Imugene’s CF33 took another 3 shots into the face of cancer in the past week with more and more results affirming the oncolytic viruses effectiveness as a successful terminator of solid tumours.
#cancer killer
Shot 1
Last week we learned of the development of the oncolytic virus, CF33, and its derivatives for the peritoneal-directed treatment of gastric cancer, peritoneal metasteses, oncolytic and local immunotherapy. The results highlighted CF33’s dose-dependent infection, replication, and killing of both diffuse and intestinal subtypes of human Gastric Cancer cell lines. In summary at day 91 of the trial, seven out of eight mice were alive in the virus-treated group versus one out of eight in the control group (p<0.01).
Shot 2
Then a week later Professor Yuman Fong and his team published an article in the journal of "Molecular Cancer Therapeutics." - a journal of the American Association for Cancer Research. Co-authors include Yanghee Woo and Suzanne Warner from City of Hope, plus Nick Eade from Imugene.
CF33 was utilised to treat liver cancer tumours in the study with the results being that in instances where the cancer was directly injected, all the liver cancer solid tumours in mice were eradicated. In addition the study was successful in eliminating cancerous solid tumours in all mice where the CF33 was just injected into the bloodstream, taking only two days longer take effect.
Shot 3
Then on Friday Imugene’s professional management team displayed further confirmation CF33 is safe and potentially a life saving treatment for cancer patients with solid tumours, with “The FDA clearance of the IND allows Imugene to start patient recruitment and dosing in a first-in-class Phase 1 clinical study for the onCARlytics platform in patients with solid tumours. That being “A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors (OASIS).”
But whether as a stand alone treatment or when forming the nucleus of Imugene's CF33-CD19 onCARlytics arm, founder Professor Yuman Fong sees CF33 as proving effective in the treatment of cancer.
The excitement has been backed up by those involved on the ground with the “in human” trials for Imugene's CF33 and Vaccinia.
Even industry luminaries such as Dr Jakob Dupont, with a dozen FDA approvals under his belt, were speaking of CF33 and Vaccinia as ground breaking in the media.
But despite the excitement being at palpable levels, not to mention the heart palpitations no doubt being exercised by all involved with CF33 and Vaccinia, clearly as this tweet illustrates, not all the world (i.e., Europe) is aware of Professor Fongs wonder drug
Although the news may not have travelled all over the globe yet, it’s sure to travel as far as the leading investment firm Sinnova in the US, where Dr Jakob Dupont took up an appointment last week.
“We’ve had the pleasure of knowing Jakob for a number of years, he has had a broad impact across the healthcare landscape, and we are extremely pleased to have him join us,” said Jim Healy, M.D., Ph.D., Managing Partner, Sofinnova Investments. “With Jakob’s track record of leading and advancing numerous clinical programs dedicated to addressing high unmet medical needs, in particular within the field of oncology, he will add incredible value to our team and our portfolio companies by helping select and support new clinical-stage investment opportunities.”
“I’m excited to join the Sofinnova Investments team and look forward to contributing to the long-term success of the organization and patients by focusing on robust science and therapeutic areas with high unmet medical needs across Sofinnova’s portfolio,” said Dr. Dupont.
Who was it that was going to be handling Imugene’s future NASDAQ listing in the US, were it to come about? JP Morgan? Maybe not now…The mind boggles.
