February 23, 2015 Vaccibody AS announces filing of a Clinical Trial Application (CTA) to initiate the First in Man Clinical study of its lead Drug Candidate VB10.16
Vaccibody AS, a biopharmaceutical company focusing on immunotherapy and vaccines, is pleased to announce the filing of a CTA to initiate the first in man clinical study of its lead drug candidate VB10.16. The CTA was filed with the Paul Ehrlich Institute, the Federal German Regulatory Agency and Agency for Vaccines and Biomedicines.
The planned study is an exploratory safety and immunogenicity study (equivalent to a Phase I/IIa study) of VB10.16 in women with high grade cervical intraepithelial neoplasia (CIN 2/3). It will be conducted at 4 centers in Germany. The authorities now have up to 90 days to assess the application.
Tom Pike, Chairman and Acting CEO of Vaccibody, commented: “Filing the first CTA is a significant milestone for any drug candidate. In addition to being the gateway to explore the safety and effect in man it also implies that a long list of demanding drug development steps have been completed, including toxicology testing, drug manufacturing to GMP standards along with a long list of quality assurance measures. We are very pleased with this accomplishment and look forward to initiate the study as soon as regulatory clearance is obtained”
Principal investigator, Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover, Germany:, commented: “VB10.16 immunotherapy has the potential to offer a non-invasive systemic treatment of patients with CIN 2/3 and in addition cure the underlying cause of the disease, namely the HPV infection and at the same time prevent the side effects of screening, diagnosis, treatment and follow up of these women. There is a high medical need for an effective and safe medical therapy which will reduce the need for surgical interventions and thereby reduce the burden of the observed adverse effects of these procedures.”
The company’s lead product, VB10.16, is a DNA vaccine developed to treat and prevent the recurrence of human papillomavirus type 16 (HPV16) induced cancers and pre-cancers. The first disease that will be targeted is the very common pre-cancerous condition of the cervix, CIN 2/3. Other HPV induced cancers such as head and neck cancers, penile cancer and anal cancers are additional expansion possibilities.
About HPV16 and CIN and Cancer Development
Persistent HPV infection can lead to neoplasia, or precancerous changes, in cervical epithelial cells. All pre-cancers and cancers of the cervix are caused by HPV infection. HPV16 has been reported to be the most common virus type in high-grade CIN accounting for approximately 55%-60% of all cervical cancers. In addition, HPV16 is estimated to be associated with approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers.
Cervical cancer is the fourth most common cancer in women and currently affects approximately 530,000 women worldwide and results in over 275,000 deaths annually. Although there are currently two approved vaccines (Gardasil® and Cervarix®) to prevent HPV-caused cancer these vaccines do not prevent disease in already infected individuals. Due to epidemiological factors (eg. the very high number of individuals already infected and the long time from infection to cancerous development) and incomplete vaccination coverage it is estimated that it will take 20-40 years before these vaccines will have a significant impact on the incidence and prevalence of cervical cancer.
Current standard therapy for CIN 2/3 varies between countries and normally involves surgical removal of visible lesions. These are associated with bleeding, infection, cervical stenosis, scarring, infertility and pre-term deliveries in subsequent pregnancies.
As a result, there is a significant need for an effective therapeutic vaccine to treat CIN and prevent cervical cancer caused by HPV16.
About Vaccibody AS
Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies and prophylactic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s internal lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV induced pre-malignancies and malignancies.
Vaccibody also offers its proprietary Vaccibody technology to other pharmaceutical companies for the improvement of their immunotherapy and vaccines. In 2014 the company announced one such agreement with the global veterinarian company Phibro Animal Health, for the development of vaccines for poultry.
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