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The gap between the last batch data and the IND submission I would imagine is going to be relatively short. I should think it is written at this stage and it is a matter of dropping PQ3 batch data in and filing. Wonder when we will find out about the new partners and which programs they will be partnering J&J for HIV would be fantastic- although partners (plural) were mentioned..

that is sounding shlightly more upbeat :)

no worries SocialistB - I honestly think at some stage big pharma wont be thinking is the risk reward profile right to get involved but whether they can afford not to get involved as this is potentially quite disruptive. I would be surprised if Vlad hasn't seen any of the in-vivo data at this stage but as I have said before that would be a big signal if this works in test animals. If this can also be developed to treat cancer and resistant bacteria it is even more of a head scratcher.

Initially when I heard about the CBR approach I thought that the patient population would be limited due to the technology being a cell based approach which would mean very high cost treatment in specialist centers that would be probably limited to the US/EU Japan and a scattering of other countries and for patients that are critically ill or exposed to some rare virus. It is a huge logistical nightmare using a cell based approach because you would have to take the patient blood samples transform with recombinant CBR freeze and supply back to the hospital for treatment. Or develop an off the shelf allogenic CAR-M which would probably have graft versus host issues like the current allogenic CAR-T products. However, the new piece of information that makes me believe this is possible at scale is the BMR - Bait macrophage engager. This could be a fusion protein containing viral receptor bound to a protein that engages the macrophage endocytic receptor for endocytosis and processing by the cell. The significance of this is that this protein could be made through the existing bioproduction techniques at industrial scale and truly be an off the shelf injectable treatment for virus X. Pretty amazing.

Its a bit of a headscratcher - how do you you put a value on an antiviral product that has a patient population of crica 8 billion most existing treatments focus on either inhibiting the replication of the virus or blocking binding sites/ integrase inhibitors etc most are partially effective or manage the disease state (anti-HIV drugs) but you only have to name a few of those to get an idea of the potential market:
Gilead - Sovaldi -Anti HCV - peak sales $10.3 billion per annum
Merck - Molnupiravir circa $5 billion sales this year
Pfizer - Paxlovid : sales to top $30 billion this year
https://www.fiercepharma.com/pharma/paxlovids-sales-ascent-cant-last-forever-globaldata-says
Global anti-HIV market circa $30 billion
all this from 3 viruses - there are another 50 or so clinically significant viruses - If Hemogenyx can demonstrate that their new approach is effective I couldnt even project what sort of value could be attributed to this.

It was HFH....:

"I posted earlier saying I believed this was a once in a lifetime opportunity and I’m pleased to say I now have permission from Hemogenyx to update you all on the following:

* CDX is progressing well and Hemogenyx are working with one of the leading global pharmaceutical companies in the world to take it forward to IND.
* CAR-T is also progressing well and PQ3 results will be announced within the next 10 trading days with IND following shortly after. It’s important to note that if no questions are raised by the FDA in 28-30 days Hemogenyx immediately became a clinical company.
* CBR The absolute jewel in the crown, and why Vlad is so excited! At present Hemogenyx are testing CBR on multiple viruses, one of which is Covid. This includes ALL variants including the latest strain from China. With vaccines being nearly 70% less effective it is quite possible Hemogenyx will be first to market with a cure. Vlad is VERY bullish on this becoming a real paradigm shift in the world of treatment for viral diseases. In fact Hemogenyx believe CBR will become the Microsoft of the pharmaceutical world.
I am told large investors are buying, the biggest of pharmaceutical companies are interested in getting involved in progressing CBR and Institutional Investors are on the sidelines waiting for the opportunity to buy in. How do you put a value on the above? Certainly I’ve set a new target this year and that’s between 50p and £1. Not without risk and a lot of work to do, but I’m holding ALL my shares for a long long time. GLA"

Or on the NYSE Euronext?

Who knows though might be sooner- there is an accelerated route for patents which in theory CBR meets the scope : https://www.uspto.gov/patents/initiatives/accelerated-examination#:~:text=The%20USPTO%20has%20established%20procedures,under%20the%20accelerated%20examination%20program.

think normally 18M for patent so should arrive Q2 /Q3

It is nice to see positivity on here replacing the incessant trolling of the last 2 years. Personally for me I am looking to see the animal in-vivo data for CBR because in my opinion and because of its mode of action, if it works in animals it will work in humans. Those results would confirm to me we are not just talking about millions any more but at the very least 100's millions. With early stage CAR-T's being picked up already in 2023 for the 100 million mark it could be the perfect storm - Excited to find out and wont be selling anytime soon - Best of luck all. H

Was a good point Chris - I am thinking that a structured deal may be more likely on the car-t / bispecific antibody at this point : I have seen more and more of this for early phase assets where a nominal upfront payment (Xmillion) is paid with mile stone payments coming at IND approval, through the stages of clinical trials and for BLA approval and commercialization (royalties on sales). Deals tend to get done earlier in the oncology space because it is so competitive. Fingers crossed and I am inclined to think along similar lines.

