Cytovation to present full safety and efficacy data from the CICILIA Phase I/IIa trial evaluating CY-101 in solid tumors at ESMO 2024

  • 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 

Cytovation Announces Appointment of Ellen Lubman, MBA to its Board of Directors

Bergen, Norway, December 20, 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumour membrane immunotherapy CyPep-1, today announced the election of Ellen Lubman, MBA, to its Board of Directors.

“We are excited to welcome Ellen, who brings extensive experience and a well-proven track record across business development, finance, and fundraising in biopharma, to Cytovation’s Board,” said Stein Christian Mohn, Chairman of Cytovation. “Her insights and expertise will be invaluable as we continue to build our business based on advancing the development of CyPep-1 as an important new treatment for cancer patients.”

“The team at Cytovation is deeply committed to bringing a potentially important new treatment option to a significant number of patients with cancer through a truly differentiated approach targeting aberrant Wnt/β-catenin signalling,” said Ellen Lubman. “I look forward to working closely with the Board and management team to help the Company achieve its mission to deliver this novel therapy for a wide range of cancer types, starting with Adrenocortical Carcinoma and expanding into other beta-catenin-driven indications, including Liver and Colorectal Cancer.”

Prior to joining Werewolf Therapeutics as Chief Business Officer and Head of Investor Relations and Corporate Communications in August 2020, Ms. Lubman served as the Chief Business Officer at Impel NeuroPharma, Inc., a publicly traded biotechnology company focused on neurological diseases, from October 2018 to July 2020. Prior to Impel, she was the Vice President of External Science & Innovation at Forest Labs, from February 2014 until its acquisition by Actavis plc in July 2014, and served in the same role at Actavis through June 2018 during which time Actavis merged with and renamed itself Allergan plc. Prior to Allergan, Ms. Lubman held numerous executive and leadership roles at Kadmon Pharmaceuticals, Bristol Myers Squibb, Celtic Pharma Management, L.P., Robertson Stephens Investment Bank and Abbott Labs. Ms. Lubman has also served on the Board of Directors of Reunion Neuroscience, Inc., a privately held biotechnology company, since June 2021. She also serves as an Advisor to GeneCentric Therapeutics, Inc. where she recently held a role on the Board of Directors, and TMRW.org. Ms. Lubman’s other affiliations include Daedalus Innovation Fund of Weill-Cornell, the Red Door Community, a cancer non-for-profit previously known as Gilda’s Club of NYC, and Executive Women in BIO.

Ms. Lubman earned her MBA from Stanford Graduate School of Business with a focus on Global Management, holds a Certificate in Pharmacology from the University of Medicine and Dentistry of New Jersey and a B.A. in Biology from Rutgers College.

About Cytovation 

Cytovation ASA is a clinical stage immune-oncology company focused on the development of CyPep-1, a first-in-class immunotherapy.

CyPep-1 has a unique mechanism of action, specifically eliminating cancer cells by targeting the plasma membrane, releasing neo-antigens, and inhibiting the WNT/β-catenin pathway. This dual mode of action promotes an inflammatory microenvironment and induces a tumor-specific immune response by in situvaccination.

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/Chief Financial Officer: contact@cytovation.com 

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

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/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

Cytovation appoints Olav Hellebø to its Board of Directors

Bergen, Norway, July 5th, 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 appointment of Olav Hellebø to its Board of Directors. 

Mr. Hellebø brings extensive international leadership experience, both in the US and Europe, across major pharmaceutical and biotechnology companies. Previously, he was Chief Executive Officer at ReNeuron, the UK-listed biotechnology company and, prior to this, Clavis Pharma, a Norwegian oncology company. 

Before joining Clavis, Mr. Hellebø headed up the global immunology franchise at UCB Pharma and before that was head of UK commercial operations at Novartis. He also held a number of senior commercial roles at Schering-Plough, including leading its US commercial operations in the areas of oncology, cardiovascular and hepatitis-C representing annual sales in excess of $2 billion. He holds an MBA from the IESE Business School, Barcelona, and a Bachelor of Business Administration from Hofstra University in the US. 

