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May 18, 2022

Imugene, City of Hope doses first subject in Phase I solid tumour trial

The trial will assess the safety and tolerability of oncolytic virus CF33-hNIS as monotherapy or along with pembrolizumab.

Imugene and City of Hope have dosed the first subject in Phase I clinical trial of a new cancer-killing virus, CF33-hNIS (Vaxinia), in individuals with advanced solid tumours. 

The oncolytic virus is developed by City of Hope, which licenced patent rights covering CF33 to Imugene. 

In preclinical lab and animal models, the virus demonstrated to diminish colon, lung, breast, ovarian and pancreatic cancer tumours.

The multicentre, dose-escalation trial will assess the safety and tolerability of intratumoral or intravenous dose of CF33-hNIS as a single agent or along with immunotherapy, pembrolizumab, in adults with metastatic or advanced solid tumours (MAST).

It intends to enrol 100 subjects across nearly ten trial centres in the US and Australia.

Initially, a low dose of the virus will be offered to trial subjects who previously received a minimum of two lines of standard of care therapy. 

Following administration of the lowest doses of CF33-hNIS to subjects in the single therapy arm and acceptable safety is reported, some new trial subjects will be given the oncolytic virus plus pembrolizumab.

An engineered antibody, pembrolizumab boosts the ability of the immune system to attack cancer-causing cells. 

Activation of the study site and subject recruitment in the US portion of the trial is underway.

Imugene CEO Leslie Chong said: “The dosing of the first patient in our Vaxinia study is a significant milestone for Imugene and clinicians faced with the challenge of treatment for metastatic advanced solid tumours. 

“In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of Vaxinia and the oncolytic virotherapy platform.”

Oncolytic virus treatment is made possible by genetically modifying viruses found in nature for infecting, replicating in and killing cancer cells without impacting healthy cells. 

In October 2019, the company announced plans to assess two different versions of CF33 oncolytic virus technology in separate Phase I trials.

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