Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) reports that the the Cohort Review Committee (CRC) has confirmed the Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx, will proceed to the second dose cohort.
The CRC unanimously agreed PD1-Vaxx to be 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 three patients dosed with lowest dose of PD1-Vaxx (10mcg) as monotherapy. At 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.
Principal Investigator Professor Gary Richardson from the Cabrini Hospital in Melbourne said, “The Cohort Review Committee for the study today reviewed the first low dose cohort of patient’s data and has recommended to proceed to the next dose escalation due to safety and tolerability.”
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 MD and CEO, Leslie Chong, said 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 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 three patients each.
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 are very encouraged by the progress to date. We look forward to continuing this study and reporting to the market of its progress,” Mr Chong said.
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.
