Genocea doses first patients in Phase I/IIa trial of GEN-009

3rd January 2019 (Last Updated January 3rd, 2019 00:00)

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.

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.

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.

"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."

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.

Genocea 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.”