CY-101 Enters Phase 2 Trial for Adrenocortical Carcinoma Through Cancer Research UK Collaboration
Key Insights
Cytovation (search)'s CY-101, a synthetic peptide, will be evaluated in a Phase 2 trial for adrenocortical carcinoma (search) (ACC) patients, a rare and aggressive cancer with limited treatment options.
Cancer Research UK's Centre for Drug Development will manage the multi-national trial across the UK and Europe, while Cytovation (search) will supply CY-101 for the study.
CY-101 targets and destroys cancer cells, stimulates an immune response, and inhibits the Wnt/β-catenin (search) pathway, potentially overcoming immunotherapy resistance in ACC.
Cancer Research UK, Cytovation (search), and the Norwegian Cancer Society (search) are collaborating to advance the clinical development of CY-101, a novel synthetic peptide, into a Phase 2 clinical trial for patients with adrenocortical carcinoma (search) (ACC). This rare and aggressive cancer, affecting the adrenal glands, presents a significant unmet medical need due to limited treatment options.
CY-101's Dual Mechanism of Action
CY-101, developed by Cytovation (search), is a bifunctional immunotherapy designed to selectively target and eliminate cancer cells while simultaneously stimulating a systemic immune response. The peptide also inhibits the Wnt/β-catenin (search) signaling pathway, a key driver of immunotherapy resistance observed in cancers like ACC. Preclinical and Phase 1 data suggest CY-101's potential to address the specific mechanisms of ACC, offering a new therapeutic avenue for patients.
Phase 1 CICILIA Trial: Promising Early Results
Early clinical data from Cytovation (search)’s Phase 1 CICILIA trial demonstrated encouraging outcomes in patients with solid tumors. Notably, two ACC patients experienced clinical benefit, with one achieving 18 months of progression-free survival while continuing treatment on a named-patient basis. These findings support further investigation of CY-101 in ACC.
Collaborative Trial Design and Execution
Under the collaboration agreement, Cancer Research UK’s Centre for Drug Development (CDD) will sponsor, design, and execute the Phase 2 trial. Cytovation (search) will be responsible for providing CY-101 for the study. Cancer Research Horizons, Cancer Research UK’s innovation arm, will oversee the commercial relationship between the three organizations. The Norwegian Cancer Society (search) will provide co-funding to support the trial.
Addressing a Critical Unmet Need
"This collaboration represents a critical step toward addressing the needs of ACC patients who currently have very few treatment options," said Lars Erwig, Director of the Centre for Drug Development, Cancer Research UK. "Cytovation (search) has made impressive progress with CY-101 so far and we are excited to build on our existing partnership with the Norwegian Cancer Society (search) to take its development further."
Multi-National Trial to Enhance Patient Recruitment
Due to the rarity of ACC, the Phase 2 clinical trial will be conducted across multiple sites in the UK and Europe to ensure robust patient recruitment. The Norwegian Cancer Society (search)’s support will facilitate access to additional resources, patients, and clinical trial sites, which is crucial for studying rare diseases.
"We are very excited about this partnership... We believe CY-101 has the potential to be transformational for the treatment of ACC and other cancer types and are eager to bring this innovation to patients," stated Lars Prestegarden, CEO of Cytovation (search).
Ingrid Stenstadvold Ross, CEO of the Norwegian Cancer Society (search), added, "Together with Cancer Research UK’s Centre for Drug Development and Cytovation (search), we are bringing new hope to patients while highlighting Norwegian research on the international stage."