• Imugene starts dosing of first patient in Phase 1 trial
  • Anteotech successfully registers EuGeni Covid-19 RAT in Europe
  • Cardiex gets new classification from the FDA

Imugene doses first patient in Phase 1 trial

Clinical stage immuno-oncology company, Imugene (ASX:IMU), said its Phase 1 clinical trial of cancer-killing virus CF33-hNIS VAXINIA has officially begun, with the dosing of the first patient.

Imugene and clinical partner City of Hope, a renowned cancer hospital in Los Angeles, said the Phase 1 trial will start by delivering a low dose of CF33-hNIS to cancer patients with metastatic or advanced solid tumours, who have had at least two prior standard of care treatments.

Once this is done and acceptable safety has been demonstrated, certain participants will then receive the experimental oncolytic virus in combination with pembrolizumab, an engineered antibody that improves the immune system’s ability to fight cancer-causing cells.

“Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as CF33-hNIS,” said Dr Yuman Fong of City of Hope.

“We are hoping to harness the promise of viralogy and immunotherapy for the treatment of a wide variety of deadly cancers.”

This US component of the Phase 1 trial is conducted under the US FDA investigational new drug (IND) process following FDA IND clearance in December.

In all, the study aims to recruit 100 patients across approximately 10 trial sites in the US and Australia.


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Anteotech registers RAT in Europe

Anteotech (ASX:ADO) surged as much as 40% this morning after advising that it has successfully registered an updated EuGeni COVID-19 Rapid Antigen Test (RAT) in Europe.

Currently unavailable in Australia, the EuGeni is Aneteotech’s fast solution for rapid point-of-care testing. With a small and portable benchtop design, it can be easily transported in the clinic and on the field for use by healthcare professionals.

The new European registration is for the same core SARS-CoV-2 Ag RAT registered in April of 2021, but now covers multiple use claims.

The use claims include combined nose and throat sampling and nasal mid-turbinate sampling, on top of the original nasopharyngeal sampling method.

To establish these new use claims, AnteoTech had completed clinical performance evaluations in the US and the UK that focussed on validating the test’s effectiveness in detecting the Omicron variant of SARS-CoV-2.

In addition, the company is also currently conducting a clinical trial in Europe, which is evaluating the updated multiple-use claim. Results from this study will enable EuGeni to be included in the EU Common List registration application.


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CardieX gets FDA classification

CardieX (ASX:CDX) was up 15% after being advised by the FDA that its CONNEQT companion app has been classified as a non-device MDDS (Medical Device Data System), rather than an accessory to a Class II Medical Device.

This classification provides the company with flexibility not only when it comes to launching the application, but it also de-risks the pathway to market for CardieX’s upcoming new devices.

This is due to the fact that there will not be a requirement for a full separate submission to the FDA for the consumer companion app.


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Starpharma’s nasal spray shows effectiveness

Starpharma (ASX:SPL) said its broad-spectrum antiviral agent in VIRALEZE nasal spray, SPL7013, achieved 95% and 99.7% reduction of virus infectivity against the two most significant influenza viruses, A and B, respectively.

SPL7013 demonstrated irreversible virucidal properties against both types of influenza virus.

Influenza A and B viruses are responsible for seasonal epidemics of influenza, and influenza A viruses are known to cause flu pandemics.

Starpharma says this virucidal action of SPL7013 against influenza virus is in contrast to other antiviral agents used in marketed nasal sprays that were tested as part of its experiment.

This includes hydroxypropyl methyl cellulose (HPMC) and iota-carrageenan, neither of which demonstrated virucidal activity.


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