GEN-009 Vaccine Description
Genocea's GEN-009 is an investigational, personalized adjuvanted vaccine developed to treat patients with solid tumors.
A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System), will be used to identify neoantigens in each patient's tumor recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).
GEN-009 is a neoantigen vaccine candidate in a Phase 1/2a clinical trial to treat a variety of solid tumors. Unlike other neoantigen vaccines, ATLAS identifies neoantigens optimized for patients’ T cell responses and their tumors, underscoring the advantages of the technology for neoantigen selection. Neoantigens are personalized tumor mutations that are seen as “foreign” by an individual’s immune system. A personalized vaccine, therefore, targets these neoantigens, “educating” the immune system to find and kill the tumor. By including empirically confirmed neoantigens to which patients have pre-existing responses, we create personalized cancer vaccines to which patients’ immune systems are already primed.
On September 17, 2020, preliminary results of a pilot trial of GEN-009, a neoantigen vaccine containing immunogenic tumor-specific neoantigens, in combination with PD-1 inhibitors in advanced cancers, were presented. The results build on the Part B findings shared previously, which evaluated the preliminary immunogenicity and efficacy of GEN-009 in combination with standard-of-care checkpoint inhibitor-based regimens (CPI) in an initial cohort of five patients with advanced solid tumors. All five patients received GEN-009 approximately four months following the start of CPI treatment.
New follow-up scans, ranging from 91-233 days post-vaccination, confirm the previously disclosed findings, with tumor reduction or stable outcomes for all five patients, including three RECIST-criteria changes in tumor size (2 PR, 1 CR) after vaccination and likely attributable to GEN-009. The new results suggest that GEN-009 vaccination could be used in conjunction with CPI-based therapies to augment their effects. In addition, 100 percent of patients had neoantigen-specific responses elicited by vaccination, in some cases with evidence of epitope spread. No significant adverse side effects were reported, with only mild symptoms associated with the vaccine adjuvant.
On November 9, 2020, Thomas Davis, M.D., CMO of Genocea, stated in a press release, “Augmenting the breadth of an immune response against relevant cancer-specific targets through GEN-009 can deepen CPI response in patients with advanced disease."
Genocea’s mission is to identify the right tumor targets to develop life-changing immunotherapies for people who have cancer. The proprietary ATLAS™ platform comprehensively profiles each patient’s T cell responses to potential targets, or antigens, on that patient’s tumor. To learn more, please visit www.genocea.com.
GEN-009 Vaccine Indication
GEN-009 is indicated to treat solid cancer tumors.
GEN-009 Vaccine Dosage
GEN-009 is administered by subcutaneous injection.
GEN-009 Vaccine News
April 29, 2021 - Genocea Biosciences, Inc. provided a business update for the first quarter ended March 31, 2021. The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the American Society of Clinical Oncology (“ASCO”) 2021 Annual Meeting from June 4 - June 8, 2021.
November 9, 2020 - In follow up to data shared at the European Society for Medical Oncology Virtual Congress 2020, the company shared expanded clinical and immunogenicity findings from Part B of its ongoing GEN-009 Phase 1/2a trial, which evaluates GEN-009, Genocea’s neoantigen vaccine, in combination with PD-1 inhibitors in advanced cancers. Of the nine CPI-sensitive patients, three patients experienced a novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including 2 PRs and 1 CR. Five additional CPI-sensitive patients have shown disease control post-vaccination for up to 11 months. Five of seven patients appear to have stabilized disease within the CPI-resistant population lasting up to seven months. GEN-009 elicited strong anti-tumor immune responses with CD4+ and CD8+ T cell responses observed at day 50 post-vaccination and peak ex vivo responses occurring on Day 92. Early data from two patients tested so far show a complete absence of circulating tumor DNA by day 50, consistent with a vaccine clinical effect. There was also emerging evidence of epitope spreading in patients who successfully responded to therapy. GEN-009 was safe and well-tolerated.
September 17, 2020 - Genocea Biosciences presented additional clinical response and immunogenicity data from the first five patients vaccinated in Part B of the ongoing GEN-009 Phase 1/2a trial at the European Society for Medical Oncology Virtual Congress 2020.
July 30, 2020 - Genocea Biosciences announced it would present initial clinical data today on the first 5 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, in advanced solid tumors.
June 3, 2019 - Post-vaccination T cell responses detected to 91% of vaccine neoantigens, including CD8+ T cell responses to 53% of vaccine neoantigens.
GEN-009 Vaccine Clinical Trials
Clinical Trial NCT03633110: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine. GEN-009 is currently in a Phase 1/2a clinical trial (GEN-009-101) that consists of two parts: Part A: A study of the safety and immunogenicity of GEN-009 as monotherapy in certain solid tumors cancer patients with no evidence of disease. Patient enrollment in this part of the study is complete; Part B: A study of the safety, immunogenicity, and preliminary antitumor activity of GEN-009 in adult patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head, and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma.