Vaccibody moves forward with HPV-study
The primary objectives of the phase IIa study are to assess T cell mediated immune responses in the peripheral blood and to evaluate early signs of efficacy.
-We have been encouraged to see the outcome of the phase I trial and are excited to initiate this phase IIa clinical study. This offers a chance to get information on how patients respond to the Vaccibody immunotherapy platform, says Principal investigator, Prof. Dr. med. Karl Ulrich Petry, Department of Obstetrics & Gynaecology Klinikum Wolfsburg.
Moreover, the treatment can potentially also cure the underlying HPV infection, Petry comments, and thereby prevent recurrence and may protect from other HPV induced cancers.
Will outlicence the vaccine after phase II
– We are pleased to announce the vaccination of the first patient. Surgery is currently the only available therapy to remove abnormal cervical lesions caused by HPV-virus, and thereby stop the progression to cervical cancer, says Martin Bonde, CEO Vaccibody.
Bonde says that the plan is to have enough patients recruited by the end of Q3 and hence the first read out of the data in Q1, 2018.
-As of now we see that we will need a phase IIb/III study involving more patients, maybe up to 150-200. As of now we plan to out licence this product if we see the right responses, says Bonde.
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. Vaccibody also has a strong focus on so-called cancer neoantigen vaccines and is in late preclinical development with this program.
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.