Member Info for Haywain

In short if this works which the science seems to suggest it will - It is a big F'ing deal! Especially to those who need it.

Quite right sprint - I should have said in addition that "The only proven curative treatment for the relapsed or refractory (R/R) AML is allogenic hematopoietic stem cell transplantation (HSCT) which requires highly toxic conditioning regimens often associated with fatal side effects. Thus, there still remains an urgent need for the development of safe yet effective new therapies for the treatment of AML." - A significant number of patients with RR AML are not able to survive the conditioning regimens necessary for HSCT - so yes no (satisfactory) available alternative

Sprint - It wont be volunteers : it will be patients in specialised oncology centers who will collect plasma sample from the patient through apheresis. These samples will be shipped to Hemo who will transfect with lentiviral vector to confer the anti-FLT3 binding ability to the patients T-Cells. The cells will then be expanded (cultured to increase number), and delivered back to the patient. As part of the IND there will be a clinical protocol that will define which patients would be eligible for the treatment, how they would measure efficacy of the treatment, the number of patients from which data would need to be collected , ethical considerations etc etc etc - It is typically a very detailed program and one which now has FDA endorsement to proceed. Professor Cohen Van will be running the trial who is a big hitter in the medical oncology world and currently Director of the Wesley Center for immunotherapy (Seidman Centre), Devision chief, haematology and cellular therapy (cleveland medical centre) and clinical professor at CWRU school of medicine - It was actually his idea to target FLT-3 because they noticed that there is a correlation between over expression of FMS-Like tyrosine kinase 3 receptors (FLT-3) in the cancerous cells in patients with relapsed refractory (RR) AML with particularly poor outcomes -ie no treatment option is currently available for these patients.

Suggest you read the following paper if you want to understand what is unique about Hemo CAR-T over others : https://ashpublications.org/blood/article/136/Supplement%201/4/473807/Preclinical-Development-of-Anti-FLT3-CAR-T-Therapy

Dont think he has totally sold out according to JHFH and HH - just sold some and taken a bit of a step back

You may be talking about what percentage of pre-clinical assets ultimately become clinical assets - where you are searching for your best drug candidate then a 90% attrition seems about right

Erm - now sure where you got 10% from - I have never had an IND rejected.

Nice summary eyeflyingmunst !

FDA normally do notify you at least a week or so in advance if there are further issues - so I agree dhub

I havn't got level II hopefully some big buys pop up then

If hemo do eventually sign a deal I think the structure will be much like the one announced by REDX this morning where they received 10m upfront payment and up to ~900m in milestone payments and royalties. Just to point out the REDX deal is for a number of pre-clinical assets and they are small molecules - for a clinical stage CAR-T I imagine the upfront element would be larger. I have noticed a lot of companies doing these type of deals where they share the risk and reward for successful development programs.

Pumpkin blocked and all of the Cucurbitaceae family for good measure - that includes all gourds, squashes and melons... you know who you are!

He1 is another company in natural resources - I was going to reply to you earlier mickey but was late for a meeting - Then I saw HH beat me to it - Funding by prevail if it opens up the pathway to pay for clinical program is a no brainer especially if you look at the early stage phase1/phase2 acquisition price tags that have been assigned by big pharma for CAR-T assets over the last year or so. You are no longer talking about 10's millions but a log factor higher.

I have no problem with funds being raised at 6p, particularly if that can underpin the phase 1/2 clinical studies particularly because having a clinical candidate is the threshold for the majority of perspective big pharma suiters - Its a black and white different league being pre-clinical vs clinical particularly for CAR-T IMO

Dont think it is related - Hemo CAR-T is an anti FLT3 CAR-T which is CD135 if not mistaken

Saint -I know exactly what it is and I share the view that it is potentially a platform technology that could be applied across many (already approved) drugs & I am sure it will come good as I am sure Hemo will

BdfInvestor - I am not underplaying Avacta or cross deramping shares : tell me what was inaccurate about what I posted? Just not a good example to use in comparison to Hemo is all for the reasons I mentioned. If you read my post I gave an example of how improving performance of existing drugs in terms of their off target toxicity is actually a good strategy - Vyxeos was ultimately bought by Jazz for 1.5 Billion : I am just saying compare apples with apples please.

To your point JDRC regarding the Avacta offering - They are developing their affimer technology to improve the off target toxicity of exisiting treatments - Their lead candidate is doxorubicin - doxorubicn was approved by FDA in 1974 ... not saying that is not worthwhile - vyxeos liposomal formulation of cytarabine and donarubicin did exactly that for instance - But it is very different to what Hemo are developing - As an aside the market cap of Avacta is 220million with 1 pahse 1a about to complete....

Sorry - Same day as HH not HT

I wouldn't read into the length of time it takes other than if no RNS post 30day period is up. I have had notifications approaching midnight on day 30 US east coast time for straight forward reviews. I have also had early notifications for complex issues... The fact is you cant guess - occasionally they go over the review period but that is rare in my experience and they dont like doing it because they have internal metrics to hit. Think I picked the same day as HT (unknowingly).