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Chester,

I can see where you're coming from but the trial for those 16 patients was run in the adjuvant setting. As they'd had their tumours surgically removed the only way to measure efficacy was progression free survival - there was no tumour to measure. However, the current trial is being run in patients with metastatic inoperable melanoma and response to treatment can be measured by the amount of tumour reduction. Of course ultimately progression free and overall survival are the best measures of efficacy but you may have to wait years for those results if your drug is successful.

So you can't compare the results from those 16 patients with the current trial although of course the data all adds to the case for SCIB1. I don't think Scancell will have to wait for survival data from the current trial, they should be able to move to a phase II/III fairly quickly and if the results of the phase II are good enough they should be able to attract a partner for the phase III.

Chester,

How are you going to measure 'survival expectancy'?

Ray -

The Ultimovacs trial that is about to read out recruited 156 patients and is a randomised study with the comparator arm being treated with nivolumab and ipilimumab alone. So they are a stage ahead of Scancell in terms of development. At this stage, I don't think we need to think in terms of whether SCIB1 is better, we just need to hope that the Ultimovacs results are good and above all aren't a fail. If they are good enough to attract a massive deal for Ultimovacs then so much the better.

https://classic.clinicaltrials.gov/ct2/show/NCT04382664?term=UV1&draw=2&rank=1

A reminder that to date Redx has:-

1) signed deals worth a potential $1.7 billion

2) received and banked $58.5 million in milestones/upfront payments

3) initiated 5 clinical trials

4) a proven track record having created a drug which has made it all the way through to FDA approval in leukaemia and lymphoma and is helping to save lives right now. Jaypirca now owned by Eli Lilly and FDA approved is predicted to generate multi billion dollar sales

5) attracted respected blue-chip life sciences specialist funds

Given Redx's abandoned RTO with Jounce and the fact that Lisa has often discussed a NASDAQ listing, it should come as no surprise to anyone who has carried out the most basic research here that Redx may at some stage reconsider a move to NASDAQ and I'm sure the same can be said for the majority of AIM listed bios. However, we now know for sure that it's not happening now.

Finally regarding funding, we know that the new deal with Jazz takes the cash runway through to 2025 but in addition existing deals with Jazz and AstraZeneca have potential near term milestones of another $15m. They also have another 2 programmes for partnerships. Redx have some important data read outs coming in H1 and have the cash to take them through to and beyond those inflection points.

The point is that Lindy simply could not announce these agreements if they didn't exist. These mAbs haven't yet been developed into a defined product and each one could result in several different products . Potential partners will have to evaluate them using their own tech to see whether they have merit as ADCs, TCBs, CAR-T or whatever. This is a very different scenario from 'discussing' an existing drug in clinical trials with published data. From memory the Genmab deal came from one of three different evaluations, I have no idea how many (if any) of the current 5 will lead to a formal licensing deal but it would be disappointing if they all failed to result in a deal.

rats - of course the risk of 'sexing up' news releases is that it damages credibility with those who matter most to the future of Scancell ie. potential pharma partners and fund managers.

Darkprince,

Except there is something concrete and this is much more than the ususal biotech CEO line of 'we're speaking to a number of interested parties' . These are formal evaluations whereby Scancell share the commercially sensitive and confidential data set for the relevant mAb with the other party thereby allowing the pharma/biotech in question to fully evaluate alongside their own tech.

Matt,

BioNTech are developing an anti-glycan mAb. They acquired BN321 (was MVT-5873) when they bought MabVax back in 2019 and like Scancell's SC129 it targets the sialyl-di-Lewisa glycan. It's currently in phase 1 trials also in pancreatic cancer.

Regarding milestone payments from the Genmab deal, I think we've discussed this before. If Genmab take SC129 into clinical trials then it would be standard practice for a milestone to be generated upon clearance of the IND with the FDA (clinical trial approval) or first patient dosed. It would be incomprehensible to me for Lindy to negotiate and sign a deal without this as a trigger point for a milestone, but it's not going to be tens of millions of £s. Milestones will increase in size in line with advancement down the development path to market.

By the way, it's a good thing if others are also seeing value in anti-glycan mAbs and are prepared to spend hard cash developing them as it validates Scancell's approach. It's the science others won't touch with a barge pole you have to worry about. Success from others in the field can only heighen interest in and demand for Scancell's mAbs and will be reflected in the valuation of any deals.

https://classic.clinicaltrials.gov/ct2/show/NCT06069778?term=biontech&draw=5&rank=36

I have no idea whether this has already been posted but in case it hasn't, Samantha Paston will be presenting on behalf of Scancell at the conference below to be held in September in Amsterdam. Since joining Scancell from Immunocore she's kept a low profile so good to see her name amongst the speakers.

https://oxfordglobal.com/biologics/events/mrna-vaccines-oligonucleotide-therapies-2024

Cleanerworld

I'm not sure you have understood my post.

I didn't say the conference wasn't relevant, nor did I say that the fact that Sarah Danson is involved in other trials is a negative - quite the opposite in fact. I simply believe that it's not the forum for presenting new data and those building up expectations may be disappointed. Worth noting that the deadlines for abstract submissions for both AACR and ASCO have now passed, although I think ASCO late breaking deadline isn't until March. If the SCIB1 results are as good as we hope and expect, these are the sort of platforms Scancell will be hoping to use and of course they must present previously unpublished data.

