Vaccine Info

GEN-009 Cancer Vaccine

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.

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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, 2019Post-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 NCT03633110Safety, 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.