NEW YORK – Oslo, Norway-based Vaccibody on Thursday announced that it had entered into a licensing agreement with Roche subsidiary Genentech to develop and commercialize VB10.NEO, Vaccibody's investigational DNA-based, individualized neoantigen vaccine for the treatment of patients with locally advanced or metastatic cancers.
Under the terms of the licensing agreement, Vaccibody will conduct development of the agent through the end of its Phase Ib clinical trial, after which Genentech will develop and commercialize the agent, covering all clinical, manufacturing, regulatory, and commercialization costs. Genentech will pay Vaccibody $200 million upfront, and Vaccibody will be eligible for up to $515 million in potential payments and milestones in addition to low double-digit tiered royalty payments on potential sales of the commercialized agent going forward.
VB10.NEO is designed to induce cellular immune responses unique to the neoantigens expressed by each patient's tumor. The safety and preliminary anti-tumor activity of the vaccine is currently being evaluated in a Phase I/IIa clinical trial for patients with locally advanced or metastatic melanoma, non-small cell lung cancer, urothelial cancer, clear-cell renal cell carcinoma, urothelial carcinoma, or squamous cell carcinoma of the head and neck. According to Vaccibody, interim results from the trial have suggested a clear link between selection of high-quality neoepitopes, generation of strong neoepitope-specific CD8+ T cell responses, and clinical responses. At an interim analysis in 2019 of the first 14 patients treated with the personalized vaccine, clinical responses were observed in half of all patients across tumor types. Â
"Genentech is widely recognized as one of the foremost leaders in leveraging the immune system to develop therapies for cancer and is a scientific pioneer within the neoantigen cancer vaccine space," Vaccibody CEO Michael Engsig said in a statement. "They are therefore the partner of choice for the further development and commercialization of our innovative next-generation cancer vaccine platform for generating individualized therapies."