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Burble,

I'm in the same boat, couldn't watch the webcast and have only had a chance to look at the slides and I also noticed the change from Q1 to H1. A couple of other points:-

Slide 14 lists the portfolio of anti-glycan mAbs, but what's happened to SC88? It seems to be missing from the list, not sure whether that's deliberate or simply an oversight.

Slide 19 details near term milestones and for Modi1 it states ' RCC in combination with checkpoint inhibitors expected in H1 2025' I wonder whether there was any explanation around that, ie. are we only expecting an update on the RCC cohort or will it be results from all cohorts?

Pretty much as expected. Interims gave a good idea of cash burn which has come in at just over £18m but they have sufficient cash to take them through that all important SCOPE study read out. A couple of points:-

1) SC134 is definitely available for licensing

2) No mention of Modi-1 neoadjuvant arm although I may have missed it

3) Now 61 employees and over 85% are employed in R&D

4) Vulpes seem to have reduced their holdings by a small amount from just under 120m in January to just under 118m at 31st August. I don't remember an RNS?

4) The full report has already been uploaded to Scancell's website which is in itself an improvement on previous years but more importantly, Scancell have finally moved with the times and updated the format and presentation of its annual report. A vast improvement.

Smithfields -

From your 11.50:- 'There's no 'meat on the bones'

Angle have licensed in tech. required to carry out NGS sequencing from both CTC and ctDNA liquid biopsies. They've told you what the tech. does, why they've bought it and what they're going to do with it. It's perfectly normal for commercially sensitive financial terms to remain confidential. What else are you expecting?

Exactly, we have no clue (with any accuracy) as that figure is at best 9 months out of date and we don't know the cash burn or what R&D credits may have been received. We'll have a much clearer picture next week.

We will have a much better idea of Scancell's finances in just a few days with the publication of the annual report and at that point it will be easier to have more realistic discussions around funding. At the moment we have no clue (with any accuracy) as to the current cash burn or cash position. For sure though, Scancell will not want to be planning and signing contracts for the phase 2/3 study without having a clear strategy for funding in place and it will be interesting to see how much they divulge during the analyst briefing.

By the way, I may be wrong but I get the impression that some may think the fact that Scancell are holding an analyst briefing is in itself a sign that something may be announced, but these briefings are just standard practice now and good to see Scancell taking the opportunity to communicate with analysts and shareholders.

Johnny,

I was a little surprised that the RNS didn't outline the financial terms, as you say there would be no need to mention figures. Perhaps they simply assumed that the existence milestones/royalties were implicit with the use of the term 'licensing agreement'.

In the past they have confirmed that milestones/royalties would be due and you give 2 good examples in your post, however they didn't mention any financial terms in the most recent case when they licensed the SNAPvax technology from Vaccitech (now NASDAQ listed Barinthus). The RNS to announce that agreement followed a very similar format to the PharmaJet one and yet we know from Barinthus' SEC filings that the agreement with Scancell involved upfront, milestone and royalty payments.

If it was a regulatory requirement to disclose then I'm sure Scancell would have done so and even if they had plans to sign a deal with BMS, that wouldn't have negated their disclosure obligations. Time will tell whether Scancell can/want to partner before the phase 2/3 . They may prefer to carry out the phase 2 and then look to license at a higher valuation. Another possibility that hasn't really been discussed here is a simple clinical trial collaboration with BMS in advance of the phase 2 whereby BMS provide support, advice and also supplies of Ipi/Nivo where necessary. That would potentially allow Scancell to expand the trial to Europe.

Either way, Scancell are approaching an exciting period and it will be interesting to see how it all plays out.

I'm not so sure they are early. Prior to 2020 final results were usually released in mid to late September and once even as early as August. The results last year were exceptionally late due to delays with the audit from BDO who were appointed in 2019 and replaced in February 2024 with new auditiors RSM who will have carried out the audit this year. So perhaps we're simply back to normal reporting timescales enabled by a more efficient service from the Company's auditors.

More details here on the PharmaJet agreement:-

'Under the agreement, PharmaJet will receive development and regulatory milestone payments, as well as royalties on commercial sales of the combined Stratis and the advanced melanoma vaccine. Scancell will be responsible for the clinical and regulatory development as well the commercialization of the combined product.'

https://biotuesdays.com/2024/09/17/pharmajet-and-scancell-forge-alliance-to-develop-and-commercialize-needle-free-dna-vaccine-for-advanced-melanoma/

'

Thanks for posting Billy and really good to see recognition for LD, well done to her. Let's hope she wins now.

Chelsea,

Yes, although there's no reason to think it's an issue for this mAb any more than for any other in development no matter what the target. The patent doesn't cover the target antigen itself as that's produced naturally. The inventiveness is in the structure, design etc. of the mAb. So unless Scancell have made a direct copy of BMS mAb with identical amino acid sequencing and targeting exactly the same parts of the antigen, there's no reason to think this is an issue.

If you think about it, the whole sector tends to follow the same targets. For example, look at how many HER2 or PD-1 targeting drugs there are, so the fact that Scancell and BMS are both targeting FUCOSYL-GM1 shouldn't raise any particular concerns about IP protection over and above those that always accompany any new drugs in development.

