GEN-009 Vaccine Description
Genocea's GEN-009 is an investigational, personalized adjuvanted vaccine, that is being developed for the treatment of 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 that are 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).
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 July 30, 2020, Genocea announced initial clinical data today on the first 5 patients from Part B of the ongoing Phase 1/2a study, which explores the combination of GEN-009 and checkpoint inhibitor-based regimens in advanced solid tumors.
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 continue to suggest 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.
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
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 will 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 tumor 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.
- Up to 15 patients in each disease cohort will be enrolled and will receive GEN-009 in combination with an approved PD-1 inhibitor therapy (nivolumab or pembrolizumab).
- Additionally, approximately 15 patients whose disease progresses during the screening period may be enrolled in a separate relapsed/refractory disease cohort.