Member Info for crumbs

Something different... Adaptimmunes US quarterlies...list of potential TCR competitors who is that I see!

'TCR T-cells: TCR T-cells are being developed by competitors that are directed towards a multitude of targets including: AFP, CD20, HPV-16 E6/E7, KRAS, MAGE-A1, MAGE-A3, MAGE A3/A6, MART1, NRAS, NY-ESO-1, p53, PRAME, TGFßRII frameshift antigen WT1, as well as personalized neoantigens. Juno Therapeutics (a Celgene Company) has developed an engineered TCR therapeutic candidate where the end TCR is purported to have enhanced affinity through stem-cell selection. Juno’s candidate JTCR016 (WT1-specific TCR), in collaboration with Fred Hutchinson Cancer Research Center and the National Cancer Institute (NCI), is currently undergoing a Phase 1/2 trial in NSCLC and mesothelioma setting as well as a separate Phase 1/2 in AML. Medigene AG has reported development of a PRAME TCR therapeutic candidate (MDG1011), which has begun a Phase 1/2 clinical investigation in AML, MM and myelodysplastic syndromes. In addition to Juno there is a growing number of TCR companies that are adopting approaches to TCR affinity enhancement, for example Axis Therapeutics, Takara, Takara Bio, Fred Hutchinson Cancer Centre and Immatics. In addition other TCR-focused competitors include, but are not limited to: 3T, Adaptive Biotechnologies (with Genentech), AgenTus, Atreca, Baylor College, Bellicum, BioNTech, bluebird bio, Captain T cell, Cellular Biomedicine Group Inc, Cell Medica Ltd, Cytovant Sciences, GigaMune, GSK, Immunocellular Therapeutics, Immunocore, Intellia Therapeutics, Inc (with Ospedale San Raffaele), Juno Therapeutics, Kiromic, Kite Pharma (Gilead), Lion TCR LTD, MD Anderson Cancer Center, MediGene AG, NCI, Neon Therapeutics, PACT Pharma, Parker Institute, Refuge Biotechnologies Inc., Roswell Park Cancer Institute, Scancell (with BioNTech), Tactiva Therapeutics, Takara Bio Inc, Takeda (T-CIRA), TCR Cure, T-Cure, TCR x immunotherapies, T-Knife, Tmunity, University of Leiden, Zelluna (with Oslo University Hospital) and Ziopharm Oncology.'

I think konar is talking more about confidence in BOD being straight with us not us all selling out as we have no confidence in the science ...most of us do but certainly, BOD handled this one poorly anyways at last at very long last SCIB1 is going back into trial

What I would like to see is any kind of BioNtech collab update

nana lol .... I reckon you could get enough volunteers to do that for you:))

Boom they certainly could have been more open and we would have all understood... trying to hide facts is not good as it makes you wonder what else we are not being fully told about so I hope lessons have been learnt... shame that the excitement of getting back into the clinic has been sullied by all this ...

I'm happy enough with that... the UK will be the main arm now... It would still be good to get a US arm running (I'm not sure it ever will though the intent seems to be there ) but not vital as now data will be incoming.....

Think FDA is not unknown for it... note Jansen chose not to run their trial using ichor.2 in US

'The design of the study hasn’t changed…i.e 25 patients in total.

Yes, the Trigrid 2.0 device will be used in the UK and the US arm of the study. The MHRA were happy with the Trigrid 2.0 data files provided and had previously approved the use of an earlier version of the device in our first clinical study.'

I just want to know how many UK patients are expected to be dosed... have emailed Cliffy ...I hope it is 25 :)

Unclear for me is how many patients will now be dosed? Will it be all 25 or not?

From proactive:

'Scancell Holdings PLC (LON:SCLP) is to begin the UK arm of the phase II trial of its flagship skin cancer treatment immediately.

The trial is testing the safety and efficacy of SCIB1 in 25 metastatic melanoma patients who are also receiving Merck’s blockbuster checkpoint inhibitor Keytruda.

UK regulators gave the study the green light back in April, but it is yet to get underway because of delays in receiving approval from the US Food and Drug Administration, which was needed before recruitment could start.'

The trial is approved in UK... so UK has no FDA issues with the device being used with SCIB1...

It will only be positive if US arm is not still hanging over us... really like I say they may as well all but abandoned US arm and stated more patients as in the full amount planned for trial will be recruited in the UK...

Yeah which is why... reluctantly I think they may as well ditch US plans and up recruitment numbers in UK.... and let Ichor make a complaint to FDA as really it is them a US company whos tech is being denied in the US.... especially if incoming data shows the combo to be effective (which I think it will)

Well, we already have an idea of how results will go seeing as SCIB1 has already proven itself in the clinic... The value of US trial would have been huge though with KF and those top clinics involved but really data is data wherever it is gathered and could be US patients are going to be losing out on lifesaving treatments due to their own FDA....

'Professor Poulam Patel, Chief Investigator, commented:



"There remains an urgent need for improved therapies in melanoma. Based upon our previous successful trial with SCIB1 alone we are excited to see if the addition of SCIB1 to current, standard treatment with pembrolizumab increases our anti-cancer response rate."

I'm excited too.... though a little deflated at the saga behind getting here :)
least now we know what is happening!

Well, there are loads of pembro combo trials going on.. But Ichor is a US company so do not think it is anything biased against scancell being UK based... your right about patients though... no time to wait... good to hear Poulam is involved again too

On one plus side apart from at least SCIB1 is going back into patients who ought to benefit... it might now work out cheaper than the original US one? though needs to be decided soon on how many UK patients will be dosed to make it a statistically significant trial.

Agree agree... But why is it the US IND has to be removed before UK can begin? does anyone know reasons for that?...... got a feeling the US trial will never happen... can't blame scancell for that but this whole SCIB1 combo has been a right dragged out mess of a trial ... At least it will now begin and scancell did act on the FDA being A holes

Yeah, I think that too... why they have not at least knowingly to us made a move in here is still a mystery though... It to my mind one day will happen that one of the many players get the value of having Lindy and her techs in their fold.

Nah less than 5k lol .... hopefully with some positive news the retreat from the march we were enjoying to and beyond 10p will be over and it'll be constant blue days again... we know this can shift fast

I wonder if the new website that was being 'worked on' at time of last AGM will ever appear :) ... Diggle is not even on BOD on it yet...
I don't know it could be we are in for some big news that blows the disquiet away... or indeed nanas possible take could be it... hanging on for US approval as really that is what the trial was all originally about... best clinicians in best clinics in biggest market with success having a maximum impact.... Anyways you might have clocked my buy today