Speaking of potential NASDAQ listings and commercialisation surely in my opinion Imugene have enough data, information and pending results to start standing on their own two feet from a commercial perspective. Their oncology leaders are saying everything they saw in animal trials, they are now seeing in humans. That they are witnessing “unequivocal signs of cancer killing in humans”. I note Vaxinia Founder Professor Yuman Fong is on record as saying he is convinced one day his oncolytic virus shall some day become human therapy, in combination with several other therapies. I therefore would be pushing, as early as the onCARlytics webinar tomorrow, for a stronger commercial stance. Following on from the FDA Approval the CF33 CD19 (i.e., Imugene owned) in combination with Blinotumomab Trial (i.e. Amgen Owned), I would be recommending the business team at Imugene COMMENCE NO FURTHER CLINICAL TRIALS OR COMBINATIONS unless there is a monetary sum involved. There needs to be a monetary gain for Imugene from here on in. That includes collaborations with Celularity, Estrella Therapeutics, or Arovella. Why on earth would we offer up the keys to the Holy Grail of Cancer for free? It’s preposterous, verging on the ridiculous in my opinion. The business team needs to urgently start returning value to long term holders of IMU, as opposed to continually opening the door on further research and development to third parties for free. The poster presentations presented last November at ASCO highlighted CF33 - CD19 - onCARlytics effectiveness at treating solid tumours in conjuction with CAR T therapies. But guess what? On their own CAR T therapies were ineffective in the treatment of solid tumours in cancer patients. As noted in my previous post(s) CAR T’s have only been effective in treating blood cancers to date, with little or no efficacy in the treatment of solid tumours. In my opinion the onCARlytics trial with Blinatumomab, sold under the brand name Blincyto, having been shown to be successful pre clinically, should be enough to place Imugene in the dress circle when it comes to sounding out potential suitors and asking them to cough up large sums for a seat at the CF33/Vaxinia/CD19/onCARlytics table. No more freebies I say. As shareholders we had the great news of OSR results for Her Vaxx last year, only to then have wade through years more of Phase 2 trials with Pembroluzimab before realising a commercial or monetary gain. Likewise PD1 Vaxx, where an upfront payment and milestone remuneration for FDA approvals and Phase 2 success could well have been negotiated, given the complete and partial responses realised in that B cell blockbusters first hit out.
Last time I checked the solid tumour cancer market was forecast to be worth hundreds upon hundreds of billions of dollars in years to come. In my opinion Imugene’s business team now need to stop with the science for a day or two and start focusing on the financial impact of their forthcoming Vaxinia results, and their potential commercial influence on this massive market. Let’s face it, with the evidence mounting on the side of CF33 Vaxinia, in addition to onCARlytics, it’s not a hard sale is it? I mean if Monil Shah and his team cannot incept new clinical trials, collaborations and combinations without a commercial agreement of some nature, find someone who can. Cut their KPI’s and punt them if they cannot get license deals with CAR T players over the line. The current business line up have been in control of the sale side of the business for up to two years now, and I as a shareholder haven’t seen a brass razoo from them. Apologies for sounding somewhat harsh, but sometimes you need to call it how it is. Pre clinically CF33 has killed all cancer lines against the NC1 60, no wait a minute, lets add 20 more and kill them. It’s now proven to be safe in humans, and at escalating dosage levels I might add. Vaxinia is tackling up to 10 solid tumour lines in up to 100 patients here and in the US, and is already turning solid tumours in late stage cancer patients from cold to hot. As recently as Friday Imugene CEO and Managing Director Leslie Chong, although saying she could not say to much about the oncolytic virius trial(s), noted there were positive signs. People may well say you need to wait for this result and that result in clinical trials, for confirmation of this and verification of that. Indeed wait for advanced and more extensive pre and post clinical trial results. I call bullshit on that. It’s an excuse not to stand up and be counted as IMO a $10 billion dollar plus company with a share price that should be well over a dollar. When the onCARlytics FDA Approval was announced on Friday a commercial director at Imugene should have been all over the Financial Review, The Australian and the Wall Street Journal discussing the oncology platforms ability to not just potentially cure cancer, but to tap into the billions and billions and billions of dollars available in the huge untapped solid tumour market. They should be discussing and outlining potential revenue and sales figures attributable to future licensing deals with leading CAR T players such as Novartis and Bristol Myers Squibb, not to forget Amgen. Seriously, don’t get me started…
Look to put it bluntly if Imugene were a Genentec, or even a mini Genentec looking to establish an extensive pipeline of cancer drugs through a long term Research and Development (R&D) strategy, I may be able to stomach their ongoing penchant to pursue more and more onCARlytics combinations and collaborations without a monetary gain. But that is because Genentec had a commercial relationship in place at the time of extending their R&D focus, that being with the Big Pharma Roche. Conversely, Imugene at this point in time has no commercial relationship in place with a Big Pharma partner.
