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


  • The shares of Imugene Limited (ASX:IMU) inched higher following a promising update on its oncolytic virotherapy candidate, CHECKvacc.
  • City of Hope® has received the FDA IND approval to initiate a Phase 1 clinical trial of CHECKvacc (CF33-hNIS-antiPDL1).
  • Dr Yuan Yuan, MD, PhD, will be the Principal Investigator leading the Phase 1 study.

Shares of clinical stage immuno-oncology player Imugene Limited (ASX:IMU) gained as much as 8.6 per cent to AU$0.38 during the early morning trading session, following the release of a significant update on its oncolytic virotherapy candidate, CHECKvacc.

Imugene informed that the City of Hope® has received the US Food and Drug Administration (FDA) Investigational New Drug (IND) approval to commence a Phase 1 clinical trial of CHECKvacc (CF33-hNIS-antiPDL1). City of Hope® is globally recognised as an independent cancer research and treatment center near Los Angeles.

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The FDA approval of the IND allows the City of Hope® and the Company to begin patient recruitment and dosing in a Phase 1 clinical trial for TNBC (triple-negative breast cancer) patients.

Details of clinical trial

The title of the clinical trial is “A Phase I Study of Intratumoral Administration of CF33-hNIS-antiPDL1 in Patients with Advanced or Metastatic Triple Negative Breast Cancer”. Imugene informed that Dr Yuan Yuan, MD, PhD, will be the Principal Investigator leading the Phase 1 study.

The purpose of the trial is to evaluate the safety as well as the initial evidence of efficacy of intra-tumoral administration of CHECKvacc against metastatic TNBC. The trial will include a dose-escalation, followed by an expansion to twelve patients at the final dose or the recommended phase 2 dose (RP2D).

Principal Investigator Dr Yuan Yuan is excited to be a part of this important CHECKvacc study and the search for effective new treatments for TNBC, given that there are limited treatment options for patients currently.

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Know about CHECKvacc

CF33-hNIS-antiPDL1 or CHECKvacc is an immune checkpoint inhibitor armed chimeric vaccinia poxvirus developed from the lab of CF33 inventor Professor Yuman Fong. Dr Fong is a noted expert in the oncolytic virus field and the Sangiacomo Family Chair in Surgical Oncology at the US-based City of Hope®.

As per Dr Yuman Fong, CHECKvacc oncolytic virus is a promising therapy for several cancers. However, his team is particularly interested to test CF33-hNIS-antiPDL1 first in triple negative breast cancer as it is a huge unmet need.

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The pre-clinical studies at the City of Hope® have shown encouraging results in triple negative breast cancer patients when an immune checkpoint inhibitor (particularly a PD-L1 inhibitor) is combined with CF33 to produce CHECKvacc. Besides, pre-clinical data has demonstrated that the CHECKvacc construct can inhibit cancer growth better than Amgen or Genelux oncolytic virus.

Notably, CHECKvacc holds the potential to solve the industry problem of additive toxicity of combined checkpoint inhibitors if the safety of CF33 is maintained in combination.

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