TRI engages pharma manufacturer ahead of Phase 1 brain imaging trial

Our biotech Investment TrivarX (ASX: TRI) just engaged Australian pharmaceutical manufacturing specialist Syntro Health to prepare its Stabl-Im product for clinical trials.

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TRI is trying to solve the "early detection" problem in brain cancer.

The plan for the tech is by having patients swallow a small dose of a non-radioactive stable isotope, which is taken up by replicating (cancerous) cells.

A standard MRI can then "see" those labelled cells at this early stage, before a larger, physical tumour has developed.

This means (IF it works) that tumours could be caught early, non-invasively and radiation-free, using the MRI machines already sitting in hospitals.

Today's agreement has Syntro Health doing the laboratory formulation work, getting the Stabl-Im investigational product ready to be administered to patients.

Syntro operates TGA-licensed cGMP (current Good Manufacturing Practice) facilities and specialises in manufacturing investigational products for clinical trials.

So some parts being organised here for what TRI needs to get the trial underway:

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It is the next building block after TRI secured supply of the stable isotope product in July (which we covered here) and completed the trial design work flagged in last month's progress update (covered here).

First patient enrolment is still scheduled for Q1 2027.

What is TRI’s tech?

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.

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? Hopefully a non-invasive AND radiation-free way to see tumours early.

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

We have 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.

See our most recent Deep Dive on TRI here: TRI - Cancer diagnostics. Ex- $5BN Telix Chief starts as CEO in 13 days

What do we expect TRI to deliver?

In September TRI included the below plan, so we can start to tick off the milestones:

(source)

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

Phase 1 human safety trial

The phase 1 safety trial is expected to begin before the end of the 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 (source)
• 🔄 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