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I guess all very valid points. LD did say at the AGM that they were continuing to develop the glymab platform and identify other targets, so I guess the more targets they validate the more value the whole platform may have. Be that as individual products or as a whole.

Agree though, clinical data will be important to validate the platform in humans and that may add further to the value of the products generated by it.

I’m just curious, Genmab obviously have liked what they saw on the first mAb to spend more on a second.

If after these two bites of the cherry Genmab like what they see, what are people’s thoughts on them then moving quickly to buy the entire platform rather than wait for someone else to get there before them?

If another deal was done with another company I would hope that could also expedite the decision.

No mention of SCLP within the article I'm afraid CW.

After decades of disappointment, efforts to create vaccines that can stimulate the immune system to fight cancer are showing renewed promise. Breakthroughs are possible in the coming year. The optimism stems from advances in mRNAa technology and personalised medicine, and in particular from a melanoma vaccine called mRNA-4157, developed by Moderna and Merck, that is performing well in trials. In 2025 the FDA, America’s drugs regulator, could approve the vaccine. And in Britain the NHS’s Cancer Vaccine Launch Pad, a tie-up with BioNTech, a pioneer of covid vaccines, aims to fast-track thousands of patients into trials for mRNA-based personalised vaccines for colorectal, pancreatic and melanoma cancers.

Personalised vaccines are tailored to a patient’s specific mutations, and aim to train the immune system to recognise and attack cancer cells based on their unique genetic make-up. First comes a biopsy, then the sequencing of the tumour, the identification of mutations likely to generate proteins that would be recognised by the immune system, and finally the manufacturing of a vaccine to target those markers. This can all be done within six weeks, thanks to advances in mRNA technology made during the pandemic, and to progress in artificial intelligence, which is used to predict the molecular markers most likely to stimulate the immune system into action.

But the process is expensive, so parallel efforts are under way, by BioNTech and others, to develop “off-the-shelf” vaccines that work in wider populations by targeting common tumour markers. There is also growing interest in exploring vaccines’ potential use as an adjuvant, or booster, to treatments in earlier stages of cancer, alongside surgery or chemotherapy. Some researchers think cancer vaccines could one day even be used preventively in high-risk individuals.

Personalised cancer vaccines provide highly targeted treatment, but their complex manufacturing process makes them costly to produce. The coming year will be crucial. Success would be a vindication of the decades of effort spent trying to create a new way to fight cancer. But with so many past failures, those in the field are taking nothing for granted

Also in addition I’ve just noticed in that Covidity RNS it states ‘intradermal injection using the PharmaJet Tropis® Needle-free Injection System or via intramuscular delivery using the PharmaJet Stratis® system.’

In the RNS dated 17th September (https://www.lse.co.uk/rns/SCLP/strategic-partnership-with-pharmajet-3vn39muo6y7afsw.html) Scancell announced the use of the Tropis. Would this strategic partnership have cost money?

If so, i would assume this strategic partnership would need to be amended or a second partnership be developed to use the Stratis.

If SCLP paid something for access to use the Tropis, could this mean they need to pay another amount for the Stratis access.

Berm

If you look back at the Covidity trial, when PharmaJet was selected there were two different administration routes - intramuscular and intradermal. (See RNS https://www.lse.co.uk/rns/SCLP/scancell-selects-pharmajet8217s-needle-free-systems-si55pofvwqgchvf.html).

I’m curious whether they’ve looked back at this data and realised they could improve the response rate even further by changing the administration route for the SCOPE trial.

My worry though is if this is indeed a new cohort (I too haven’t heard of this cohort before) how long that will take to get through ethics, MHRA sign off etc, there is a real risk that timelines will slip again. I wonder whether a third party has asked for this data to be generated or whether it was an internal decision made - if the former, I would forgive them. If the latter, why wait till this late stage when this could have been run in parallel when the iSCIB1+ arm opened.

Curious. But given none of this was spoken about a month ago, either things have changed rapidly or the company needs to be more transparent with shareholders. I guess we sit and wait a little bit longer to find out.

Excellent news! Struggling for WiFi on the ferry but this was a nice surprise to wake up to.

IMHO two bites of the cherry signals that the glymab platform is something special. Wouldn’t surprise me if Genmab ultimately become the owners of that platform in the next few years.

Currently at a national bioprocessing conference. Was having a conversation last night with some people knowledgeable around current mRNA manufacturing and personalised medicines.

From a regulatory perspective, the regulators currently are mandating father for personalised mRNA vaccine manufacturing, batches cannot be manufactured in parallel. So an individual patient vaccine goes through the entire process from start to finish, then has QP release before the next patients vaccine starts manufacture.

