Imugene Limited (ASX:IMU, OTC:IUGNF) has welcomed the dosing schedule for the third monotherapy cohort of its phase-1 trial of the immunotherapy PD1-Vaxx on three patients.
Barring any unforeseen clinical observations, the optimal biological dose of 100µg is expected to be ratified at the next Cohort Review Committee (CRC), poised for the first week of October.
Clinical results continue to indicate that PD1-Vaxx is showing early signs of an immune response in patients, with antibodies to the target biomarker PD-1 evident in validated assays.
Completion "will be a milestone"
IMU managing director and CEO Leslie Chong said: “Phase-1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development.
“The completion of the monotherapy component of our phase-1 trial will be a milestone for Imugene and clinicians treating Australians faced with the challenges of lung cancer.”
To determine optimal biological dose
The first-in-human, phase-1, multi-centre, dose-escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer.
Medical investigators are testing three different doses of PD1-Vaxx with the primary goal being to determine safety and an optimal biological dose as a monotherapy (mOBD).
Efficacy, tolerability and immune response will also be measured.
Determination of mOBD will be made by the CRC and requires successive dosing within cohorts of at least three patients each.
Designed to treat tumours
Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction.
This then ultimately produces an anti-cancer effect similar to Keytruda®, Opdivo® and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.