TRI secures product supply for Phase 1 brain cancer imaging trial - on track for CY2026

Our biotech Investment TrivarX (ASX: TRI) just secured supply for phase 1 clinical feasibility trials of its Stabl-Im brain cancer imaging tech.

TRI is developing a non-invasive brain cancer imaging technology which is trying to solve the early detection issue that the current standard of care has.

More specifically, by finding cancer before it's big enough for a standard MRI to see in the brain.

Here is how the tech works:

• A patient swallows a small dose of a compound (a non-radioactive stable isotope)
• The stable isotope is taken up by “replicating cells” (these are the cancerous cells).
• A standard MRI machine then "sees" the labelled cells, because stable isotopes have slightly different magnetic properties from their normal counterparts.

MRIs are good at seeing structure, eg a tumour, but not cellular activity, so they usually only pick up cancers once they have already grown (2-3mm in size).

TRI's tech (IF it works) could mean brain cancers are picked up at the earliest stage, when they are still tiny cells.

The end result? A non-invasive AND radiation-free way to see tumours early.

(source - video with Dr Daniel Tillett ) (slides from P3 here)

We compared it to trying to spot a handful of troublemakers in a stadium of 50,000 people.

From a distance, everyone looks the same. But hand every troublemaker a flare, wait for them to light them up and suddenly they're easy to pick out from the crowd.

That's what TRI's tech does, it makes the cells that matter light up on an MRI, so tumour activity can be spotted at a stage where it would otherwise blend into healthy tissue.

Today, TRI secured product supply to start dosing human volunteers - with the trial on track to start this year.

(source)

The trials planned for later in the year will be the first time TRI’s tech is tested in humans.

The main thing we want to see from that first phase is if it’s safe and if there are any side effects from patients going through this process.

We would also get some initial data on the performance of the imaging platform from the planned trial, so it will be the first indication on how the tech works in a real life setting from a trial.

This follows TRI's recent engagement of specialist CRO Beyond Drug Development back in May, which new CEO Dr Danielle Meyrick has worked with before.

We covered that here: TRI to progress Phase 1 safety trial for brain tumour imaging tech

(Dr Danielle Meyrick has actually worked with them before)

So planning and preparation on this trial is already advanced and progressing.

Commencement is still subject to ethics and site approvals, so this is another step towards the trial underway, so next up we can expect more updates on the progress getting to trials

What do we expect TRI to deliver?

In the short term it will be all about the phase 1 safety trial.

Phase 1 human safety trial

In the short term it will be all about the phase 1 safety trial, expected to begin in H2 this year (source).

We want to see TRI’s tech tested in patients with confirmed brain tumours, to demonstrate safety, imaging precision, and reliability.

Here are the milestones we are tracking:

• 🔄 Complete trial design
• 🔄 Manufacture stable isotope compounds
• 🔲 First-in-human dose
• 🔲 Phase 1 trial completed
• 🔲 Phase 1 trial results

FDA Regulatory Pathway

While the trials happen we also want to see TRI go through the regulatory process with the FDA.

Here are the milestones we are tracking for FDA engagement:

• 🔲 Pre-IND (Investigational New Drug) meeting with FDA
• 🔲 IND application submitted
• 🔲 FDA approved IND for TRI’s tech
• 🔲 (bonus) FDA Fast Track / Breakthrough / Orphan designation