• New funds provided largely by existing investors, led by Sandwater 

• Phase 2 trial to be delivered through novel agreement between Cytovation, Cancer Research UK and the Norwegian Cancer Society 

• New preclinical data highlighting potential of CY-101 in ACC and other cancer types driven by a dysfunctional Wnt/β-catenin pathway, including colorectal cancer, to be presented at AACR annual meeting 

Bergen, Norway, April 23, 2025 – Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, announces that it has raised NOK62 million (US$6m) largely from existing investors, led by Sandwater. 

These funds will be used to advance CY-101 into a multi-national Phase 2 clinical trial in patients with adrenocortical carcinoma due to start in late 2025 and with first clinical readouts expected in 2026. The trial will be conducted through a partnership between Cytovation, Cancer Research UK and the Norwegian Cancer Society under an agreement announced in January 2025 (click here for press release). 

CY-101, a membranolytic inhibitor of the Wnt/β-catenin pathway, has demonstrated early signs of antitumor activity in the Phase 1 CICILIA trial – particularly in tumors with dysregulated Wnt/β-catenin signaling. 

New preclinical data being presented at the American Association of Cancer Research (AACR) annual meeting (Chicago, IL; April 25-30, 2025) by Cytovation and its collaborators at the Luxembourg Institute of Health, provide further insights into the mechanistic basis of CY-101’s activity. 

The studies, conducted in in vivo immune-refractory models of ACC, colorectal carcinoma (CRC) and melanoma, demonstrated that CY-101 eliminates ACC and CRC tumors, enhances the efficacy of anti-PD-1 activity and triggers a systemic antitumor immune response. 

These findings support the potential of CY-101 as a novel therapeutic for difficult-to-treat cancers such as ACC, and more broadly for tumors with dysregulated Wnt/β-catenin signaling, like CRC and hepatocellular carcinoma (HCC), among others. 

“As we continue to explore the novel mechanism of action of CY-101 and its translation into meaningful clinical activity, our conviction in its potential to address tumors driven by the Wnt/β-catenin pathway only grows stronger,” said Lars Prestegarden, CEO of Cytovation. “We are grateful for the continued support of our investors, whose confidence – alongside the strength of our outstanding partners – positions us well to advance CY-101 into Phase 2 trials and generate impactful clinical data.” 

Poster Presentation at AACR 

Title CY-101 Inhibits Tumor Growth and Improves Anti-PD-1 Immunotherapy in Beta-Catenin-Driven Tumors 

Poster Number 2231 

Session Title PO.IM01.02 – Modulation of Tumor Microenvironment: Enhancing Immunogenicity and Counteracting Suppression 

Date / Time April 28, 9:00am-12:00pm Central Time 

Authors Margaux Poussard et al. 

Link to abstract Abstract 2231 Cytovation-AACR 

Link to ePoster Poster 2231 Cytovation-AACR (available from 12pm CT on April 28) 

 

About Cytovation 

Cytovation ASA is a clinical stage immune-oncology company focused on the development of CY-101, a first-in-class bifunctional immunotherapy. 

CY-101 has a unique dual mechanism of action, specifically eliminating cancer cells by targeting the cell membrane and releasing neo-antigens, and by inhibiting the Wnt/β-catenin oncogenic pathway to restrict tumor growth and reverse immune exclusion associated with β-catenin expression. Dysregulation of this pathway has been associated with several different cancer types including colon, liver, uterine, lung and ovarian cancer, among others. This dual mode of action induces a systemic, tumor-specific immune response. 

For more information, please visit www.cytovation.com. 

Contact Information 

Cytovation 

Federico Grego, Chief Operating Officer/Chief Financial Officer: contact@cytovation.com 

MEDiSTRAVA 

Frazer Hall / Mark Swallow: cytovation@medistrava.com 

February 13, 2025 03:00 ET | Source: Cytovation

• Brings over 30 years of life sciences industry experience
• Co-led the McKinsey Global Life Sciences practice

Bergen, Norway, February 12, 2025 – Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, announces the appointment of Mr. Martin Dewhurst to its Board of Directors.

Stein Christian Mohn, Chairman of Cytovation, said: “On behalf of the Board I extend a warm welcome to Martin, who brings over 30 years of experience in the life sciences sector to help guide Cytovation through the next important phase of its development.”

“Following its recent partnership with Cancer Research UK and the Norwegian Cancer Society, Cytovation is strongly positioned to advance CY-101 as a potentially transformational new treatment for Wnt/b-catenin driven cancers, an area of very high unmet need. I look forward to bringing my experience and strategic insight to help Cytovation unlock and capture the potential of this exciting programme,” said Martin Dewhurst.

