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Imugene gets ethics approval to start Phase 1 clinical trial of immunotherapy candidate for lung cancer in the US

Last updated: 15:12 03 Sep 2020 AEST, First published: 15:30 03 Sep 2020 AEST

Imugene Ltd - Imugene gets ethical approval to start Phase 1 clinical trial of new non-small cell lung cancer immunotherapy candidate PD1-VAXX in the US
The first hospital in the US to receive ethics approval is the Hackensack University Medical Center in New Jersey

Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has received Western Institutional Review Board (WIRB) approval to commence a Phase I clinical trial of its checkpoint immunotherapy candidate, PD1- Vaxx in the US for non-small cell lung cancer.

The US component of the Phase I trial will be conducted under the Food and Drug Administration (FDA) investigational new drug (IND) process.

The clinical-stage immuno-oncology company said site activation and patient recruitment will proceed after FDA IND approval scheduled for the fourth quarter of 2020.

Paradigm shift

Imugene managing director and chief executive officer Leslie Chong said: “The start of our USA study is a significant milestone for Imugene and clinicians treating Americans faced with the challenge of lung cancer.

“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential.”

“The concept of teaching and inducing the body to generate its own antibodies targeting PD1 expressing cells represents a paradigm shift in oncology, and is a novel treatment method for cancer.”

First in-human trial

The first hospital in the US to receive WIRB ethics approval is the Hackensack University Medical Center in New Jersey.

Additional clinical sites will be opened at the Mayo Clinic in Phoenix Arizona and the Ohio State University Medical Center in Columbus, Ohio.

The first-in-human, Phase 1, multi-centre, dose-escalation study of PD1-Vaxx will enroll patients with non-small cell lung cancer.

Medical investigators will test different doses of PD1-Vaxx as a monotherapy and in combination with immune checkpoint inhibitor drugs.

The primary aim of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy and later in combination with immune checkpoint inhibitors.

Efficacy and immune response will also be measured.

Imugene with Proactive at ASX Small and Mid Cap Conference

Imugene Ltd (ASX:IMU, OTC:IUGNF) CEO and managing director Leslie Chong chats with Proactive's Jonathan Jackson live from the ASX Small and Mid Cap Conference in March 2024. The biotech stock is a clinical-stage immuno-oncology company that's developing a range of new and novel immunotherapies...

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