- Imugene Limited (ASX:IMU) has dosed its first patient in PD1-Vaxx Phase 1 trial in Melbourne.
- An optimal biological dose as a monotherapy will be determined after review by Imugene’s Cohort Review Committee.
- Imugene intends to bring new options and treatments for lung cancer, which accounts for a major health burden in Australia.
Shares of Imugene Limited (ASX:IMU) marked an uptick of about 8% to $0.13 on 1 December 2020 post a significant update on its B-cell cancer immunotherapy, PD1-Vaxx. Interestingly, Imugene has announced the dosing of its first patient in Phase 1 clinical trial of PD1-Vaxx in Melbourne.
The first patient has been dosed following the receipt of three ethics approvals in Q3 2020 to initiate the Phase 1 clinical trial of PD1-Vaxx in Australia. The three approvals were provided to Sydney-based Macquarie University and Chris O’Brien Lifehouse, together with Cabrini Hospital in Melbourne.
Significantly, the Company has also obtained FDA IND approval to initiate PD1-Vaxx’s Phase 1 Trial in the US. The FDA approval has placed Imugene in good stead to start patient dosing in Phase 1 clinical study in the US in lung cancer patients.
Imugene is actively recruiting patients with NSCLC (non-small cell lung cancer) in its first-in-human, multi-centre, Phase 1, dose-escalation study of PD1-Vaxx. Three different doses of PD1-Vaxx will be tested by medical investigators under the continuing trial.
The Phase 1 study of PD1-Vaxx is targeted at determining safety and an optimal biological dose as a monotherapy (mOBD), besides measuring tolerability, efficacy and immune response.
Determination of mOBD
Imugene informed that an optimal biological dose as a monotherapy will be determined after CRC’s (Cohort Review Committee) review and requires dosing in succession within cohorts of minimum 3 patients each.
Importantly, Imugene’s PD1-Vaxx CRC is co-chaired by an independent clinical immunologist and the Company’s CMO, Dr Rita Laeufle, and comprises all study investigators. The committee will meet to assess tolerability and safety data post the last patient in every cohort has concluded 30 days of treatment.
The approval to enrol lung cancer patients to the next dose level will be given if the committee confirms a particular dose as tolerable and safe. It is worth noting that the highest dose level delivering the best immune response will become the mOBD.
Promising Opportunities in Lung Cancer Market
According to the Australian Lung Foundation, about 12,800 Australians get diagnosed with lung cancer disease each year in Australia. As per the research foundation’s 2019 Impact report, about 12,817 Aussies were diagnosed with lung cancer in 2019, which was about 35 people a day.
Lung Foundation Australia’s Impact Report states that the economic burden of lung cancer for diagnosed patients has been estimated at $297.2 million. Australian dies every hour from lung cancer. Unfortunately, this type of cancer has one of the lowest survival rates of any cancer in Australia, with just 17% of Aussies surviving 5 years after diagnosis.
Tapping the promising market opportunity, Imugene is evaluating the safety, tolerability, and immunogenicity of IMU-201 (PD1-Vaxx) as monotherapy and in combination with Standard of Care (SOC) treatment in participants with PD-L1 expressing NSCLC. The Company seems passionate about bringing new options and treatments for lung cancer, which accounts for a major health burden in Australia.