Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
January 3, 2019

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

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.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

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.”

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU