Investors in IMU have much to look forward in the first half of 2023. Finally the results of Imugene's clinical trials into their immunotherapy viruses and vaccines are set to be announced to the market. It has been a long time coming for many long term holders of the somewhat beleaguered biotech stock, though it may be well worth the wait, as many of the trials reach their climax on and around the same time as one another.
IMU Holders - Five reasons to smile in 2023
Firstly Imugene’s CF33 trial started administering the oncolytic virus to TNBC patients at the City of Hope Medical Research Facility back in October 2021. The first 3 subjects of dose level 1 were enrolled sequentially for safety monitoring. The initial 3 subjects were treated sequentially and the study the followed the Phase I Queue 3+3 (IQ 3+3) design. All things being equal the trial can now be expanded to a dose level of up to 8 subjects after a single DLT had been observed. Then enrolment to the final RP2D may be expanded to include up to 12 patients for efficacy assessment. This is the pointy end of proceedings or indeed the “sweet spot” as noted by Imugene CEO Leslie Chong wherein the trial supervisor Dr Yuan Yuan can determine the efficacy of CF33 in Triple Negative Breast Cancer patients when administered with the optimal biological dose of the virus.
Secondly and indeed similarly Imugene investors await results of HER Vaxx, their B cell vaccine being administered for the first time at its optimal biological dose rate in combination with Merck’s Keytruda. Given HER Vaxx in earlier trials was shown to extend life expectancy in gastric patients over the standard of care by up to 5.6 months, one could well assume when administering the drug at the optimal (i.e., higher) dose rate, the results stand to be even more impressive. Let’s not forget the fact the Imugene’s B cell vaccines are safe and easy to administer. As CEO Leslie Chong notes “The dosing is also so easy. A patient comes in, they get a prick, and they go home. There’s no two hours of infusions. It saves time and resources on both the patient and the hospital.”
Thirdly and no less impressively Imugene’s potent parental oncolytic virus Vaxinia is now proceeding through two dose escalation phases in its concurrent IT and IV clinical trial administered to MAST (metastatic advanced solid tumours) patients. This trial is perhaps the jewel in the crown for many IMU investors when one takes into account The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models. By far Imugene’s most extensive trial to date the study is currently recruiting up to 100 patients across approximately 10 trial sites in the United States and Australia. And from all accounts the Vaxinia founder Professor Yuman Fong is pleased with the results to date and is looking forward to the ensuing months wherein patients in the trial are able to dosed with both Vaxinia and Keytruda (i.e., pembrolizumab), a combination from which he anticipates strong efficacy can be realised.
Fourthly long term holders have not forgotten about Imugene’s successful PD1 Vaxx. Phase 1 PD1 Vaxx trial results were as follows:
Four patients were in the 10-microgram dose cohort, and one patient achieved a complete response, meaning all signs of cancer disappeared in response to the treatment.
Out of six patients in the 50-microgram dose cohort, two achieved stable disease, which means the tumour is neither shrinking or growing.
Finally, four patients participated in a 100-microgram dose cohort, and one patient achieved partial response, meaning their tumour shrank in response to treatment, while two more reached stable disease status.
Now what’s exciting about PD1 Vaxx is that not only has it been shown pre clinically to exhibit signs of efficacy when combined with Imugene's HER Vaxx, it is soon to be trialled with Roche’s Tercentriq. In August of this year Imugene announced of the initial PD1 Vxx trial results “Taken together, these data support further evaluation of IMU-201 in NSCLC.The next steps are to evaluate immune mediated response to IMU-201 and to combine with the check point inhibitor, atezolizumab (i.e., Tercentriq). Having agreed to a 5 year supply agreement with Roche in January of 2022 both Imugene and Roche are sure to be keen to progress the combination further. Particularly when one considers the blow Roche took in May 2022 when their shares fell 6.5%. Back then the news that a combination of the new drug tiragolumab and Roche's established Tecentriq drug did not slow disease progression in newly diagnosed cases of advanced non-small-cell lung cancer when compared with patients on Tecentriq only, hit Roche hard. The news came after the fact that in March tiragolumab had failed to slow progression of a different, more aggressive form of lung cancer. Perhaps now more than ever Roche is looking to Imugene and PD1 Vaxx as a pathway to success in the lucrative immunotherapy space.