Martin spent a large part of his career at McKinsey & Company, where he co-led the global life sciences practice. His expertise spans global biopharma, medtech, genetics, and consumer health. Notably, he co-founded and led the McKinsey Health Institute, a non-profit entity focused on addressing fundamental health challenges.

Beyond McKinsey, Martin serves as a Senior Advisor with the financial firms PJT Partners, Lightrock, and GHO Capital Partners, and holds board positions with companies including Distalmotion, a Switzerland-based medtech company specializing in robotic surgery.

Martin earned a BA from the University of Oxford and his MBA, Management from INSEAD.

About Cytovation 
Cytovation ASA is a clinical stage immune-oncology company focused on the development of CY-101, a first-in-class bifunctional immunotherapy.

CY-101 has a unique dual mechanism of action, specifically eliminating cancer cells by targeting the cell membrane and releasing neo-antigens, and by inhibiting the Wnt/β-catenin oncogenic pathway to restrict tumor growth and reverse immune exclusion associated with β-catenin expression. Dysregulation of this pathway has been associated with several different cancer types including colon, liver, uterine, lung and ovarian cancer, among others. This dual mode of action induces a systemic, tumor-specific immune response.

For more information, please visit www.cytovation.com.

Contact Information 

Cytovation 
Federico Grego, Chief Operating Officer/Chief Financial Officer: contact@cytovation.com 

MEDiSTRAVA
Frazer Hall / Mark Swallow: cytovation@medistrava.com 

• CY-101 well tolerated with early signs of clinical activity, especially in tumors with dysregulated Wnt/β-catenin signalling
• CY-101 granted Orphan Drug Designation in US for the treatment of Adrenocortical Carcinoma, a Wnt/β-catenin driven tumor type

Bergen, Norway, September 13, 2024 – Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional immunotherapy CY-101 (CyPep-1) announces that it will deliver a poster presentation at ESMO 2024 entitled “Safety and activity of CY-101 in patients with advanced solid tumors: the Phase I/IIa CICILIA trial.” Data from this study, evaluating intratumoral (IT) administration of CY-101 monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with heavily pretreated advanced solid tumors, show that CY-101 is well tolerated at the recommended Phase 2 dose (RP2D) of 20 mg. Furthermore, these data demonstrate early signs of antitumor activity, especially in tumors with dysregulated Wnt/β-catenin signaling.

CY-101 is a synthetic peptide with a dual mode of action that both inhibits the oncogenic Wnt/β-catenin pathway by activating Axin2 and has a pore-forming membranolytic effect on cancer cells that exposes antigens and triggers a systemic tumor-specific immune response. Interim results from CICILIA were reported in 2023 (link to press release here) confirming that all trial endpoints were met, with CY-101 demonstrating a consistent safety profile across tumor types and strong early signals of efficacy.

Data from the ESMO poster show that no dose-limiting toxicities were observed in the dose- escalation part of the study with the RP2D defined at 20 mg. Analyses of paired tumor biopsies demonstrated induction of cancer cell death in >70% across tumor types at the RP2D, translating to a clinical benefit in several different cancer types. Notably, among six patients with adrenocortical carcinoma (ACC) receiving CY-101 monotherapy, a disease control rate of 50% (n = 3/6) was observed, with durable responses (> 6 months) in two patients. Both patients expressed β-catenin and had somatic mutations in the Wnt/β-catenin pathway.

Separately, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to CY-101 monotherapy for the treatment of ACC. Orphan Drug Designation is granted to investigational therapies that are intended for the treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the US. Orphan Drug Designation provides several benefits to drug developers, including certain development cost benefits in the US, increased FDA interaction and eligibility for seven-year market exclusivity following approval.

“We believe CY-101 is a potentially important new treatment option that offers a truly differentiated approach to targeting Wnt/β-catenin driven cancers, an oncogenic pathway dysregulated in more than 20% of cancers,” said Lars Prestegarden, CEO of Cytovation. “Our early data clearly confirm that CY-101 warrants further investigation in larger studies, and we are very pleased to receive Orphan Drug Designation for CY-101 in ACC. We look forward to advancing towards our planned Phase 2 trial in ACC with registrational intent.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merk & Co., Inc., Rahway, NJ, USA.

####

About Adrenocortical Carcinoma (ACC)

ACC, also known as adrenal cancer, is a rare cancer with a very poor prognosis and few treatment options. In the metastatic setting there is no approved treatment option after first line. 

