Special Report: A new breakthrough formulation for Race Oncology’s lead asset drug Zantrene means it has significantly increased its potential market.

Race Oncology (ASX:RAC) is poised to increase its addressable market significantly after revealing that it has developed an improved IV (intravenous) delivery method for its lead drug, Zantrene.

Race researchers, led by Dr Benjamin Buckley in collaboration with the University of Wollongong, have developed a new formulation of Zantrene that enables peripheral (arm or leg vein) IV delivery to patients with the codename RC220.

Previously, Zantrene had to be delivered into the aorta near the heart using what is called a central line catheter because the drug is not very soluble in blood and can crystalise and block the flow of blood in smaller veins.

While this central line approach works, it wasn’t ideal for many patients and clinicians.

The new RC220 formulation on the other hand, is able to keep Zantrene from crystallising in the blood even when it is infused into a smaller peripheral arm or leg veins.

The new formulation also allows Zantrene to be infused faster, improving the patient’s treatment experience.

Race’s chief scientific officer, Dr Daniel Tillett, says this was a significant development for the company that could exponentially expand Zantrene’s addressable market.

“This new formulation now enables patients to be treated outside of a major hospital or within their own homes, making Zantrene much more accessible and potentially increasing its market potential significantly,” Tillett told Stockhead.

A more immediate impact of the new RC220 IV formulation is improved patient recruitment potential for future clinical trials. It will also reset the patent clock on Zantrene.

“If you can reformulate a generic drug, then you’ve basically got a new drug,” explained Tillett.

“A patent life starts when the patent is submitted, so it would last another 20 years from today.”


Zantrene’s cardioprotection potential

Zantrene has been in the spotlight recently as it was also discovered to be effective in reducing the risk of heart damage for patients undergoing chemotherapy.

In a breakthrough pre-clinical research program last November, Zantrene was shown to protect the heart muscle cells from a type of chemo drug called an anthracycline (the most common drugs for chemo-induced cell death), while improving the killing of breast cancer cells. Later studies reinforced this breakthrough data in another anthracycline, called Carfilzomib, used to treat Multiple Myeloma.

When combined with an anthracycline called doxorubicin, Zantrene was also found to protect the hearts of mice from its damaging effects, even when the chemotherapeutic dose was increased.

The scientific community has known for decades that chemotherapy is highly effective in destroying cancer cells and reducing the risk of cancer spreading.

But what people may not know is that high doses of chemo drugs can cause serious heart disease, and sometimes even irreversible heart failure.

Whilst the anthracyclines chemo drugs are one of the most effective anti-cancer treatments ever developed, they also cause these unwanted, potentially lethal side effects to the heart.

This discovery of Zantrene has presented Race with a huge opportunity because chemotherapeutics are amongst the world’s most prescribed and used drug for treating cancer.


A diversified pipeline

Race Oncology is not all about Zantrene, and the company is making important steps outside of the drug in what it calls its Pillar 3 ‘Beyond Zantrene’ Strategy.

Last week, Race announced that it was plunging itself into the booming RNA-based drug discovery space.

The company has contracted the Monash Fragment Platform (MFP) at Monash University to complete a fragment-based screening program aimed at discovering novel drugs that inhibit the m6A RNA demethylases FTO and ALKBH5.

“Race is now one of the leading companies in the world clinically in this new area, which is the m6A RNA methylation system,” Tillett said.

“This area has been found to be super important not only in cancers, but also more broadly, as these enzymes are found in a lot of metabolic diseases like diabetes and obesity.”

A drug screening program with Monash will start immediately, and those molecules that are found to bind to the proteins will be transformed into drug leads, and ultimately clinical drug candidates.

“We will leverage all the knowledge that we’ve built up over the last three years around the m6A space to build a drug development program around it,” says Tillett.

“It’s very exciting opportunity that opens up a huge potential for the company beyond just cancer, and to look to develop treatments for other diseases like diabetes.”


The AML clinical trials

In Israel, Race’s Phase 1b/2 Zantrene study into AML (acute myeloid leukemia) is progressing well, moving from the Phase 1b dose escalation phase to Phase 2. Encouragingly, clinical responses were observed in this very heavily pre-treated AML patient population, with 50% of patients bridged to a stem cell transplant.

In Australia, a separate trial looking at Zantrene in patients with a rare form of AML, called extramedullary AML, has commenced. The trial is now expanding beyond Australia to Italy and Spain.

Tillett says this EMD AML study is the first clinical trial in the world to investigate the targeting of the FTO protein – a key part of the m6A RNA pathway – as a potential cancer therapy for AML.

“Many other biotech companies and researchers have generated exciting results in animal and human correlation studies, but no one has yet been able to run a clinical trial targeting this pathway,” said Tillett.

“We are the first in the world to be able to treat patients for cancers driven by m6A RNA problems.”


This article was developed in collaboration with Race Oncology, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.