The CF33, Vaxinia and Oncarlytics Deal, page-216

Today was put simply amazing for long term IMU holders. Today we visualised proof that CF33 is actually working. Yes it is safe, yes it is tolerable. Those boxes had already been ticked. We were aware the virus may have been replicating. Now we know it is. Most importantly, wait for it, we now have visual proof, affirmation albeit confirmation. CF33 is killing cancer in patients.

See above - Patient COH-008 received CF33-hNIS-antiPD-L1 at DL3 (1x10 to the 6 PFU). Injected lesions were superior left chest wall nodules. Injected nodules demonstrated necrosis on clinical exam (red oval).

CF33 and Vaxinia founder Professor Yuman Fong told us in Sydney last month Imugene were seeing “unequivocal evidence of cancer killing in humans”. He then went on to say “everything we saw pre clinically with animals, we are now seeing in humans”.

Today we came to the understanding that even at exceptionally low doses CF33 is working. The TNBC cancer patients in Imugene’s City of Hope Phase 1 trial are on deaths door. Their cancer is virulent, rampaging through their helpless bodies as it were. Yet still CF33 is present. At the higher dose of 10 parts to the 6 (see above), still an extremely low dosage level, we begin to visualise the death of the patients cancerous solid tumours. “Remarkable”, to say the least.

Both CF33 and Vaxinia are currently progressing at the behest of the FDA through the cohorts toward their sweet spot, their optimal biological dosage rate. Is it 10 parts to the 8? Or do we need to ratchet it up a notch to ten parts to the 9? Either way we are still beneath Professor Fong’s estimated dosage rate wherein toxicity could arise. Still well within the safe therapeutic zone as it were.

See above WMHB - A hypothetical example of the effect CF33 and Vaxinia have on cancer at increased dosage rates

We are now seeing large amounts of Merger and Acquisition activity in the Healthcare sector. Some pundits are suggesting health is the only space that’s any good at present, as banks, manufacturing, mining and other sectors start to feel the pinch of turning economic tides. Many of these biotech deals are for companies whose products treat only one or a few types of illnesses. From companies whose products only treat a narrow array of blood cancers. As you are aware Imugene’s Vaxinia is currently trialling on up to 10 seperate solid tumour types, from pancreatic, lung, colon and colectoral cancers to name but a few. If successful, as is currently the case, the drug should most certainly be fast tracked through the FDA as a breakthrough therapy, in my opinion. For it is meeting one of if not the largest unmet needs in the world. Solid tumours comprise up to 90 percent of cancer cases, with the number of patients growing rapidly, year in year out.

So why isn’t the market and IMU share price reacting? If the Merck’s and Pfizer’s are paying tens of billions for rare disease products and ADC’s, why not Imugene’s game changing cancer therapies. Despite the fact Imugene’s trials need to progress a few steps further, haven’t they seen enough? Look you must question the capacity of Monil Shah and his team to sell this ground breaking research to entrepreneurs, fund managers, healthcare companies and the public at large. Okay so IMU Chairman Hopper says it’s not his place to sell shares to us, but how else do you add value to shareholders? You may be enhancing your product suite, providing compelling medical evidence as it were, but bottom line increases in the share price must ensue, otherwise you have failed dismally from a commercial point of view. We all love the science, some of us now even get it. But the clock is ticking. If there is no talk of discussions with Big Pharma in the near term, no Nasadaq listing in the offing, and no real time updates on existing clinical trials, the natives are soon to become rather restless. Chairman Hopper says if you aren’t prepared to go the distance, hop off the ship, but I tend to disagree.

Let’s take Her Vaxx as an example. The drug, like its B cell side kick PD1 Vaxx, exemplified strong trial results. When you start extending the life of cancer patients by over 5.7 months, and in some instances totally curing late stage patients of dreaded diseases such as gastric and lung cancer, you’re on a winner from where I sit. If I was steering the ship I would have put some serious pressure on Monil Shah to close out this B cell platform with an upfront payment from Big Pharma and progress milestone payments upon noted completion dates (i.e., subsequent clinical trials completions and FDA approvals). Why go down another rabbit warren with other side effect riddled competitors in combination trials when you could have thrown the upfront payment into developing your war horses, CF33 and Vaxinia? After all, if CF33 and Vaxinia are successful, won’t monoclonal antibodies and even the B cell platform be rendered obsolete one day? Let’s face it, with a few hundred million in the kitty Imugene could be fast tracking CF33 and Vaxinia trials on up to three times the number of patients now, across multiple cancer lines.

But I’m not here to throw stones. I applaud the work of Imugene’s CEO Leslie Chong and her team in delivering first rate CF33 and Vaxinia trials in rapid time. If indeed fast track approval is granted by the FDA to Professor Fong’s wonder drugs, I am confident oncologists and medical practitioners shall push them just as hard as they have Keytruda. Perhaps even harder, given their safety attributes. Once again Keytruda’s rise to fame is worth assessing, when we consider where CF33 and Vaxinia may land in the near term.

Source : Statista.com

Make no bones about it, Imugene in my opinion is a ten billion dollar stock, based on the fundamental developments in recent times. Today the company opened the door to the holy grail of cancer, the solid tumour market. “Necrosis in late stage Triple Negative Breast Cancer patients when dosed with CF33 at only 10 parts to the six”, I say. What’s that worth in the real world? Or in the fair dinkum department, for those true blue Aussies among us? But maybe therein lies the problem. There aren’t too many true blue Aussies, and it’s a big world out there. What a pity they haven’t heard of Professor Fong and Imugene. Actually, come to think of it todays announcement probably didn’t even make the news in Australia. Who was handling the Media and PR relations for Imugene? Their name escapes me.

On a final note today’s announcement was again somewhat drab, and weak in my opinion. No mention of necrosis, (i.e., death of cancer cells), no mention of the sheer success in achieving these transformative outcomes. When it comes to Imugene announcements it’s like “All is well down on the farm, Papa hopes to be able to milk one more cow this winter”. Really? It’s becoming quite a joke is it not? Imugene gives erring on the side of caution a whole new parameter. It doesn’t actually hurt to explain in plain English what you are seeing guys. From where I come from information is actually power.

Managing Director Leslie Chong some time ago spoke about Imugene putting some long pants on and heading into town, or words to that effect. I believe it’s high time Imugene did just that. The current appalling state of the share price, the insipid company announcements and the lack of commercial enterprise from Monil Shah and his team of merry men is starting to wear a bit thin. Imugene is now a multi billion company performing as but a shadow of its real self. Step up and be counted I say.

The era of procrastination, of half-measures, of soothing and baffling expedients, of delays is coming to its close. In its place we are entering a period of consequences.

Winston Churchill




Best of luck to all long term holders - seek investment advice as and where necessary - Opinions only