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RuckRover Sorry to hear that. Not sure how often we stop to appreciate the reality of taking part in clinical trials from a patient's point of view. If you take part in an early stage, open label trial then you have no idea whatsoever if the drug is safe or if it has any efficacy whatsoever. It could make you far sicker than when you started and potentially may even be fatal. If you're unlucky enough to take part in a trial that fails then you have wasted precious months when you could have been receiving an alternative treatment that might have helped. To minimise these risks you can go for a late stage, randomised trial where more is known about safety and efficacy. However, you then run the risk of being allocated to the placebo arm so although you'll be contributing to the greater good, on a personal level you're missing out on the new treatment. While we discuss risk, your post was a great and timely reminder of a very different kind of risk being taken every day by these patients.

Well congratulations for discovering it and thanks for posting on bb.

You're quite right - I missed that. So up, running and in use in Europe but in US? Master file was submitted to FDA back in Feb so surely must be cleared now?

Excellent news today - there may not be the hype and spikes in SP that we are seeing in other stocks but how many AIM bios have taken a new drug through successful phase III trials in over 1200 patients and have reached the next stage of NDA submission? A seriously impressive achievement and the whole MTFB team should be congratulated.

Let's hope Scancell are one of those in the making!

The nonsense was your statement re. Scancell spending 3 years and £4m developing mRNA vaccines, I didn't suggest any such thing. If you don't want to answer my question on the patents then that's up to you - it could have been a useful contribution to holder's understanding (including my own). As for reasoning driving this - it was a simple comment from a much longer post in answer to a question from ONW. It was my opinion - no hidden agenda and it was meant to be positive! Your last post actually highlights my point perfectly. Do you think BioNTech would be more or less interested in Scancell if Moditope peptides could also be incorporated into one of their mRNA vaccines? Anyway, I will leave it there.

Your IP?

Nonsense - I haven't suggested that at all. Over recent weeks/months we have seen major pharma. companies such as Eli Lilly and Sanofi signing billion dollar deals for mRNA vaccines. It makes perfect sense for Scancell to protect their IP in this area (if appropriate) and will make it a much more attractive proposition for anyone looking in. If Scancell were then approached with an offer for a similar deal, do you think they should/would turn it down? I simply made the point that a huge effort is going on behind the scenes, especially in the area of Moditope IP. I was honest enough to point out that I don't fully understand it and don't know where it's heading but there is no doubt in my mind that a good part of it is to cover T cell therapy area. It's not as simple as your 11.20 states, it's not a question of the original patent giving them protection for any citrullinated epitope being used in any setting in any manner in any disease. If it was they wouldn't need to bother with any other applications. You have to look at all of the claims and make sure that every aspect is covered which is exactly what Scancell are doing. Going back to my last post, do you know the reason for each of the divisional patent applications and exactly what they cover?

lol - it was just a comment on the patent applications. I think most people are able to understand that securing IP to cover TCR, CAR T, mRNA (whatever) doesn't mean scrapping the current pipeline but simply makes the Moditope platform a much more attractive proposition to anybody looking in. The reason I said that I don't know is because that's the truth - perhaps you can use your technical/scientific knowledge to tell us what each of the divisional patent applications covers?

There's a steady stream of predictable news over the coming months which hopefully will have a cumulative effect as far as sentiment and SP are concerned. Whether any one of them individually (and which one) will be the catalyst for a major increase in the SP is much harder to predict. It wouldn't surprise me at all to see a sharp upturn in interest here in the build up to the CRUK Grand Challenge and a win for LD's team could/should trigger some excitement. Like all LTH's here, I have my pet theories but I really wouldn't want to post here as they are just that - theories. Would make the following points though:- 1) There is a discernible change in attitude towards cancer vaccines - an acceptance that they may well have an important role in the correct setting. Ever increasing knowledge of the tumour microenvironment and how the immune system functions has helped to explain the damaging failures of the early vaccines and increase understanding of the potential of current and future vaccines. 2) There is clearly a huge amount going on in the background at Scancell. You only have to look at the patent applications that are being filed for Moditope some of which seem to be aimed at the field of adoptive T cell therapy. It may well be that it's no more than routine securing of IP over as wide an area as possible, or that it's just to cover the BioNTech collaboration for TCR's. But are they also looking at mRNA vaccines? CAR T? I don't know and I don't even know if it's possible with Moditope but it's certainly a hot area at the moment. 3) I know I've said it before but Scancell will be in a very different place in a relatively short period of time. Once the SCIB1 combination trial is up and running, we'll be looking forward to results and talking about the start of the Modi trial and the outcome of the BioNTech collaboration. This protracted, frustrating and very boring period of waiting almost in limbo will be over. Thank goodness!

