Cytovation Reports Promising Interim Results from Phase 1/2a CICILIA Study with CyPep-1 in Solid Tumors

Cytovation Reports Promising Interim Results from Phase 1/2a CICILIA Study with CyPep-1 in Solid Tumors

Findings confirm unique dual mechanism of action and fast-to-market target indication for potentially registrational trial

• All CICILIA trial endpoints met, with CyPep-1 demonstrating consistent safety profile across tumor types and strong early signals of efficacy.
• Further evidence for novel dual mechanism of action combining inhibition of Wnt/β-catenin oncogenic pathway with tumor-specific cell destruction and immune activation through neoantigen release.
• Approx 20% of all solid tumor types are driven by aberrant Wnt/β-catenin signaling.
• Cytovation to investigate CyPep-1 in further clinical trials starting with Adrenocortical Carcinoma (ACC) with aim to unlock its potential in a broad range of solid tumors.

Bergen, Norway, October 11^th, 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, announces positive initial data from Part 2 of its Phase 1/2a CICILIA basket trial with all trial endpoints met. 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.

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 congress (October 20^th – 23^rd).

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. Pre-clinical 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.