Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present initial clinical data today on the first five patients from Part B of the ongoing Phase 1/2a study, which explores the combination of Genocea’s neoantigen vaccine, GEN-009 and checkpoint inhibitor-based regimens (CPI) in advanced solid tumors. The webcast and presentation will feature Dr. Maura L. Gillison, MD, PhD, Professor of Medicine, Department of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center.
The trial combines GEN-009 with a Standard of Care (SOC) CPI-based regimen approximately four months after the SOC CPI-based regimen is started. The preliminary findings from the first five patients show three achieving independent RECIST responses starting from the first GEN-009 dose. These responses show an acceleration of shrinkage beyond that of the CPI regimen, creating a novel response plot that supports the effect being attributable to the addition of GEN-009. One such patient achieved a complete response (“CR”), while two demonstrated partial responses (“PR”). Overall, two of the first five patients achieved CRs and three experienced PRs.
These results are corroborated by the patients’ immune responses. Neoantigen-specific CD4+ and CD8+ T cell responses were detected in 100% of patients, with all patients responding to multiple vaccinated antigens. Early comparison of T cell responses post-checkpoint (pre-vaccination) and post-vaccination show that T cell responses are specific to GEN-009 and not augmented by checkpoint blockade.
“We are incredibly encouraged by these initial results,” said Dr. Gillison. “The breadth and magnitude of immune responses validate the complete and partial responses observed in the five patients evaluated. We believe incorporating GEN-009 into standard-of-care immunotherapy regimens may help boost the effectiveness of immune checkpoint inhibitor therapy in patients with advanced disease.”
“We are very pleased this initial data set continues to validate antigen selection using our proprietary ATLAS™ platform,” said Chip Clark, President and Chief Executive Officer, Genocea. “We look forward both to reporting data from approximately ten additional patients this fall and to initiating the clinical trial for the neoantigen cell therapy GEN-011, which should similarly benefit from ATLAS to drive anti-tumor responses through T cells targeting the right neoantigens in checkpoint-refractory patients.”