Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) has completed enrolment of the first cohort of patients in a Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx.
The clinical-stage immune-oncology company has enrolled the first three patients in the first low dose PD1-Vaxx cohort with non-small cell lung cancer.
Significant milestone
Imugene managing director and chief executive officer Leslie Chong said: “The start of our study with first patient dosed in Australia just 18 days ago was a significant milestone for Imugene and clinicians treating Australians faced with the challenge of lung cancer.
“I’m encouraged by the speed at which our Australian hospitals have recruited the first cohort of patients.”
Three different doses of PD1-Vaxx to be tested
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 will test three different doses of PD1-Vaxx.
The primary goal of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy (mOBD).
Efficacy, tolerability and immune response will also be measured.
Determination of mOBD
Determination of mOBD will be made by the Cohort Review Committee (CRC) review and requires successive dosing within cohorts of at least three patients each.
The CRC will meet to review safety and tolerability data after the last patient in a cohort has completed 30 days of treatment.
If the CRC confirms the dose in the cohorts as safe and tolerable, then approval will be given to enrol patients to the next higher dose level.
The highest safe dose level with the best immune response becomes the mOBD.
B-cell activating cancer immunotherapy
PD1-Vaxx is a B-cell activating cancer immunotherapy designed to treat tumours such as lung cancer.
It interferes with PD-1/PD-L1 binding and interaction and produces 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.