The CF33, Vaxinia and Oncarlytics Deal, page-532

Vaxinia results pending and the odds are pointing to success

Imugene’s oncolytic viral therapy is extending further and further toward achieving its goal of successfully treating an array of solid tumours. Following on from Professor Yuman Fong’s statement wherein he said “everything we saw in animals we are now seeing in humans”, when referring to the current Check Vacc and Mast Trials, recent pre clinical trials have continued to produce astonishing results. Here small caps discusses the success of CF33CD19t when combined with Artemis T cells in treating Hepatocellular carcinoma (HCC) is the most frequent type of liver cancer
and the sixth most common cancer worldwide. It also stated that The combination strategy can be applied to otherwise target-less tumours such as HCC, and this shows the potential this could be applicable to a wide array of solid cancers as an effective immunotherapy approach.

See https://*********.com.au/imugene-presents-abstract-pre-clinical-liver-cancer-treatment-response/ for more details.

In April Professor Yuman Fong tweeted of Imugene’s City of Hope licensed CF33’s success in treating up until now almost impossible to treat cancers including colon, rectal, stomach, pancreatic, ovarian, appendix, liver, bile duct and mesothelioma. This is brilliant news as these cancers are often seen as a life sentence when patients are in the late stages of the disease.

As you are aware Imugene are now over 12 months into their clinical trial for Vaxinia, wherein they are treating up to 100 patients with solid tumours in up to ten hospitals both here and in the US. In early March patients were treated in combination with Pembroluzimab (i.e., Keytruda) in IT and IV format, whilst in early April the monotherapy arm of the trial received an escalated dose of Vaxinia in both IT and IV format. At the time Imugene CEO and Managing Director Leslie Chong discussed the continued positive signs being received and once again reiterated Imugene’s confidence in being able to deliver positive outcomes for patients. This acknowledgement reaffirmed Professor Yuman Fong’s views of a month earlier wherein he stated he was seeing “unequivocal signs of cancer killing in humans”.

See IMU - ASX Announcements for further details

In Australia clinical trial practitioners must notify regulators within 72 hours of a significant safety incident or within 15 days of a safety incident wherein adverse patient outcomes are said to have occurred. I note the FDA requires in their “IND safety report” 15 day reports documenting similar detail, whilst a “7 day report” is required by them for unexpected fatal or life-threatening suspected adverse patient reactions. Given that the ASX has not been notified of either incident in recent weeks, one can draw the rightful conclusion Vaxinia is continuing through the initial cohort in combination with Keytruda, in addition to the current cohort of the monotherapy arm, without incident, again in a safe and controlled manner with little or no toxicity.

We as IMU investors are close to being notified of the MAST trials results in the existing cohorts, if recent history is anything to go by. Professor Fong has previously noted the OV begins to take effect with two weeks of being administered to patients, hence he should by now be in a position to visualise patient responses to Vaxinia both here and overseas, in combination with Keytruda and as a stand alone vessel. Being at an accelerated dosage rate Professor Fong is anticipating potentially better patient outcomes. As outlined earlier if results from the intravenous administration are promising that opens the door to a plethora of additional collaborations with Car T and allogenic therapy manufacturers who espouse to produce “off the shelf” style products available at competitive pricing to the growing population in need of such cancer drugs. I myself having spent hours now aside Professor Yuman Fong am supremely confident in the outcome of the existing OV trial(s). His confidence and at times excitement when speaking of his 33rd virus gives me great hope this potent and resilient oncolytic virus can succeed in not only regressing, but eliminating solid tumours in a vast array of cancer indications. Recent pre clinical studies in conjunction with Imugene’s ongoing “in human” trials have strengthened my resolve. Once the current cohorts are cleared and the biopsies from the existing OV’s independently verified, if indeed there are substantial signs of efficacy, as alluded to during the March Roadshows, the tide then turns toward commercialisation. Fast track FDA approval would appear ominous should the safety profile continue to remain strong, therefore the world may well open up for Imugene’s business team, who are no doubt planning the how, what and why for’s as we speak.

Best of luck to ALTH’s

DYOR - seek investment advice as and when required - Oponions Only