Director of Peptide Drug Substance, Pharmaceutical Sciences & Manufacturing, Genocea Biosciences
Pioneering NeoAntigen Immunotherapies via ATLAS: GEN-009, a Neoantigen Vaccine Based on Autologous Peptide Immune Responses
Genocea Biosciences is developing personalized cancer immunotherapies via its ongoing Phase 1/2a trial (GEN-009) for the treatment of solid tumors; using its proprietary Antigen Lead Acquisition System (ATLAS™) to select tumor neoantigens for synthesis into peptides.
In this presentation Genocea will describe the following…
− Each patient’s own peripheral blood T cells and antigen-presenting cells are tested for immunogenicity against every patient-specific tumor mutation with a cytokine read-out.
− Neoantigens identified by ATLAS elicit patient-specific stimulatory CD4+ or CD8+ T cell responses.
− Unlike in silico models, ATLAS is also able to identify inhibitory neoantigens that can suppress immune control of tumors. These inhibitory neoantigens are excluded from the vaccine
− GEN-009 vaccine consists of 4-20 synthetic long peptides (SLPs) administered with the adjuvant poly-ICLC (Hiltonol).
GEN-009, the company’s lead neoantigen vaccine candidate, has demonstrated via ATLAS to be best-in-class based on its ability to provide Post-vaccination T cell responses detected to 91% of vaccine peptide neoantigens, including CD8+ T cell responses to 53% of vaccine peptide neoantigens
• In the five patients for whom immune response results are available to date, GEN-009 monotherapy elicited T cell responses to 91% of the vaccine neoantigens administered.
• GEN-009 has proven to be unique among neoantigen vaccines in its ability to elicit ex vivo CD8+ T cell responses, which were observed for 47% of vaccine neoantigens. Inclusive of the results seen after in vitro stimulation, the CD8+ T cell response frequency was 53%.
• GEN-009 has been well tolerated to date, with no dose-limiting toxicities.
Dr. Daniel B. DeOliveira has 20 plus years of contributing to drug discovery and pharmaceutical science primarily in the area of peptides and peptidomimetics. He has led drug discovery efforts focusing on rare diseases, oncology and nuclear medicine. He received his PhD in Medicinal Chemistry from Boston University, under the leadership of Prof. Richard Laursen. He went on to do his initial immunology studies, to MIT, designing tight binding MHC antigens that could function as synthetic T-cell antigens. After several years at MIT, Dr. DeOliveira took a position in the private sector at Dyax Corp. where he established and managed a peptide research group to meet the needs of peptide based projects at Dyax Corp, a company focused on rare hereditary diseases. Dr. DeOliveira’s research while at Dyax contributed to the eventual FDA approval of Kalbitor (Ecallantide, DX-88) a treatment for hereditary angioedema. Following Dyax, he took an opportunity at Ipsen Bioscience, a mid-size pharmaceutical company, with a strong research program focused on peptides as therapeutic drugs for rare diseases. While at Ipsen, he worked on several peptide-related projects including a Ghrelin agonist (Relamorelin™, BIM-28131) and a MC4R agonist (Setmelanotide™, BIM-22943) both currently in Phase-3 clinical studies. He also led a nuclear medicine program aimed at targeting Neuroendocrine Tumors, where he developed a successful, novel approach to solve the kidney rate limiting effects of radio-theranostics (PRRT) and also successfully designed a peptide / small molecule combo to target Neuroendocrine tumors via non-SSTR mechanism. He is currently Director of Pharmaceutical Sciences & Manufacturing at Genocea, working on T-cell immunity aiming to successfully develop neoantigen cancer vaccines for Genocea’s GEN-009 program currently in Phase 1/2a clinical trials.
He has been awarded several patents based on peptide therapeutics and has several more patent applications under review by the US patent office. He has over two dozen peer-reviewed publications, been a speaker at several conferences and has been the recipient of several Ipsen awards. He has been an organizer of Pep-Talks in the Boston Cambridge area, as well as the Cambridge Peptide Showcase East. He currently is serving as a Board Member and President of the UMass Dartmouth Alumni Association.