Dispelling the oncolytic virus (OV) market mythsOn May 14 CG...

Dispelling the oncolytic virus (OV) market myths

On May 14 CG Oncology Inc. (Nasdaq CGON) rose 7.4% to $27.76 per share for a market cap of $1.8 billion. Thats the equivalent of $2.7 million AUD or approximately 5 and a half times Imugenes current market cap. CG Oncology is slightly more advanced than Imugene (IMU ASX) considering it is now entering phase 3 trials for its oncolytic virus, focusing on patients suffering from bladder cancer. Earlier this year the company commenced a Phase III PIVOT-006 clinical trial of their drug cretostimogene for the treatment of intermediate-risk non-muscle invasive bladder cancer (NMIBC). Overall recurrence-free survival (RFS) is the trial’s primary endpoint while secondary endpoints include RFS at 12 and 24 months and progression-free survival. In a move not too dissimilar to that of Imugene’s Vaxinia CG Oncology's oncolytic virus cretostimogene is under evaluation in a Phase II trial (CORE-001) in combination with pembrolizumab for the same indication (i.e., bladder cancer).

When it comes to existing treatment for bladder cancer Bacillus Calmette-Guérin (BCG) is thestandard treatment option for non-muscle invasive bladder cancer. Last year, Merck & Co., the only maker and supplier of BCG to the United States, informed the AUA they were experiencing a global shortage of BCG due the growing use and need for this product around the world. The bladder cancer market size was estimated at USD 5.25 billion in 2023 and is projected to reach USD 7.52 billion in 2030 at a CAGR of 4.60% during the forecast period 2023-2030. Bladder cancer occurs when the cells that make up the bladder begin to multiply uncontrollably. BCG treatment is not chemotherapy but a type of immunotherapy costing between $30,000 USD per patients up to $200,000 USD if the treatment is prolonged for up to 5 years.

How much of the bladder cancer market CG Oncology’s oncolytic virus Cretostimogene can capture is unclear at this moment, given it is not even approved by the FDA for widespread administration as of yet.However preliminary results suggest it could fill a void currently inaccessible by the treatment of BCG, as noted herein by the Mayo Clinic in the US.

For high-grade, non-muscle-invasive bladder cancer that's unresponsive to BCG, a new immunotherapy called cretostimogene grenadenorepvec is on the fast track for FDA approval, says Dr. Tyson. Mayo Clinic is participating in a phase 3 clinical trial testing cretostimogene grenadenorepvec.

"We presented data at the annual meeting of the American Urological Association in 2024 showing promising results from a study conducted in patients with BCG-unresponsive, non-muscle-invasive bladder cancer," says Dr. Tyson. "As part of the trial, it's administered once a week for six weeks, and it's well tolerated, so patients don't have many side effects. Then we reassess them for three months, and if they've had a good response, they go on maintenance Cretostimogene for three, six, nine, 12 and 18 months." Preliminary study results showed that out of 112 people who had completed the treatment course, 75.2% had a complete response, meaning that their cancer had not recurred. Eighty-three percent of complete responders who had one year of follow-up maintained their complete response beyond one year.

But whether your oncologist recommends BCG treatment or Crestostimogene in the future, according to Dr Tyson there is much hope for bladder cancer patients. "If you have non-muscle-invasive bladder cancer, you're unlikely to die from your disease, and it's becoming more unlikely that you will lose your bladder," he says. "For muscle-invasive bladder cancer, the landscape has totally changed with EV/pembro. There's a lot of reason for hope. There's a lot of reason to think you can beat this disease.”

So what does CG Oncology have to do with Imugene and their flagship OV candidate Vaxinia? And what is the point in all this information, when it comes to Imugene?

Well, I guess from my perspective to assume that just because the oncolytic virus is not worth much today it is not going to be worth much tomorrow, is a ludicrous assumption. If as predicted drugs such as Crestostimogene and Vaxinia are able to treat diseases such as bladder and bile duct cancer, who knows what the oncolytic market is going to be worth 20 years from now. As an example in the early 2000s before Tesla and now BYD came along the Electric Vehicle (EV) market was worth next to Knicks. Now looking ahead, it is expected that the EV market will demonstrate a steady annual growth rate (CAGR 2024-2028) of 9.82%. This growth will ultimately lead to a projected market volume of US$906.7bn by 2028.

Professor Yuman Fong, the inventor of the Imugene licensed oncolytic virusVaxinia has stated publicly that when his OV is successful in reaching and infecting a cancer patients solid tumour, it works. Therefore it is now a matter of tweaking Vaxinia dosage rates, and ensuring the most appropriate mode of delivery is ascertained for this potent parental version of his 33rd oncolytic virus. To this end Imugene is pursuing delivery methods for Vaxinia with the Imugene licensed Oncarlytics, in addition to third parties such as RenovoRX, to facilitate targeted infusion of the virus to the solid tumours themselves. Professor Fong has long espoused the virtues of his virus stating it has the potential to treat any type of cancer, as it did preclinically. During a webinar on his last visit to Australia Professor Fong noted that even incurable diseases such as mesothelioma have been suppressed by the power of Vaxinia.

Today Imugene’s Vaxinia has an FDA fast track designation to treat patients with bile duct cancer, yet clearly given the initial success in the treatment of gastrointestinal cancer patients during their current and ongoing Phase 1 dose escalation trial of the virus, there would appear much scope for the drug to achieve further FDA recognition. By way of background I note Vaxinia already has produced partial responses for two patients suffering from advanced melanoma, as but one example of the drugs undoubted ability to trigger immune responses within solid tumour patients.

Can oncolytic viruses such as Crestostimogene and Vaxinia and their owners CG Oncology and Imugene blow up to be anywhere near as big as Tesla and BYD are?

Despite the musings of some dare I say it ill informed posters on these threads one thing is for sure, and that is the oncolytic virus market size today is irrelevant to what size it is going to be tomorrow, as the value of stocks such as CG Oncology attest. If I myself were to assume a cynical stance I would suggest that unlike CG Oncology the only reason Imugene (IMU ASX) is worth less than a billion USD currently is that its owners have not had the fortitude of those at CG Oncology to list the stock on the Nasdaq bourse, where most of the worlds biotech investing resides. But that’s for another day. The bottom line is the solid tumour market brings with it rivers of gold for any drug capable of arresting cancer in these otherwise sick patients, who account for approximately 90 percent of all current cancer diagnosis. And from where I sit todays oncolytic viruses unlike those before them, that were either too toxic, or indeed to weak to produce meangful results, are set to make a difference for what is now a huge unmet need.

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