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Summary
- Imugene has received a second human research ethics approval to kickstart its Phase I clinical trial of PD1- Vaxx in Australia.
- While the second ethics approval has been received by Sydney-based Macquarie University, Chris O’Brien Lifehouse attained the first one.
- The latest ethics approval presents a second independent review of PD1-Vaxx pre-clinical safety and efficacy data.
- Imugene has planned to commence patient screening for PD1-Vaxx Phase 1 trial in August this year.
Clinical stage immuno-oncology firm based in Australia, Imugene Limited (ASX:IMU) has received a second human research ethics approval from the Sydney-based Macquarie University Human Research Ethics Committee (HREC) to kickstart Phase I clinical trial of PD1-Vaxx in Australia.
Following the key update, Imugene’s stock is trading 8.3 per cent higher at $0.039 as at 12:24 PM AEST.
PD1-Vaxx is the Company’s anti-cancer immunotherapy designed to treat tumors 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 treatment of a range of cancers.
Source: Company’s Wholesale Investor Presentation (July 2020)
Key Details of Ethics Approval
The ethics approval has been received by Macquarie University hospital situated in Sydney, which is the second Australian hospital to attain it post Chris O’Brien Lifehouse. Imugene notified that additional clinical sites will also be opened in Australia and the United States subsequent to submission of investigational new drug (IND) application to the Food and Drug Administration (FDA).
The latest ethics approval presents a second independent review of PD1-Vaxx pre-clinical safety and efficacy data. In other words, the approval is a confirmation that the Company has completed all the crucial pre-clinical safety and efficacy testing of PD1-Vaxx necessary to begin human clinical trials.
Imugene will undertake the Australian component of the PD1-Vaxx Phase I trial under Australia’s Clinical Trials Notification (CTN) Scheme, implying the Company will notify the Therapeutic Goods Administration (TGA) of ethics approval and finalise local site initiation activities.
According to Imugene’s Managing Director and Chief Executive OfficerLeslie Chong, the initiation of Australian study is a remarkable milestone for the Company and clinicians treating Australians suffering from lung cancer.
PD1- Vaxx Phase 1 Trial on the Horizon
Source: Company’s Wholesale Investor Presentation (July 2020)
Imugene has planned to initiate the first-in-human, Phase 1, multi-centre, dose escalation study of PD1-Vaxx this year, which will involve patients with non-small cell lung cancer expressing PD-L1. As per the Australian Lung Foundation, around 12,800 Australians are detected with lung cancer every year.
Under the trial, medical investigators will test separate doses of PD1-Vaxx as a monotherapy and subsequently in combination with immune checkpoint inhibitor drugs.
While the primary aim of the Phase 1 trial is to determine safety and an optimal biological dose as a monotherapy and later alongside immune checkpoint inhibitors in combination, the clinical trial will also assess efficacy, tolerability and immune response.
Imugene has planned to commence patient screening for PD1-Vaxx Phase 1 trial in August this year.
Way Ahead
Source: Company’s Wholesale Investor Presentation (July 2020)
