On October 11, 2023 Cytovation ASA, a clinical stage immune-oncology company focused on the development of CyPep-1, its first-in-class, dual-acting targeted tumor immunotherapy, reported positive initial data from Part 2 of its Phase 1/2a CICILIA basket trial with all trial endpoints met (Press release, Cytovation, OCT 11, 2023, View Source;utm_medium=rss&utm_campaign=cytovation-reports-promising-interim-results-from-phase-1-2a-cicilia-study-with-cypep-1-in-solid-tumors [SID1234635850]). In this heavily pretreated, advanced and metastatic patient group CyPep-1 exhibits an excellent safety profile with no dose-limiting toxicities and has shown strong early signs of efficacy across solid tumor types.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "The initial efficacy data from our CICILIA basket trial are highly encouraging and important to informing our view of the future development pathway for CyPep-1. They confirm our pre-clinical findings suggesting that CyPep-1’s unique, dual mechanism of action could offer an important treatment option for patients whose tumors are driven by an aberrant Wnt/β-catenin signaling pathway, which is estimated to drive up to 20% of all solid tumors and can be as high as 90% in certain types. Our fast-to-market strategy in Adrenocortical Carcinoma is intended to provide us with a bridgehead from which to rapidly expand development of CyPep-1 into other beta-catenin-driven indications, like Colorectal and Liver Cancer, bringing a potentially important new treatment option to significant numbers of patients." The early signals of efficacy from CICILIA confirm the importance of CyPep-1’s unique dual mechanism of action with the most promising responses seen in patients with tumor types characterized by aberrant Wnt/β-catenin pathway signaling and with liver metastases. This is consistent with pre-clinical findings, further details of which will be presented at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) congress (October 20th – 23rd). Furthermore, these pre-clinical and early clinical findings support the Company’s decision to rapidly advance development of CyPep-1 with an initial focus on metastatic Adrenocortical Carcinoma (ACC), a rare and highly aggressive tumor type driven by Wnt/ β-catenin and with no approved treatment options after first line. Cytovation is planning to start a Phase 2 trial in ACC in 2024 with registrational intent. This strategy provides a fast and cost-effective route to market, while validating the broader potential of the CyPep-1 platform for future development indications in β-catenin-driven solid tumors.
About CyPep-1
CyPep-1 is a unique and highly differentiated synthetic peptide therapy that has the potential to change the outlook for large cancer patient populations where there remains an urgent need for new treatment options. CyPep-1 has a unique dual mechanism of action, combining inhibition of the Wnt/β-catenin oncogenic pathway with tumor-specific cell destruction and immune activation through neoantigen release and in situ vaccination. Preclinical and early clinical findings have demonstrated that CyPep-1 is safe and well tolerated with no dose-limiting toxicities and strong signs of biological activity and clinically relevant responses.