Shot in arm for Noxopharm

Positive results for a product promising a breakthrough in the use of mRNA drugs sent Noxopharm shares skyrocketing by 50 per cent on Wednesday morning.

New data showed that SOF-VAC – Noxopharm’s proprietary asset – significantly reduced mRNA-driven inflammation in animals.

In the animal study, inflammation from mRNA was reduced by around 50 per cent when SOF-VAC was added.

NOX said this was an important finding, says NOX, because many side effects of mRNA vaccines were due to inflammation.


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The company said the ability of SOF-VAC to reduce the inflammatory side effects of mRNA had several potential benefits.

It could enable mRNA vaccines to be given with higher doses, creating longer-lasting protection and a decrease in the frequency of booster shots required.

SOF-VAC could also support the combination of mRNA vaccines (or other types of RNA vaccines) for different diseases into one syringe, as well as supporting future mRNA drugs that require high and repeated doses to treat a variety of diseases.

The study was conducted together with NOX’s strategic partner, the Hudson Institute of Medical Research, in Melbourne.

With this phase completed, Noxopharm has now largely concluded its planned development work on SOF-VAC, and is now seeking a commercial partner to take the asset forward.

According to Precedence Research, the mRNA market in 2022 was $US40 billion, and is expected to grow to $US137 billion by 2032, at a compound annual growth rate of 13 per cent.

“Our results are a significant milestone in the development of SOF-VAC. They show that it works in reducing inflammation, which should translate into fewer side effects from mRNA vaccines,” said NOX CEO, Dr Gisela Mautner.

“We have now taken SOF-VAC to the point where we consider the data is strong enough for it to be of interest to other companies, and so are stepping up our efforts to find the right partner to continue its clinical development.”

Starpharma up 25pc on Phase 2 results

Starpharma (ASX:SPL) surged 25 per cent after announcing final positive results from its completed Phase 2 open-label clinical trial of anti-tumour drug DEP cabazitaxel.

The trial has met its objectives, with endpoints demonstrating positive anti-tumour efficacy in multiple cancers, and confirming the drug’s favourable safety and tolerability profile.

The results show that heavily pre-treated, advanced prostate cancer patients, when treated with DEP cabazitaxel, achieved a median progression-free survival (PFS) that was more than 50 per cent longer.


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The median overall survival (OS) was also 10 per cent longer than published data for competing drug Jevtana at the same dose.

In advanced, platinum-resistant ovarian cancer patients, DEP cabazitaxel achieved a disease control rate (DCR) of 66.7 per cent, and an objective response rate (ORR) of 17.6 per cent, which compares favourably to standard-of-care therapies.

And in advanced gastro-oesophageal cancer patients, DEP cabazitaxel achieved a median PFS and median OS that were 53.1 per cent and 28.5 per cent longer, respectively, than similar patient cohorts treated with standard-of-care paclitaxel.

Starpharma said these results create significant market opportunity for DEP cabazitaxel.

Imagion reports top line on breast cancer study

Imagion Biosystems (ASX:IBX) rose 8 per cent after reporting some encouraging top-line performance of its world’s first molecular MRI test.

Imagion’s MSH2IA was designed to enable molecular MRI that detects lymph node metastatic HER2+ breast cancer in newly diagnosed patients.

In the study, 13 patients were administered with the MagSense HER 2 Imaging Agent.

Results show the drug was safe and well-tolerated, as there were no MSH2IA-related adverse events.

Complete results will be released at December’s San Antonio Breast Cancer Symposium.

Following these results, IBX said it has now closed all clinical study-related activities throughout Australia, with the final study site now taking no further enrolments.


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AFT Pharma gets another FDA approval

AFT Pharmaceuticals (ASX:AFP) says the US FDA has approved its Maxigesic IV, the intravenous form of its patented pain relief medicine, for sale in the US.

This approval represents AFT’s second FDA approval within a year.

The medicine is now positioned to go on sale either at the tail end of FY24 or early in FY25.

That event will trigger a milestone payment of $US6 million to AFT from the US licensee of the medicine Hikma Pharmaceuticals.

AFT is entitled to 65 per cent of this under its profit share arrangements. The remainder goes to Belgium’s Hyloris Pharmaceuticals, which co-developed the product

AFT also qualifies for a $US2.9 million reimbursement of regulatory fees paid to the FDA for Maxigesic IV, which it expects to receive in the current financial year.

The US analgesic market is the world’s largest, worth $US6.83 billion in 2023, and is forecast to grow by an estimated 4.89 per cent a year until 2028.

“We now have two medicines that can begin to take a share of this market – Maxigesic IV and Maxigesic Rapid, the rapid dissolving tablet prescription form of the medicine that was approved by the FDA in March 2023,” said AFT’s co-founder and CEO, Dr Hartley Atkinson.

This content first appeared onstockhead.com.au

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