January 24, 2018 Vaccibody AS announces conditional approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI)) as well as approval by the central ethics committee in Heidelberg (Ethikkommission Medizinische Fakultät Heidelberg); Reiterates estimate to start cancer neoantigen trial in Q1, 2018.
Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, today announces conditional approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI)). The Company estimates that remaining conditions, which relates to securing and documenting certain aspects of the quality of the vaccine to be used, will be met to allow for final approval of the CTA in Q1, 2018 in line with previously communicated timelines.
Also, the Company has received approval by the Central Ethics Committee in Heidelberg (Ethikkommission Medizinische Fakultät Heidelberg) for the clinical trial.
Martin Bonde, PhD, Chief Executive Officer of Vaccibody, said, “We are very pleased to take these important steps towards the initiation of the clinical phase I/IIa for our cancer neoantigen vaccine. We look forward to starting the trial evaluating the safety, feasibility and efficacy of VB10.NEO in combination with standard of care checkpoint inhibitor therapy. The clinical trial will enroll patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder and head&neck cancer. A total of 40 patients is planned to be enrolled in the phase I part of the trial.”
About Vaccibody AS
Vaccibody is a clinical-stage 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