Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) has received US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to initiate a phase-1 clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx in the USA.
The approval allows Imugene to initiate patient recruitment and dosing in its USA phase-1 clinical study in non-small cell lung cancer (NSCLC) patients.
Hackensack University Medical Center in New Jersey is the first hospital in the USA to begin patient dosing.
Additional USA clinical sites will be opened subsequently at the Mayo Clinic in Phoenix, Arizona, and Ohio State University Medical Center.
The primary aim of the phase-1 trial is to determine safety and determine optimal biological dose as a monotherapy as well as to measure efficacy and immune response.
“Crucial step forward”
Managing director and CEO Leslie Chong said: “Receiving our IND approval for PD1-Vaxx from the FDA is a crucial step forward for Imugene.
“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.”
September quarter highlights
The company enjoyed a productive September quarter and is well-funded to pursue commercial and clinical milestones.
Quarterly research and development expenditure wasA$4.2 million and the company continues to monitor expenditure carefully ahead of the four clinical trials and associated expenditure planned for the remainder of 2020
Imugene had A$26.6 million in cash and cash equivalents on hand as of September 30, 2020.