This week realised a further slowdown in US housing prices and the housing market in general, with the prospect of lower inflation in the near term as a consequence. Jobless numbers increased slighly and consumer confidence fell. It is a pity so much misery has to to reaped upon thousands if not millions of individuals and households at the expense of lower inflation.
However there was some good news on home soil. The week past brought with it a brilliant performance by Imugene. All those associated with the company should be both proud and excited by their contribution to the evolution of this dynamic biotech thus far.
Keeping in mind as I was trained as an economist, not a scientist, please afford me some slack as I take time out to discuss some of the major players in the week that was, including how they came to enter our lives.
Yuman Fong
After 30 years as an esteemed surgeon on the West Coast of the US in New York Yuman Fong decided to move all the way to the other side of America, away from his three children, colleagues and friends to realise a dream, that being to cure cancer. In Los Angeles he was aware the City of Hope Institute would support him through the provision of over one hundred research assistants and medical technicians. He was on a mission. Whilst still practicing as a surgeon one day a week (to keep his finger on the pulse) he was able to continue doing what he was proficient at, cutting bowel cancer and other solid tumours from the liver of patients. Patients who travelled from all over the US and the world to be saved by him. Though whilst performing surgery, in the back of his mind he believed he could create a virus that would potentially infect cancer cells, replicate and continue to kill “cancer cells only," within the human body.
After years of research Fong settled on Vaxinia, a genetically modified small pox virus, due to not only its potency, but due to the fact it was in ample supply. If successful, (as it was later found to be in animal trials), it could be manufactured and produced in abundance to treat cancer patients on mass. However as oncolytic viruses had proven too powerful in the late 1900s, Fong needed to ensure his virus was not harmful to patients. And let’s not forget viruses are tricky to assess, when one considers Poisson distribution. For if you infect cells at an MOI of one, does that mean that each cell in the culture receives one virion? During his research Fong ascertained that at the power of 1 to 10, at relatively low levels of particle distribution, his virus was effective in replicating itself. Moreover at dosage levels of up to 6 to the power of 10, he found the virus did not produce excess toxicity and adverse effects in his subjects during his preclinical trials. The results during these pre clinical trials were outstanding, somewhat overwhelming to say the least. Fongs Vaxinia virus wiped out practically all cancer lines against The US National Cancer Institute (NCI) 60 in mice and petri dishes. He now simply had to amass enough data to ensure his prodigy would remain in his hands, and not on the shelf in the back room of a big pharmaceutical player. Enough data to ensure the FDA would approve a trial for his oncolytic virus known as Vaxinia.
The Vaxinia Trial
After years of engineering, re engineering and testing his Vaxinia virus, Fong’s City of Hope-developed oncolytic virus was shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models. Finally in May 2022 having teamed up with an Australian entrepreneur, Paul Hopper, and Hopper’s CEO at Imugene (IMU ASX) Leslie Chong, Vaxinia began being administered to human patients, in a Phase 1 clinical trial at the City of Hope. At the time Daneng Li, MD, principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research noted, "Now is the time to further enhance the power of immunotherapy, and we believe CF33-hNIS (Vaxinia) has the potential to improve outcomes for our patients in their battle with cancer.” Fong had realised his dream of seeing Vaxinia treated to humans, though he was anxious, nervous and restless, all at the same time. How would his virus react when injected into patients? He rang the clinic countless times during the first night. Are they ok? Is everything alright?
We now know Vaxinia was found to be safe, as the phase 1 trial has proceeded through the initial cohorts trialled at the blessing of the FDA. Fong is today excited by the fact up to 100 patients with metastatic or advanced solid tumors in the intratumoral (IT) or intravenous (IV) trial can be treated not only as a monotherapy but in combination with pembrolizumab, Keytruda (a leading immunotherapy drug) without having to seek further approval from the FDA.
Nb. As immunotherapy designed for one cancer type may not be effective in all patients and may lose effectiveness during treatment, combination therapies rather than mono-therapies are seen as a strategy to overcome this shortcoming at the time of treatment.
Enter Saul Priceman
But it didn’t stop there for Yuman Fong. PD-L1 a protein that acts as a kind of “brake” to keep the body’s immune responses under control, was in the mix. Fongs research had shown oncolytic viruses can prime a person’s immune system and increase the level of PD-L1 in tumors, making immunotherapy more effective against cancer. Other researchers at the City of Hope had heard of these developments and were no doubt eager to pursue all angles when it came to progressing the treatments effectiveness even further. A few years before entering the Phase 1 Vaxinia trial Fong had met with a then young haematologist from the other side of campus, Dr Saul Priceman. Priceman got to thinking, why don’t we infuse the Vaxinia virus with CD 19, a biomarker for normal and neoplastic B cells, as well as follicular dendritic cells. By expressing CD19, with the addition of PD-L1 the “brakes” on the immune system could be released, leaving T cells free to kill cancer cells. The T cells would even have a target on the solid tumour for which to attack, given the CD 19 imprint. Hence Oncarlytics Imugene style was born in May 2021.
As early as last week we learned that when CF33/CD19 was added to Eureka Therapeutics produced Artemis T cells in preclinical trials, the combination resulted in significant tumour killing within multiple solid tumour types including liver, pancreatic and breast cancer. Priceman was indeed so excited he is turning his attention to treating brain cancer using Oncarlytics. Meanwhile according to all reports Fong appears so convinced his Vaxinia is successful in treating solid tumours within late stage cancer patients, he is turning his attention toward earlier stage cancer patients, if not preventative medicine for cancer patients worldwide.
What does it all mean for shareholders of Imugene?
During the week many questions were asked of Yuman Fong and Saul Priceman as they traversed between investor groups, hospitals and shareholders in Melbourne and Sydney, Australia. One asked how could Fong prove to the FDA his Vaxinia virus was actually working in human tissue. Yuman then proceeded to explain that through the use of advanced medical imaging the trial supervisors could actually visualise first hand the progression of the virus through the human body, as they had within mice trials years before. My mind began racing. Perhaps on December 9 when Fongs CF33 virus is presented on the world stage we may even be able to glean from the presentation hints of efficacy in addition to safety. Though once again I am mindful of the fact CF33 is being administered to late stage Triple Negative cancer patients who have failed on all other treatment arms, and that like Imugene’s Her Vaxx before it, CF33 was administered at very low dosage rates to the trials cohorts 1 and 2 participants.
Irrespective of the December results it is now full steam ahead in both the CF33 and Vaxinia trials. The world awaits, as no doubt do countless numbers of cancer patients, waiting in the wings for an infusion of Fong’s wonder drugs. And reading through these threads, particularly following posts from holders such as TB, Davy, Kluck, Footie, Sagittarius, Steine, The Captain, Tin Tin, Jase and more recently Outlander, to name but a few, one cannot help but feel excited by all Imugene has laid before us in the week that was. To be graced with the presence of humble, self effacing scientists with a profound story to tell, was nothing short of spectacular. Personally I have never felt so comfortable and assured my family and friends have their investment in good hands. I do believe we are sitting on the precipice of something great here. Something that shall one day transcend all the meaningless discussions over share prices, money, personal wealth and accumulation.
That said I couldn’t help but feel after the week that was Yuman Fong and Saul Priceman were good people, kind people. Viewing my avatar I drifted back to the words of John Steinbeck in “The Grapes of Wrath," wherein he quoted “Our people are good people; our people are kind people. Pray God someday kind people won't all be poor.” And I mused that for those of us lucky enough to have crossed paths with Yuman and Saul, maybe we won’t have to be.
DYOR - Seek investment advice as and when required - Opinions only
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