• Cleo Diagnostics confirmed milestones from its ovarian cancer test-kit study
  • Radiopharm granted ethics approval for first human trial in Australia


Cleo Diagnostics delivers milestones on ovarian cancer test-kit

Cleo Diagnostics (ASX:COV) has confirmed early milestones in the development program of its ovarian cancer test-kit.

Cleo says it has finalised the selection of biomarkers to be used in the test-kit, along with completing the development for a prototype of the scoring algorithm.

Cleo confirmed that Surface Plasmon Resonance Analysis has shown that the core antibodies of lead asset, CXCL10, are binding to their respective targets – which means they are suitable for commercial development.

Hybridomas needed to produce the supporting biomarker antibodies are also well progressed, with expected completion of the full test-kit panel in Q2 of 2024.

These findings were obtained following the evaluation of 334 patients in a clinical study; the results of which are currently being prepared for publication in a peer-reviewed medical journal expected to be released by end of this year.

A key objective for Cleo is to develop its own antibodies and target proteins which will allow control of supply, quality, cost and high-performance of key reagents that will underpin the reliable manufacture of its test-kits.

The company says it is also preparing a further patent application based on the findings.

“The commercial foundation for our ovarian cancer test-kit targeting the initial surgical triage market is coming together quickly,” said Cleo CEO, Richard Allman.

“We are running a number of initiatives in parallel which are designed to place the company in a strong position to achieve key milestones set this financial year.”


Radiopharm to start Phase 1 trial

Meanwhile, Radiopharm Theranostics (ASX:RAD), a developer of radiopharmaceutical products, announced it has been granted Human Research Ethics Committee (HREC) approval to commence a clinical trial in Australia.

The First-In-Human Phase I study will investigate therapy using the company’s RAD204 drug for patients with PDL1- positive non-small cell lung cancer (NSCLC).

The study will be conducted at Princess Alexandra Hospital in Brisbane, with the support of leading oncology care provider GenesisCare.

The technology underpinning the trial is Radiopharm’s proprietary nanobody from its NanoMab platform, which targets the PDL1 expression in NSCLC, the most common type of lung cancer.

The company says this is is an area of high unmet need, and there is potential for the treatment to be the “first in class” radiopharmaceutical therapy targeting PDL1.

In Australia alone, approximately 12,200 patients are diagnosed with lung cancer per year, making it the fifth most common disease in the country.

Worldwide, it was estimated that there were more than 2.2 million cases of lung cancer in 2020, with NSCLC accounting for approximately 85% of all lung cancer cases.

“NSCLC carries a poor prognosis for patients currently, and we’re striving to make a difference on that front, with excellent support being provided by our partners at GenesisCare Contract Research Organization,” said RAD’s CEO, Riccardo Canevari.




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