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Chester - really sorry but think we have to be a bit careful in suggesting that significant tumour shrinkage will immediately be announced to the market. They won't drop everything and issue an RNS if they spot tumours rapidly shrinking, the standard clinical trial process must be followed and results will be announced in line with that process.

Also, tumour shrinkage will only be picked up on imaging and we have no clue how often the patients will be scanned. It may be that they won't scan until after 12 weeks or 3 doses or whatever, in which case they won't even know how the size of the tumours has changed. Scancell have confirmed that they expect safety and immunogenicity data to be available in H2 2022 and efficacy data in 2023. That suggests imaging data may not be available at the next update, but we should be learning for the first time about the immune response in humans to this vaccine - exciting stuff.

Please don't think I'm trying to nit pick here, but if folk believe there's a chance that Scancell will immediately RNS tumour shrinkage, they're going to be concerned if we hear nothing and assume that it's bad news. In reality, we will be given results (good or bad) as and when the data has been collected, verified and anlaysed.

corr - vimentin

Konar,

I'm so glad you (and some others) have mentioned the patients behind this news . You're right, we do owe them a huge debt of gratitude.

I'm not aware of any automatic switch from the low vimetin only dose to the higher dose of the full Modi1 vax (all 3 peptides) for this cohort, but obviously Scancell would need to confirm one way or another. The dosing period is up to 2 years and clearly it wouldn't be right to leave these 3 patients on a less than optimum dose for 2 years. A similar situation arose with the original SCIB1 trial and Scancell applied to the MHRA for permission to switch the lower dose safety cohort (also 3 patients) to the higher dose they had selected for the expansion phase of the trial. I assume they'll do the same here if required, but again it's a question for Scancell.

Also should point out that we can't say yet that there are no safety issues. Today's RNS bodes well but the next cohort is really important as they'll be receiving all 3 peptides at the high dose.

Konar,

You're correct, that slide is out of date, the best place to go for the final Modi1 trial design is Trinity Delta's note of the 12th April - see figure 7 in the link below.

Regarding your 15.11 - we can't read anything at all into this regarding efficacy. Regulators won't take into account efficacy when making decisions regarding dose escalation in a phase 1 study. It will be done on safety alone and an initial cohort of just 3 patients is fairly standard. However, given the strength of the immune response generated in preclinical research and the fact that Moditope really is breaking into new territory, safety and toxicity was by no means a given. If the MHRA had any concerns , they would have asked for data from more patients at this dose, so today's RNS is really very good news indeed.

https://www.trinitydelta.org/research-notes/a-fresh-impetus-in-delivering-immune-oncology-vaccines/

Some good coverage here for C4X Discovery

https://www.thisismoney.co.uk/money/investing/article-11113263/SMALL-CAP-IDEA-C4X-Discovery.html

Nice mention here for Redx although they only mentioned 2 of the 3 Redx licensing deals and forgot the Ras/Raf/MAP kinase deal worth up to £400m

https://www.thisismoney.co.uk/money/investing/article-11113263/SMALL-CAP-IDEA-C4X-Discovery.html

Kashdog,

At least you recognise and acknowledge that you're deviating from your normal strategy and emotions are coming in to play - even if you're not quite sure which emotion!

Kashdog,

Just to add in answer to your SCIB1 comment - those are 2 completely different trials, but I think you might have known that:)

Morning Kashdog,

I don't think anyone here could disagree that there has been an inordinate delay in getting Modi1 into the clinic. It has nothing to do with covid, but is down to technical problems in manufacturing the vaccine. More specifically in conjugating the peptides to the amplivant adjuvant. Frustrating, but this is cutting edge technology and I understand that chemical synthesis of hydrophobic peptides is extremely complex and challenging. Full credit to Scancell for overcoming these issues.

There has been plenty of independent verification of the potential of Moditope in the preclinical setting - every single peer reviewed research paper, the BioNTech agreement (BioNTech would not have signed before carrying out due diligence on the preclinical data package), The calibre of the CRUK Grand Challenge team which was built around developing a Modi3 - some really big international names in the field of oncology research. etc. etc.

