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Genocea Presents Updated Long-term Safety, Immunogenicity and Durability Data from GEN-009 Neoantigen Vaccine Phase 1/2a Trial Part A at Virtual ASCO 2020Data show immune responses occur rapidly after only two vaccinations and can be sustained for more than one year Part B is exploring the vaccine's ability to reduce tumor size beyond the standard-of-care therapy alone CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents 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. Data will be shared by Roger Cohen, M.D., University of Pennsylvania Abramson Cancer Center, during a video poster presentation (Abstract #3107) at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020 from 8:00 – 11:00 am EDT. 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. 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 does given over a six-month period with immune responses occurring rapidly after only two vaccinations. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant. In addition, there are several notable patient outcomes:
“The fact that seven of eight patients continue without progression is encouraging. The vaccine has been well tolerated with only mild injection site reactions. Vaccinated patients have generated both CD4+ and CD8+ ex vivo immune responses with immunogenicity manifested to 99% of the vaccinated antigens,” said Dr. Cohen. 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 as 12 months. The Part B trial continues with patients diagnosed with advanced disease who are receiving GEN-009 in combination with standard of care regimens, including immune checkpoint inhibitors. This cohort will explore the vaccine's ability to reduce tumor size beyond the standard of care therapy alone. “Together, these data suggest that ATLAS-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination,” said Thomas Davis, M.D., Chief Medical Officer of Genocea. “We look forward to advancing the GEN-009 Phase 1/2a Part B trial and reporting those results, and additional Part A results, later in 2020.” About Genocea Biosciences, Inc. Forward-Looking Statements Investor Contact:
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