Imugene Webinar November 8, 2023
Prior to joining Imugene Ltd, Dr Woodard worked on a wide range of drug development projects in solid tumours, haematologic malignancies, and non-malignant haematologic disorders
A comprehensive webinar today presented IMU investors with a chance to see Imugene’s new CMO Paul Woodard up close and personal for the first time since his appointment. Clearly an impressive individual with a wealth of experience, his coverage of CF33 Vaxinia and the viruses ability to kill solid tumours from a number of angles was a key take home for me. The ability to add payloads to Vaxinia has the potential to increase the drugs efficacy, whilst the mechanism by which Vaxinia primes the immune system to eliminate cancer cells is equally as important. Particularly when it comes to hearing it from an astute professional such as Woodard. He is not talking about maybe’s, what if’s or possibles, he is speaking clearly of the drug Vaxinia’s mode of operation as visualised in ongoing human trials.
We are now acutely aware of the fact it’s all about dosage rates, when it comes to the ongoing Vaxinia (MAST) Trial. Both Woodard and Imugene CEO and MD Leslie Chong anticipate stronger signals and patient responses as the dosage levels administered to patients increase. This leaves investors with one of two options. Firstly do they accept that even at low dosage rates Vaxinia is working, and capable of achieving breakthrough status with the FDA? Or secondly do they wait for the results of the existing cohorts dosed at 10 parts to the 8, (in other words a much stronger dose of Vaxinia), to arrive on the FDA’s doorstep? Leslie Chong’s response when it came to the notion Imugene may pursue a significant breakthrough therapy strategy with the FDA was “stay tuned”. I take that to mean “watch this space”. Therefore if I was sitting on the sidelines waiting to invest in IMU shares, I probably would either act sooner rather than later, or move elsewhere. In the event of recognition by the FDA of significant breakthrough therapy status, it would be difficult to envisage IMU doing anything other than skyrocket. One would be hard pressed to find a biotech stock that has done otherwise, having been granted such approval by the USA’s leading pharmaceutical regulatory authority.
At present as we await the ongoing results of Vaxinia at higher dose rates, investors can be buoyed by news today of Vaxinia showing positive responses in the monotherapy arm of the current trial. Reading between the lines this is medical speak for “Vaxinia works on its own”. This must be music too the ears of Imugene’s business department, who were no doubt set to work on the financials surrounding Vaxinia combinations with a myriad of other monoclonal antibodies, such as Keytruda. For them perhaps of even more significance from todays webinar was affirmation that other than a few flu like symptoms in the short term, patients had otherwise experienced no harmful side effects, having been administered Vaxinia. Quite amazing when one takes into consideration the worlds leading cancer drugs, including but not limited to Keytruda, Opdivo and Herceptin, all have the tendency to produce one or a number of deleterious side effects following patient administration. Another reason for the FDA to take a long hard look at Vaxinia’s appeal over and above the existing standard of care, when determining whether the drug warrants significant breakthrough status.
So where too now? I suppose its not only all about dosage rates. Nor is it all about realising a pattern of results in one specific indication such as bile duct cancer (as alluded to in my previous posts). It may be as much about deciding how Imugene plans on rolling out their now successful treatment arm, as a stand alone or combination therapy, with either Oncarlytics, Azer cel, or both. Do they out license the drug to a Big Pharma partner for a hefty upfront payment and massive milestone figures payable upon subsequent FDA approvals for further cancer indications? Do they run the gauntlet and wait for the mother of all take over offers in mid to late 2024 when the results come home to roost, upon primary endpoints in the Vaxinia (Mast) Trial being reached? I’d probably do neither. If I was running the Big Show (btw how good was Maxwell), I’d be saying to the market, we are in control here, the aces are in our pocket, we hold all the cards. As such we are not prepared to enter negotiations, liaise with or talk with you unless you hold either 10, 15 or perhaps 20% of the IMU share registry. That way shareholders would receive a strong return on their investment in the near term, as willing participants sought to strengthen their position on the IMU register. As prospective partners started buying up Imugene shares with a view to entering meaningful out licensing, sale or take over plans with Imugene. Alternatively such acquirers of large quantities of IMU stock may be granted preferential treatment in the event of an Imugene listing on the NASDAQ bourse, were such a move to eventuate. Now Vaxinia has stood up, its time for the financial aficionado’s in the team to do likewise.
Vaxinia, key personnel, ongoing results and financial strategy aside, my heart goes out to those who have seen their disease stabilise in recent months both here and in the US, having had the conviction to enrol in the MAST Trial. All thanks to their oncologists who have taken the risk of enrolling candidates into a virus trial, at a time when a virus itself was wreaking havoc in the broader community. Not to forget the courage of their families, who, having witnessed their loved ones fail time and time again on previous treatments, only to see their conditions worsen, probably thought they “had heard it all before,” by the time they were presented with Vaxinia. And last but not least all the front line staff working around the clock to care for and support these late stage cancer patients in their hour of need. It’s a great story, and one that continues to unfold, under the guidance of Imugene’s impressive new Chief Medical Officer, Dr. Paul Woodard.
DYOR Seek investment advice as and when required Opinions only
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