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)).

On March 8, 2018 Vaccibody AS, a clinical stage company focused on developing personalized neoepitope cancer vaccines to target solid tumors, reported that approval of Clinical Trial Application (CTA) for its cancer neoantigen phase I/IIa trial by German regulatory authorities (Paul Ehrlich Institute (PEI) (Press release, Vaccibody, MAR 8, 2018, View Source [SID1234525139]).

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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."