Imugene Received FDA Guidance for VAXinia’s Clinical Development Pathway


  • Imugene received US FDA guidance on the development pathway for VAXinia (CF33-hNIS).
  • FDA provided feedback on adaptive Phase 1 clinical development plans and non-clinical development pathway for VAXinia.
  • The Company has initiated regulatory planning for carrying out trial in the US and Australia.
  • Phase 1 trials of PD1-Vaxx and CHECKvacc are also planned for the near future.
  • Imugene is also progressing with Phase 2 trial of HER-Vaxx at multiple sites across India and Eastern Europe.

Australia-based clinical stage immuno-oncology firm, Imugene Limited (ASX:IMU) has received guidance from the US Food and Drug Administration (FDA) with regards to the development pathway for oncolytic virotherapy VAXinia (CF33-hNIS).

Following the update, IMU’s stock marked an uptick of ~1.8 per cent on the ASX, closing the trading session at $0.057 on 6th August 2020.

VAXinia is the Company’s lead oncolytic virotherapy for the treatment of solid tumours and an unarmed construct of CF33, which is expected to enter Phase 1 clinical trial in the near future.

Imugene has planned to conduct first-in-human, adaptive phase 1, multi-centre, dose escalation study of VAXinia (CF33-hNIS) to examine intratumoural and intravenous administration lines as monotherapy and in combination with immune checkpoint inhibitors. The patient population targeted under Phase 1 trial includes those suffering from advanced or metastatic melanoma, non-small cell lung, gastric, colorectal, Triple Negative Breast Cancer (TNBC), bladder, head and neck and renal cell cancers.

FDA Guidance Received for VAXinia

Imugene had a pre-IND (Investigational New Drug) meeting with the FDA to attain regulatory guidance and agreement of the pre-clinical, manufacturing, chemistry and clinical development plan to be incorporated in an IND for the Company’s VAXinia oncolytic virotherapy.

The Company has obtained feedback from the US FDA on the development plan for VAXinia Phase 1 MAST (Mixed Advanced Solid Tumors) study design on the following aspects:

  • Part 2 of the study in combination with immune checkpoint inhibitors,
  • Safety monitoring plan,
  • Proposed patient population, and
  • Approach for assessing drug exposure during the study.

Besides these areas, Imugene has also attained guidance from the FDA on key aspects of non-clinical investigations and valuable response on studies needed to support the Phase 1 development plan.

Imugene intends to stay flexible in identifying regulatory pathways amid COVID-19-driven uncertainty. Consequently, the Company is pursuing a regulatory pathway in Australia, along with the US strategy.

Other Clinical Trials in Pipeline

In addition to VAXinia Phase 1 MAST study, Imugene has also planned Phase 1 trial of CF33’s armed construct, CHECKvacc, in TNBC patients. Pre-clinical studies conducted at US-based City of Hope have exhibited promising results in TNBC patients when CF33 is tested in combination with an immune checkpoint inhibitor (mainly a PD-L1 inhibitor) to produce CHECKvacc.

Additionaly, Imugene is in the process of undertaking multi-centre, Phase 1, dose escalation study of PD1-Vaxx, both as a standalone therapy and in combination with immune checkpoint inhibitors like Keytruda® and Opdivo®. The study will initially target patients suffering from non-small cell lung cancer. The Company has recently obtained two HREC (Human Research Ethics Committee) approvals to commence a Phase 1 trial of B-cell immunotherapy, PD1-Vaxx, in Australia.

Imugene’s most-advanced B-Cell immunotherapy, HER-Vaxx is also forging ahead in merit as its Phase 1 trials in gastric cancer have successfully completed, and the Company has further received verification from Independent Data Monitoring Committee (IDMC) to continue Phase 2 clinical trial.

The Phase 2 trial is being undertaken at multiple sites across India and Eastern Europe where clinicians face trouble accessing approved antibody treatments like Herceptin® and where there is a high prevalence of gastric cancer owing to lifestyle and nutritional choices.

Must Read! Flick Through Imugene’s June 2020 Quarter Milestones

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