March 8, 2018 VACCIBODY AS ANNOUNCES APPROVAL OF CLINICAL TRIAL APPLICATION (CTA) FOR ITS CANCER NEOANTIGEN PHASE I/IIA TRIAL BY GERMAN REGULATORY AUTHORITIES (PAUL EHRLICH INSTITUTE (PEI)).
Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, today announces approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI)).
Dr. Martin Bonde, Chief Executive Officer in Vaccibody, said “The regulatory approval of this sophisticated study with our individualized neoantigen vaccine VB10.NEO is a critical milestone for the company. We are 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 are 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