- Imugene has received first ethics approval in the US to start PD1-Vaxx’s Phase I trial.
- The approval has been granted to Hackensack University Medical Center, based in New Jersey USA.
- Imugene has planned to proceed with the site activation and patient recruitment following the receipt of FDA IND clearance, scheduled for Q4 2020.
- The Phase I trial of PD1-Vaxx is planned to start in 2H 2020.
Australia-based immuno-oncology company Imugene Limited (ASX:IMU) has recently marked a great leap forward by attaining the first ethics approval in the US to kick-start Phase I trial of new cancer immunotherapy, PD1-Vaxx. The approval has been received from the Western Institutional Review Board (WIRB).
Recently, Imugene received three ethics approval from the Human Research Ethics Committee to initiate PD1-Vaxx’s Phase I trial in Australia. Three hospitals, including Chris O’Brien Lifehouse, Macquarie University and Cabrini Hospital attained the approvals. The approvals validated that Imugene has completed all the required pre-clinical efficacy and safety testing of PD1-Vaxx necessary to start the human clinical trials.
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Additional Details on Ethics Approval
New Jersey-based Hackensack University Medical Centre is the first US hospital to receive WIRB ethics approval for initiating PD1-Vaxx’s Phase I trial. Imugene notified that further US clinical sites will also be opened at the Ohio State University Medical Center in Columbus, Ohio and the Mayo Clinic in Phoenix, Arizona.
Moreover, Imugene informed that the US component of the Phase I trial will be carried out under the US FDA’s IND (Investigational New Drug) process. The Company has planned to proceed with the site activation and patient recruitment following the receipt of FDA IND clearance, scheduled for Q4 2020.
Know About PD1-Vaxx’s Phase-1 Trial
Imugene’s PD1-Vaxx is a B-cell immunotherapy, peptide cancer vaccine designed to treat tumours like lung cancer by interfering with PD-L1/PD-1 interaction and binding. It aims to produce an anti-cancer effect similar to Opdivo®, Keytruda® and the other immune checkpoint inhibitor (ICI) monoclonal antibodies, which are revolutionising the treatment of multiple cancers.
Imugene is aiming to develop an anti-PD-1 immunotherapy for the treatment of patients suffering from lung cancers that overexpress the ligand of PD1, PD-L1/2. As per Imugene, the therapies with monoclonal antibodies targeting PD-1 and its ligands (PD-L1 and PD-L2) are associated with significant response rates in multiple cancers and have transformed the cancer treatment.
Imugene’s current PD1-Vaxx trial is targeting the most common type of lung cancer, non-small cell lung cancer (NSCLC), accounting for around 80 per cent of cases. Under the Phase I Non-Small Cell Lung Cancer Study, PD1-Vaxx will be testing three distinct doses to determine:
- Immunological data, and
- Recommended Phase 2 dose for the expansion stage of the study.
These doses will be tested both as a monotherapy and along with immune checkpoint inhibitor drugs. Planned to start in 2H 2020, the Phase I trial will be carried out at up to six to ten sites in North America and Australia under the US FDA IND application.
Below is the study design of PD1-Vaxx Phase I trial:
PD1-Vaxx, Imugene’s B-cell checkpoint inhibiting vaccine, is in advanced stages of beginning a Phase I clinical study in lung cancer. Imugene expects opening this remarkable study in Australia imminently.
IMU traded at $0.050 on 8th September 2020.