I note some people out there still have questions and doubts about CF33, Vaxinia and Oncarlytics, the treatment arms being discussed on this thread. And with good reason, as Imugene CEO and Managing Director stated earlier this year there is no current FDA Approval for an oncolytic virus when administered intravenously. Therefore this market is virtually non existent when it comes to the bigger picture with respect to cancer treatment revenue. As of today despite numerous efforts from a vast array of companies, success and FDA approvals for this treatment arm appear some time away.
Though Vaxinia founder Professor Yuman Fong addressed this issue both in November 2022, and thereafter as recently as March 2023, when visiting Sydney Australia. In November he mentioned CF33/Vaxinia was advantageous from an IV administration perspective due to its potency at relatively low dosage levels. He noted at the time there is a plentiful supply of the oncolytic virus (OV) with potentially millions and millions of patients having access to the drug if and when FDA approval for the OV is granted. With this in mind Imugene took the step in October 2022 of teaming up with US manufacturer ABL, a company with specialized expertise in developing and manufacturing solutions for biopharma. Imugene plans to work with ABL as a partner of choice over the long-term, remaining active throughout the entirety of the CF33 platform’s life cycle. Imugene recently transferred to ABL the technology for the manufacturing and analytical processes. ABL is now planning to deliver the first phase of the project with a cGMP batch of Vaxinia targeted to be manufactured and released this year.
In March this year when addressing shareholders Professor Fong noted that despite requiring higher levels of Vaxinia when administered intravenously as opposed to intratumorally, due to secretion from a patients body, Vaxinia was exhibiting signs of successfully replicating and infecting their cancer cells within. The ability of Vaxinia, the powerful and more potent parental strain of CF33, to prove effective when administered intravenously, is what gives Professor Fong so much confidence when discussing the future of his oncolytic virus. Vaxinia is currently treating up to 10 solid tumour types in up to 100 patients both here and throughout the US, including I believe but not limited to pancreatic, liver, lung and colon cancer. If successful as you may be aware Professor Fong aims to take the resultant biomarker results to the FDA to illustrate how well the body responds to his Vaxinia treatment, with a view to ultimately obtaining FDA approval for use across all solid tumours types. Could this FDA approval be fast tracked as a significant “breakthrough therapy”? A resounding yes was the response of Imugene Managing Director and CEO Leslie Chong, when asked the question as late as last month in an Australian interview.
These exciting developments are coming to a head now in April and May 2023. For as @Gossy29 points out whilst CF33 was successful when administered intravenously in preclinical trials, the current clinical in human trials are soon to produce results at close to if not approaching the Vaxinia’s optimal biological dose level. Having dosed the first patient with Vaxinia in combination with Pembroluzimab (i.e., Keytruda) in early February, Imugene shall have results from this dose escalation in the coming weeks. In my opinion if the Vaxinia results show “unequivocal signs of killing cancer in humans”, as suggested by Professor Fong, then Imugene is set to end 2023 well north of $1. Why wouldn’t such a result occur? Healthcare analysts such as Roth Capital already have price targets for the stock at .71 cents, and that is without any forecast revenue from the now well advanced Vaxinia trial (see below from the Roth Capital report as at February 28, 2023).
The above table is an extract courtesy of Roth Capital, as sourced from Imugene.com in the section on their website entitled Analyst Coverage.
Please click on the image for a deeper analysis
Much deliberation surrounding Imugene’s oncolytic viral therapy stems from individuals reticence to believe Professor Yuman Fong. For what he is saying to the naked eye does, as he has noted previously, appear unbelievable. How can a virus infect only cancer cells? How can it be administered intravenously in a safe and efficacious manner, when as noted here on these threads, this process has not occurred successfully up until now? I guess the simple answer to these questions could be to point the non believers to the experience and reputation proceeding Professor Yuman Fong. As stated in Imugene’s recent corporate presentation Dr. Fong has had leadership roles in regulatory aspects of gene therapy, including serving as Chair or the Recombinant DNA Advisory Committee of the National Institutes of Health of the United States. Dr. Fong has been inducted into the American Institute of Medical and Biologic Engineering and the National Academy of Medicine. And more importantly Dr Fong represents the City of Hope, in Los Angeles, a leading research and treatment center for cancer, diabetes and other life-threatening diseases. City of Hope has been ranked as one of the nation’s “Best Hospitals” in cancer by U.S. News & World Report for over 10 years. With this in mind what would drive Professor Fong to put not only his name and reputation on the line, in addition to that of The City of Hope’s, by making false and erroneous claims?