Excellent news, from memory this is the 5th deal from Redx (including Pirtobrutinib). $10m upfront and total potential value of up to $870m. Next milestone will be clearance of the IND but Jazz will pay Redx to carry out the preclinical development to take it to that stage thereby generating more revenue and giving some element of control.

Ee - recruitment of a good CFO with appropriate life sciences experience can't be easy so much better to take their time and find the right person.

Burble - thanks for that, much appreciated.

Ee

Regarding the composition of the Board, it will be interesting to see but Sally's departure has no impact on Audit/Remuneration/Nominations committees so they don't have to replace her and can probably quite comfortably continue as they are. I still think at some stage it would be good to have a CFO on the board.

As for WG Partners, I know they acted as joint bookrunner in last placing, but they're not listed on Scancell's website as joint broker and I understood the appointment of a broker had to be notified. Unless I've missed that announcement, they simply seem to have appeared at the bottom of RNS's as joint broker.

Unless the RNS has been poorly worded, Dr Callum Scott is being appointed as Head of Development, but he's not being appointed to the BOD, so this isn't a board position. This was also the case with the recent CFO and Head of Business Development appointments. So the question is whether they are looking to replace Sally in terms of nos. on the board or are they happy to run with just the Chairman and 4 directors?

I'm sure I must have missed it, but does anyone know when Scancell announced the appointment of WG Partners as joint broker?

BOJO,

The neoadjuvant study gives Scancell anopportunity to understand exactly how Modi1 is performing at a molecular level, to see and provide hard evidence of the mechanism of action and to ensure that the vaccine is performing as expected in the following ways:-

1) It will tell them what sort of immune response each patient has generated - ie.exacly which epitopes have they responded to. How many patients have responded to all 3 peptides, just 2, 1 or zero? This will give them confidence that they have selected the best combination of vimentin and enolase peptides and that one isn't dominating the others.

2) What type of T cell response was generated in terms CD4/CD8 and were they actually killing tumour cells?

3) They will be looking at which patients responded the best and was there any common biomarker to identify them? Obviously the ability to predict responders would be very useful for future patient selction.

4) Perhaps most importantly they will be comparing the response of patients treated with Modi1 as a monotherapy with those treated with Modi1 in combination with checkpoint inhibitors.

In addition to safety, the whole point of a phase I/IIa trial is to learn how the drug performs in the human body, whether it merits further development and to inform the design of the next stage of trials. Obviously the results from the neoadjuvant study will be invaluable in helping to achieve this.

That's about the limit of my non-scientist understanding, but I'm sure Lindy would be more than happy to answer directly if you email her.

BOJO

Thanks - definitely worth listening to again. Lindy was very precise, the new patent application is for SCIB1 with checkpoints. Probably the single most important detail from the whole presentation for me. The short patent life of SCIB1 is an issue that hasn't really been discussed but was always there in the background. It wasn't just the impact on the valuation of SCIB1 but also essentially meant that the whole future of the ImmunoBody platform relied on successful results from the iSCIB1+ cohort of patients. This new patent application means that Scancell are not totally dependent on iSCIB1+ and it also could have relevance for the timing and valuation of any potential partnership deals.

Kashdog

Thanks!! I haven't had time to catch up on all posts.

Will be Interesting to see when it's published exactly what they're covering.

Violindog,

I guess the likelihood of success is little more than a function of the stage of development and is always going to be quite low for a phase I/IIa product in advance of the full results. Having said that, I'm surprised that it is so much lower than Moditope given their relative stages of clinical development. I haven't had a chance too look back at previous valuations but can understand that at this point in time it's more difficult to value ImmunoBody. The likelihood of success for SCIB1 must be low simply due to the patent expiry date and we have yet to see any data for iSCIB1+. Hopefully all will change with full clinical results from iSCIB1+.

Can anyone here remember exactly what Lindy said about the new patent application? From memory it was for ImmunoBody and not Moditope, but did she specify whether it was SCIB1 or iSCIB1+ in combinatioin with CPIs?

A new research note with revised valuation to reflect recent fundraise has been published by TD today:- Scancell: multiple platforms and opportunities

https://www.trinitydelta.org/research-notes/heading-into-important-2024-clinical-catalysts/

Burble,

Thanks very much for taking the time and trouble to report back. Fascinating to read comments from a highly experienced expert from a top institution and certainly adds perspective.

Important to look at this in the context of the setting for these therapies. They are FDA approved, but only for patients who have either relapsed or failed to respond to other therapies. They're not a first or even second line treatments - they're an end of the road, last chance opportunity and that makes a huge difference to the risk/reward assessment. It's also worth noting this sentence:-

'The researchers noted that the “rate of T-cell malignancies observed is far lower than that seen with some other treatments.”'

The treatment landscape for blood cancers is very different from solid tumours and of course Scancell are not in that market, however it's good to see the continued oversight from the FDA and that postmarketing reporting has resulted in action.