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 and SMS-oncology sign agreement on conduct of phase I/II trial with CyPep-1 in solid tumors

Bergen, Norway and Schiphol, the Netherlands (8 August 2019) – Cytovation AS (“Cytovation”) and Specialized Medical Services-oncology BV (“SMS-oncology”) today announce that SMS-oncology has been selected as the CRO to conduct the phase I/II clinical trial with CyPep-1 in patients with advanced solid cancers.

In recent months, Cytovation has progressed through preclinical and toxicology studies with its lead candidate CyPep-1, a first-in-class lytic agent. Through its unique pharmacological properties, CyPep-1 selectively targets and lyses tumor cell membranes based on their altered molecular composition. This mode of action kills cancer cells, releases tumor antigens, and potentially induces a tumor-specific immune response by in-situ immunization.

Cytovation is currently initiating a first-in-human trial with intratumoral injection of CyPep-1 and aims to reach first in patient (FPI) milestone by the end of 2019. An agreement is now concluded with the oncology dedicated CRO SMS-oncology in Schiphol, the Netherlands.

The study is designed as an open-label, dose escalation phase I/II trial to evaluate the safety, efficacy and pharmacokinetics of intratumoral CyPep-1 in patients with advanced solid cancers. The multicenter trial in Europe will enroll approximately 18 patients. SMS-oncology is developing the protocol and giving guidance regarding patient inclusion criteria and investigational sites for a best-fit and seamless transition to clinic. This will be followed by full conduct of the trial, expected to commence in Q4 2019.

Mr. Kjell-Inge, CEO of Cytovation: “We are excited CyPep-1 is now progressing to the next phase of development, which is an important step for our company. We are pleased with selecting SMS-oncology as our partner in this transition to clinic. From the initial discussions, they lived up to their reputation as experts in the field of early phase and immuno-oncology trials. Preparations of the trial are moving forward in a fast pace, and we feel confident our trial will be conducted in an optimal and valuable matter with our goals is mind.”

Ms. Philine van den Tol, CEO of SMS-oncology: “We are delighted to support Cytovation and look forward to jointly make the CyPep-1 trial a great success. It is exactly these type of innovative projects SMS-oncology leverages great experience in, and beyond all, is passionate
about. The enthusiasm of Cytovation is catching and our team can’t wait to see results of this promising first-in-class lytic compound.”

CyPep-1, in a cream formulation for topical application, is currently being evaluated in a phase I trial in patients with HPV-induced cutaneous tumors (warts).

Cytovation initiates clinical development programme with CyPep-1,a first-in-class lytic agent for tumor immunotherapy

BERGEN, NORWAY, 18 March 2019 – Cytovation AS, a privately held biotech company, announces that the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as a new topical therapy for HPV-induced warts. The initiation of this clinical trial marks the start of the clinical development of CyPep-1 in dermatology and oncology applications, with a Phase I trial of CyPep-1 in malignant tumors planned to start in the second half of 2019.

  • First patients treated in a Phase I study with CyPep-1 as an investigational therapy for benign, HPV-induced cutaneous tumors (warts).
  • Novel targeted lytic mechanism offers broad application for multiple indications.
  • Further clinical trial in malignant tumors to start in 2H 2019.

CyPep-1 has been designed and developed by Cytovation. It is a first-in-class lytic agent with broad application across benign and malignant tumors as a result of its novel mechanism of action. CyPep- 1 selectively targets tumor cells, forming pores that destabilise and rupture the membrane to kill the cell and release neoantigens into the microenvironment and circulation, while leaving healthy cells intact. The release of neoantigens enables cytotoxic CD8 positive T-cells to mount a systemic immune response offering the possibility of long-lasting immunity against the tumor and, in the case of warts, HPV infection. For more information about the mode of action, click here.

Cytovation has formulated CyPep-1 as a cream for the topical treatment of HPV-induced warts, a large medical need for which there are currently no approved drug therapies. The Company has also developed CyPep-1 as a solution for intra-tumoral injection, as a single agent or in combination with checkpoint inhibitors.

