Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company’s lead neoantigen vaccine candidate at the virtual 2020 American Society for Clinical Oncology (ASCO) Annual Meeting from May 29-31.
The analysis evaluates eight patients from Part A of the trial who were vaccinated with GEN-009 as adjuvant therapy, focusing on the onset and duration of induced immunity and clinical outcomes. Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year. All patients received dosing as planned with five doses given over a six-month period. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant.
GEN-009 vaccination also generated immune responses across 99% of neoantigen targets while avoiding inhibitory peptides also known as Inhibigens™, or antigens that drive inhibitory T cell responses. Both CD8+ and CD4+ responses were measured in both ex vivo and in vitro assays, and were detected as early as day 29 extending as far out as 12 months.
“I am pleased to see early and durable immune responses and favorable patient outcomes in Part A of the GEN-009 trial,” said Roger Cohen, M.D., Associate Director of Clinical Research, Abramson Cancer Center. “While we can’t assess the specific contribution of the vaccine in the adjuvant setting in this mixed population, the progression-free survival, safety and immunogenicity results support the role that GEN-009 could play in the therapy of multiple tumor types.”
“We are very pleased to find that these patients have done so well with GEN-009 vaccination. The breadth and durability of immune response as well as the clinical outcomes strengthen our excitement to see the effects of combination therapy in patients with measurable tumors,” said Thomas Davis, M.D., Chief Medical Officer of Genocea. “We are eager to elaborate further on our latest GEN-009 findings at the upcoming ASCO meeting and look forward to sharing additional data from Part B of this study on the benefits of the vaccine in patients receiving immune checkpoint inhibitors later this year.”
ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
Title: GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.
Presenter: Roger B. Cohen, M.D., University of Pennsylvania Abramson Cancer Center
Date: May 29, 2020
Time: 8:00 – 11:00 a.m. EDT