I think it’s safe to say that as of today Imugene on the whole is effectively de-risked. Whilst we would like to have suggested this was the situation in late 2021 and even as late as early 2022, the company’s leading clinical trials were yet to either deliver OSR results or commence and move through the critical initial 28 day period without incident.
Today the company’s four pre-eminent drugs have all moved successfully from pre clinical to post clinical status without scientific failure. All have been proven to be safe and exhibit low levels of toxicity. Ethics committees, the FDA and Independent Review Committees as and when required have all agreed to allow the Imugene trials to proceed past the dosing of the first patient in each trial respectively. We now simply await efficacy data on the much anticipated CF33 and Vaxinia, yet are buoyed by the exuberance shown by Leslie Chong, Yuman Fong and other company representatives when discussing these oncolytic virus trials.
The Imugene clinical trials commenced on the following dates:
CF33 0ctober 20 2022
VAXINIA 18th of May 2022
HER VAXX 1 September 2017
PD1 VAXX 1 December 2020
Most importantly now Her VAXX has delivered favourable OSR results the companys B cell platform has proven itself to be safe and indeed efficacious. More recently the fact Vaxinia has moved past the critical 28 day stage since dosing the first patient without incident,ensures the final piece of the de-rsking puzzle has been put in place.
To say the entire process has been plain sailing scientifically is not to underestimate the vagaries faced by both the clinicians supervising the trials and the patient involved. As an example In Imugene’s PD1 Vaxx trial one patient of 10 suffered from immune related pneumonitis after two administrations of IMU-201 and discontinued from study treatment. Pneumonitis whilst not common is a rare consequence of immunotherapy treatment. More specifically pneumonitis is a rare but serious irAE that occurs after therapy with PD-1, PD-L1, and CTLA-4 inhibitors. If untreated it can be fatal though the good news is treatment with corticosteroids is generally effective and results in prompt resolution of symptoms.
Given the scientific de-risking of their existing drugs it’s now full steam ahead for Imugene as clinical trials continue, combination trials begin and more and more patients are recuited. As an example the Vaxinia trial mentioned above is to recruit 100 patients to the existing trial commenced in May of this year. And Vaxinia, like all of Imugene’s drugs is both novel and extremely promising in nature. The City of Hope Org notes on their website when speaking of the trial “Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as CF33-hNIS,” said Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope and the key developer of the genetically modified virus. “We are hoping to harness the promise of viralogy and immunotherapy for the treatment of a wide variety of deadly cancers.”
So if the company is effectively de-risked from a scientific standpoint, what about other investments risks. Well the market risk in the field of immunotherapy is not significant. This market segment is forecast to grow at high single digit if not low double digit Calendar Annual growth rates for decades to come, as patients opt for sustainable methods of cancer treatments that are less prone to side effects than the xisting standard of care. The recent offer by Merck to acquire Seagen for a cool $40 bn USD should allay anyones fears that the market for developing transformative therapies in the field of cancer care is anything but alive and well.
Then what about credit or finance risk. Well it’s safe to say Imugene derisked themselves from adverse financial outcomes and cash burn in 2021 when they made the decision to raise around $95m AUD, placing it on top of their already healthy bank balance courtesy of government R&D grants and option expiries.
Finally to regulatory approvals, have Imugene succeeded in de-risking their business from the problems associated with obtaining Ethics, FDA and territial approvals? The short answer is yes. By teaming up with world leading practitioners at the City of Hope and the Mayo Clinic in the USA, together with Melbournes leading universities and hospitals Imugene has successfully obtained health and governemnt approvals as and where necessary. Whilst independent review committees (IRC) have continued to recommend and support the ongoing development of Imugene’s vaccines at every turn. The Her VAXX IRC even went as far as to cut the clinical trial short saying it would be unethical to continue as was in light of the encouraging Her VAXX safety profile when contrasted to that of patients receiving the existing standard of care in the Phase 2 trial. Meanwhile having been granted long term patents for their drugs throughout South East Asia, in Europe and America it’s safe to say the company has been sufficiently de-risked from both a marketing and regulatory perspective.
I for one was waiting for the final roll of the dice, that of the Vaxinia trials initial phase to run it’s course before I could safely open a good bottle. Yes the Her VAXX OSR results were reason to cheer. But now with the companys potent oncolytic viruses proving safe in humans the de-risking process is a fete accompli from where I sit. There was always the risk these viruses would not prove as safe when administered to humans as they did in pre clinical trials conducted with mouse models. Yet given the CF33 trial in patients with triple negative breast cancer patients has been running since October 2021, I think we can safely put that risk to bed.
The company is effectively de-risked. But what does that mean from an investment perspective? In essence it should mean now is a great time to invest. The upside or blue sky is dependent on a combination of macroeconomic forces, market volatilty and the continued success of ongoing clinical trials, together the weighting big Pharma gives to the combination of CF33-CD19 and Imugene’s soon to be released oncarlytics exploratory data. Though now the company is effectively de-risked from a scientific, market, credit, finance and regulatory viewpoint, there is very little downside for those choosing to invest over the longer term. Although markets look further and further out for potential upside in the ever lucrative biotech sector, there is always one foot on the brakes until drugs jump through the initial post clinical hurdles outlined above. And I’m pleased to say Imugene has done so in style.
Best of luck to all long term holders and everyone on this thread. DYOR my opinions only.
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