Interesting article from Penn State seems to back up what hemo are thinking for the use of CAR-M thought I would share: https://www.pennmedicine.org/news/news-releases/2022/january/first-in-human-trial-with-car-macrophages-shows-the-cell-therapy-safe-feasible-for-solid-tumors#:~:text=What%20Are%20CAR%20Macrophages%3F,for%20example%2C%20anti%2DHER2.

North or South? I have an office in Dublin - Could have an Irish arm to the celebration?

The best part about this approach is that it targets the very thing that makes viruses infectious - all viruses target a cell surface receptor to gain entry into the cell. After gaining entry they commandeer the host cell machinery to replicate. If the virus did not have the ability to bind the receptor it would be ineffective. BME's are even more exciting because potentially these dont involve cellular engineering presumably - small protein with part receptor part immune engager - this lends itself to being made at very large scale whereas the cell based therapies represent a huge logistical challenge if individual patient apheresis is required.

"Major advantages of our CBRs and BMEs for combatting viral infections include:

(1) the use of a "bait" makes CBRs and BMEs insensitive to mutations of the targeted virus, preventing the development of resistance (unlike antibodies); as long as the virus is infective and uses the same "door" to enter a cell, it will be eliminated by CBR-based treatments. The bait resembles a handle of the door that the virus uses to enter a cell.

(2) CBRs and BMEs are assembled from parts of naturally occurring cellular receptors and/or engagers that are responsible for the function of immune cells and endow the host's own immune system with the ability to destroy invading pathogens.

(3) CBRs and BMEs are modular synthetic receptors and/or immune cell engagers that can be reconfigured rapidly to attack almost any virus. It is important to stress that this new technology also works in cancer, on malignant cells. This work thus strengthens the Company's anti-cancer work, and importantly opens up many opportunities to work with public bodies, such as the military, the National Institutes of Health, the Biomedical Advanced Research and Development Authority ("BARDA"), as well as other leading public health-focused foundations."

dhub - IND is a submit and wait 30 days for objections - If no objections clinical study may proceed if they have discussed the right things in the pre-IND meeting and listened to the feedback there shouldnt be any objections.

apologies for the emetic effect their Sscott234 - I will try to be more miserable in my future posts

It was the mice that lured me in originally - A mouse with an entirely human immune system is a pretty unbelievable development tool for projecting what will happen in humans - (if it works in the mouse model then it has a very good chance of working in humans) and of course we know that CDX does work in the mouse model. However biologic drugs are very expensive to develop so Hemo switched to developing a CAR-T based on the same technology because the financial burden is much lower to gain proof of concept. The CAR-T alone should provide the financial run way to develop the CDX to a point that big pharma are interested. The potential antiviral baited -immune cell (CBR) if it works in-vivo is a game changer in my opinion because it can be adapted to treat any virus. Could be the cash cow that keeps giving - Anyway I am please to see that the long termers are getting something to smile about and it is refreshing to see a bit of excitement on this board -long may it continue.

Totally agree- especially if it works in-vivo it could be huge.

It would be timely to receive an update on Hemo's CBR technology and the results of the in-vivo testing. We are almost a year on from the proof of concept RNS - You never know, Vlads comment about "exceeding all expectations" could be related to this : https://www.lse.co.uk/rns/HEMO/cbr-update-fywrltwvmef20hc.html

yes potentially it does look like a multimillion/billion pound operation - they have already been given the go ahead to work out of their facilities for Hemo-car-T - most of the manufacturing risk is already taken away in my view: the only question for me is whether or not what the product is efficacious in clinical studies which we will know shortly. I have been involved in due diligence (risk assessment) for acquisition of entities from small cap companies from a chemistry manufacturing control perspective and many have not looked too dissimilar to hemo including one that the company for which I work for company paid in the Billion range for a product undergoing phase 3 studies in AML - not more than 20 working in the acquired company many of whom became multimillionaires when the acquisition went through due to their share holdings. The point being it is absolutely about the science not about the facilities or anything else. Acess to money is always a hurdle but if you get get the science right and the rest will follow.