March 1, 2016 Completion of enrolment according to the study protocol for the phase I part of the VB C-01 study with VB10.16 immunotherapy for patients with HPV16 induced high grade lesions of the cervix
Vaccibody AS announced today the successful enrolment of all twelve patients required for the phase I part of the multicentre trial VB C-01 – an exploratory, open-label, multicenter phase I/IIa study of VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
As per protocol twelve eligible patients are needed to study the safety and immunogenicity of two different dosing schedules of VB10.16 in patients diagnosed with CIN 2 during this first phase I part of the study. Patient number 12 received her first vaccination on Friday 26 February 2016. The best schedule will be selected and evaluated in the subsequent phase IIa expansion part in both 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.
Martin Bonde, CEO of Vaccibody, commented: The successful completion of enrolment of the required number of patients for the phase I part of the study is an important milestone for Vaccibody. Positive results from this trial will have a significant impact not only on the development of the company’s lead product VB10.16 but also represent a proof of principle for Vaccibody’s Vaccine Platform Technology and the potential to use this platform in further indications.
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-human study will evaluate the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3). Also, Vaccibody is exploring the novel and promising area of neoantigen-based individualized cancer vaccines and is using the Vaccibody technology to generate first-in-class therapeutics to treat cancers with a high unmet medical need.