Genocea Files Investigational New Drug Application for Neoantigen Cancer Vaccine Candidate GEN-009

Genocea Biosciences (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical program testing the safety, immunogenicity, and clinical efficacy of GEN-009, the company’s lead personalized neoantigen cancer vaccine candidate.

As quoted in the press release:

“We are excited to have advanced GEN-009 one step closer to the clinic,” said Chip Clark, president and chief executive officer of Genocea. “Our GEN-009 program is designed to use our proprietary ATLAS platform to include only empirically confirmed neoantigens and to exclude what we’ve identified as inhibitory neoantigens in each patient’s vaccine. 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, therapeutic benefit for patients.”

Click here to read the full press release.