Why IMU is a multi multi bagger, page-21699

OV’s, Vaxinia, marketing and musings, by WMHB

There are currently 90 clinical trials either starting or underway utilising oncolytic viruses. Yet despite the influx in this category of cancer therapy T- Vec remains the only FDA Approved oncolytic viral therapy in the US. This is perhaps because oncolytic viruses work through the stimulation of ones immune system, and most trials have historically been performed on patients whose immune systems were shot, due to the extensive treatment already undertaken prior to participating in an oncolytic virus trial. Recent successes in the field including CG Oncology’s adenovirus carry a gene that spurs infected cancer cells to produce an immune-stimulating molecule, promoting attacks by T cells. In essence these viruses enhance ones immune system and in doing so stimulate ones immunity, empowering the virus in the fight against cancer. In CG Oncology’s case the strategy has worked. As noted in my previous post(s) data showed that the oncolytic virus being investigated by Irvine, California–based CG Oncology eliminated tumors in 64% of 66 patients with bladder cancer that didn’t respond to mainline treatment.

The goal is to make oncolytic viruses potent enough to infect and destroy solid tumours, in order to replicate some of the brilliant results evident in animal trials. science.org discusses the difficulty in doing so due to the fact cancer cells are congenial for the viruses because they frequently shut down the first line of defense—known as the interferon response—against viral infections.

Virologist Grant McFadden of Arizona State University notes however oncolytic viruses such as the herpes simplex viruses and adenoviruses that are often modified to make them safer and more potent—can reproduce in tumor cells but not in healthy cells. “They can have major impact,” McFadden says.

Like CG Oncology adenovirus Imugene's Vaxinia is in the race to create an oncolytic virus that is effective in treating solid tumours within cancer patients. Vaxinia is the potent parental strain of Professor Yuman Fong’s 33rd oncolytic virus, known as CF33. Having displayed positive signals in late stage patients whose cancer had metastasised in November 2023, much rests on results from a current crop of patients dosed at the higher 10 parts to the 8 dose of Vaxinia. Trial supervisors are banking on the higher dose increasing the potency of Vaxinia, in order to produce even stronger signs of efficacy within these late stage patients.

There is much riding on the Vaxinia results when it comes to the progression of Imugene’s immunotherapy pipeline. The company has prioritised this therapeutic arm of treatment over and above their B cell therapies, i.e., Her Vaxx and PD1 Vaxx, with a view to being able to combine CF33 Vaxinia with their other therapies, Oncarlytics, and the recently acquired Azer Cel allogeneic therapy. As a consequence many investors have been keeping their powder dry before pulling the trigger to invest in Imugene, sitting back and waiting until the forthcoming Vaxinia results are revealed. It goes without saying that if the soon to be released Vaxinia results are again positive, as they were last November, there is sure to be an influx of capital from the sidelines, as those following the IMU Story have some surety this oncolytic virus is one potent enough to actually work.

The upside for Imugene investors this week was that the company’s cash burn increased significantly, for the first time in a long time, as highlighted by the release of their half yearly financials. Spending money is an important part of any small biotechs strategy moving forward, because data is of the essence, and the only way one can amass data is through conducting clinical trials. Clinical trials cost money, and a lot of it I might add. The existing Vaxinia Trial is set to expand beyond the initial 100 participants gazetted by Imugene to be treated, both here and in the US, due to the Fast Track FDA Approval awarded the drug in the indication of bile duct cancer. A further 10 patients are set to be enrolled within that indication, with a view to capitalising on the complete response announced early in November by Imugene’s CEO and Managing Director, Leslie Chong. Although the market size within this indication is relatively small, Vaxinia has exhibited signs of efficacy in broader gastrointestinal cancer indications, thereby increasing the market size applicable to the drug, if indeed the ensuing results continue to prove positive.

Much is made of the 4 P’s, Product, Place, Price and Promotion, when it comes to marketing products. Immunotherapy drugs are no exception to the rule. In Vaxinia Imugene may well have the right product, given its potency and apparent safety. They would appear to be in the right place at the right time, with regulators in search of drugs to treat the huge unmet need associated with endometrial cancers. We know Vaxinia can be manufactured at a fraction of the cost of existing Big Pharma immunotherapies, including but not limited to MAB’s such as Keytruda, Opdivo and Jemperli. Vaxinia’s ability to scale at a reasonable price, is therefore one of its most appealing attributes. Whilst when it comes to promotion, the Board at Imugene shall no doubt be counting on the upcoming Vaxinia results being good enough for the drug to promote itself. Many investors may be in the same camp, knowing full well product promotion is not exactly the company’s long suit. Either way if the Vaxinia results are bloody good next week, or the week after, with 3 of the 4 P’s in their kitbag Imugene is certain to send some shock waves through the Big Pharma community.

Although to the best of my knowledge there has only been a handful of patients dosed at 10 to the 8 since the companies last announcement, investors shall be hoping that’s enough to highlight Vaxinia’s increased potency at higher dosage rates. Having now had their 42 day scans, these patient results have only to be peer reviewed prior to being released to an anxiously awaiting media. Let’s hope Team Imugene realises the importance of getting these results into the public domain sooner rather than later, to propel the ongoing IMU share price upward in 2024, as opposed to the downward trend so apparent in 2022, 2023. Many IMU investors are still underwater at current prices, and that is something the Board need to change, if they are to stay ahead of the curve in what is a competitive space for investment dollars. Whether its lithium, Bitcoin, AI or the next best thing, cost of living pressures and increased market awareness have meant there are less funds available to participate in the much larger pool of investments on offer in 2024. Imugene must therefore seek to utilise this opportunity to promote the merits of Vaxinia over and above existing oncolytic viruses (OV’s), as Seagen was effectively able to do in the field of Anti Drug Conjugates (ADC’s.) If Imugene can be successful to this end, as Seagen found in 2023, there are rivers of gold awaiting them in 2024. Solid tumours account for close to 90 percent of all cancer diagnosis at present. If Imugene is successful in producing efficacy in but a small portion of this market, then the cost of a ticket to Noosa later this year may well be the least of their shareholders worries.

Best of luck to all LTH’s

DYOR Seek investment advice as and when required Opinions only