

Upon successful completion of this phase I tranche of patients, the combination trial will move to a three arm, phase II open-label, multi-center trial of CyPep-1 in combination with Keytruda to evaluate the efficacy and safety of intratumoral CyPep-1 in patients with advanced HNSCC (head and neck squamous cell carcinoma), melanoma, or TNBC (triple negative breast cancer) receiving prior standard of care.

Initial results from phase 1 of the combination arm safety study are expected early in 2022 with the phase II combination trial scheduled to start shortly thereafter.

Previously in Part 1 of the CICILIA trial 12 patients were recruited 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 monotherapy study were encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals were positive and remain consistent with the preclinical proof-of-concept data previously generated.

Both the phase I part of the combination program with Keytruda and the three phase II arms are part of a clinical trial collaboration and supply agreement with MSD.

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

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy 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.

Cytovation AS is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class tumorolytic agent targeting the cell membrane of tumor cells.


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