Usually in traditional manufacturing of medicinal products, batches can start stage 1 of a process quickly after the previous batch has finished and moved on to stage 2. Massively increasing throughput, lowering costs and improving site efficiency.

A second fact I learned as a result of that. Currently the capacity for personalised mRNA medicine manufacturing in the UK is approximately 3000 doses per year.

Therefore, there is a huge opportunity for Scancell and their off the shelf non-personalised vaccines and a real chance of disrupting existing players. SCIB1/iSCIB1+ is easier to manufacture and because it’s not bespoke for each patient, this means they can manufacture large batches in a very streamlined way.

If I’m honest, my real worry is this will be breadcrumbs rather than a full meal. Again backloaded heavily. Hopefully the new CEO is able to be at that negotiating table.

‘Anticipated that all cohort 3 patients will reach week 25 during H2 2025.’

Am I reading this right that the iSCIB1+ trial has now slipped into the back half of the year? If funded through to Q3, that doesn’t leave a lot of cash on the table to fund the Ph2/3 trial - so hoping that either further glymab deals get done or partner pays for it.

Miavoce

Two aspects I don’t think people really appreciat when it comes to Covid vaccin trials. Many other clinical trials were halted or paused, freeing up capacity to do covid vaccine trials and other studies related to the pandemic. Secondly, due to the fact these would not have existing therapies the trials were simple to run because you just had to prove they were better than not doing anything at all.

Furthermore, with all clinical trials and new products there is a thing called post market surveillance. This continues after a product reaches the market and allows for healthcare providers and patients to report side effects or reactions to a product even after it has been approved by regulators. This could be considered a phase 4 real world clinical trial that continues for the life of a product and is very valuable because it provides data on drug effects both positive and negative in the general population so has far more diversity of patients - both in demographics, but also comorbidities or polypharmacy.

If any longer or delayed effects were seen in any of the approved covid vaccines, this reporting mechanism could be used to update approvals or guidance on the safety of vaccines on thr market and provides a further layer of protection to patients and end users.

Dracula,

I can actually answer that for you given I was at a work meeting with a life science company on Wednesday who played a huge part in getting the AZ vaccine to market.

In Jan 2020, Oxford Uni approached them and said ‘this vaccine could work, but we need help with manufacturing to meet potential demand if this new virus becomes a pandemic’

The company then moved and deployed teams to answer this, working 24/7 round the clock they managed to condense 9 months worth of work into 3. So even before we went into lockdown, basically Oxford knew how to manufacture should they need to.

This organisation was working at risk, massively parallelising experiments and feeding data to the regulators as it came in. When usually they would wait to file everything in one dossier.

Every company involved in the vaccine development worked in this manner, at risk and threw staff and resources at the problem, making decisions on the fly. But these were all informed by vast amounts of previous experience and building on technologies they already had knowledge and data on.

In turn the regulators didn’t wait for a single final submission, but allowed orgs to build up that final submission as and when data came in. Whilst maintaining the high quality they are known for. This meant condensed timelines yet maintained safety.

In essence the entire system worked as one, focussed on a single challenge. It wouldn’t happen in normal times, because that’s not how the industry usually works. But for Covid, it’s why we managed to get safe and effective vaccines to market in such quick time.

So time, money and focussing on a single problem got vaccines to market without sacrificing the quality and effectiveness we’re used to. I’m sure SCLP could do the same if a) they had money and b) the entire system wanted to tackle a single problem which could affect the entire population. But sadly that’s not the environment we live in.

Good spot Berm!

Violin,

Unfortunately I don't think this is directly linked to SCLP, across the whole of AIM I think there has been a lot of people selling up because of the potential for incurring tax should the chancellor change the rules later today. I've seen many of my AIM portfolio going down over the past few weeks, not because of a lack of good news. Hopefully once the dust settles over the coming weeks, things may start to look rosier.

LD does go on and answer the first question in the Q&A session saying that whilst SCIB1 is not fully recruited yet and due to the simon 2-stage clinical trial design they only need 27 responders, those last few data points may mean the read out slips into 2025.

If it's not captured on that recording, I have my own recording of the AGM from the other side of the room.

I do agree with somebody below, I wish they had properly recorded it and put it out on the website - rather than us relying on our own phone recordings.

Mia

'Where did you get 'SCIB1 read out - December/early Jan' from - all I hear in the recording was Q4 ?'

LD says quote 'So we're hoping to report on the SCIB1 data by the end of this year, but the iSCIB1+ data...[shuffling on recording] A2 populations will be into the next year.'

This was quite early in LDs presentation.

I agree with pre-clinical deals on further SCIBs, especially if the SCIB platform could be designated as a new modality, it would then allow many other companies to licence the technology and start developing their own for their own indications/targets.

