Imugene winds up September quarter with a string of developments in multiple clinical trials - Kalkine Media

Highlights

• Imugene Limited has released its quarterly report for the three-month period ended 30 September 2022.
• IMU dosed the first patient in its nextHERIZON Phase 2 clinical trial during the quarter.
• The company received the DIR licence from the Australian Government for the VAXINIA Phase 1 trial’s expansion in Australia.
• IMU has partnered with Arovella for a new preclinical trial combining Arovella’s iNKT cell therapy with Imugene's onCARlytics (CF33-CD19) platform.

Clinical-stage immuno-oncology company Imugene Limited (ASX:IMU) has released its quarterly report for the three-month period ended 30 September 2022. The quarter was marked by significant advancement in several clinical trials, successful capital raising, key appointments, and numerous commercial landmark achievements across all facets of the business.

Throughout the quarter, the company continued to be driven by its vision to help transform the lives of millions of cancer patients with improved and effective cancer treatment. To know about the key developments, keep reading!

IMU crossed critical milestones in multiple trials

• The first patient was dosed in the nextHERIZON Phase 2 clinical trial at the Queen Elizabeth Hospital in Adelaide during the quarter. The trial is being conducted to investigate the safety and response rate of IMU's immunotherapy candidate HER-Vaxx in combination with chemotherapy or pembrolizumab in patients having HER-2+ gastric cancer.
  
  In August, City of Hope® dosed the first patient in cohort 3 in the Phase I clinical trial of the oncolytic virotherapy candidate CHECKvacc (CF33-hNIS-antiPDL1). This is a first-in-human, Phase1, single-centre, dose-escalation study of CHECKvacc on patients diagnosed with triple-negative breast cancer (TNBC). The study’s objective is to evaluate the safety and initial evidence of the effectiveness of intratumourally delivered CF33-hNIS-antiPDL1 against metastatic TNBC. The trial design involves a dose escalation, followed by expansion to 12 patients at the final dose, which will be the recommended Phase 2 dose.

Image Source: Company Website

• In September, the Company's Phase 1 MAST (metastatic advanced solid tumour) study investigating the safety of CF33-hNIS (VAXINIA) reached critical milestones in the trial. The opening of cohort 2 for intratumoural (IT) administration followed the clearing of IT cohort 1, while intravenous (IV) cohort 1 (IV) opened in parallel. Also, the Cohort Review Committee (CRC) concluded that VAXINIA is safe, without any dose-limiting toxicities or any serious adverse reactions observed, and advised Imugene to open the second VAXINIA Phase 1 cohort at the mid-dose level following the completion of the review meeting.
  
  In addition, Imugene received the DIR licence from the Australian Government Office of the Gene Technology Regulator (OGTR) during the quarter to expand the trial within Australia. The licence titled 'Clinical trial of a genetically modified (GM) chimeric orthopoxvirus (CF33-hNIS) as a cancer treatment', is essential as part of the national regulatory framework for dealings involving the intentional release of genetically modified organisms into the environment.
• In September, Imugene and Arovella Therapeutics Ltd (ASX:ALA) signed a research agreement for a strategic collaboration to conduct a preclinical trial of ALA’s iNKT cell therapy (CAR19-iNKT) and IMU’s onCARlytics (CF33-CD19) platform to eliminate solid tumours. Imugene is evaluating a range of CD19-targeting therapies in combination with onCARlytics, in which Arovella's ALA-101 – the lead iNKT product of Arovella – will be included.

Image Source: Company Website

Miscellaneous developments contributing towards IMU’s success

• Data from non-small-cell lung cancer patients in the Phase 1 IMPRINTER trial was presented at the IASLC World Conference on Lung Cancer as a poster titled ‘Phase 1: IMU201 (PD1-Vaxx), a B-cell immunotherapy as monotherapy or in combination with atezolizumab, in adults with non-small cell lung cancer’.
• Imugene received firm commitments for an AU$80 million placement at AU$0.20 per share in September. The capital raised via the placement has paved an extended pathway for the company's diverse pipeline of clinical programs and corporate growth opportunities.
• Mike Tonroe was welcomed on board as Chief Financial Officer during the quarter. He holds immense experience in the biopharmaceutical industry as well as international finance leadership, having served in different roles, such as that of a company secretary and a CFO, at different organisations and in different regions, such as the United States, UK, Australia, Canada, and Hong Kong. Also, Imugene appointed Dr Jakob Dupont, an industry and drug development expert, as Non-Executive Director and Dr Sharon Yavrom as Executive Director, Clinical Scientist.

IMU’s shares were trading at AU$0.185 on the ASX on 9 November 2022.