PD1 Vaxx - 2020 and beyond - 1,000 days in the life of a drug
It's interesting looking back at this announcement and in doing so review Imugene's performance during the 1,000 days Imugene's PD1 Vaxx's trial recipient has been free of lung cancer, as noted in this announcement on September 12, albeit against the backdrop of another patent approval, this time in Japan. Upon reflection I see the whole PD1 Vaxx journey as a complete failure in that Imugene has missed an enormous opportunity to grab Professor Kaumaya's bull by the horns and drag it kicking and screaming forthwith into as many patients as is humanly possible. Why oh why Imugene did not out source, scavenge and seek an accept an upfront payment from a marketing bohemoth after the initial phase 1 trial results and use their subsequent monetary instalment (however small) to push then push some more into a full scale phase 2 trial for PD1 Vaxx is beyond me. Many other small biotechs before them have successfully trodden that path. For here we are 1,000 days down the track with little to show for the initial partial and indeed complete response achieved by the drug. Given most phase 2 trials take on average about 2 years to complete, with approximately 100 patients, where are we today? Well to put it bluntly we sit on phase 1 results (i.e., with fewer than the typical average phase 1 patient enrolment number of 20 to 100 patients), and short of any phase 2 results to speak of for the drug. Many on these threads point to the fact when it comes to clinical trials things take time, and Leslie Chong is forever saying Imugene's mission is to move at rapid speed. But are they? Can they, given their current funding and lack of distribution networks or big pharma clout? Clearly not.
I can't help but think given the patent cliff facing PD1 Vaxx contemporaries Keytruda and then Opiva, were Merck or Bristol Myers behind the Imugene wheel PD1 Vaxx would be just about to wind up a large phase 2 trial and be approaching the gates of the FDA for fast track approval into the market place beyond. In 2021 Imugene's refusal to go all out and secure a partnership orout licensing agreement for this clearly exceptional immunotherapy has left me, and no doubt many other shareholders scratching their heads. Meanwhile the Imugene BOD is scratching around trying to raise $18 million AUD from a bunch of local Aussie punters fed up with the lack of commercial direction and therein results for such potentially ground breaking drugs. Just for the record Keytruda, a competitor to PD1 Vaxx (albeit with significantly more side effects), has earned over $50 billion USD in the 1,000 days since Imugene's Phase 1 lung cancer patient was given the all clear.
Irrespective of what anyone thinks or says if I was in Professor Kauyama's shoes I'd be disappointed in the time Imugene has taken to develop PD1 Vaxx, given the promise shown back in 2020. Given the first patient was dosed in their small phase 1 trial in 2020, 3 years later and Imugene is only now dosing the first patient in a phase 2 trial. I won't use this platform to contrast the speed at which Big Pharma is progressing from phase 1 through phase 2 trials suffice to say the average time taken to complete a phase 2 trial is approximately 2 years at present, if not a bit less for the big boys. And here we are well over two years later in PD1 Vaxx's journey and just kicking off with how many patients thus far? Who knows...
Short of continually going back to the Bell Potter well things could have and should have been done a whole lot faster, with a bit more support from a major suitor to kick things along. We could have been deep into Professor Kaumaya's other masterpieces, had deeper pockets held the reigns. It's starting to look like the country town parents endeavouring to go it alone, as their next generation is heading for the cities. Imugene needs to get on their bike and start to make things happen, before the world outside continues to pass them by. That said, as Waren Buffet once noted “In the business world, the rearview mirror is always clearer than the windshield." In addition Buffet is famous for noting "Price is what you pay. Value is what you get." In other words don't focus on short-term swings in price, focus on the underlying value of your investment. I guess Imugene's BOD shall be wishing the latter holds true when we meet this November.
At this stage I'm confident those left standing are leaning on the adage that “Time is the friend of the wonderful company, the enemy of the mediocre,” but I'm confident in saying most can't stand up for much longer. I keep thinking one tenth of something is better than 100 percent of nothing, and had Imugene pulled the trigger on one tenth when it came to PD1 Vaxx in 2020, that could be worth a hell of a lot more that the 100 percent we hold today. But as with all things Imugene, I stand to be corrected.
DYOR Opinions only
p.s How many other late stage lung cancer patients wish they could live for 1000 days cancer free? We won't know now until 2026, but I'm thinking there may have been a few takers back in late 2021.
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