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 

CyPep-1 Shows Preliminary Safety, Tolerability and Early Signs of Efficacy in Part 1 of its Ph I/IIa CICILIA Trial Which Now Moves to Expansion Phase

  • Part 1 of the monotherapy trial successfully concluded having reached the planned target dose
  • Favorable safety profile maintained with tolerability and continued promising early signs of efficacy
  • Study to be expanded as planned

BERGEN, Norway, Sept. 23, 2021 /PRNewswire/ — Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, today announced that it has successfully completed Part 1 of its Ph I/IIa CICILIA study having reached the planned target dose of CyPep-1 while maintaining a favorable safety profile.

To date the trial has recruited 12 patients with a range of solid tumors, each patient having received a minimum of three intra-tumoral injections of CyPep-1. Safety and tolerability in this first part of the study have been encouraging with no serious adverse events or dose-limiting toxicities, while early efficacy signals are positive and remain consistent with the preclinical proof-of-concept data previously generated.

Read more here

 

Cytovation Announces Clinical Collaboration with MSD to Evaluate its First-in-class Tumorolytic Agent CyPep-1 in Combination with KEYTRUDA

BERGEN, Norway, July 30, 2021 /PRNewswire/ — Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD to evaluate the safety and efficacy of CyPep-1 in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy.

Read more here

 

Cytovation Announces Dosing of First Patient in its Phase I/II CICILIA Trial Investigating CyPep-1 in Patients with Solid Cancers

Bergen, May 29th 2020 – CyPep-1 is a novel lytic immunotherapy that both selectively binds and destroys tumor cells and promotes an anti-tumor immune response. Bergen, Norway, and Schiphol, the Netherlands (May 26, 2020) – Cytovation AS (“Cytovation”), a clinical-stage biotechnology company focused on developing CyPep-1, a next-generation lytic immunotherapy, is pleased to announce that the first patient has today been successfully dosed in its Phase I/II CICILIA clinical trial. The CICILIA trial will investigate CyPep-1 in patients with advanced solid cancers (ClinicalTrials.gov Identifier: NCT04260529).

 

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