And fifthly, but by no means finally CAR T providers may be looking to Imugene as an entry point into the lucrative Solid Tumour market following the 3 poster presentations from Imugene in November of this year at the renowned Annual Meeting for the Society for Immunotherapy of Cancer (SITC) in Boston, USA. As an example Imugene’s CF33-CD19t oncolytic virus (onCARlytics) when targeting hepatocellular carcinoma (HCC) in combination withArtemis® CD19 T cellsresulted in significant tumor killing. Many of you may be aware that to date on their own CAR T cells and allogenic therapies have only proved successful in targeting blood cancers, as opposed to the much more lucrative and prevalent solid tumour market. Surely Imugene is bound to gain a huge amount of interest from the Car T market segment when trials of their Oncarlytics platform hits human patients some time in 2023. Many in the medical research community as far back as ASCO 2022 have been excited by the ground breaking work performed by Imugene’s partner Saul “Cancer asskicker” Priceman M.D’s in the Oncarlytics PSCA CAR T space.
Macroeconomics and IMU
Much was made of a statement in a recent post wherein I compared Imugene’s performance to that of the ASX 200. IMU has fallen up to 12 times more in price than the ASX 200,a factor many believe to be attributable to the macroeconomic doom and gloom that was 2022. Whilst I acknowledge Imugene was susceptible to macroeconomic headwinds I would note that during the third quarter of 2021 as the market began to slow the IMU share price skyrocketed, independent of the prevailing macroeconomic circumstances and market sentiment of the day. Given that up to 50% of investment and funds are by their very nature either index or passive investment managers, stocks tend to overshoot on either the upside or indeed downside as analysts either buy into or sell out of stocks based on their quarterly performance figures. Stocks that aren’t flavour of the month tend to catch a cold must faster than those that are in vogue, often irrespective of the macroeconomic machinations of the day. That said I do acknowledge the role macroeconomic forces played in influencing the 2022 share performance of growth stocks such as Imugene.
We all get it wrong from time to time. Most recently on the third Friday in December IMU took a price hit due to what many thought was “triple witching," i.e., with the expiration on the same day of stock options, stock index futures, and stock index options contracts. As it turned out it wasn’t simply triple witching that brought the selling on, a large player actually wanted to exit the stock. Was it a rebalancing act into fixed interest and cash at the end of the quarter? Was it a move into another growth play? Or was it to meet their end of year liquidity requirements? Was it simply pre-empting a move wherein IMU may exit the ASX leading indexes at some time in the future? We may never know, but what was clear was that on the last day of the month the seller had moved on, leaving IMU in a strong position to recommence the upward trend realised in June of 2022, when the HER Vaxx trial results at the time set the stock alight.
Imugene, the JP Morgan Health Care Conference and IMU Performance
Taken in their entirety one can now visualise the extensive pipeline and vast array of shots on goal the team at Imugene possess. With multiple approvals from the FDA and immunotherapies found to be both safe and low in toxicity there is room in their pipeline for many more combinations with big pharmaceutical firms themselves eager to invest time and money in this profitable space. In the interim with pending results front and centre of investor minds in 2023, there could not be a better time to present at the JP Health Care Conference in early January. In the past analysts including myself have been critical of management for not engendering enough support in the IMU stock. Fellow poster @Merino1 highlighted the lack of meaningful communication coming from Imugene on this thread yesterday when they noted:
https://www.theguardian.com/science/2022/dec/30/man-year-to-live-now-cancer-free-after-immunotherapy-trial
An interesting piece relating to a UK clinical trial. The science is working and this treatment appears to be the new frontier in oncology. Imugene needs to take a leaf from the big pharma playbook… get some real life patient stories placed in multiple media… it gets people talking and searching for the stocks in the sector.
Yet Imugene’s appearance on the Fox News “Trending Today” program and then Professor Yuman Fongs recent nightly news hitout on US KPLC TV are steps in the right direction from a communication's perspective. Whilst one cannot under estimate the impact the forthcoming JP Morgan Healthcare Conference is going to have on IMU moving forward. Insiders at IMU are aware of Professor Fongs statement that his oncolytic virus may one day become “human therapy," however many outside the scientific community would be unaware of the promise Fong holds in meeting the huge unmet need that is cancer. And in particular the potential his virus has to cure cancer through the treatment of solid tumours, which up until now have been untreatable. One can only imagine the interest there is going to be from the US investment community when Imugene presents to this esteemed health care conference in early January 2023.
Imugene did produce strong announcements in 2022. The problem for the share price was that none of these announcement, other than the HER Vaxx OSR data of June were related to efficacy in human trials. As noted above in this post, thats’ all about to change. Imugene is set to evolve from a research and development company participating in annual cancer conferences for the scientific communities benefit, into a dynamic fast paced investment vehicle participating in leading Health Care Conferences for the investment communities benefit. Add to that mix some solid upcoming trial results early this year and you have the recipe for increased awareness, increased demand and an increasing share price. Looks like the perfect storm from where I sit, on Day 1 of 2023.
DYOR - Seek investment advice as and where necessary - Opinions Only
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