Post-Vaccine Immune and Pathologic Markers Associated with Durable Clinical Benefit in Metastatic Melanoma Patient Cohort
Top-line Results, Including 52-Week Clinical Outcomes, from Full NT-001 Trial in Melanoma, Non-Small Cell Lung and Bladder Cancers Expected Later in 1H 2019
Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, today presented updated data describing the immune and pathologic markers associated with durable clinical benefit in patients enrolled in NT-001, an ongoing Phase 1b clinical trial evaluating NEO-PV-01 in combination with nivolumab (OPDIVO® or anti-PD-1 therapy). The data were highlighted in an oral presentation titled, “The Personalized Vaccine, NEO-PV-01 with Anti-PD-1, Induces Neoantigen-Specific De Novo Immune Responses in Patients with Advanced or Metastatic Melanoma: Association with Clinical Outcomes,” at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta.
NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the neoantigens identified by Neon’s proprietary bioinformatics engine, RECON®, as being the most therapeutically relevant for an individual patient. The data presented today, which reflect a cutoff date of August 31, 2018, include 23 patients with metastatic melanoma who received at least one dose of NEO-PV-01 and who either remained progression-free or had progressed by week 36 after the initiation of anti-PD-1 therapy. Patients who did not progress by 36 weeks were classified as having durable clinical benefit (DCB). The data indicate that RECON-based prediction of neoantigen quality correlates with DCB and serves as clinical validation for RECON’s ability to identify therapeutically relevant neoantigens.
“Our new analysis has shown two post-vaccine markers, epitope spread and tumor pathology, that clearly associate with durable clinical benefit. Of the patients tested, we observed epitope spread – which is a cascade of neoantigen recognition beyond those included in the vaccine – in all patients with DCB. Furthermore, the majority of patients with DCB displayed marked reductions in tumor content only after vaccination. We are encouraged by these associations and look forward to evaluating patient outcomes, including clinical responses and progression-free survival, in the more mature 52-week topline data set expected mid-year,” said Richard Gaynor, M.D., President of Research and Development at Neon Therapeutics.
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