Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has received Cohort Review Committee (CRC) approval for the Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx and will proceed to the second dose cohort.
The CRC unanimously agreed that PD1-Vaxx is safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed after CRC review of all safety and tolerability data for the first 3 patients dosed with the lowest dose of PD1-Vaxx (10mcg) as monotherapy.
After the completion of the review meeting, the CRC advised Imugene to proceed with opening the second PD1-Vaxx Phase 1 cohort at the 50mcg mid-dose level.
“No observed toxicity”
Imugene MD & CEO Leslie Chong said “We are pleased with the results that we have seen so far with no observed toxicity.
“Everyone supporting the study who are involved in developing this important new cancer therapy is very encouraged by the progress to date.
“We look forward to continuing this study and reporting to the market of its progress.”
PD1-Vaxx as a monotherapy
Clinicians at study sites in Australia and USA will also determine if the administration of PD1-Vaxx as a monotherapy in patients who have progressed on standard of care immune checkpoint inhibitors will prolong survival, delay tumour progression, or reduce the tumour burden in patients with lung cancer.
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, and produce 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.
Phase I multi-centre study
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.
The primary goal of the Phase 1 trial is to determine the 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 Cohort Review Committee (CRC) and requires successive dosing within cohorts of at least 3 patients each.