Flick Through Imugene’s June 2020 Quarter Milestones

Summary

• Imugene made considerable progress in its deep product pipeline during June 2020 quarter, incurring an expenditure of $3.2 million.
• During the quarter, the Company presented two abstract presentations at AACR Annual Meeting, received IDMC confirmation over the safety of HER-Vaxx Phase 2 trial and announced the publishing of preclinical new mimotope cancer vaccine research in a prestigious journal.
• Post the reporting period, the Company received two HREC approvals to begin a Phase 1 clinical trial of PD1-Vaxx in Australia.
• With a cash balance of $30.1 million as at 30^th June 2020, Imugene said it is well-financed to back its commercial and clinical milestones.
• The Company estimates its total available funding to support for about 8.3 quarters.

Clinical stage immuno-oncology company, Imugene Limited (ASX:IMU) marked an uptick of ~22.6 per cent to $0.065 on ASX following the release of its solid June quarterly results on 27 July 2020. As at 11:50 AM AEST on 29 July 2020, IMU is trading at $0.057.

During the quarter, Imugene made considerable progress in its deep product pipeline, incurring an expenditure of $3.2 million.

The Company’s product pipeline broadly comprises four prospective drugs, including B-cell cancer immunotherapies: HER-Vaxx (HER-2), B-Vaxx (HER-2) and PD1-Vaxx (PD-1) and oncolytic viruses: CHECKvacc (CF33 & aPDL1) and VAXinia (CF33). While HER-Vaxx and B-Vaxx are under Phase 2 clinical development, the other three are poised to enter Phase 1 clinical trials.

Let us quickly gaze through the key developments reported by Imugene during June 2020 quarter:

Presented PD1-Vaxx and VAXinia’s Clinical Development Plan at the AACR Annual Meeting

Imugene attained acceptances for two abstract presentations presented at the American Association for Cancer Research (AACR) 2020 Annual Meeting in April this year. These presentations were originally accepted for the AACR Annual Meeting to be held in San Diego from 24^th 29^th April, which was later rescheduled as a virtual event due to COVID-19 pandemic.

Presented by Dr Seymour Fein, consultant Medical Director to Imugene, the first abstract presentation discussed VAXinia’s (CF33-hNIS) clinical development plan.

The Company has planned to undertake a first-in-human, phase 1, multi-site, dose escalation study of VAXinia, which will investigate intratumoural and intravenous administration lines as monotherapy and in combination with immune checkpoint inhibitors (ICIs) in a proposed patient population. The tumour types eligible for this study include metastatic melanoma, head and neck, gastric, lung, TNBC, bladder, colorectal and renal cell cancers.

On the other hand, Dr Anthony Good, the Company’s Vice President of Clinical Research, presented second abstract presentation that discussed PD1-Vaxx clinical development plan.

The Company is in the process of undertaking the first-in-human, phase 1, dose escalation study of PD1-Vaxx, which is targeting patients with non-small cell lung cancer and will be examining various doses of PD1-Vaxx as monotherapy and in combination with ICIs.

Received IDMC Confirmation Over Safety of HER-Vaxx Phase 2 Study

In May this year, the Independent Data Monitoring Committee or IDMC confirmed HER-Vaxx safety and recommended continuation of its Phase 2 study without modification.

The validation from IDMC encouraged Imugene to continue with its HER-Vaxx Phase 2 study, which has been designed to evaluate the efficacy, safety and immune response in 68 patients with metastatic gastric cancer over-expressing the HER-2/neu receptor.

Imugene also reported during the quarter that the patients receiving B-cell immunotherapy HER-Vaxx were responding positively. The Company’s HER-Vaxx continues to enrol patients under the open label Phase 2 study and is waiting on patients to proceed to review the second interim analysis. Consequently, the IDMC will review this data.

Announced Publishing of Preclinical New Mimotope Cancer Vaccine Research in Prestigious Journal

On 28^th May 2020, Imugene notified that preclinical research in relation to its mimotope vaccines targeting ICIs has been accepted and published in the prestigious journal “Frontiers in Immunology”.

Conducted under the leadership of Imugene’s Scientific Advisory Board member Professor Dr Ursula Wiedermann with Dr Joshua Tobias as lead author, the ground-breaking research from Vienna identified that mimotope peptides when incorporated into the Company’s exclusive immunotherapeutic vaccine delivery platform, produce antibodies that bind particularly to immune cells expressing the PD1 biomarker.

These naturally produced antibodies prevent a protective mechanism on cancer cells, allowing the immune system to destroy those cancer cells, akin to animal models of breast cancer.

Subsequent to the quarter, Imugene also attained two Human Research Ethics Committee (HREC) approvals to begin a Phase 1 clinical trial of PD1-Vaxx in Australia. The first approval was given to Chris O’Brien Lifehouse, a comprehensive cancer hospital based in Sydney, while Macquarie University received the second approval.

Financial Update

Imugene informed that its listed IMUOA options exercisable at $0.026 per option are presently in the money, with IMU shares having closed at $0.053 per share on 23^rd July 2020 (which is over double the exercise price). The Company mentioned that the expiry date for the IMUOA option holders is 30^th November 2020, which is the last date to exercise these options.

With a cash balance of $30.1 million as at 30^th June 2020, Imugene stated that it is well-financed to back its commercial and clinical milestones. While the Company expects a rise in expenditure as it progresses with its four clinical programs, it estimates its total available funding to support for around 8.3 quarters.