Vaccibody AS is pleased to announce that it has received the approval from the regulatory authorities (Paul Ehrlich Institute), of its clinical trial application for VB10.16 immunotherapy, the company’s lead drug candidate for the treatment high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
The open label exploratory first-in-human study is divided in two phases; a phase I part where different vaccination regimens of VB10.16 will be tested in CIN 2 patients, followed by a phase II expansion phase, where the best vaccination schedule will be tested in CIN 2 and CIN 3 patients. The primary objective of the study is to evaluate the safety and tolerability of three doses of 3 mg VB10.16. The secondary objectives are to assess T cell mediated immune responses in the peripheral blood as well as in the pre-malignant tissue of the CIN 2/3 lesions and to evaluate early signs of efficacy by means of HPV clearance and CIN regression.
The study is being conducted at four highly experienced and well-recognized clinical sites in Germany with Professor Peter Hillemanns, Head of Department of Gynecology and Obstetrics at the Medical University of Hannover as the coordinating investigator. The study design was developed in close interaction with the participating investigators and the German regulatory authorities.
Martin Bonde, CEO of Vaccibody commented: The initiation of the first clinical study is an important milestone for Vaccibody in the development of its lead product candidate VB10.16 but also for the validation of Vaccibody’s Vaccine Technology Platform for the development of tailor made, more effective vaccines. We are pleased with the approval by the German Authorities which attests the high quality of our preclinical data and the well-designed clinical trial protocol.
The company’s lead product, VB10.16, is a therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies.
About Cervical Intraepithelial Neoplasia (CIN) and Cervical Cancer
Per year approximately 530,000 women are diagnosed with cervical cancer worldwide and over 275,000 women die of the disease annually. Invasive cervical cancer is preceded by a long phase of pre-invasive disease called Cervical Intraepithelial Neoplasia (CIN). Globally the number of high grade lesions (CIN 2/3) the immediate precursors to malignancy, is estimated to be in the range of 10 million.
Virtually all cervical cancers are caused by high risk HPV types. Among the different high risk HPV types known, HPV16 has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It can be detected in up to 60 % of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers).
Current standard therapy for CIN 2/3 varies between countries and regions and often involves surgical removal of the affected tissue. These invasive procedures are associated with bleeding, infection, cervical stenosis, scarring and most importantly pre-term deliveries in subsequent pregnancies. As a result, there is a significant need for an effective therapeutic vaccine to treat existing HPV infection and associated pre-malignancies and malignancies of the cervix and thereby prevent the development of cervical cancer caused by human papillomavirus.
About Vaccibody AS
Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, prophylactic and therapeutic vaccines which target cancer and infectious diseases, for human and veterinary use. Vaccibody’s lead program is focused on VB10.16, a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-man study will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).
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