Cast an Eye Over Imugene’s Impressive Achievements in 1H FY20

Australian-headquartered clinical stage immuno-oncology firm, Imugene Limited (ASX:IMU) has released another set of robust operational results for the half-year ended 31^st December 2019. It was certainly a remarkable half-year for the biotech player, which observed significant developments across all the key products in its pipeline, including CF33 (CHECKVacc and Vaxinia constructs), HER-Vaxx and PD1-Vaxx.

Let’s gaze through the key operational activities reported by Imugene across its product pipeline during the half-year:

CF33 Set to Move into Phase 1 Clinical Trials

Marking a significant milestone, the Company finalised the acquisition of Vaxinia Pty Ltd, along with an exclusive license to a promising oncolytic virus technology, CF33 in November 2019. The oncolytic virus CF33 is a chimeric vaccinia poxvirus developed by Chair of Surgery, Professor Yuman Fong at City of Hope.

During the half-year, the Company’s management continued to focus on the clinical development of CF33, which has been developed in two different constructs: CHECKVacc (CF33-hNIS-antiPDL1) and Vaxinia (CF33-hNIS). hNIS or human iodide symporter is a gene present in both the constructs and enables tracking of virus and radioiodine therapy.

Vaxinia Phase 1/2 Trial

The Company intends to undertake a first in human Phase 1/2, nonrandomized, multi-centre, open-label, dose-escalating study interrogating intravenous (IV) and intratumoral (IT) administration routes of ‘Vaxinia’ CF33-hNIS study.

The potential indications may incorporate patients with melanoma, bladder, GI, metastatic lung, TNBC, colorectal tumours refractory to standard therapy or for which no standard therapy exists.

The key objectives of this trial include:

Determining safety and efficacy of CF33-NIS in multiple tumour types, and evaluating safety in line with CTCAE 5.0 criteria

The Company notified that the safety of CF33-hNIS will be measured by the assessment of the frequency, type and severity of adverse events, immunogenicity, physical examination and changes in clinical laboratory tests (chemistry and haematological), etc.

Establishing a maximum feasible dose for further potential combinations with immune checkpoint inhibitors (ICIs) to move to Phase 2 clinical trials

The clinical trial will include a dose escalation to assess intravenous and intratumoral administration to determine a maximum feasible dose, succeeded by a run in of combination of CF33-hNIS with ICI to ascertain recommended phase 2 dose.

The Phase 2 study is targeted to evaluate the viral kinetics of CF33-hNIS in multiples tumour types and to obtain therapeutic signal, for which it could enrol up to 100 patients.

Also Read Imugene Announces Completion of Clinical Grade GMP Batches by CF33 Oncolytic Virus Constructs

HER-Vaxx Phase 2 Clinical Trial Currently Underway

The Company’s management continued to monitor the data collection and enrolment for HER-Vaxx Phase 2 clinical trial during the half year, which included:

• working with oncologists on the study to ensure that eligible patients are enrolled,
• adding additional countries, and
• guiding the CRO or Contract Research Organisation to monitor the sites and data attentively.

The Company is targeting HER-2 positive gastric cancer patients in its ongoing clinical trial for HER-Vaxx as these patients have less access to the approved therapies. Moreover, gastric cancer is more severe than breast cancer, presenting a considerable market opportunity for HER-Vaxx immunotherapy.

The Company has already completed the Phase 1b stage of the study, identifying the optimal dose for the Phase 2 study. The Company has so far presented the Phase 1b study results of HER-Vaxx at:

The Company is planning to publish and/or present additional patient data from Phase 1b trial of HER-Vaxx at further international conferences in 2020.

The Company continues to gain numerous media attention and was featured in Life Science Leader magazine and the Pharma Letter in February 2020.

Moreover, the Company is progressing with the enrolment of metastatic gastric cancer patients overexpressing HER-2 under Phase 2 study, whose endpoints are progression-free survival, overall survival, immune response and safety.

Recently, the Company has been granted a Notice of Grant for Patent Application 15/316868 from the United States Patent and Trademark Office. The patent protects B-cell immunotherapy HER-Vaxx.

To Know More, Read A Smash Hit by Imugene: Received Core US Patent for HER-Vaxx

PD1-Vaxx Phase 1 Trial to Commence Soon

The Company is on track to commence PD1-Vaxx Phase 1 clinical trial in 2020, targeting patients with non-small cell lung cancer (NSCLC). The trial is to be conducted at up to six to ten sites in North America and Australia under the US FDA Investigational New Drug application.

Moreover, the PD1-Vaxx will be tested in three different doses to determine immunological data, safety and recommended phase 2 dose for the expansion stage of the study. The assumption of Phase 2 study is to increase patient enrolment to specific cancer indications.

The Company has recently completed GMP manufacturing and Toxicology Studies for the immunotherapy, PD1-Vaxx.

Read Imugene Announced Completion of GMP manufacturing and Toxicology Studies for PD1-Vaxx

Other Developments

In addition to these developments, the Company appointed three renowned personalities to its Oncolytic Virotherapy (OV) Scientific Advisory Board, including Professor Yuman Fong, Professor Prasad S. Adusumilli and Dr Rebecca Auer.

Review of Financial Performance

The Company’s net assets improved to ~$65.02 million as at 31^st December 2019, owing to a successful $24.6 million capital raise (before costs) at the end of 2019 and the acquisition of Vaxinia Pty Ltd.

Moreover, owing to a considerable rise in clinical trial and research activities undertaken by the Company, it reported a loss of ~$4.8 million for the year ended 31^st December 2019. The Company had cash reserves of ~$36.8 million as at 31^st December 2019.

In a nutshell, Imugene performed substantially well during the half-year, delivering a remarkable operational performance in line with its clinical development goals. The Company is ideally positioned to progress with the development of its B-cell immunotherapies, supported by a highly skilled and efficient management team.

IMU is trading at $0.024 on 28^th February 2020 (1:15 PM AEDT).

Disclaimer