Imugene (ASX:IMU) ticks off key clinical milestones in June 2022 quarter

Highlights

• Imugene Limited (ASX:IMU) ended June 2022 quarter on a high note marking remarkable progress on its various clinical programs.
• Imugene received positive final overall results for HER‐Vaxx from the HERIZON study, a Randomized Phase 2 Trial in advanced gastric cancer.
• The company won HREC approval to begin a Phase 2 clinical trial of HER‐Vaxx in combination with pembrolizumab.
• Imugene reported a cash balance of AU$99.9 million at the end of the quarter.

Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) has released its quarterly activities and cash flow report for the quarter ended 30 June 2022. The report reflects how the company is treading the path to success across all facets of the business.

During the quarter, the ASX-listed company ramped up its clinical programs, enriched product pipeline, strengthened operations and delivered on various commercial goals.

Here’s a quick look at some of the key developments in the June 2022 quarter.

HER‐Vaxx

Imugene received positive final overall survival data from its Phase 2 study of HER‐Vaxx in HER‐2/Neu overexpressing advanced/metastatic gastric/GEJ cancer after a randomised clinical HERIZON study.  The report stated that there was a 41.5% survival benefit for patients treated with HER‐Vaxx as well as standard of care (SOC) chemotherapy versus SOC chemotherapy alone. An overall survival HR of 0.585 was obtained with a p‐value of 0.066. The results also suggested that HER‐Vaxx does not add toxicity to SOC chemotherapy.

The longest HER‐Vaxx treated patients usually remain alive for 2.5 years; however, there is one patient who has been alive for almost 3 years now. All the patients have showed the strongest anti‐HER‐2 antibody levels from their dosing schedule on HER‐Vaxx.  

Also, HERIZON‐extension Cohort Review Committee (CRC) confirmed HER‐Vaxx at 100μg to be safe for use in the nextHERIZON (pretreated metastatic HER2 positive gastric cancer) study with no dose‐limiting toxicities (DLTs) and no serious adverse reactions. It is likely that HER‐Vaxx (100μg) will boost the production of antibodies in patients which will further bring about better clinical response for HER‐Vaxx.  

CHECKvacc
Imugene and City of Hope® have administered the first dose on a cohort 2 patient in the Phase I clinical trial of oncolytic virotherapy candidate, CHECKvacc.  

The first‐in‐human, Phase 1, single‐centre, dose escalation study of CHECKvacc is recruiting patients with TNBC (triple negative breast cancer). The study is being conducted to analyse the safety and initial evidence of the efficacy of intra‐tumoral administration of CF33‐hNIS‐antiPDL1 (a unique chimeric orthopoxvirus) against metastatic TNBC.  

Oncolytic Virotherapy CF33

In the Phase 1 clinical trial estimating the safety of cancer‐killing virus CF33‐ hNIS VAXINIA, Imugene dosed the first patient having advanced solid tumour.

The multicenter Phase 1 trial will first deliver a low dose of CF33‐hNIS to cancer patients having metastatic/advanced solid tumours who have had at least two prior lines of SOC treatment. The investigational treatment will be provided as an injection, either directly into tumours or intravenously.  

Crucial appointments
Imugene bolstered its Scientific Advisory Board (SAB) with the appointment of Dr. Yanghee Woo, who is MD, FACS, Surgical Oncologist and Associate Professor of Surgery, City of Hope. A renowned surgeon‐scientist, Dr. Woo holds immense clinical experience and expertise in gastric cancer and robotic surgery.

Post the June quarter, Mike Tonroe was appointed as Chief Financial Officer and Dr Sharon Yavrom as Executive Director, Clinical Scientist to the management team.

Image Source: ©2022 Kalkine Media®

Other key developments of the June quarter:

• In May 2022, Imugene was granted approval from Human Research Ethics Committee (HREC) to start Phase 2 clinical trial of its immunotherapy candidate, HER‐Vaxx, in Australia.
• Imugene has completed and delivered a batch of HER‐Vaxx for use in all planned clinical trials (neoHERIZON and nextHERIZON) in patients with HER‐2 positive gastric cancer.
• Imugene presented abstracts on its CHECK‐Vacc and PD1‐Vaxx programs at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting, held in June in Chicago. The publication on CHECKVacc elaborated the company’s Phase 1 trial in adults having triple negative breast cancer, while the PD1‐Vaxx abstract talked about its Phase 1 IMPRINTER trial results in patients having non‐small cell lung cancer.