Chelsea,

An international patent was filed for Scancell's FUCOSYL-GM1 targeting mAb back in 2020. It was published in March 2021 and is now undergoing normal processing and examination by the various national patent offices. Hopefully someone will correct me if I'm wrong, but I'm pretty sure SC134 has also been enhanced with Avidimab which also has its own patent.

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021043810&_cid=P11-M0XIB1-90969-6

ESMO abstracts are now live and although Scancell aren't presenting any this year, there is one that is of particular interest .

A while back I mentioned that BMS were developing a mAb targeting fucosyl GM1 in small cell lung cancer and commentators believed this was the only anti fucosyl GM1 mAb in developmment. Although it may be the only one in the clinic, Scancell of course have SC134 which also targets fucosyl GM1 in SCLC but they intend to develop it as a TCB. This is the mAb that was the subject of the recent peer reviewed paper (link below).

BMS are presenting the results from an interim review of their ongoing phase 2 clinical trial at ESMO and of course the results could be important for the future development of SC134. It's a randomised trial looking at BMS-986012 in combination with chemo and Nivolumab (Arm A) versus chemo + Nivolumab alone (Arm B). I can't post the link but if you search the ESMO programme for paper 17860 you should find it. I've summarised the main results below:-

-As of Sep 26, 2023, 132 pts had been randomized.

-Arms (both n = 66) were balanced for baseline characteristics.

-The safety profile was similar between arms.

-PFS did not significantly differ between arms: mPFS was 5.8 months in Arm A vs 5.2 mo in Arm B.

-mOS was 15.6 mo in Arm A (23 deaths) vs 11.4 mo in Arm B (30 deaths).

Conclusions

BMS-986012 + CE/NIVO showed a tolerable safety profile as 1L ES-SCLC Tx, alongside a promising signal of improved OS vs CE/NIVO alone.

It will be intersting to see what coverage the presentation gets.

https://www.esmo.org/meeting-calendar/esmo-congress-2024/programme

https://aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-24-0187/747388/SC134-TCB-targeting-fucosyl-GM1-a-T-cell-engaging

Yes they could make any discovery at any time - but you can be sure you wouldn't find out about it until the patent had been filed. It takes years from discovery to first clinical data.

'data publication and patent filings appear to go together'

Sorry, but as a general rule that's just not the case. Scancell would not and could not carry out clinical trials and reach the stage of having data without protecting the IP way before the product ever got anywhere near the clinic. Using Moditope as an example, they kept the discovery of Moditope completely under wraps until the patent application had been filed. So the patent was filed on 7th August 2012 and on 15th August they issued an RNS announcing the its. That came completely out of the blue and there had been no clues, no publication of any preclinical research etc.

EE,

I've just looked very quickly, but I can only find 2 new patent applications since Sep '22. Where are you searching and could you perhaps be looking at publication date rather than fiing date? Publication date is usually 18 months after the filing date.

Re. the enforced Moditope silence, I think they were waiting for the patent to be filed rather than approved. Once patents are published, in effect they form prior art for any subsequent applications from other parties looking to patent the same invention. So the race for Scancell was to get the patents filed which is sounds simple but really isn't. It ususally takes several years for Scancell's patents to be granted.

So in answer to your question, once an application is filed and especially once published I don't think there is any particular link to news flow. Konar is pretty good on patents, so may be worth getting his opinion.

Link below is to a Biotech TV interview with Antoine Papiernik, chairman of Sofinnova who are a VC firm specialising in the life sciences sector. They sometimes invest alongside Redmile. Well worth a listen, if nothing else to get some insight into how these companies view the sector and their portfolio companies. From about 11mins in he discusses public markets and biotech in Europe versus the USA.

https://www.biotechtv.com/post/sofinnova-partners-antoine-papiernik-september-5-2024

Just to clarify the situation regarding the 86%. Lindy has confirmed that it relates to the responses of the original 11 of 13 patients previously communicated and that it isn't new information. Makes complete sense because it would have been an odd platform to choose to announce updated results and I'm sure not the one Lindy would have chosen.

There has also been a good deal of debate regarding the fact that 22 patients have been recruited to the iSCIB1+ cohort with calculations being made on possible response rates etc. etc. Lindy has also confirmed that Scancell make the decisions when it comes to the futility test, no regulatory approval is needed and no amendments to the trial protocol etc. Whether or not they continue to recruit is therefore up to them. The fact that they've recruited 22 patients is clearly a very positive sign both in terms of the decision from Scancell and the fact that investigators are continuing to recruit to the study but we just have to wait for updates from Scancell to find out what the response rates were.

Ee

ha ha that's a little harsh.

Thought it was interesting to hear more of Lindy's background and that she sounded very relaxed and interviewed well. Have to say they did seem to spend an inordinate amount of time discussing her dyslexia when they could have been discussing the cutting edge science being used to tackle the second most common disease known to mankind.

Viiolindog

Yes, I had thought that Genmab might be the other party as LD had previously said they were interested in a second mAb but clearly it's not Genmab but another company. Her comments on they sort of companies most interested in these mAbs is interesting too - suggests a larger bio/pharma company rather than a smaller biotech.

DeAar

Excellent find, thanks for posting