Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) has notched up a key milestone with dosing of the first patient in cohort-2 in the phase-I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx.
The first patient in the mid-dose (50µg) cohort-2 was dosed at the Hackensack University Medical Center in New Jersey, USA, and the first-in-human, Phase-I multi-centre dose escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer.
Medical investigators will test three different doses of PD1-Vaxx.
The primary aim of the phase-I trial is to determine safety and an optimal biological dose as a monotherapy (mOBD).
Efficacy, tolerability and immune response will also be measured.
“Significant milestone”
Managing director and CEO Leslie Chong said: “The start of our FDA IND approved clinical trial formally in the USA, the largest pharmaceutical market globally, is a significant milestone for Imugene.”
Shares have been as much as 10% higher this morning to A$0.11 while the company's market cap is approximately $466.3 million.
Imugene’s PD1-Vaxx is a B-cell cancer immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction, and produce an anti-cancer effect similar to Keytruda®, Opdivo® and the other immune checkpoint inhibitor monoclonal antibodies that are transforming treatment of a range of cancers.