Finalization of enrolment in the HPV16 therapeutic vaccine (VB10.16) phase IIa of trial VB C-01.
Vaccibody AS announces that enrolment of patients will be finalised in December 2017 for the expansion phase (phase IIa) of its multicentre trial VB C-01. The enrolment goal was 15-20 patients and 16 patients have been enrolled to date. Enrolment continues throughout December. Patients will receive 4 vaccinations over 16 weeks and followed by 32 weeks follow up to assess safety and efficacy of the therapeutic VB10.16 DNA vaccine. The treatment with VB10.16 has been well tolerated so far. No serious adverse advents (SAEs) have been reported. The most common adverse event (AEs) were transient mild to moderate local site reactions at the administration site. Vaccibody expects to report 6 months results from the phase IIa by Q3 2018, and final results in Q1 2019.
VB C-01 is an exploratory, open, 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 (HPV16). A total of 16 patients were enrolled in the dosing phase I and 15-20 patients will be enrolled in the expansion phase IIa of the trial.
Appointment of Agnete B. Fredriksen as President & CSO, Mette Husbyn as Chief Technical Officer
Vaccibody’s Chief Scientific Officer (CSO), Agnete Brunsvik Fredriksen, PhD, has been appointed President & CSO of Vaccibody. Agnete Brunsvik Fredriksen is co-founder of Vaccibody and has been a key driving force in moving Vaccibody scientifically and operationally forwards.
Mette Husbyn PhD was appointed Chief Technical Officer (CTO) and joined Vaccibody in October 2017. Mette Husbyn holds a PhD in peptide chemistry from University of Oslo. Mette has since 1990 worked in CMC drug development throughout all clinical stages from early research to NDA/MAA filings in pharma and biotech companies.
“I am very pleased to announce today’s promotion of Agnete which highlights her talent, skill set and outstanding achievements” said Martin Bonde, CEO of Vaccibody. “I am also very pleased to announce that we now have Mette Husbyn on board as CTO with her very solid experience and achievements within CMC/production. With our cancer neoantigen program well on the way into the clinic it is critical that we have the right leadership in place to drive the continued success of our pipeline and the company.”
About Vaccibody AS
Vaccibody is a biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. Vaccibody is a leader in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. Vaccibody’s front runner program (VB10.16) is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study (phase I/IIa), which is now fully enrolled, evaluates the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).
Martin Bonde CEO
Oslo Research Park
0349 Oslo, Norway