Member Info for Haywain

Interesting article on CAR-T manufacturing for those that want to understand the complexity/timelines associated with generating suitable clinical material - one would imagine a lot of this work will have been complete but needs to be replicated under GMP conditions with the production strain lentivirus. I am more familiar with protein based biologics rather than CAR-T so it was an interesting read: https://www.sciencedirect.com/science/article/pii/S2372770516300390#bib60

that is correct - file IND wait 30days answer any questions FDA may have in the window if resolved study may proceed

I still think that this will be a CAR-NK approach with a chimeric bait receptor - The novel piece is the bait receptor because traditionally scientists have approached the problem the other way around looking for molecules that would bind the virus rather than using the protein that the virus binds to as a molecular trap for the virus to be destroyed by the NK cell. The part that I dont understand is how this works on a cellular level ie how is this used to kill cancer cells or virally infected cells other than be the traditional approach of designing a chimeric receptor to search out specific markers expressed by the cell (which wouldn't be new or seminal)? There is some evidence that NK cells can perform a regulatory role at the the interface of the innate and adaptive immune system informing the adaptive immune system through the regulation of dentritic cells, priming T1-helper T2 helper cells and ultimately CD8 cytotoxic T-cells which would then specifically target virally infected cells - which is something that couldnt be proved in-vitro- I guess with my rudimentary immunology understanding I will just have to wait a year and a half to read the patent.. Would like to know though if anyone has any thoughts on this?

Makes you wonder if this is what Dr Walts was brought in for around the potential government/military grants / negotiations for virus X uses of the platform

The fact that it is novel and as far as they are aware nobody else is working on similar technology and that it will work on any virus within a given class and that there is a viral bait mechanism is very interesting - sets the mind boggling : from my understanding of immunology , the immune system normally goes after the virally infected cell and not the virus itself. viruses have mechanisms of hiding the virally infected cells from our immune system. It seems to me the only bait I can think of that would not be strain specific would be the viral entry protein for spike protein recognition - ie in the case of covid ACE2 recptor - What if they had engineered an Immune cell to carry a part of the ACE2 receptor to attract viral binding of covid directly to the immune cell (which cell would fit the bill?) - when the virus is bound, it is phagocytosed and parts of the virus are displayed to inform the adaptive immune system - Just a thought : but seems to match the clues from the RNS - any immunologists on here that could shed any light ?

doesnt put a ? on hemos stance at all - you are referring to a drug much later in development with phase 3 data applying for an NDA which is a totally different situation. The drug is a checkpoint inhibitor and not a car-t.

Must be a very recent change to the process as I went through the old process a few months ago with a different development project. But regulatory agencies are continually looks for ways to improve their processes so it is possible especially for oncology products in the rare disease sector.

or just provided a written response to the companies questions - they dont always agree to the meeting if the questions are straight forward

I had thought it would be car-NK too I believe Vlad has spoken about car-NKs in the past

seems like there is precedence for using this piece of kit to generate material suitable for clinical studies: https://bioprocessintl.com/bioprocess-insider/automation-the-only-way-to-truly-scale-cell-therapy-manufacture-says-lonza/

he has counted the number of cells in his bioreactor

GLOBALLY TRUSTED: Partners in more than 42 countries, representing the complete spectrum of life sciences—from research laboratories and biotech startups to big pharma
VALIDATED: There are more than 140 Selexis-generated research cell banks being used for clinical programs and eight marketed products in cancer, autoimmune/inflammatory and metabolic/genetic disorders
FOCUS ON INNOVATION: 210 granted patents that cover innovations in genetic elements, procedures/ transfection, cell line engineering, and devices related to cell line development and protein expression
RAPID: Can move from transfection to banking of a high-expressing and stable production-ready research cell bank in as little as 8-12 weeks depending on cloaning strategy

not quite as double the amount of shares have been printed n the interim - peaked out around the 50M mark

Share price and cost of development - Speaking of which if I were Hemo I would be filing an ODD application for the CAR-T program sooner rather than later which would waive some of the application fees -this can be agreed with FDA upfront (90 day turn around) before filing the IND and if approved would grant the following:
Potential Pediatric Research Equity Act (PREA) requirements exemption
Waiver of the marketing application user fee
Tax credits and research grants for qualified clinical testing expenses
FDA protocol assistance

IMO of course

Sorry CBR

I think (albeit speculation) the CDX may be related to a CAR-T or CAR-NK cell treatment for viruses as there is interest in chimeric antigen receptor T and NK cells as potential antiviral treatments for various viruses. Some form of platform tech that could be rapidly manipulated to provide emergency treatment for virus X..

Could you point me in the direction of the instructions as to how to join the AGM electronically? many thanks, H

Skip to 8.40 if you want to understand the market size: https://www.youtube.com/watch?v=6kG7G_Hwo9U

Correct - 30 Day review period for IND submission : I am working on several at the moment. My experience is that the management teams from big pharma are particularly risk adverse and would rather pay multiples for a sure thing rather than a pittance for a 75% sure thing from a safety quality and efficacy perspective. This is of course dependent on the stakes and the market. For hot markets of which AML is one then you tend to see lots of competition for early stage showing promising results. Actually AML is one of the markets I am personally involved with hence my continued investment in Hemo - this is one of the most impressive solutions I have seen having followed this space for 20 or so years.

I have a couple of friends who work in Regeneron - I have worked in the pharmceutical industry for 20 years developing biopharmaceutical drugs some of which overlap with the indications that Hemo are working on: personally I find their work extremely interesting. All development programs carry risk and need financing but the strength of the ideas and caliber of scientists involved makes this a very interesting long term prospect: the science is sound and the potential is huge.