Olav currently serves on the Board of Antev, a UK-based private biotechnology company with a focus on prostate cancer. 

Stein Christian Mohn, Chairman at Cytovation said: “We are very pleased to welcome Olav to our Board of Directors. We believe that his extensive and broad-ranging experience in the industry will prove invaluable for the advancement of CyPep-1 and the continuing growth of the company as we continue to make excellent progress in our ongoing clinical program both in Europe and the US.” 

Olav Hellebø, added: “CyPep-1 has great potential as an innovative treatment for solid tumors where there is significant unmet medical need despite recent advances in cancer treatment. I look forward to working with the talented team at Cytovation to help bring this unique therapy to patients.” 

*** 

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, specifically eliminating cancer cells by targeting the plasma membrane, releasing neo-antigens and inhibiting the WNT/B-catenin pathway. This dual mode of action promotes an inflammatory microenvironment and induces 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 

Cytovation raises $8 million in Series A extension financing round for clinical advancement of CyPep-1, a first-in-class targeted tumor membrane immunotherapy

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 

Cytovation appoints Iman Barilero as Chief Development Officer

Bergen, Norway, 21 March 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 that Dr. Iman Barilero has joined the company as Chief Development Officer. 

Dr. Barilero brings three decades of experience as a strategic executive in the global healthcare industry, successfully designing innovative and integrated patient-centric and value-based regulatory development pathways, in all phases of drug development and across all major global pharmaceutical markets. This effort has culminated in global market approval of several novel medicines in oncology and CNS disorders. She has held leadership roles in a number of biotech and big pharma companies, including Lundbeck, Johnson & Johnson, Roche, Sanofi and Bristol Myers Squibb. 

Dr. Barilero obtained her PhD in Molecular and Cellular Pharmacology from the University of Paris VI while working at the Cancer Research Unit of Institut Gustave Roussy, and she is currently a faculty member at the Tufts Center for Study of Drug Development, with a focus on regulatory sciences and evidence generation. 

Cytovation’s lead asset, CyPep-1, is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer cells and is currently in Phase 1/2 clinical trials. 

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We’re delighted to have someone with Iman’s wealth of experience join Cytovation as we progress CyPep-1 through clinical development. Iman has worked across Big Pharma and biotech, and her support will be invaluable as the company enters its important next stages of development and growth.” 

Iman Barilero, PharmD, PhD, Cytovation’s Chief Development Officer, added: “CyPep-1 represents an exciting new approach to cancer immunotherapy, and it’s great to be joining Cytovation at a time when the asset has such strong clinical momentum backed by promising early data. I look forward to working with the team on advancing CyPep-1 closer to marketing authorization and commercialization.” 

CyPep-1 eliminates cancer cells by targeting the plasma membrane, forming pores that release cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a systemic, tumor-specific immune response. A synthetic peptide, CyPep-1 has been designed for easy and scalable manufacturing and is highly stable – an uncommon feature in these molecules. 

Phase 2 expansion studies will investigate CyPep-1 both as a monotherapy and in combination with the immune checkpoint inhibitor KEYTRUDA® (pembrolizumab). A number of these indications are orphan indications with few available treatments, which could allow for accelerated approval. 

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

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. 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 / George Underwood: cytovation@medistrava.com 

Tel: +44 (0)20 3928 6900 

Cytovation announces first patient dosed in Phase 2a study investigating CyPep-1 monotherapy in advanced melanoma refractory to checkpoint inhibitors

Bergen, Norway, 15 February 2023 – Cytovation ASA, a clinical stage immune-oncology company focused on the development of CyPep-1, its first-in-class targeted tumor membrane immunotherapy, announces that the first patient has been dosed in its Phase 2a study investigating CyPep-1 monotherapy in patients with advanced melanoma refractory to checkpoint inhibitors (CPIs). 

