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Australian-headquartered clinical stage immuno-oncology firm, Imugene Limited (ASX:IMU) is actively implementing risk mitigation and business continuity strategies amidst the global COVID-19 pandemic to continue with its planned activities. The Company is in close cooperation with its clinical operations partners to make sure the needs of its clinical trials are met whilst ensuring the safety and well-being of its patients.
Notably, Imugene is rapidly progressing towards the development of its B-Cell immunotherapies and oncolytic virotherapy (CF33), designed to treat a range of cancers in conjunction with emerging immunotherapies and standard of care medications.
The products in the Company’s deep product pipeline comprise CHECKvacc (CF33 & PDL1), VAXinia (CF33), PD1-Vaxx and HER-Vaxx (HER-2). The Company is on track to undertake four clinical trials in 2020 to foster the development of these products:'
HER-Vaxx in Phase 2 Development Stage
The B-cell immunotherapy, HER-Vaxx is the most advanced product in Imugene’s pipeline, which is currently under development for the treatment of HER2-positive gastric cancer.
The Company has successfully completed HER-Vaxx’s Phase 1b trials, that demonstrated a potent polyclonal response to HER2/Neu, a readily identifiable cancer target. The preliminary immunology and clinical response data from Phase 1b trials was encouraging and was published and presented across various cancer conferences around the world, including AACR, ASCO GI, ASCO, ESMO GI, ESMO and ESMO Asia 2019.
At present, the Company is enrolling into the open label Phase 2 study and waiting on patients to progress to review the provisional safety data. The Company notified that the Independent Data Monitoring Committee (IDMC) will review this data. The HER-Vaxx Phase 2 IDMC roster comprises a veteran IDMC chair with immuno-oncology experience, bio-statistician and gastric-oncologist.
Also Read! A Smash Hit by Imugene: Received Core US Patent for HER-Vaxx
Phase 1 Trial of PD1-Vaxx to Commence Soon
Imugene will be progressing with the Phase 1 trial of its anti-PD-1 B-Cell immunotherapy, PD1-Vaxx this year. The B-Cell immunotherapy cancer vaccine, PD1-Vaxx has been designed to fight cancerous tumours in the lung, in a similar way and effect as other market transforming immuno-oncology drugs like Keytruda® and Opdivo®.
The Company is about to begin with Phase 1 trial of PD1-Vaxx, targeted at non-small cell lung cancer, which is one of the most common forms of cancer accounting for 80 per cent of cases. The Company will be conducting the trial at up to 10 cancer research centres within Australia and the US.
The Phase 1 trial is aimed at testing 3 different doses to ascertain immunological data, safety and initial investigation of an ideal Phase 2 dose for the trial’s expansion stage.
Must Read! Imugene Announced Completion of GMP manufacturing and Toxicology Studies for PD1-Vaxx
Human trials for CF33’s Constructs to Begin Shortly
Acquired in November 2019, the chimeric vaccinia pox virus CF33 is a cancer fighting virus that recombines multiple strains of the vaccinia virus as well as other species of pox virus. It has significantly better cancer fighting qualities than a single strain virus.
Supported by the positive pre-clinical data, Imugene is in the stage of establishing Phase 1 human trials for CF33’s two constructs, CHECKvacc and VAXinia in 2020. Pre-clinical data has demonstrated that these constructs shrank injected and distant tumours, not directly targeted but in the metastatic spread.
Several indications, including lung cancer, TNBC, pancreatic cancer, colon cancer and ovarian cancer were targeted in pre-clinical study, and the results attained were more than encouraging. The outcomes showed superior replication and subsequent killing of cancerous cells along with an indication that they are more effective than other existing viruses used in the fight against cancer.
Interesting Read! Imugene Announces Completion of Clinical Grade GMP Batches by CF33 Oncolytic Virus Constructs
Key Details of Phase 1 Trials
The Phase 1 trials of the constructs will be undertaken at eminent cancer research centres in the US, including the City of Hope Cancer Center.
The current proposed patient population comprises those with triple negative breast cancer (TNBC), metastatic lung, bladder, GI, head, melanoma and neck, colorectal cancers resistant to standard therapy or for which there is no standard therapy for the first phase of the study.
The Phase 1 trial will also include a dose escalation to assess intravenous and intratumoural delivery. The aim of the Phase 1 trial is to:
- determine safety and obtain signals that may include effectiveness in multiple tumour types, and
- establish a maximum feasible dose for potential further combinations with immune checkpoint inhibitors as an indication to progress into Phase 2 clinical trials.
It is worth noting that Imugene is well positioned with enough capital to weather the medical, social and economic crisis amidst COVID-19 pandemic. Significantly, the Company’s strong financial health is matched by the incredible workflow from its scientists. With blue chip collaborations, IMU is eyeing potential of a synergistic relationship with Big Pharma.
IMU traded at $0.027 on 14 April 2020 (10:57 AM AEST).
Also Cast an Eye Over Imugene’s Impressive Achievements in 1H FY20
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