TrivarX Engages CRO to Advance Stabl-Im Imaging Platform Into Phase 1 Trial
TrivarX engages specialist CRO to advance Stabl-Im Phase 1 safety trial
TrivarX Limited (ASX: TRI) has engaged Beyond Drug Development, a specialist contract research organisation (CRO), to progress its planned Phase 1 safety trial for Stabl-Im. The proprietary MRI-based imaging platform is designed to visualise actively replicating tumour cells using stable isotopes, without the need for radioactive tracers. With the company targeting trial commencement during H2 CY26, the appointment marks a concrete step in moving Stabl-Im from preclinical planning toward human data.
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A safer alternative to traditional oncology imaging
How Stabl-Im works
Stabl-Im uses stable isotope labelling combined with MRI to image actively replicating tumour cells, removing the reliance on radioactive tracers that characterise conventional imaging approaches. The platform is designed to provide earlier and more biologically meaningful insights into tumour activity, cellular proliferation, and treatment response.
Key differentiating features of the technology include:
- Leverages existing MRI infrastructure, with no new equipment required
- Designed to detect tumour activity earlier and more meaningfully than traditional techniques
- Provides insights into cellular proliferation and treatment response
- Intended as a safer, more accessible alternative to current imaging methods
The oncology imaging opportunity
Current gold-standard imaging methods rely on radioactive tracers, which carry both accessibility and safety limitations for patients and clinical settings. Stabl-Im’s stable isotope approach is positioned to address these constraints across oncology, with the company also noting other potential indications beyond cancer imaging, though specific details on these have not been disclosed.
Why the CRO appointment strengthens the clinical pathway
Beyond Drug Development is a boutique therapeutic product development consultancy and CRO focused on early-phase product development for biotechnology and pharmaceutical companies globally. The organisation provides strategic, regulatory, and clinical development support across a range of innovative therapeutic and diagnostic programmes.
Incoming CEO Dr Danielle Meyrick commented on the significance of the engagement:
Dr Danielle Meyrick, Incoming CEO
“Engaging Beyond Drug Development represents an important milestone as we progress Stabl-Im through early clinical development and toward future Phase 2 efficacy studies. Importantly, having worked with the group previously, I know firsthand that Beyond brings highly relevant expertise across early-phase clinical development, regulatory strategy and imaging product advancement, which positions the program strongly as we progress toward commencement of the Phase 1 safety study.”
The personal dimension to this appointment carries weight. Dr Meyrick’s prior working relationship with Beyond provides a direct, firsthand endorsement of the organisation’s fit and capability for this programme.
Beyond’s credentials relevant to this engagement include:
- Team members averaging more than 20 years’ experience across clinical development and regulatory strategy
- Specialist regulatory toxicology expertise with over 30 years’ experience supporting therapeutic and imaging product development programmes
- A specific focus on early-phase product development, directly aligned with Stabl-Im’s current stage
What the engagement covers
The initial scope of work establishes the groundwork that must be completed before the Phase 1 trial can commence. The engagement covers:
- Completion of the Phase 1 clinical protocol
- Preparation of clinical and regulatory documentation
- Clinical site selection activities
These are near-term, trackable deliverables for investors monitoring progress toward the H2 CY26 target commencement date.
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Phase 1 trial structure and what comes next
The proposed Phase 1 study is expected to be an open-label, sequential-cohort design evaluating the safety and tolerability of Stabl-Im in healthy volunteers following oral dosing. Its primary purpose is to generate initial human safety and tolerability data, which is a regulatory prerequisite before progressing into Phase 2 efficacy evaluation.
The table below summarises the planned clinical pathway. Note that Phase 2 details have not been disclosed in the announcement and the corresponding row is directional only.
| Stage | Study Type | Population | Primary Goal | Target Timeline |
|---|---|---|---|---|
| Phase 1 | Open-label, sequential-cohort | Healthy volunteers | Safety and tolerability data | H2 CY26 commencement |
| Phase 2 | TBD | TBD | Efficacy evaluation | Post Phase 1 completion |
For investors, the H2 CY26 commencement target represents a material catalyst. Human safety data from the Phase 1 study is the gateway to efficacy evaluation, broader clinical development, and ultimately commercialisation discussions for the Stabl-Im platform. With protocol development and planning activities now underway following the CRO engagement, the programme has moved into an active development phase with defined near-term milestones to monitor.
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