Imugene makes speedy progress in clinical trial activities in FY21


  • Imugene Limited (ASX:IMU) achieved several significant milestones during the last financial year.
  • The Company progressed with the development of its product pipeline over the year.
  • Imugene closed the year with substantial cash reserves of about AU$29.48 million.

Australia-based Imugene Limited (ASX:IMU) has recently released its full-year statutory accounts for the year ended 30 June 2021. The Company continued to progress with its clinical trial and research activities during the last financial year while achieving several significant milestones.

Imugene recorded a significant increase in its net assets to about AU$65 million over the year, on the back of successful raises through the exercise of options and the acquisition of CF33 CD19. Meanwhile, the Company closed the year with substantial cash reserves of around AU$29.48 million.

Following the end of the financial year, the Company also unveiled a massive AU$95 million capital raising to fund its clinical trial pipeline until 2025.

Let us quickly scan through the key operational developments that shaped the last financial year for the Company:


During the financial year, Imugene progressed with the development of its B-cell immunotherapy HER-Vaxx, which is currently undergoing Phase 2 clinical trial.

In November 2020, the Phase 2 interim efficacy and safety data for HER-Vaxx were assessed at the Independent Data Monitoring Committee or IDMC meeting. The committee reported no safety concerns after the review and viewed this preliminary data as largely in favour of an HER-Vaxx survival effect.

Subsequently, the Company’s HER-Vaxx completed enrolment into the open-label Phase 2 trial in January this year. Afterwards, the Company met its secondary clinical endpoint of 24 events for Progression Free Survival (PFS) for HER-Vaxx in April 2021. Imugene recently released the PFS data for HER-Vaxx and is now awaiting the events needed for the Overall Survival (OS) evaluation.

Related Read: Imugene unveils encouraging PFS data for HER-Vaxx immunotherapy

Over the year, the HER-Vaxx data was presented at the American Association for Cancer Research Annual Meeting and ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting. Moreover, the Phase 1 clinical trial data for HER-Vaxx was published in the prestigious American Association for Cancer Research journal - Clinical Cancer Research.

Good Read: Imugene presents encouraging data on HER-Vaxx at ESMO World Congress on GI Cancer 2021


Imugene continued with the Phase 1 Non-Small Cell Lung Cancer (NSCLC) study of its B-cell immunotherapy, PD1-Vaxx, during the financial year.

In November last year, the Company received the US FDA (Food and Drug Administration) Investigational New Drug (IND) approval to commence the Phase 1 clinical trial of PD1-Vaxx. Soon after the IND approval, the PD1-Vaxx CRC (Cohort Review Committee) decided to dose escalate to the next highest dose level in cohort 2. The CRC evaluated the low dose cohort of NSCLC patients’ safety, toxicity, tolerability, and immune response.

In a CRC meeting held on 4 April 2021, clinicians reported no safety, toxicity, or tolerability issues with PD1-Vaxx in cohort 2. The CRC approved the enrolment of patients to the current highest dose level. As a result, the Phase 1 study was able to open enrolment for cohort 3, the highest dose after successful completion of cohort 2.

Related Read: Imugene Ticks Off a Key Milestone in PD1-Vaxx Phase 1 Trial, Shares Up


In June this year, Imugene’s CHECKvacc received an FDA IND clearance to undertake a first in human Phase 1, open-label, non-randomised, dose-escalation, single centre study of intratumoral (IT) administration of CHECKvacc (CF33-hNIS-anti PD-L1). The study will be conducted in patients with metastatic TNBC (Triple-negative breast cancer) tumours refractory to standard therapy or for which no standard therapy exists and who have injectable lesions.

The trial will involve a dose escalation, followed by an expansion to twelve subjects at the final dose (RP2D).

Must Read: Imugene shares soar as CHECKvacc's Phase 1 trial gets FDA nod


Imugene hit a major milestone this year as it obtained the worldwide exclusive licence of the patents covering the cell therapy technology - onCARlytics™ (which includes CF33-CD19).

City of Hope scientists led by Dr Saul Priceman, Ph.D. and Prof. Yuman Fong, MD, have combined two potent immunotherapies — Imugene’s CD19 oncolytic virus and CD19 CAR (chimeric antigen receptor) T cell therapy. The aim is to target and eradicate solid tumours that are otherwise difficult to treat solely with CAR T cell therapy.

Also Read: Imugene Enters into Licensing Agreement with City of Hope for Patents Covering onCARlyticsTM

Lately, the Company announced an exclusive strategic partnership with Celularity to explore the therapeutic potential of the combination of CyCART-19 and onCARlyticsTM. CyCART-19 is Celularity’s CD19 targeting CAR placental-derived investigational T-cell therapy.

Related Article: Imugene Limited updates on its research collaboration agreement with Celularity

Way Ahead

Imugene shares closed the trading session at AU$0.41 on 8 September 2021.





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