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.
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.
UPDATE: June 3, 2019, Post-vaccination T cell responses detected to 91% of vaccine neoantigens, including CD8+ T cell responses to 53% of vaccine neoantigen
Clinical Trial NCT03633110: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine