Genocea Biosciences has dosed the first patients in its Phase I/IIa clinical trial evaluating the safety, immunogenicity, and clinical efficacy of GEN-009 for the treatment of cancer.
Part A of the three-part trial is designed to investigate the safety and immunogenicity of GEN-009 as monotherapy in cancer patients who have no evidence of disease but are at high risk of relapse.
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The first part of the trial saw Genocea enrol nine patients who earlier received treatments for melanoma, non-small cell lung cancer, head and neck cancer, or urothelial carcinoma.
Once immunogenicity data is achieved from these patients, Genocea plans to commence Parts B and C of the Phase I/IIa trial.
Part B is expected to see GEN-009 evaluated in combination with checkpoint inhibitors in patients with advanced or metastatic solid tumours.
Part C will involve patients whose disease has progressed in spite of checkpoint inhibitor therapy.
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By GlobalDataGenocea Biosciences chief medical officer Dr Tom Davissaid: “Importantly, our GEN-009 vaccines use our ATLAS platform for neoantigen identification.
“Unlike machine-based approaches that predict neoantigens and only evaluate the patient’s tumour, ATLAS also uses each patient’s own immune cells not only to identify true neoantigens that already trigger anti-tumour cytokine responses, but also to eliminate inhibitory antigens that are frequently selected for vaccine inclusion by such in silico approaches.”
Dr Davis further added: “With Part A of the trial now fully enrolled, we are in a better position to predict when we will have the first immunogenicity data from these patients.
“As a result, we are updating our guidance today and look forward to reporting top-line results from this part of the study late in the second quarter of this year or early in the third quarter.”