Cytovation’s Chief Scientific Officer, Lars Prestegarden, said: “We are very pleased to achieve this first clinical milestone with CyPep-1 and to begin its formal clinical development. We have designed CyPep-1 to exploit key differences between healthy and tumor cells and have seen strong evidence of its efficacy in preclinical tumor models. We are excited to see if these results can be translated to humans both with this new trial in warts and the future trial in cancer. Both trials are expected to start during 2019 and we are looking forward to reporting first findings later in the year.”

The clinical trial with CyPep-1 is a randomized, placebo-controlled, double-blind Phase I study. The study is being conducted at the Centre for Human Drug Research (Leiden, the Netherlands) and will enrol 58 patients with cutaneous warts. Results are expected in the late 2019. (ClinicalTrials.gov Identifier: NCT03846648).

Cytovation announces appointment of Ole-Erik Iversen as Scientific Advisor

BERGEN, NORWAY, 20 January 2017 – Cytovation AS, a privately held biotech company developing CyPep-1 for the treatment of skin disorders announces the appointment of Professor Ole-Erik Iversen as Scientific Advisor.

Professor Iversen has been Professor of Gynecology & Obstetrics at University of Bergen since 1992, having previously held positions at the Department of Surgery at Molde Hospital; the Department of Gynecology & Obsetrics at Haukeland Hospital (University of Bergen); and was Research Fellow of The Norwegian Cancer Society (1984-1986).

Since 2000 he has been Principal Investigator (Norway) for several Phase II and III clinical trials for Merck and GSK (Gardasil and Cervarix). From 2007 he was also Member of Merck Scientific Advisory Committee on Second Generation HPV vaccines (Gardasil 9). He is currently Advisor to the Health Directorate and Norwegian Cancer Registry on use of HPV testing in triage and primary screening to replace cytology.

Cytovation CEO Kjell Inge Arnevig said: “We are pleased to welcome Professor Iversen to Cytovation. He joins the Company at an exciting time, with lead candidate CyPep-1 currently in pre-clinical development for the treatment of warts caused by the HPV virus. We are confident that Professor Iversen’s extensive experience in HPV vaccines will assist Cytovation to achieve its goals.”

Cytovation announces two key appointments to the management team

BERGEN, NORWAY, 3rd October 2016 – Cytovation AS, a privately held biotech company developing CyPep-1 for the treatment of skin disease, announces the appointment of two key members to the Cytovation team. Raj Airey joins as Venture Developer and Federico Grego as Strategic Counsel.

Raj Airey is a venture developer and investor with extensive experience in health sector and senior leadership roles with-in blue chip multi-nations like Pfizer (NYSE PFE) and Baxter ( NYSE: BAX ). He has been an entrepreneur building business from concept to reality and has founded several companies and exited two in healthcare and been involved in many fund raising and licensing deals across the globe. Raj brings 28 years of operating experience in healthcare industries in many global locations which include including UK, Belgium, Hungary, Slovakia, Poland, Spain and India/SEA. He has considerable track record of turnarounds and building successful organisations in fast moving environments. He conceived and found Wizzcare Home Health Solutions a pioneer in home care and telehealth company in India which was sold to Indian’s leading E health business. He also co-founder in India's first Healthcare accelerator (www.healthstart.co.in) which has invested extensively in portfolio Mhealth companies and some of which these is active board member and mentor. Raj holds BSc from London University and Executive education from Harvard and Insead.

Federico Grego has close to 20 years of professional experience gained in the bio-pharmaceutical and banking industries. In the bio-pharma sector, his key areas of responsibility have included Marketing & Sales, Business Development, Innovation Management, and General Management, both in early-stage and larger company settings, in Europe and the U.S. He brings very relevant experience acquiring and integrating start-ups into larger companies, and also successfully negotiating and managing out-licensing deals to global big pharma players. His advisory role at Cytovation complements his executive responsibilities as CEO of Spire Bioventures and other advisory roles at several early-stage companies. Mr. Grego holds a BA from Tufts University, an MBA from IESE Business School, and an AMP from Harvard Business School.

CEO of Cytovation, Kjell Inge Arnevig, said: “We are pleased to welcome Federico and Raj to the Cytovation management team. We are thrilled to have them both join the team at this exciting time in Cytovation’s developement. Both have an impressive track record and extensive experience in the sector, which we are confident will help Cytovation achieve its goals.”