March 2, 2017 Vaccibody AS announces approval of amendment of IMPD allowing to start of expansion phase in its phase I/IIa study with VB10.16 immunotherapy for patients with HPV16 induced high grade lesions of the cervix
Vaccibody AS announces today that inclusion of patients in the expansion phase (phase IIa) of its multicentre trial VB C-01 can be initiated as the company was informed by Paul-Ehrlich Institut („PEI“), the German regulatory authorities, that an amendment to the IMPD (Investigational Medicinal Product Dossier) for VB C-01 has been approved.
In a press release of 23/12 2016, Vaccibody informed that the company was required to submit an amendment to the IMPD for VB C-01 before the phase IIa could be initiated. This amendment was filed in January by the company which now has received the approval of the amendment and can start enrolling patients in the phase IIa. It is expected that the first patient in the phase IIa will be vaccinated in March. Vaccibody expects to report final analysis from the phase IIa trial in Q1 2018. Further results from the phase I part of the trial will be reported in H1 2017.
VB C-01 is an exploratory, open-label, multicenter phase I/IIa study VB10.16 immunotherapy for the treatment of high grade Cervical Intraepithelial Neoplasia (CIN 2/3) caused by human papillomavirus 16 (HPV 16).
4th Quarter results released
Vaccibody also today released its report for 4th quarter of 2016. Continued work on the finalization of the clinical phase I part of the VC C-01 is ongoing. Vaccibody’s cancer neoantigen program is making progress according to plan, including pre-clinical work, bioinformatics and pilot productions of personalized vaccines.
Change in management
Vaccibody’s Chief Clinical Officer, Mona Welschof, resigned from her position in February. The company has engaged with an interim CCO and does not expect any delays in its clinical programs. A search for a new leadership of the clinical department in Vaccibody has been initiated.
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 from 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). Vaccibody also has a strong focus on so-called cancer neoantigen vaccines and is in late preclinical development with this program.