Imugene is in the drivers seat now following on from the outstanding scientific results they have achieved in recent weeks, not to mention the outstanding achievement on Friday last wherein their third platform onCARlytics has now seen the light of day, in collaboration with a Big Pharma giant in Amgen. They now need to drive hard and fast bargains with anyone wanting to play ball. A prospective FDA Fast Track Approval for either CF33, Vaxinia or both is in the offing. This is absolutely bloody huge. Never been done or seen before, to use the Aussie vernacular. Played good, done strong as they say out west. A virus that only kills cancer and is safe in humans, you are kidding aren’t you? LC said once upon a time Imugene may one day have to put her long pants on and come to town. Well that time has come. Friends, Romans, Countrymen lend me your ears, is the mantra I’d be assuming if I were in control. This is no time for lying down nor second guessing. When it comes to future direction, collaborations, supply agreements and commercial relationships Imugene need to call the tune, lay down the law, make the decisions, define the rules of engagement and run the show. When you have the keys to the castle it’s up to you to decide who comes in, and more importantly, what they need to pay to come in. Don’t take it the wrong way, I’m in no way slamming management, who have done an excellent job in creating compelling science with which to take to market accompanied by a Big Pharma, be it Merck, Pfizer, Roche or whomever. But it’s time shareholders began to discuss the opportunity cost of spending more money on onCARLytics trials with the likes of Estrella, Celularity and Arovella. Let’s be honest, don’t they need us more than we need them? Perhaps the $10m or more dollars spent on the said prospective onCARlytics trial(s) would be better spent on a worldwide marketing campaign visa vie YouTube, Meta, Reddit, Twitter, Quora, Medium, the WSJ or even Time Magazine as an example, with Professor Yuman Fong and Saul Priceman presenting this transformative medical breakthrough to the world. Maybe there are some trolls and sceptics who may not tune in, but to me these esteemed individuals are going to sound very believeable to the majority of punters in the world. Have a “How to invest in Imugene” button at the bottom of the video (article). Then see if we turn over more than few million dollars in IMU shares each day.
Before you rush to conclusions and suggest everything is in hand, things are progressing well, Monil Shah is to present in Tasmania in July, think of the veracity of the situation at hand. The prospective commercialisation of Vaxinia is bloody enormous. It’s bigger than Imugene and even Big Pharma to put it mildly. I know I’m going to cop some heat for being so forthright, but the writing has been on the wall for some time now. IMU is hugely undervalued and the ongoing focus on scientific conventions, scientific speak and biopharma politics isn’t cutting through. Yes Imugene’s investor and public relations has improved and been somewhat better of late. But we are talking about a very small audience are we not? Yes the creation of compelling science to entice a Big Pharma into your web may be the path of least resistance, but is it the best path? Surely a potential cure for cancer with the chance of satisfying a huge unment need safely at competitive prices is superior to chemotherapy? In my mind it’s superior to anything on the medical radar, a cure for COVID included. Are Big Pharma even the best vehicle to control this revolutionary treatments destiny? Sure they can play a role, but what of the planet's 2,640 billionaires worth $12.2 trillion? I’m quite sure only a few of them read scientific journals, but I’m confident more than a few would enjoy the opportunity to take an investment and seat at the Vaxinia table with Professor Yuman Fong, with a shot at curing cancer. That is if they heard about it.
In conclusion let’s get on our bikes, challenge the status quo and spread the word of what is now the chance of a lifetime to particpate in life changing medicine that has the potential to meet a huge unmet need. The runs are on the board. Imugene has lit the flame, it’s now up to us to carry the torch. Chances are you or someone you know are to be diagnosed with cancer in this lifetime. Remember that with a safe and cost effective treatment plan not only you but countless other poorer, disaffected and otherwise helpless individuals could benefit from such a universal therapy.
Best of luck to LC and all the team at IMU, Monil Shah included and to all LTH’S.
DYOR Seek investment advice as and when required Opinions only
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