Imugene achieves new milestone: First patient dosed in Phase 1 trial of VAXINIA

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Imugene achieves new milestone: First patient dosed in Phase 1 trial of VAXINIA

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Imugene continuing with clinical trials
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  • Imugene Limited (ASX:IMU) and City of Hope have announced the dosing of the first patient in the Phase 1 trial of VAXINIA.
  • The clinical trial aims to test the cancer-killing oncolytic virus CF33-hNIS against advanced solid tumors.
  • VAXINIA study aims to recruit 100 patients across ten trial sites in Australia and the US.

Australia-based Imugene Limited (ASX:IMU) has hit a new milestone with the dosing of the first patient in its VAXINIA (CF33-hNIS) study. The first patient has been dosed in a Phase 1 clinical trial of VAXINIA, which is evaluating the safety of the novel cancer-killing virus CF33-hNIS when used in people suffering from advanced solid tumors.

Good Read: Where does Imugene’s oncolytic virotherapy CF33 currently stand?

VAXINIA is the City of Hope-developed oncolytic virus, which has been shown to shrink colon, ovarian, lung, breast, and pancreatic cancer tumors in preclinical laboratory and animal models. Notably, City of Hope is the first in the world to test CF33-hNIS in people with metastatic solid tumors. Imugene holds an exclusive license from City of Hope for the patent rights covering CF33.

 City of Hope’s view on VAXINIA clinical trial

Following the crucial update, Imugene shares rallied by over 6% to A$0.175 as of 12:40 PM AEST.

Phase 1 trial of VAXINIA

The multicenter Phase 1 trial of VAXINIA will begin by delivering a low dose of CF33-hNIS to cancer patients with advanced or metastatic solid tumors, who have had at least two previous lines of the standard of care treatment. The investigational treatment will be delivered either intravenously or as an injection directly into tumors.

Imugene informed that once patients in the single therapy group have been treated with the lowest doses of VAXINIA and acceptable safety has been demonstrated, some new study participants will get the experimental oncolytic virus in combination with the immunotherapy pembrolizumab. The engineered antibody pembrolizumab boosts the immune system’s ability to fight cancer-causing cells.

The clinical trial is expected to run for around 24 months and is funded from existing budgets and resources. The ongoing clinical trial is titled:

Title of VAXINIA clinical trial

Clinical trial sites for Phase 1 trial

The Phase 1 study aims to recruit 100 patients across about ten trial sites in the US and Australia. City of Hope is the first clinical institution in the US to receive ethics approval to commence VAXINIA’s Phase 1 trial. Additional clinical sites are expected to be opened across the US in 2022.

Related Read: Imugene wins ethics approval to start Phase I clinical trial of VAXINIA, shares shine

The US component of the Phase 1 trial is undertaken under the Food and Drug Administration (FDA) investigational new drug (IND) process following FDA IND clearance in December last year. The Company is proceeding with site activation and patient recruitment.

Imugene’s MD view on VAXINIA clinical trial

Do Not Miss: Imugene wins ethics approval to commence Phase 2 HER-Vaxx study in Australia


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