In my opinion the reason Professor Fong is convinced Vaxinia may well become human therapy when administered intravenously, is not simply a matter of the drugs plentiful supply, nor its safety and efficacy, but as with Electric Vehicles (EV’s), it comes back to government policy. Governments, regulators and the FDA are screaming out for cost effective solutions to the current burden on the tax payer associated with cancer care. According to the Australian Bureau of Statistics more than 300,000 Australians skip radiology each year because of the cost. So existing cancer treatments are well out of reach for many individuals. Whilst according to the Sydney Morning Herald (SMH) Medicare covers 63 per cent of the total cost of cancer care, ranging from 51 percent for prostate cancer to 89 percent for lung cancer. These figures impose a significant burden on the tax payer purse. As we are finding with government support for Electric Vehicles, this fiscal strategy can have resounding effects on the growth of market segments. In addition to government support I would note that when your product is less expensive than the competition, as is the case with Imugene’s Vaxinia, your bottom line can grow immeasurably overnight. Take BYD Auto for example, a leading supplier of EV’s worldwide. For the first quarter of 2023 BYD delivered 264,647 all-electric vehicles, up about 85% from the same time last year. BYD delivered 283,270 plug-in hybrids in Q1, up just more than 100% compared with the first quarter in 2022. When compared to their more expensive competitor Tesla, BYD EV sales grew 2.5 times faster than Tesla in the latest quarter according to Barron’s.
BYD currently have their top of the range BYD Atto for sale in Australia at approximately $48,011 according to whichcar.com.au When examining the existing government fiscal strategy pertaining to EV’s a little closer, as thedriven.io did in December last year, I discovered a person on a $75,000 salary gets a better deal on the $47,000 Atto 3 compared to Honda’s $36,700 HR-V wagon — and an even better one if secondhand mark ups continue to price used models higher than new ones, according to a comparison by leasing company Inside Edge. The driven.io therefore concludes that when applying the government’s new EV fringe benefit tax exemption, the reduction in take-home pay on a novated lease Atto is $900 compared to $1000 for the HR-V, and over a three year lease the Atto 3 scores just over $20,000 in savings versus just under $10,000 for the Honda. thedriven.io notes the government’s new fringe benefit tax exemption for battery electric (BEV), hybrid and plug-in hybrids (PHEVs) that cost less than $84,916 was designed to make EVs more affordable for businesses versus petrol and diesel cars. Not bad for a vehicle such as the BYD Atto that runs for about a third of the cost of a petrol vehicle. BYD manufacture sedans and hatchbacks that are much less expensive than their BYD Atto, and a move to import them would be sure to set the Australian EV Market on fire.
As was the situation with the EV market, as noted on these threads, the barely existent oncolytic virus market could indeed take off exponentially. Contrary to what many of the naysayers believed but a few years ago, the EV Market has done just that. Invented by renowned surgeon and cancer researcher Professor Yuman Fong, the acclaimed City of Hope’s Vaxinia may well provide the impetus to spark a change in government and regulatory policy when it comes to cancer treatment as we know it. If as Professor Fong stated recently the virus is successful in curing solid tumours within humans, as he saw in animals close to a decade earlier, then Imugene’s safe, efficacious and less expensive cancer therapy may indeed provide a solution for those currently unable to afford radiation. If not the chemotherapy market may rise by more than 50 percent, as forecast in a modelling study published in the The Lancet Oncology (see archive.cancerworld.net). Such an outcome would not be ideal for government and cancer patients alike. The heavy cost burden of chemotherapy, in terms of both expense and side effects, is one which Imugene is desperately trying to avoid. I wish them and Professor Fong all the best in their endeavours.
DYOR - Seek investment advice as and when required - Opinions only
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