Lindy Durrant is presenting in September at the Phacilitate Leaders Europe Conference which is being held in London. Also worth noting that BioNTech are an exhibitor at same conference. Some interesting speakers and companies taking part - Adaptimmune, Cellectis, Autolus amongst others. http://www.phacilitate-leaders-europe.com/speakers-2017 (Thanks to twitter poster for heads up)

Yes there was a poster presentation but that was it. Oncimmune said that they hope to publish in a peer reviewed journal at some stage but may want to validate the data in a larger study first. You make some good points Konar and you may well be right. It just seems a bit premature to adopt a companion diagnostic that hasn't yet been tested with SCIB1 in the target patient population (patients with tumour present) let alone in patients being given a combination of SCIB1 and PD-1. I can see a case for using the combination trial for Oncoimmune to carry out further testing but to actually base patient recruitment on their as yet unproven assay??? I just don't know. Hopefully, it's not too long now until trial appears on clinical trials register and we may find out more.

Konar, Although Sally Adams will be heavily involved in design and running of the trial, Scancell will need to appoint a CRO. Looking forward to seeing who they use and very much looking forward to the RNS announcing their appointment as it will be a sign that all systems are go. As for Oncimmune. The study was very small, as far as I know they have never published the results and they were in resected patients only. Obviously the SCIB1 trial will be recruiting patients with tumours in situ not resected. I wrote to Oncimmune last year and asked whether the EarlyCDT assay could also be used in these patients to predict who would respond to SCIB1. They replied that they believed so but didn't yet have the data to support that and they would need a larger study to confirm. So it seems a bit early for Scancell to tie themselves to a companion diagnostic for the SCIB1 combination trial. But WDIK?

In answer to your earlier question, the FDA approval process for medical devices is different to that for new drugs and requirements depend on how the device is classified. The new Ichor device won't have received marketing approval yet but that doesn't really matter as far as the Scancell trial is concerned - it's whether or not the FDA have agreed to its use in clinical trials. At the end of Feb, Ichor submitted their Medical Device Master File to the FDA. This allows the FDA to review the device and assuming they are happy, the Master File can be used in support of IND applications from multiple sources (ie.different companies). We know for sure this has happened as the J&J trial has now opened for recruitment and is using the new device. We can therefore assume that the FDA have reviewed and are satisfied with Ichor's Master File. So it's nothing to be concerned about if you can't find a link on FDA's website to show the device has been approved.

Interesting theories - very much hope that Oncoimmune aren't involved. I'm not sure that the CRO was known back in 2015, in fact I'm not sure it's ever been known. It certainly hasn't been announced (unless I'm mistaken). Worth remembering too that the trial design has changed and I don't think they could negotiate with CRO and agree costs until they had finalised version.

Any 3rd parties may simply be routine rather than being a sign of anything significant. For example, Eurogentec will no doubt be required to contribute to the manufacturing and chemistry part of the IND, not sure but the CRO may well need to be involved etc., etc.

You are correct

Afternoon all. Balerno, what exactly are you looking for/hoping to see on the FDA website?

David Huang is presenting at the World AMR Congress in Washington in Oct - he's making keynote address 'Updates to Iclaprim clinical development program' on 25th Oct. Looking at synopsis of his presentation, seems he'll be presenting new clinical and non-clinical data and I wonder whether this may be the extra data they were waiting for to include with NDA? World Anti-Microbial Resistance Congress USA 2018 - Day 1 @ 17:00 Keynote Address: Updates to Iclaprim clinical development program �Nearing commercialization: Updated data from two phase 3 clinical trials �New data from non-clinical trials including in-vitro testing, global surveillance, animal testing, different indications and pathogens �Navigating the regulatory approval process: filing NDA and NAH to the FDA and EMA respectively �What�s next? Looking to future studies to address high unmet medical needs https://www.terrapinn.com/conference/antimicrobial-resistance-congress-usa/speaker-david-HUANG.stm

Clinical Trials Register has now been updated to show all 4 study centres are recruiting. Good to see that the estimated study completion date remains unchanged at 30th September. https://clinicaltrials.gov/ct2/show/NCT03427450?term=parsortix&rank=1