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Of course I'm not suggesting Scancell would bury data but nor would I expect them just to hand over their data set to any competitior. I assume that in order for the FDA to clear an IND with a lower burden of proof (ie. your small equivalence study prior to randomised trial), they'd want to see comprehensive saftey data from previous studies . Your answer is that the developer of the generic would access data from the regulators and Scancell's publications. Have to say that I find it a bit alarming that a competitor could access data held by the MHRA from Scancell's previous clinical trials unless it was already in the public domain and that safety data from publications would be sufficient but I'll take your word for it. So that brings me back full circle to question no. 1 from my 9.25. Would be good to get an answer at some stage.

1) Re. Your 8.44, but can you answer the question I asked. Does it make commercial sense to take forward an off patent SCIB1 on the basis of exclusivity in the US when it could be copied as a generic in every other market in the ROW and if so who do you think would fund it on that basis?

2) Thanks for the confirmation that anyone producing a generic SCIB1 would still need to take it through the ususal phase 2/3 clinical trial and approval process. You mentioned a small safety biomarker equivalence study prior to randomised studies. Wouldn't they need access to Scancell's SCIB1 data set for that? Do you think the FDA would simply accept the fact that Scancell had already run a phase IIa? I ask because all trials to date have been UK based only and the FDA wouldn't have had any involvement and no regulator (even MHRA) would have reviewed the results.

By the way, you're absolutely right I'm no expert in this space - most of us here aren't and that's why we have to be so careful on these forums when listening to opinions - both negative and super positive. Sometimes all you can do is go back to what the Company themselves have said. I know that also can be risky but less so than taking every comment here at face value. Think it was a shame that you didn't acknowledge in your post last night that Scancell had filed new patents whether you believe they'll be effective or not.

Sci102,

I dont insist - Scancell does.

1) You were suggesting taking an off-patent SCIB1 forward and making hay while the sun shines with the period of market exclusivity that comes with orphan drug status but how does that make any commercial sense when they only have ODD in the US?

2) Of course the burden of proof for generic drugs is lower in terms of clinical evidence but only when the original drug has already received regulatory approval. So if Scancell dropped SCIB1 now and pushed ahead with iSCIB1+ in HLA A2 only anyone trying to produce a generic version of SCIB1 would be copying a vaccine without regulatory approval, in fact one that had never even undergone randomised studies. They wouldn't get away with equivalence studies.

Look, SCIB1 is currently protected, as is iSCIB1+ . New applications have been filed to cover both vaccines in combination with checkpoint inhibitors and the priority date of those applications will obviously be before expiry of the earlier patents. If granted Scancell will have continuous protection. As Marcus has posted on ADVFN, another vaccine developer has successfully filed for vaccine/CPI combination patents in both Europe and the US. You can either trust that the Company and their patent lawyers have it in hand or not but IP protection is something that any institution looking to invest would check in their due diligence and they have raised £65m over the last 5 years.

Sci102

SCIB1 patent hasn't expired yet (think it's 2027 or 2028 but would need to check) and it doesn't have orphan drug status in Europe or any of the other major markets -just the US as far as I'm aware. Following your strategy means that they'd have to take SCIB1 all the way through phase 2/3 randomised trials, submit for approval and then ramp up sales and marketing to try and make the commercials work within the 7 year period without protection in ROW.

If they decided to go with iSCIB1+ for HLA A2 patients only then you're right, SCIB1 would be off patent, however it wouldn't have marketing approval so anyone wanting to copy would have to take their version through the whole development process including clinical trials and seek regulatory approval - would take several years and be way behind iSCIB1+.

Should also point out that Scancell have confirmed that they've filed for a new SCIB1 patent in combination with CPIs. I know you believe that won't be granted - time will tell!

The reality is of course that we simply have no idea yet how iSCIB1+ is performing in the clinic and it's going to be fascinating to see how this plays out.

Not sure whether this has already been posted but both Callum Scott and Elisa Marelli from Scancell are due to present at the upcoming NextGen Biomed Conference being held in March - courtesy of a Scancell shareholder from another group on a different platform.

https://oxfordglobal.com/nextgen-biomed/events/nextgen-biomed/whats-on/speakers

Chelsea/Chester,

They'll only push ahead with a registration trial for SCIB1 if they decicide not to go with iSCIB1+ and to reach that decision they'd obviously need sufficient data from cohorts 3 and 4. I think as you've already identified, it's too early to answer the question about minimum requirements to push ahead with the registration trial as it depends entirely on which vaccine and which delivery method they choose.

I assume they've already made progress on design of the trial and selection of study centres/investigators and once they've decided on a way forward they'll need to have advisory meetings with the FDA and tweak as required and then of course submit their IND.

Looks like they're researching prophylactic cancer vaccines so a different area from Scancell who are developing therapeutic vacccines. Nevertheless good to see big pharma investing in cancer vaccines in any form as well as UK big pharma supporting UK R&D.

Indeed but it shows just how difficult this cancer drug development business is:-

1) The trial met its endpoints on progression free survival and objective response rate but still went on to fail because sadly it didn't lead to improved overall survival.

2) Both Keytruda and Lenvima are successful FDA approved drugs both as monotherapies and in combination but as we see time and again, success in one cancer type doesn't necessarily mean success in others. You can understand why pan cancer approvals by regualtors are as rare as hen's teeth.

We all have some idea of the time, resources and effort that goes into taking a drug through to late stage trials and it's so disappointing to see a failure. Most of all though you have to feel for the paients involved who had advanced metastatic cancer and have not seen the survival benefit they hoped for and it's highly likely that many of them will have suffered nasty side effects as it's a pretty toxic combination. What a shame.