About Cytovation 

Cytovation ASA is a clinical stage immune-oncology company focused on the development of CY-101, a first-in-class bifunctional immunotherapy.

CY-101 has a unique dual mechanism of action, specifically eliminating cancer cells by targeting the cell membrane and releasing neo-antigens, and by inhibiting the Wnt/β-catenin oncogenic pathway to restrict tumor growth and reverse immune exclusion associated with β-catenin expression. Dysregulation of this pathway has been associated with several different cancer types including colon, liver, uterine, lung and ovarian cancer, among others. This dual mode of action induces a systemic, tumor-specific immune response.

For more information, please visit www.cytovation.com.

Contact Information 

Cytovation 

Federico Grego, Chief Operating Officer/Chief Financial Officer: contact@cytovation.com 

MEDiSTRAVA Consulting 

Frazer Hall / Mark Swallow: cytovation@medistrava.com 

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/βcatenin 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, 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 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.

***

About Cytovation
Cytovation ASA is a privately held, clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class immunotherapy designed to drive a systemic and cancer-specific immune response. The company is a spin-off from the University of Bergen (Norway), the city where it is headquartered. For more information, please visit www.cytovation.com.

Contact Information

Cytovation
Federico Grego, Chief Operating Officer: contact@cytovation.com

MEDiSTRAVA Consulting
Frazer Hall / Mark Swallow: cytovation@medistrava.com

Brings total Series A funding to over $28 million allowing CyPep-1 to advance into Phase 2 

Bergen, Norway, June 2, 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces the successful closing of its $8 million (NOK 85 million) Series A extension financing round. This new investment will support the progress of Cytovation’s lead asset, CyPep-1, into a full Phase 2 program for the treatment of solid tumors. 

CyPep-1 has the potential to transform the treatment of solid tumors through its unique multi-modal mechanism of action, eliminating cancer cells by: 

•  targeting phospholipids in cancer cells, 
•  forming pores in the plasma membrane, 
•  releasing antigens to the immune system, 
•  promoting an inflammatory microenvironment, and 
•  inducing a tumor-specific immune response by in situ vaccination 

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We are delighted to announce the successful closing of this latest financing round following our initial $20 million Series A round in January 2022, allowing us to advance CyPep-1 towards clinical proof of concept in Phase 2. We continue to make excellent progress in our ongoing Phase 1/2 CICILIA solid tumor basket trial, and with our IND in hand we will now expand clinical development to the US. We look forward to announcing initial results from CICILIA, including in combination with pembrolizumab, in the second half of 2023.” 

The financing round extension was co-led by existing investors Sandwater, a Norwegian venture capital firm that invests in ground-breaking companies with a positive impact across a range of industries including life science, and Canica, a large, privately owned investment company operating out of Norway and Switzerland that is focused on building highly innovative companies that aim to create value for investors and society. Cytovation also welcomed participation from several new investors reflecting the growing interest in the potential of CyPep-1 as a first-in-class targeted tumor membrane immunotherapy. 

Cytovation’s 57-patient Phase 1/2 CICILIA solid tumor basket trial is now well advanced, with top line results due in H2 2023. The Phase 2a monotherapy expansion arm builds on strong Phase 1 monotherapy data, which demonstrated a favorable safety profile along with early signals of efficacy in several tumor types. CICILIA also includes an arm in which CyPep-1 is combined with pembrolizumab, as part of an ongoing clinical trial collaboration and supply agreement with Merck/MSD. 

Cytovation is seeking to develop CyPep-1 in selected neoplastic orphan indications that may allow an expedited pathway to a first approval, while supporting the broader potential of CyPep-1 across a range of solid tumors. 

Given the significant potential of CyPep-1, Cytovation recently announced the expansion of its senior management team with the hiring of Iman Barilero, PharmD, PhD, as Chief Development Officer, and 

Helen Blanco, MBA, as VP Operations. These new team members will be central to the Company’s mission to develop CyPep-1 to enhance the lives of cancer patients suffering from a variety of solid tumors. 

About Cytovation 

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

CyPep-1 has a unique mechanism of action, eliminating cancer cells by forming pores in the plasma membrane, releasing antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination. 

The company is a spin-off from the University of Bergen (Norway), the city where it is headquartered. For more information, please visit www.cytovation.com. 

Contact Information 

Cytovation 

Federico Grego, Chief Operating Officer: contact@cytovation.com 

MEDiSTRAVA Consulting 

Frazer Hall / Mark Swallow / Evelyn McCormack: cytovation@medistrava.com