I had a conversation about Avidimab with a few of the staff afterwards and there was an interesting take I hadn't thought about.

I raised the idea about patent extension using Avidimab, but one thing that was pointed out was that this wouldn't really work. because a pharma company have to go back through the re-approval process due to the change in the drug - you'd have to go back through some trials (though maybe not all of them). If the original drug was off patent, at the same time, generics would be manufacturing a biosimilar and marketing that. Therefore, re-approval would be a cost to the company in a market where generics are being sold and there is a risk that Avidimab wouldn't improve things significantly enough to mean when it got back to market people wanted to use and pay for your new avidimab version of the drug over the previous version . So may not be a route that pharma would go down - as such, patent extension probably wouldn't be attractive. It's a really difficult thing - great product, but finding the right route in to be able to commercialise it may be difficult.

I asked whether they had explored diagnostic tools, radioligands, labelling mAbs in R&D settings (where you don't need clinical trials etc) but that was politely dismissed. I guess effort vs return would take focus of the BD team away from the real opportunities at hand.

2/2

I also asked a question around publicity - LD was true to her self that she didn't want to sing from the roof tops with weak/partial data. But that they were ready when the time comes and had the PR machinery to get the word out there. Both LD and JMC were vocal about this which I found heartening.

What was interesting, was the fact that money buys stories, but it doesn't always mean the data behind those stories is as strong as it could be. They both said that the likes of Moderna/BioNTech had invested money into the UK and into their clinical trials of personalised mRNA drugs, hence to get ROI they had the PR to back it up. SCLP didn't have that budget to compete....but what they did have was good data. So when the time is right. The data solid. They would be singing things from the rooftops.

My final take away was really on timelines.

Glymab milestone - Genmab moving forward with ADC (interesting that this seems the only modality they are using it for despite licensing it for others).

Unknown pharma - could be December

SCIB1 read out - December/early Jan (my preference for the latter)

iSCIB1+ - H1

So a strengthening pipeline of news and the next six to nine months will be very exciting.

Firstly, great to meet some of you at the AGM, was nice putting faces to names.

Now don't have train wifi issues to contend with, I've had a chance to sit down and go through some of my notes and a few points:

SCOPE Phase 2/registration trial will be held in the US/UK - during the Q&A I asked a question about the fact these are two different beasts (healthcare providers, trial set up, ethics etc) and where would the trial be coordinated from. LD assured us that they had the experience both in house and links to CROs who also knew the landscape well and could run this trial on our behalf. but that they would look to run it from the UK.

Successful registration trial would then generate a constant cash flow, meaning development of Modi-2 and SCIB-2 could proceed.

When talking about the SCOPE trial, LD mentioned that they had 7 year stability data so far on this. I then subsequently got talking to the Head of Development about this after the AGM and it was clear that this is something that from a healthcare provider point of view would be attractive, especially given the NHS greener supplier guidelines coming in - stability of mRNA drugs needs vast amounts of low-temp cold chain, DNA doesn't. Meaning just storing this as an off the shelf drug would be cheaper and greener than their mRNA equivalents.

Also interesting on the SCOPE front was how LD described our patient cohort in comparison to IO-BIO and BioNTech. They are looking at getting their monotherapy + CPI upto 50% ORR (equivalent to the double check point SOC) but without the toxicity. SCIB1/iSCIB1+ would get to 70% ORR again without additional toxicity.

A throwaway comment by LD in the Q&A said 'the lab is working on other immunobodies as we speak' this I find interesting, because they've said they want to focus on SCOPE and getting that to market. So why spend time/money/energy making new ones? Is that because the platform has such potential that by having a bank of new SCIBS in the wings with data on them, if a company wanted to buy the Immunobody platform, they would have to pay £££ more?

GlyMabs.

Interesting that the actual methodology behind making the glymabs wasn't patentable, but the actual glymabs themselves were. This could be really interesting because by not being published, SCLP can position themselves to make new ones for customers , I don't think this is the route they want to go in, but it's interesting that this could be financially generating in the future if needs be.

AvidiMab

I asked a question about this too, interestingly they are struggling to get traction on this due to the fact people don't want to re-do work to generate data to prove it's improving things. It made complete sense to me why an org may not want to include something extra in their mAb design - especially given how high drug development failure rates are! 1/2

JB1 yes that’s what she said (just listened to my own recording and LD says verbatim what you’ve posted below).

What I’m trying to work out from the tone of her voice is, is she talking in hypotheticals - when scanning patients, this is what we would consider a complete responder (in any clinical trial of this nature) or is she talking in exact numbers - when scanning patients, this is what we would consider a complete responder (in the scope trial patients we have scanned so far).