Ruck,

Not sure longs here need any reminders about patience, they have it in bucketloads - they've had to!

Scinv_temps

SCIB1 was already in phase I/2 clinical trials back in 2010 when the licensing agreement was signed. This was discussed on this board way back, and I mean years ago. I remember it clearly because following the announcement of the licensing agreement there was some debate/concern over the level of milestone payments Scancell would need to find to pay CRT if/when they further developed 105AD7. It was confirmed then that they only intended to use 105AD7 for protein vaccines and not DNA and therefore SCIB1 was unaffected and as it progressed through the clinic it wouldn't trigger any milestone payments and indeed it hasn't.

I can see that you would like some evidence, a link of some sort and others may remember and be able to find it, but am up to my eyeballs at the moment and just don't have the time to trawl back - sorry. You can believe or disbelieve, it matters not.

Scinv_temp,

Just a quick point in relation to your comments on Scancell's licensing agreement with CRT for 105AD7. This mAb was developed by Lindy and her team at Nottingham via a grant from CRUK and as you have highlighted Scancell licensed the mAb back in 2010. However, it was only licensed for use with protein vaccines, not DNA and as far as I'm aware has never been taken any further. It has no relevance to DNA ImmunoBody vaccines.

CrustyPete - your 16.51 post of the day. Let us know how you get on!

Scinv_temp - thanks

miavoce - you too and it would be good for Scancell to update and explain where they are at on approval to add this cohort and when they intend to start recruiting.

Scinv_temp

Read my question again. As I've said I understand why ID administered iSCIB1+ would work better than IM. My point is that this isn't some new discovery, Scancell must have known this all along right back to preclinial days. Why not design the trial with ID administration in the first place then? Does IM bring advantages over ID because the agreement with PharmaJet is for the IM device. So I just wondered whether given the delays in recruitment which seem to be largely driven by the HLA -A2+ patients, they've taken the opportunity to demonstrate that both routes of administration are effective opening the possibility for formulating into one dose whether it's injection or device. Your 8.59 seems to suggest this isn't possible.

By the way, no Lindy did not suggest this.

Checkpoint inhibitors are administered via intravenous infusion but it's worth noting that BMS have developed and submitted to both the FDA and EMA for approval of Nivolumab administered via subcutaneous injection. They've applied for approval for all previously approved solid tumour indications, both as a monotherapy and monotherapy maintenance following ipi/nivo doublet therapy. They should have a decision from the FDA by the end of the year (PDUFA date 29/12).

They're not alone, Roche already has FDA approval for a SC version of its PD-L1 Tecentriq and Merck have just completed a successful phase 3 trial of subcutaneous Keytruda. We may well be at the start of a major shift in the field of checkpoint inhibitors and how they are administered.

Scinv_temp - I know the rationale for creating a 4th cohort for iSCIB1+ but surely that was all known before the trial was designed. There has been research on PD-1 administered via intradermal injection, do you think the addition of this ID cohort could be to demonstrate the potential of formulating iSCIB1+ and the PD-1 into one injection with a view to partnering discussions, possibly also involving PharmaJet?

Botski, of course they couldn't leave funding until the last minute and I suspect the driver was to get it done and dusted before release of the interims for the reasons you give. If arrangements for the funding were already underway they also couldn't allow sentiment and SP to build on the Genmab news othewise it would have been at an even deeper discount.

Ruck,

Putting to one side the mechanics of how this was announced, only 5 weeks ago Scancell directors reassured investors at the AGM that they had the cash to take them to a series of value inflection points, it was all recorded and absolutely clear.

So you have to ask what's changed and why the rush to raise now? Why not let sentiment build from the 2nd Genmab deal, get SCIB1 cohort across the line and then raise from a better position? Are they really so low on cash that they couldn't wait until the new year or do they believe conditions for funding are going to deteriorate? Sorry, but it just doesn't make sense. Can only hope that one or two quality specialist funds have been brought on board and we'll get TR1s over the coming days.

CrustyPete,

I've posted several times over recent weeks and months regarding the amount of the potential Genmab milestone for SC129. Trinity Delta have given a figure of £2.5m - not enough to make a significant difference but more importantly the timing of receipt is totally out of Scancell's control. The fact that Genmab has licensed a second mAb does indeed bode well for the likelihood of milestones from the first, but these deals are heavily back end loaded and the mAbs were never going to be the answer to Scancell's funding needs in the short to medium term.

To be fair to Scancell, they have tried to manage expectations and have pointed this out several times - Lindy has mentioned that deals for other mAbs are likely to be along similar lines to the first, Trinity Delta have also pointed this out along with confirmation of the likely size of early milestones.

The real issue here is that timelines for clinical trial results have slipped and they have not been able to raise after major milestones have been announced but have been forced to raise at a much lower level. Scancell should NOT be raising funds at a lower price than the 2023 and even the 2020 raise - it's very disappointing.

Also, not sure I understand this from the RNS, I don't remember any previous discussion about the existence of a 4th cohort or 2 different cohorts for the iSCIB1 arm of the SCOPE study, one with intradermal and one with intramuscular administration. It reads that each of the iSCIB1+ cohorts will recruit 43 patients - is this a mistake or am I misreading it?

'• iSCIB1+ full cohort 3 intramuscular ORR data in 43 patients at 25 weeks;

• iSCIB1+ full cohort 4 intradermal ORR data in 43 patients at 25 weeks; '

'