Neoantigen Cancer Vaccine Candidate GEN-009 Launches Phase 1/2a Clinical Study

A biopharmaceutical company developing neoantigen cancer vaccines filled an Investigational New Drug Application to begin a limited, Phase 1/2a clinical study testing the safety, immunogenicity, and clinical efficacy of GEN-009 vaccine candidate.

This study will focus on studying the safety and immunogenicity of GEN-009 as monotherapy in cancer patients with no evidence of disease but at high risk of relapse.

Genocea plans to commence the GEN-009 Phase 1/2a clinical program during 2018 and is expected to enroll at least 6 patients previously treated for melanoma, non-small cell lung cancer, head or neck cancer, or urothelial carcinoma.

Chip Clark, president and chief executive officer of Genocea said, “Our scientific data continue to demonstrate that widely used in silico-based neoantigen prediction methods fail to identify most empirically confirmed neoantigens and, critically, misclassify as good the inhibitory neoantigens that vastly outnumber stimulatory neoantigens.”

“We, therefore, believe that ATLAS distinguishes GEN-009 from other neoantigen vaccine approaches and should enable better immune responses and, ultimately, a therapeutic benefit for patients.”

Genocea 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.

For more information, please visit www.genocea.com.