Immuno-oncology company Imugene (ASX: IMU) received a timely regulatory boost courtesy of a second Human Research Ethics Committee (HREC) approval to commence a Phase I clinical trial of its checkpoint immunotherapy candidate PD1-Vaxx in Australia.
The news comes just three days after the company announced the receipt of its first HREC approval for a Phase I trial, to be conducted at comprehensive cancer hospital Chris O’Brien Lifehouse in Sydney.
The second hospital to receive ethics approval is the Macquarie University hospital, also in Sydney. Imugene said additional clinical sites will soon be opened in Australia as well as in the United States following the company’s recent Food and Drug Administration investigational new drug submission.
The grant means Imugene has successfully passed ethics approval and confirms the company has completed all outstanding preclinical safety and efficacy testing of PD1-Vaxx to commence human clinical trials.
The Australian component of the Phase I trial will be conducted under Australia’s Clinical Trials Notification Scheme, meaning Imugene must notify the Therapeutic Goods Administration of HREC approval and complete local site initiation activities.
Imugene said it expects to commence patient screening in August this year.
According to the company, the Phase 1 multi-centre, dose-escalation study of PD1-Vaxx will involve 32 patients with non-small cell lung cancer with medical investigators planning to test different doses of PD1-Vaxx as a monotherapy and in combination with immune checkpoint inhibitor drugs.
Lung cancer diagnoses
In its most recent report, the Australian Lung Foundation estimated around 12,800 Australians are diagnosed with lung cancer each year.
In the US, experts estimate 1 in 16 people will be diagnosed with lung cancer in their lifetime. Around 225,000 people are diagnosed with lung cancer in the US every year, with a new diagnosis every 2.3 minutes.
The oncology company said its PD1-Vaxx candidate is a B-cell cancer immunotherapy designed to treat tumours such as lung cancer by interfering with the so-called “PD-1/PD-L1 binding and interaction”, and producing an anti-cancer effect similar to humanised antibody Keytruda, Opdivo and various other immune checkpoint inhibitor monoclonal antibodies that are transforming cancer treatment.
According to Imugene managing director and chief executive officer Leslie Chong, the concept of teaching and inducing the body to generate its own antibodies targeting PD1 expressing cells represents a “paradigm shift in oncology” and is a novel treatment method for cancer.
The trial is designed to determine the safety profile of PD1-Vaxx including efficacy, tolerability and immune response, but also, to establish an optimal biological dose as a monotherapy and later, in combination with immune checkpoint inhibitors.
“The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of lung cancer. Receiving a second ethics approval so soon after our first is exciting,” Ms Chong said.
“We look forward to announcing further sites in Australia and US,” she added.