Well what a week, and lots of new information to digest.
Key take ways for me.
·The CF33 virus aka Vaxinia aka Checkvacc with further applications in onCARltics is the real jewel in the crown. If even a 1/10 of what is hoped for comes to pass, we should all see a decent return on investment regardless of one’s entry price.
·B cell and Hervaxx has moved to the back burner somewhat.
On B cell and Hervaxx. There may let still be a commercial outcome for Hervaxx but I believe it will entirely rest upon the outcome of the current Next Herizon Trial. Having dug into Hervaxx the past two years I’ll summaries my view on where it is at.
In this cohort of patients, one’s expected life expectancy is 8.5 months with the current chemo treatments. The original Herizon trial quoted stats look great on paper but there is some devil in the detail.
First issue, only 19 patients received Hervaxx in the phase 2 trial as it was terminated early. The data has been defined as “statistically significant” with a P value of 0.05 (5% chance it was a fluke). But if you were to pay hundreds of millions of dollars, if not billions of dollars. Double that again, plus your time to bring it through phase 5 trials and a commercial realisation. Personally, I would like more than 19 individuals in my data set.
Second issue is how one interprets the data. Overall median survival was 14 months. Looks great next to 8.5 months, but the real kicker for Hervaxx is something called the “Plateau of survival”. I believe if not mistaken 3 patients who received Hervaxx are still alive today many years after their defined 8.5 month period, and this is what we call the “Plateau of survival”. In approximately 25% of patients who received Hervaxx it was able to trigger a large enough immune response to either stabilised their disease or in one patient’s case be completely cured. If you are the lucky 25% you’ll likely live for 5 years plus. Though if you are in the 75% your life expectancy is only an average of 6 months better than the chemo group. I figure it was Imugene’s hope that the “Plateau of survival” would have been higher at say 50% to generate the interest and investment required.
By all accounts the Herizon trial was not a bad result. My hope is that the Next Herizon trial at double dosage of Hervaxx will trigger a larger immune response and get more patients into the “Plateau of survival” whilst dosing a further 30 patients increasing the data set and lowering the P value.
As to timing on Hervaxx, a lot more patience is still need. Primary completion date is now 31/03/24. You then require a further 6 months for the chemo and Hervaxx data to differentiate. That puts us to September 2024.
On the flip side Vaxinia is by all accounts moving at warp speed. Hopefully we’ll have phase 1 trial completed with interim data released by Christmas.
The share price action on Friday perplexed me. I was really impressed by the quarterly update and what has been achieved. The company continues to tick off key milestones without any major missteps, and they appear to be managing their costs very well. Approximately they are spending $30M a year after grants and rebates. They have $150M in the bank with a very clear runway to achieve outcomes on all five technology platforms without further capital.
That’s all from me, wishing everyone good health.
The above are my opinions only and do not constitute financial advice. Investing in shares carry inherent risks. Please research carefully before making any decisions, and seek professional advice if you require it.
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