Genocea Biosciences Inc., the biopharmaceutical company developing neoantigen cancer vaccines, announced the filing of an Investigational New Drug Application with the FDA to begin a Phase I/IIa clinical program testing the safety, immunogenicity, and clinical efficacy of GEN-009, the company’s lead personalized neoantigen cancer vaccine candidate.
Genocea plans to commence the GEN-009 phase I/IIa clinical program later this year, first studying the safety and immunogenicity of GEN-009 as monotherapy in cancer patients with no evidence of disease, but at high risk of relapse. This part of the program is expected to enroll at least six patients previously treated for melanoma, non-small cell lung cancer, head or neck cancer, or urothelial carcinoma.
Genocea said it expects to announce the first top-line data from this study in the first half of 2019. Following proof of immunogenicity, Genocea expects to study GEN-009 in combination with checkpoint inhibitors in patients with advanced or metastatic solid tumors and as monotherapy in patients who have failed checkpoint inhibitory therapy.
