Good afternoon to all
Overnight, Prof Wiedermann and colleagues from the Medical University of Vienna (the inventors of Her-vaxx and the Mimotope platform used to produce it) published an extremely interesting pre-print (not yet peer reviewed) paper describing their research into the development of a B cell epitope vaccine for SARS-CoV-2, and potentially for other coronavirus types as well.
Oooh - a B cell COVID vaccine???
This is early research and the paper itself is for people with a good science background (better than my own), but it does make for very interesting reading. For those who are a bit more science light, my very brief plain English summary is as follows:
1. First some Background - for newcomers:
The B-cell epitope approach to vaccines - as used in Imugene's Her-vaxx and PD1-vaxx - is novel and still undergoing validation. The Vienna team invented Her-vaxx, and they also developed a technology for producing other B-cell epitope vaccines (the Mimotope Platform). They licensed Her-vaxx to IMU, and IMU was granted a licence to use the Mimotope platform to produce other vaccines. Working independently, and without knowledge of each other, Prof Kaumaya at the University of Ohio was also working on the development of B cell epitope vaccines - and he produced PD1-vaxx. When Imugene became aware of that parallel development they did a deal with Prof Kaumaya and he licensed PD1-vaxx and his wider B cell vaccine portfolio to IMU as well. (Prof K has a raft of other B-cell vaccines in development and the Vienna team has an equivalent of his PD1-vaxx, which was originally meant for development by IMU - but PD1-vaxx was more advanced).
Both Her-vaxx and PD1-vaxx have demonstrated "proof on concept" for the B cell epitope approach, with further validation from Prof Kaumaya's B-vaxx product. All 3 vaccines induce a solid immune response. All 3 vaccines are remarkably safe and free of any serious side effects. All 3 are much easier to administer and cheaper to produce than the "mainstream" T cell immunotherapy drugs which they emulate.
However, the jury is still out on clinical effectiveness. We have seen complete and partial responses, and stable disease, but not yet at "slam dunk" absolute "proof that this works" levels.
This could be because the B-cell vaccines are not as effective as hoped, but it is may also be because their method of working is to stimulate the innate immune system of the patient and "teach it" how to attack the cancer. That is a fabulous and exciting concept - but it requires the patient to have a well functioning immune system and unfortunately - because these are new and unusual treatments - the FDA rules required them to be tested initially on patients who are effectively end stage, and heavily pre-treated with chemotherapy. Those patients are likely to have badly damaged immune systems.
Also - the trials to date have been on very small numbers of patients.
There has been endless speculation and at times argument - here on HC - as to whether the B-cell vaccines work well enough to be clinically and commercially successful. I'm sure all of us who are holding IMU shares have been disappointed at the lack of a "deal" so far for Her-vaxx. Some have decided the B-cell approach is a dud. Others (myself included) consider that the proof of concept its strong, and that further clinical results may well demonstrate the clinical and economic viability of the approach.
Of course - the lack of a licensing deal for Her-vaxx tells us that "Big Pharma" needs more proof. It would seem that the B-cell epitope approach is still regarded by Big Pharma as new, novel and insufficiently proven. They have a huge investment in T-cell Manufactured Antibody drugs too, and moving to the B-cell approach would be a big call. We cannot know what for sure discussions have been had to date, but my feeling is that BP is waiting on the sidelines - like us. The new PD1-vaxx trial will hopefully bring us all good news, but meanwhile we are all in limbo waiting to see what happens.
2. The Latest Development:
The paper from Prof Wiedermann and her colleagues shows that they remain confident in the B cell epitope approach to vaccines. I find that reassuring, because they are scientists - and I'm not.
More interesting for methought is the fact that they are now expanding their work beyond cancer vaccines. In fact they are working on a potential vaccine for Covid, and they feel that the approach could work not just for Covid, but for other coronavirus types as well
So why might that be of interest to IMU, or to IMU shareholders?
Well - I don't expect IMU to try and buy a licence for an early stage B-cell epitope vaccine for Covid. It's a fun idea, but the company is firmly in the field of cancer therapy and they have more than enough work to do with the products they already have.
However, it seems to me that the coronavirus vaccine research may further validate the entire B cell epitope vaccine approach. The paper points out a range of potential advantages: better and longer lasting "immune memory." Better prospects of hitting the SARS-CoV-2 virus where it initially gets a hold on the body - ie in the upper respiratory tract. For that reason - stopping the infection early and reducing the contagious period, thereby limiting spread of the infection to other people and reducing "pandemic potential."
The proven high safety/low side effect profile of B-cell vaccines would also have to be a huge plus - particularly given the ongoing argy bargy over the safety of the current mRNA Covid vaccines. (I'm not taking a side on that here - just pointing out the obvious fact that many people are, rightly or wrongly, deeply concerned).
Taking this further than the current mouse model studies described in the paper will require someone with very deep pockets, but we have seen the HUGE profits from Covid vaccines reaped by Big Pharma. omg... Potentially - if one of the Big Pharma outfits took this on - they could push progress very quickly indeed. It would require large sample sizes in a clinical trial - but Covid is a "fast" disease. Trial results for a Covid trial would come much much faster than trial results in a cancer trial.
The benefit to Imugene? IF that happened, and IF it was successful, then we would likely see a rapid re-evaluation by Big Pharma of the B-cell epitope approach to vaccines, and renewed interest in Imugene's B-cell cancer immunotherapies.
These are big IFs of course, and I'm certainly not saying "this will happen."
I am saying that it's an interesting development though, and worth watching, and surely it's a whole boat load more fun than some of the circular arguments that have been raging here on Hot Copper.
Well - that's how I see it anyway. Comments welcome - critical or otherwise.
Best wishes to all - including the arguers, on both sides.
My advice?
Get out there and have yourselves a thoroughly fabulous weekend!!!!
Cheers
Dave
(20min delay)