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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, we formulate a personalized vaccine, composed of synthetic long peptides paired with the adjuvant Poly-ICLC, which we then ship 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 three parts:

  • A study of the safety and immunogenicity of GEN-009 as monotherapy in cancer patients with no evidence of disease.

  • A study of the safety, immunogenicity, and efficacy of GEN-009 in combination with an FDA-approved immune checkpoint inhibitor in patients with advanced or metastatic solid tumors.

  • A study of the safety, immunogenicity, and efficacy of GEN-009 as monotherapy in patients with relapsed or refractory solid tumors who have failed to respond to or whose cancer has progressed after treatment with an immune checkpoint inhibitor.

The first part of the GEN-009-101 clinical trial is currently recruiting. Eligible patients will have completed their treatment (e.g. Surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy) for cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), or urothelial carcinoma and show no evidence of disease by CT or MRI. For more information on this clinical trial, please visit here.


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