Finally, in terms of the actual management of the trials - most of it is carried out by 3rd parties and there is plenty of independent monitoring and oversight including:- study investigators, the principal investigator, the Ethics Committee, the regulators (MHRA/EMA/FDA) and the CRO to name a few.

It's really is a shame that it's taken so long to get Moditope into the clinic but we are where we are and at least now Scancell are finally on the brink of finding out whether the best immune response Lindy Durrant has seen in her entire career can be replicated in humans. Time will tell!!

Yes I did - intriguing and looking forward to finding out exactly what they're developing when they're in a positiion to go public.

Ruck - interesting, I had missed that.

I understood that Scancell hadn't been able to create suitable Modi1 TCRs in the lab, but were hopeful that when the Modi1 trial was underway they may be more successful when using blood from vaccinated patients. Given that the collaboration with BioNTech gave them an exlusive option to license Modi1 TCRs, it's seems perfectly sensible that the agreement wasn't open ended and just allowed to run ad infinitum. I'm sure if/when Scancell do produce promising candidates then they'll resume discussions with BioNTech and I'm equally sure that BioNTech will be keeping a watching eye on how Modi1 performs in the clinic.

As for Covidity, I know it won't be a popular opinion here, but I can't see any involvement from BioNTech - it simply doesn't fit in with their strategy. BioNTech is an mRNA pioneer, it's the very essence of the Company. Of course I may be wrong but I just don't see why they would deviate from that path and switch to a DNA vaccine. The most likely candidate for a partner for Covidity (assuming positive trial results) is one of the big biotechs or perhaps smaller pharmas who have missed the boat with 1st/2nd generation covid vaccines and are looking for a vaccine platform that can be quickly adapted to also target other infectious diseases.

If Covidity went no further, it will still have been hugely beneficial to Scancell and their shareholders. ImmunoBody comes out the other side with an extended patent life, a new improved delivery method and enhanced efficacy (assuming successful results) and Avidimab gets its first in human trial - all achieved through non-dilutive funding. Moreover, covid has triggered a resurgence in the field of vaccines and interest in cancer vaccines.

All IMO

Thanks and well spotted!

WTP

Scancell's new labs are in the Bellhouse Building - I assume their lease on the office space in John Eccles House has ended and they're just tying up loose ends by officially changing their registered address.

GF123

Thanks for your 12.01, but my comments had nothing whatsoever to do with my own timelines - I am relaxed and happy to remain invested here for as long as I can see the rationale for doing so.

We've been tick tocking since 2015 - someone needs to wind the clock up.

Cleanerworld,

No, I think they've probably just not got round to updating their site - perhaps LD hasn't yet given them the title of the presentation she intends to make.

Very odd - a quick google will take you to the agenda for the same conference last year and you'll see Lindy Durrant is shown making a presentation with exactly the same title on 10th November 2021. Highly unlikely she'd make (or they'd accept) the same presentation 2 years running.

rats,

I'm surprised by your 16.11 and I'd urge you to have another read to see exactly what your post seems to be suggesting .

Just to set the record straight, I was also in MTFB and also lost cash. At all times on the bb, Ivy was clear that he wasn't privy to any insider information and explained his connection with the CEO. The reason why Ivy and many others were so positive about the stock was simply that they had funded and run two phase 3 trials, both of which were successful and met their endpoints. In terms of clinical development, it was about as derisked as a pre-market bio can be. Can you imagine the sentiment on this bb if SCLP released 2 RNSs confirming positive Modi1 phase 3 results? So there was every reason to be positive on the bbs and that's not the same as ramping. It came as a complete shock when the FDA issued a CRL due to potential liver toxicity - something that couldn't have been picked up by anybody and totally unexpected. Then again, that's the whole point of clinical trials - to pick up unpredictable and unforeseeable events.

It's impossible for expert analysts to accurately value early stage biotech companies so it's highly unlikely that we're going to crack that nut on the SCLP bb. Any one of us can pick a figure out of the air and justify it with a series of assumptions, whether it's 5p or £5. I do wish however that folk would express their valuations in terms of market cap rather than share price - it certainly focuses the mind!