Member Info for Haywain

Correct Chris - thankyou for putting it more eloquently than I did.

As for the share price it can do what it wants - I am only interested in the data : if data is good all of this is irrelevant it will find its price and that judgment wont be made by any of us on here but by Hemo's industrial peers.

I have already provided my thoughts on this - The fact that we are now 2 weeks post infusion with no adverse events being reported significantly de-risks saftey related issues in patient 1 - Most AE's occur within this window because peak CAR-T expansion has already occurred the adverse events are immune mediated and related to expansion of CAR-T. What you cant account for with a n of 1 is patient specific factors but its a bloody good sign thus far on the safety front fingers crossed it is just as efficacious as the preclinical data suggests it will be and the patient is provided a new lease on life on to patient no 2.

The typical adverse events associated with CAR-T treatments are now de-risked as the vast majority occur early post infusion of CAR-T cells up to approximately 2 weeks into the cycle which means at least for this first patient Hemo CAR-T is safe - Only question remaining patient specific factors and all importantly markers of efficacy - 14 day sample is approaching and then the all important 28day sample. My bet is significant efficacy as was seen in the pre-clinical model.

First 3 patients - 28 days + time for lympho depletion of next patient (4-5) days x3 from the 28th day of the third patient it moves to biweekly between lympho depletions in subsequent dose cohort - is how I understand it

No worries - I agree

It targets a unique epitope on FLT3 that does not compete with FLT3 ligand binding or genetic mutations of FLT3 commonly observed in rrAML which means it is therapeutically applicable to all - yes

Its a foregone conclusion that this would meet the criteria for orphan designation and probably for Faron - don't know because I haven't looked at their product- But the application costs money and it doesn't buy you any advantage until the registrational stage of the application.

HFH - I was aware that Hemo CAR-T is third generation and may have posted about it recently. The additional safety it offers is because of the co-stimulatory domains 1st. Gen and 2nd Gen have single stimulatory domains. The benefit being you see a more controlled expansion of t-cells : CRS and ICANs the main AE’s associated with CAR-T are inflamatory mediated events which appear to be related to how quickly the T-cells expand ie rapid unrolled expansion leads to higher probability of CRS and ICANs events. The other benefit of a third generation CAR -t is that it also appears to persist a lot longer than gen1 or 2 CAR-Ts & therefore is associated with superior anti-tumour effects.

No offence taken Micky & appreciate I may be a slight outlier.

Mickey - you can think what you like but this is certainly more that a purely transactional investment for me having been involved in trying to develop biologic drugs for cancer for years. It is however, serendipitous that what is good for me financially is also good for the patient. I um unsure about any timing of a potential deal with big pharma but know that Hemo will be approached if the data in human reflect the preclinical data. It all depends on efficacy how quickly it happens ie if we see CR’s in first dose cohort that increases the probability of a deal sooner rather than later IMO.

Https://x.com/nifty_nudger81/status/1895802764070175051/photo/1

Does this mean that the day 7 blood work has been done….

I would view Hemo CAR-T success to substantially de-risk CDX : it is almost proof of concept in human for CDX - Hemo CAR-T uses the same ScFv antibody binding domain to CDX - CDX is a bispecific antibody one arm binds FLT3 in exactly the same way as Hemo CAR-T the other arm binds CD3 a protein complex found on T-Cells signaling T-cell engagement and attack of cancer cell- so in effect it is one step removed from Hemo-CART. I honestly wouldn't be surprised that if there is commercial interest in HEMO-CAR-T following phase 1 data readouts that whoever is interested in CAR-T will want to buy CDX aswell as a package - not sure they could afford not to given that it could directly compete. I would value CDX higher than Hemo CAR-T because it is an off the shelf option but would view them as complimentary therapies.

My guess would be BMS - look at the molecular targets for the two Kure.Ai CAR-T's - BCMA and CD19 could be just coincidence but this aligns perfectly to BMS commercial CAR-T's Breyanzi and Abecma for the treatment of B-cell malignancies. Kure Ai have 3 current programs one of which is Hemogenyx. Most companies investing in CAR-T technology are looking to reduce the length of time that manufacturing takes so I wouldn't be surprised if there is a link to BMS via Kure-A.I - Also believe Kohen Van Besien was involved in Kure.A.I clinical studies - https://ashpublications.org/blood/article/144/Supplement%201/94/530351/Phase-I-Study-Results-of-UF-Kure19-a-CAR-T-Product.

I appreciate that Hemo has been a hard share to hold over the years but the fact that we are now treating patients with rrAML this is what all of the efforts over the years have been about getting new treatment options to patients that need it. If Hemo CAR-T does what it is designed to do then no amount of trading will be able to control the trajectory of this share. Not long to find out.

I certainly put the odds of success higher than 50:50 and so does MD Anderson otherwise I don't believe they would have approached Hemo wanting to initiate this trial. Are there risks - yes there are - are most mitigated? yes they are. There is a carefully considered dose escalation in subsequent cohorts and M D Anderson are one of the foremost experts on CAR-T and the management of potential side effects. I wont put a number of the probability of success but it is certainly higher than a flip of a coin.

Yes he is describing triplicate treatment of chemotherapeutic and FLT3 inhibitors in the various different sub mutations of FLT3 -ITD and FLT3-TKD on overall survival etc CAR-T is way more specific and the recent sentibio - Anti-FLT3 CAR-NK complete responses, validates FLT3 as a target for the treatment of AML. HG-CT-1 will selectively bind FLT3 and kill the cell it is attached to through the release of perforin and granzymes as was demonstrated in the pre-clinical work. In addition the CAR design that Hemo selected is a third generation CAR with costimulatory domains 4-1BB and CD-28 which makes it a lot safer than Gen 1 or Gen 2 which contained stimulatory domains are were more likely to have uncontrolled t-cell expansion which can lead to cytokine storm, neurotoxicity etc associated with the earlier designs- All in all we are in a good space both in terms of efficacy and safety

I would say they could do this Hulver - the 30day window between patients mandated by FDA is exactly that so they can dose a second patient in 4 weeks time. It would be Hemo’s risk to take which comes down to the cost of production and testing versus gaining clinical data more quickly : I know what I would do as it is the data that any prospective suiters will want to see.

Believe it or not pension investor - so did I : I bought more this morning because a 12M market cap for a CAR-T entering into a 18B dollar market for AML alone is laughable.