Imugene’s cancer-hunting virus deemed safe with no side effects as trials advance to stage 2

Imugene’s (ASX:IMU) VAXINIA Phase 1 trials in the US are progressing along with the first stage of testing seeing a review committee deem the novel treatment safe for use. 

With that safety profile now attached to VAXINIA (more on what it is below,) the company and trial operators will now move ahead to IV injections of the treatment into patients with a particular kind of lump; metastatic advanced solid tumors (MASTs). 

So far, VAXINIA has been getting injected straight into tumors. While a second cohort of patients with MASTs will now move to continued intratumoral injections; a secondary parallel cohort will move towards IV injection for the first time. 

What is VAXINIA? 

Imugene’s VAXINIA is a novel cancer treatment awarded Investigational New Drug (IND) status by the USA’s health regulator; the Food and Drug Administration (FDA). 

IND status is, in part, why Imugene is able to advance this trial so quickly, the company’s novel treatment won that status back in December last year.  

Phase 1 only began in May. 

How does it work? 

VAXINIA works like this: 

1. Imugene engineer a virus cell (VAXINIA) designed to hunt out cancer cells 

2. VAXINIA is injected into the body 

3. VAXINIA viruses introduced into the tumor/bloodstream infect the cancer cells and move towards lysis; the mode by which a virus kills a cell 

Ultimately, Imugene is leveraging the mechanism of action viruses use to ‘hijack’ cells in the body and replicate, and then re-engineering that process in a way designed to eliminate cancer cells. 

Viruses have evolved in parallel with humanity (and all life on Earth,) and are among some of the most ancient organisms alive; because of this, our bodies are used to them. With this in mind, Imugene’s medical team are hopeful the novel treatment can provide better outcomes than chemotherapy or radiation therapy. 

The newly awarded safety profile for VAXINIA underpins the move ahead to IV injections.

Next steps 

Patients will continue to receive low doses of VAXINIA injected directly into tumours, though, patients in the IV cohort will receive slightly higher dosages as researchers determine where safety baselines for the treatment are. 

The company is seeking to expand its trial to 100 patients across 10 sites in both the US and Australia. 

For now, patients must have received at least two prior lines of traditional treatment; and doses are administered with pembrolizumab, a common immunotherapy. 

“Our VAXINIA trial has made headway since commencement in May…we expect this to continue as patient recruitment builds momentum,” Imugene CEO Leslie Chong said. 

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