Member Info for Haywain

Sir Marc Feldmann "In summary, we should say that the considerable potential breadth and versatility of CBR has become increasingly evident over the past fifteen months, and evidence of its practical viability has been considerably established. It is not too much to say that CBR, which we always considered to have great potential, can now be seen as possibly revolutionary, now that its widespread probable applicability to difficult or presently untreatable conditions is being established in multiple preclinical studies" - I am here to see Hemo-CAR-T and CBR come to fruition, however long that takes.

A chimeric goose-pheonix

Well done Hikki - I cant read most of this tripe. Looking forward to the next update!

The bait terminology is applied to the antiviral solutions CBR - chimeric bait receptor which appears to be the direct manipulation of macrophages to express viral entry protein ie what virus binds to to gain entry into the cell - thereby giving macrophages the ability to directly bind and destroy the virus while processing and informing other immune cells. BME bait macrophage engager appears to be a macrophage engaging protein attached to the bait viral entry protein - so instead of directly engineering the macrophage it is one step removed - virus binds bait then macrophage binding arm binds macrophage receptor. CMR - looks like directly engineering macrophages to express an ScFv (engineered binding domain of an antibody) which is raised to bind a specific tumour antigen. AME is one step removed ie a protein with an ScFV binding domain on one side and a macrophage engager on the other (or mRNA which is the template or set of instructions for the cells to make the protein themselves). - see diagram https://hemogenyx.com/technology/ although I am not sure if the headers for this diagram are mixed up re biologic and cell based therapies

Yes - CMR: Chimeric macrophage receptor, CBR: Chimeric bait receptor, BME : Bait macrophage engager, AME: antigen macrophage engager

Ha ha, Well, Chris, you've certainly taken us through a quantum leap with that explanation! Just when we thought biomedical acronyms were the toughest nut to crack, you've woven in the fabric of quantum theory, threading through entanglement with the ease of a Schrödinger's cat straddling worlds. With each mention of "absolutely maximally entangled," you've not only entwined particles but our minds, leaving us in a superposition of both understanding and bewilderment. Now, if only unraveling the mysteries of Disease X were as straightforward as a quantum entanglement puzzle!

Ok ignore that - found explanation https://hemogenyx.com/technology/

There appears to be a few programs that I was not aware of - 9 development programs including (1) Hemo-CAR-T (2) CBR/CMR tumor X (3) CBR/CMR Tumor X, (4) CBR -SARS 7 Disease X (5) CBR undisclosed target CDX (6) CDX bispecific for R/R AML conditioning (7) BME/AME - undisclosed targets for Tumor X (8) BME/AME - undisclosed targets for SARs Disease X (9) BME/AME undisclosed target for disease X. The last three are unfamiliar to me particularly the AME part - anyone know what that stands for ?

It is the same article but posted through multiple media outlets - "This is money" also posted the same article.

Hi Diggit, In some cases, a single dose of CAR-T cells can lead to long-term remission especially in blood cancers like certain types of leukemia and lymphoma where this treatment has shown promising results. However, not all patients achieve complete remission with one infusion and may require follow up infusions. In terms of time frame to be able to measure an effect I presume there is some allometric scaling to be completed from the animal studies but I wouldn't imagine the timescale would be dramatically different - as a reminder measurements were taken from the engrafted mice at 18 days post treatment where they observed a dramatic reduction of FLT3 positive cells. In addition these patients associated with the trial will be placed on long term monitoring to understand the duration of effect as well as any side effects of treatment.

To be honest I am not really sure about the 30%. being pedantic you cant divide 100 by 3 and get 30%. Does that mean safe in all 3 (or at least manageable side effects) with 1 showing signs of efficacy would equal success? That is kind of how I am reading it. Also the definition of success is important because we don't know the end points of the study -n of 3 is normally the minimum from a statistical point of view that you would select for very early stage feasibility it may not be the number of patients required to meet the clinical protocol end point. So my take is that the n-3 could provide initial proof of concept in humans which if successful (1 out of 3 showing efficacy) may be enough to access the non-dilutive funds mentioned to complete the phase1/2a study in a total of 18 AML patients. At that point the efficacy in patient population would be further understood and if Hemo CAR-T does show signs of efficacy then it would significantly de-risk the program and open doors to the big numbers that were mentioned in the article that pharma companies will pay for CAR-T products in the oncology space.

Wasn't much of an apology Stu - no matter I didnt want an apology because I really am uninterested in what you have to say was just curious whether it would be provided - Fair do's, you have marginally gone up in my estimation. If you are implying that I have some sort of relationship with Hemo other than an investor you are wrong . I do however have 22 years of experience working on biologic products and the regulators (FDA included) mostly in rare oncology indications so call it what you like - educated guess

Are you still offering a full public apology Stu for your previous rounds of scare mongering and that FDA didn't share your opinion regarding the risk/benefit assessment of autologous CAR-T therapy in terminally ill patients?

"Haywain,

How could the FDA hold Hemo’s solution when presently they have no definitive conclusion on this particular risk with Car-T ?

Don’t be so obtuse and patronizing to the many others here less informed!

Let’s see what the FDA March meeting concludes.

I presume you will offer the same as i , a full and public apology should you be wrong and new FDA requirements become apparent?

AIMO"

It wasnt me who found it - Forwarded on by a certain poster who is currently absent from the chat forum - But thought I would share

Fact is one, two or three patients may well be enough to garner significant interest depending on the outcomes - So I read it very positively.

This is an interesting excerpt - perhaps helps to explain why Hemo have achieved what they have on such a shoestring budget"The entre was provided by Professor Carl June, the ‘father’ of CAR-T, and his colleague, Dr Saar Gill, who was involved in the preclinical research on HEMO-CAR-T.

On the university’s involvement, Sandler said: “This isn’t a situation where we’ve paid [UPenn] to carry out the work. They don’t work like that. All along it been data driven.”"

Https://t.co/4skCYtLwUl

Good summary PJT in the link - Thanks I enjoyed that.

In fairness shareholders wont know that a deal has been done until it is RNSed - It will come out of the blue like the prevail investment at 6p. It may not happen to the time frame that you want but if the products are good it will happen. No amount of ranting on here is going to change that. Hemo are funded and have approval to initiate clinical studies for their CAR-T program which puts them in a good position to negotiate.

Well one thing is for sure if big pharma are sniffing around now - They will get a better deal now than if we had already started dosing patients. I agree that Milestone payments would seem the best approach. In the case of CAR-T Big Pharma companies are keen to invest early to secure promising technologies that could lead to breakthrough therapies, despite the risks associated with early clinical stages. So I am inclined to agree OrthyB some entity may show their hand before the first patient receives treatment.