• Noxopharm surged 50pc on mRNA testing of SOF-VAC
  • Starpharma jumped 25pc after completing Phase 2 study of DEP cabazitaxel
  • AFT Pharmaceuticals gets second FDA approval this year


Noxopharm up 50pc on mRNA vaccine study

Noxopharm (ASX:NOX) skyrocketed by 50% this morning after new data shows that SOF-VAC, its proprietary asset, significantly reduces mRNA-driven inflammation in animal testing.

In the animal study, inflammation was reduced by around 50% when comparing the inflammation induced by mRNA alone, versus mRNA plus SOF-VAC.

This is an important finding, says NOX, as many side effects of mRNA vaccines are due to inflammation.

The company added that the ability of SOF-VAC to reduce the inflammatory side effects of mRNA has several potential benefits.

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

It can 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 study completed, Noxopharm has now largely concluded its planned development work on SOF-VAC, and is now actively seeking a commercial partner to take the asset forward.

According to Precedence Research, the mRNA market in 2022 was US$40 billion, and is expected to grow to US$137 billion by 2032 at a compound annual growth rate of 13%.

“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.”


Starpharm up 25pc on Phase 2 results

Starpharma (ASX:SPL) surged 25% after announcing final positive results from its completed Phase 2 open-label clinical trial of 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% longer. The median overall survival (OS) was also 10% 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%, and an objective response rate (ORR) of 17.6%, 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% and 28.5% longer, respectively, than similar patient cohorts treated with standard-of-care paclitaxel.

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


Imagion reports top line on breast cancer study

Imagion Biosystems (ASX:IBX) rose 8% 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.


AFT Pharma gets second FDA approval this year

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 one 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 US$6 million to AFT from the US licensee of the medicine Hikma Pharmaceuticals. AFT is entitled to 65% of this under its profit share arrangement with Belgium’s Hyloris Pharmaceuticals.

AFT also qualifies for a US$2.9 million reimbursement of regulatory fees paid to the FDA for Maxigesic IV that it expects to receive in the current financial year.

The US analgesic market is the world’s largest, worth US$6.83 billion in 2023, and is forecast to grow by an estimated 4.89% 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.


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