RE: Prevail back HEMO to Get JV with major Pharma8 Oct 2024 20:36
My investment in hemp did rather well having bought GW Pharma shares about 15 years ago - There were may doomsayers then saying that the US would never licence a canabinoid based drug or that it was a state to state decision...
I would think it more likely that there would be a new protocol for paediatric AML as there are differences with the disease biology when compared to the adult form pf the diesease - so more new protocol rather than protocol amendment - ie nothing stopping the existing protocol in adult AML proceeding.
I marginally prioritise my own thoughts on this versus the doomsayers because primarily I have been involved in some way or form in this industry for the past 26 years and i have a relatively good understanding of the potential here- but when it comes to the finance side well anyone's guess goes. Personally I don't rule anything out. Like some others have mentioned here I like to think the science will rule the day and that principal has served me well in previous investments.
To add to the list of potentials : Roche/genetech, BMS, Merck&co., Novartis, GSK, AZ and takeda - are all known to lean on Lonza for their development and CDMO services .
It is just a shame that WuXi wont be involved in manufacturing most of them with US sanctions meaning that there will be a mass exit from WuXi by 2030. Excellent company but pity they were passing on information to the chinese government.
If the potential partners were interested in the CDX bispecific prior to the implementation of bYlok bispecific pairing technology - And I can see why they would be from the data I have seen. The bYlok system dramatically increases the purity of correctly paired bispecific antibody so the efficacy will have taken a sharp increase following this work. Vlad has his one mouse model to demonstrate the efficacy so I am looking forward to seeing the new results - Doesnt he have a conference coming up in the next week or so?
RE: When is it a legal obligation?20 Sep 2024 12:37
One thing did occur to me - I would be surprised if there were separate entities involved in the CAR-T versus the CDX because were they both to come to the market they would be in direct competition with each other- I would imagine whomever is interested in CAR-T is also interested in CDX. The additional work conducted by Lonza recently on the CDX when we were told that it was on pause until funds become available also makes me think there are discussions being held in the background with party(s) yet unknown.
RE: When is it a legal obligation?20 Sep 2024 10:54
The earliest you can file for the product licence is phase 2 - with a confirmatory phase 3 planned - they prefer initiated with at least a single patient enrolled > they might give conditional approval before the phase 3 is complete. But I agree with JHFH on this point they will need to do a deal early on the CAR-T because they dont have the means to finish the clinical work at the current market cap.
RE: HEMO: A lot of Good Things are about to Happen Here.20 Sep 2024 09:04
Well I am not sure what the legal requirements are for informing the market but they will have to inform FDA that first patient is enrolled to the study and there is a legal requirement for trials covered by an IND application to register the trial on clinical trials.gov within 21 days of the first patient enrollment - so we may see it there first - that could force the RNS because the enrollment is in the public domain.
I agree 3p is insulting- I am as convinced as I can be on CAR-T, CDX and CBR from a mechanistic point of view. If any one of these comes to fruition then the value is many many multiples of 3p. If a co-development partnership or licencing deal is struck even at this stage : it is many multiples of 3p IMO. Of course none of this might happen but MD Anderson were impressed enough with the pre-clinical data to seek Hemo out to initiate a study in AML which validates the science at least for the CAR-T up to this stage - CDX is based on the same science and uses the same FLT3 epitopes and binding domains along with a CD3 binding arm to bind T-cells to enable them to directly attack the and kill the malignant cells. The beauty of CDX is that it can be made in industrial quantities rather than being tailored to a specific patient. I personally think big pharma will be very interested in the clinical data coming out of the CAR-T study and it should add value to the CDX program as well. I don't know where to start to put a value on CBR as a platform if the pre-clinical data is good (Virus X and Brain Cancer/ + potentially many other forms of cancer) . The science is fantastic and the right people are starting to notice.
RE: I drew a chart idea for #HEMO, Bullish?17 Aug 2024 21:52
Hemotruth-: yes it can but so far only in vitro- was expecting to hear how it performed invivo in animal studies before now … that information is overdue