Imugene doses first patient in Phase 1 clinical trial of checkpoint immunotherapy candidate PD1-Vaxx for lung cancer
Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF), a clinical-stage immuno-oncology company, has dosed the first patient in a Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx, in Melbourne, Australia. The first-in-human, Phase 1, multi-centre, dose-escalation study of PD1-Vaxx is recruiting patients 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 is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of lung cancer. “Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential. “The concept of teaching and inducing the body to generate its own antibodies targeting PD-1 expressing cells represents a paradigm shift in oncology and is a novel treatment method for cancer.” Imugene’s market cap is approximately A$539 million and shares today have been as much as 9% higher to A$0.13 after hitting a new 11-year high of A$0.14 on November 24 and 25. Phase 1 trial Medical investigators will test three different doses of PD1-Vaxx. The primary aim 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 Cohort Review Committee (CRC) review and requires successive dosing within cohorts of at least three patients each. Imugene’s PD1-Vaxx CRC consists of all study investigators and is co-chaired by an independent clinical immunologist and the company’s chief medical officer, Dr Rita Laeufle. The CRC will meet to review safety and tolerability data after the last patient in each cohort has completed 30 days of treatment. If the CRC confirms a particular dose as safe and tolerable, then approval is given to enrol patients to the next dose level. The highest dose level with the best immune response becomes the mOBD. Transforming treatment of cancer The Australian Lung Foundation estimates 12,800 Australians are diagnosed with lung cancer each year. 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 the treatment of a range of cancers.