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We are developing a broad pipeline of precisely targeted cancer immunotherapy candidates. We are currently evaluating the safety, immunogenicity, and efficacy of our lead cancer vaccine candidate, GEN-009, in a Phase 1/2a clinical trial.

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Neoantigen Cancer Vaccine Program

There is growing excitement around personalized – or neoantigen – cancer vaccines as a way to offer new hope to millions of people suffering from cancer. 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. 

Our lead program, GEN-009, is a personalized cancer vaccine that uses our proprietary ATLAS platform to optimize target selection so that the vaccine has the best chance of targeting the right tumor mutations in each person. (Read more about our ATLAS platform here.) Once we identify the best neoantigens for a patient, a personalized vaccine, composed of synthetic long peptides paired with the adjuvant Poly-ICLC, is formulated and shipped to the clinical site. 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.

We are currently evaluating the safety, immunogenicity, and efficacy of GEN-009 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).

    • In addition, approximately 15 patients whose disease progresses during the screening period may be enrolled into a separate relapsed/refractory disease cohort.

Neoantigen adoptive t cell therapy program

ACT or “adoptive T cell therapy” involves the isolation and expansion of tumor- or neoantigen-specific T cells to create therapeutics targeting patients’ cancers. There are currently a variety of methods being used to develop ACTs, most of which involve genetic engineering of a patient’s T cells and delivering them back to the patient.

In our GEN-011 program, we are using ATLAS to identify patient-specific neoantigens that stimulate that patient’s immune system, and then isolating the T cells that are activated by those neoantigens. We can then expand these autologous (the patient’s own) T cells to create a therapeutic.

We believe that our first-in-class GEN-011 approach could provide a number of advantages over existing methodologies such as TIL (tumor infiltrating lymphocyte) therapy or TCR (T cell receptor) therapy, including:

  • Greater potential immunogenicity and efficacy by:

    • Including both CD4+ (helper) and CD8+ (killer) T cells identified through ATLAS

    • Excluding T cells’ “inhibitory” neoantigens

    • Including multiple antigen-specific T cells to broaden the anti-tumor effect and mitigate risk of tumor escape

  • Using a patient’s own non-engineered T cells could improve on safety and the speed and cost of manufacturing

We are currently conducting preclinical studies of GEN-011 with an aim of filing an IND to begin clinical study in the U.S. in the first half of 2020.


At Genocea, we use our ATLAS platform to develop transformative immunotherapies for people with cancer.

We continuously evaluate collaboration opportunity to maximize the value of our ATLAS and other programs, to harness outside capabilities and extend our geographic reach.

For partnering inquiries, please contact:
Sudhir Rao