The study is an expansion arm of its ongoing Phase 1/2 CICILIA trial in solid tumors, which is being conducted in The Netherlands, France, and Spain. The Phase 2a study builds on encouraging data from the first phase of the trial, which has demonstrated a favorable safety profile for CyPep-1 monotherapy along with strong early signals of efficacy in several tumor types. 

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer cells. Administered by intratumoral injection, 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 systemic, tumor-specific immune response. A synthetic peptide, CyPep-1 has been designed for easy and scalable manufacturing and is highly stable – an uncommon feature in these molecules. 

Melanoma is the first of several indications that will be explored in Phase 2 expansion studies, which will investigate CyPep-1 both as a monotherapy and in combination with the immune checkpoint inhibitor KEYTRUDA® (pembrolizumab). A number of these indications, including melanoma subgroups, are orphan indications with few currently available treatments, which could allow for accelerated approval. 

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We continue to be very pleased with the clinical development progress of CyPep-1, and are excited to be launching this Phase 2a expansion arm, building upon our strong Phase 1 monotherapy data. Patients with metastatic melanoma that is refractory to checkpoint inhibitors are left with few treatment options and a high unmet need.” 

Preclinical data has also shown that CyPep-1’s mechanism of action is highly amenable to combination with other immunotherapies. Cytovation has an ongoing clinical research collaboration with MSD to explore CyPep-1 in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), and melanoma. 

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

About Cytovation 

Cytovation ASA 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. 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 / George Underwood: cytovation@medistrava.com 

Tel: +44 (0)20 3928 6900 

Cytovation presents Phase I dose escalation results at ESMO

We are pleased to share the poster recently presented at ESMO – European Society for Medical Oncology Congress 2022.

FIRST-IN-HUMAN, DOSE ESCALATION PHASE I TRIAL OF INTRATUMORAL CYPEP-1 IN PATIENTS WITH ADVANCED SOLID TUMORS
Eskens et al. Annals of Oncology, Volume 33, S758, 476P

Conclusions:
Administration of CyPep-1 is well tolerated. Both molecular and clinical findings suggest strong biologic activity.

https://www.linkedin.com/feed/update/urn:li:activity:6983491794369998849/

Cytovation collaborates with Recurrent Respiratory Papillomatosis Foundation to expand its clinical investigations of CyPep-1 into rare neoplastic disease

Bergen, Norway, 8th February 2022 – Cytovation AS, a clinical stage immuneoncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, announces that it is has entered into  collaboration with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to advance the development of CyPep-1 for the treatment of this orphan disease alongside the Company’s cancer development program.

Recurrent Respiratory Papillomatosis (RRP) is a rare neoplastic disease that is characterized by the growth of benign tumors in the respiratory tract caused by the human papilloma virus (HPV). Although they primarily occur in the larynx on and around the vocal cords, these growths may spread downward and affect the trachea, bronchi, and occasionally the lungs. Historic estimates from the RRP Taskforce have indicated an incidence among children of about 4.3 per 100,000 and among adults of about 1.8 per 100,000. Currently there are no approved treatments for RRP.

The collaboration will enable Cytovation to draw upon RRPF’s extensive knowledge and network in preparation for a Phase I/II study to be initiated in 2H 2022.

Kim McClellan, RRPF President, commented: “We are delighted to be combining our expertise with Cytovation’s to help investigate CyPep-1 in RRP. For people with rare diseases like RRP, new clinical studies can help advance our understanding of the condition and potentially address the significant unmet needs faced by patients every day. We believe CyPep-1 has great potential and we’re excited to test its efficacy in this difficult condition.”

“The opportunity for CyPep-1 in this rare disease indication highlights its broad potential not just across solid cancer types, but also across neoplastic diseases in general,” added Lars Prestegarden, MD, PhD, CEO of Cytovation. “We are very pleased to enter this new collaboration with RRPF, which will extend our clinical development plan with CyPep-1 beyond studies targeting cancers – both as a monotherapy and in combination with checkpoint inhibitors – into non-cancer neoplastic rare diseases. We look forward to working with RRPF and to initiating clinical studies in RRP later in 2022.”

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cells. CyPep-1 eliminates these 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.

About Cytovation

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

About the Recurrent Respiratory Papillomatosis Foundation

The Recurrent Respiratory Papillomatosis Foundation is on a mission to find a cure and ultimately eradicate RRP, so that it becomes a disease of the past. On our journey to find a cure, we will be funding promising research proposals, spreading awareness of RRP, and supporting patients and caregivers on their RRP journey.

With our voices united, we can and will work to end the burden of this disease on patients and caregivers. For more information visit: rrpf.org

Contact Information

Cytovation

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

MEDiSTRAVA Consulting

Frazer Hall / Mark Swallow / George Underwood: cytovation@medistrava.com

Tel: +44 (0)203 928 6900

Cytovation raises $20 million in Series A financing round to advance clinical development of CyPep-1, a first-in-class targeted tumor membrane immunotherapy

Bergen, Norway, 25th January 2022  – Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy, announces the successful closing of its Series A financing round, raising a total of NOK 180 million ($20 million). 
 
Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: “We are extremely pleased with the strong support we have received during this latest investment round. We continue to make excellent progress with CyPep-1 in our Phase I/II CICILIA clinical trial and following promising data from the first monotherapy part of the study, we have begun patient dosing of CyPep-1 in combination with Keytruda in patients with a range of solid tumors. These new proceeds will enable us to further advance and expand our clinical development plans in cancer, and we look forward to reporting further data from this clinical program in 2022. Additionally, we will now have the financial flexibility to investigate opportunities to expand our CyPep-1 development pipeline.” 
 
The Series A round was led by Sandwater, a Norwegian venture capital firm that invests in groundbreaking companies across a range of industries including life sciences, and Canica, a large, privately owned investment company operating out of Norway and Switzerland focused on building highly innovative companies that aim to create value for investors and society as a whole. 
 
The new funds will primarily be directed towards clinical development of Cytovation’s lead asset CyPep-1, a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target cancer 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 in combination with checkpoint inhibitors. 
 
Proceeds will be used to: 
  • Progress the CyPep-1 oncology program to Phase II, including expansion of single-agent arms, as well as three combination arms with KEYTRUDA® (pembrolizumab) in head and neck squamous cell carcinoma (HNSCC), triple negative breast cancer (TNBC), and melanoma, in collaboration with MSD 
  • Explore opportunities for pipeline development with CyPep-1 targeting patients with high unmet medical need 
 
Morten E. Iversen of Sandwater commented: “We are very pleased to be supporting Cytovation, a company that reflects our investment ethos of investing in innovative companies that we believe can make a real impact across society. We believe CyPep-1 has a very promising future, backed by an excellent and highly experienced management team.” 
 
Christer Kjos of Canica added: “Cytovation shares our entrepreneurial approach and willingness to take on new challenges with commitment and passion. We believe the company has reached an exciting point in its development and look forward to the time when this potential new treatment can bring benefit to a wide variety of cancer patients.” 
 
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. 
 
About Cytovation 
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. 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 .  
 
About Sandwater 
Sandwater is an impact focused venture capital fund accelerating ambitious companies to make a change that matters. Since 2016, Sandwater has invested in early stage companies and scale-ups with future-proof business models mainly located in the Nordics. Sandwater currently has 15 companies in its portfolio and is located in Oslo, Norway.  www.sandwater.com  
 
About Canica  
Canica is a large, privately owned investment company operating out of Norway and Switzerland focused on active, long-term ownership. Canica invests in companies that aim to create value for stakeholders and society as a whole. 
www.canica.no  
 
Contact Information 
Cytovation 
Federico Grego, Chief Business Officer:  contact@cytovation.com  
 
MEDiSTRAVA Consulting 
 Frazer Hall / Mark Swallow / George Underwood:  cytovation@medistrava.com  
Tel: +44 (0)20 3928 6900