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Moving on, good to see that the issue of funding of Scancell's vaccine is being raised at the highest levels.

According to Hansard, the Newcastle Labour MP and shadow BEIS Minister, Chi Onwurah has tabled a written question last week to Alok Sharma, BEIS Secretary of State asking about funding for both the Nottingham and Bristol Covid-19 vaccines. She asked about the decision making process that meant Oxford and Imperial have received funding for a Covid-19 vaccine but Nottingham and Bristol haven't. This is the reply from Parliamentary Under-Secretary, Amanda Solloway:-

'In Oxford and Imperial, we have two of the global front-runners in C-19 vaccine development. The teams at Oxford University and Imperial College are the most progressed in terms to developing a vaccine candidate and entering clinical trials, in the UK. As such, the Vaccine Taskforce has worked to ensure that Oxford and Imperial receive the investment from BEIS and DHSC to accelerate the development of a successful COVID19 vaccine.

The Vaccines Taskforce will continue to review and engage with other candidates and the Government is rightly proud of the work that many of our academic institutions are conducting in response to COVID 19.'

Inanaco,

No the costs aren't the same - at all.

Ruck,

Yes and that's the beauty of Moditope - it's not a vaccine that has been designed for specific cancer targets but for any cancer that expresses high levels citrullinated vimentin/enolase.

The head and neck cohort will be in combination with Opdivo (BMS' PD1) but still the same Modi1 vaccine.

Ruck,

We've had this discussion before. Don't worry, Scancell won't have to fund 4 separate clinical trials - it will be one trial.

In terms of the trial design, all we know so far is that part one will be looking at safety in 2 cohorts of patients - at a low and high dose. If more than 30% of patients show an immune response and the safety profile is acceptable , the trial will expand with 4 cohorts of patients in 4 different cancer types.

Each cohort is simply a treatment arm of the the Modi1 trial, it's not a separate, indpendent trial. There will be one CTA for the whole trial, one principal investigator, one set of ethics approval, one record on the clinical trial registers etc. etc.

By the way, good to see you posting and hope you're keeping well.

Dragon,

Trinity Delta benchmarked Scancell's previous sale of glycan mAbs with £2m up front plus £2.85 million in milestones .

Inanaco,

You need to be able to actually get the product to market in order to corner it.

In the first paragraph of your earlier post you mentioned that the CRUK site shows recruitment is due to end next month. I assume you're talking about the SCIB2 trial, do you have a link to the page?

Also, you're absolutely correct when you say that Scancell had a tough time trying to secure a deal for SCIB1. High profile failures of other trials meant that nobody wanted to touch a cancer vaccine and despite approaching dozens of companies, Scancell were unable to find a partner for SCIB1. Had those other trials been successful, then I believe cancer vaccines would have become a hot field and pharmas would have been keen to cut a deal.

Cancer vaccines were very much in the wilderness for a few years but the advent of personalised, neoantigen vaccines has sparked renewed interest in the field. The last thing Scancell need now is for other vaccines to fail in trials - we've already suffered from the impact of that. This renewed interest is only going to be maintained by success and so we should be celebrating any successful clinical trials and concerned if we start seeing failures. Every trial that fails will simply reinforce the opinions of the doubters and make the whole field just that little bit less attractive for potential partners .

Inanaco,

Any deal is obviously going to be heavily back-end loaded and for just the Modi1 TCR, I wouldn't be surprised to see an upfront of up to maybe £10m.

Konar,

You make some fair points Konar and I hope you're right.

Regarding the Modi1 trial - 12 months from now takes us roughly to the end of H1 2021. We've just found out that the start date of the Modi1 trial has now moved to H1 2021 - not Q1 but H1. Hopefully that's just out of an abundance of caution but even if they manage to set up the trial by the end of Q1, ie. March 2021, I can't see how it's remotely possible to get any results by the end of H1. They'll be running 2 cohorts at low and high dose in part 1 before they can even think about expanding into the main body of the trial. I don't believe that it's possible to recruit and complete part 1 within 3 months, let alone produce and publish any results.

You could be right and moving into clinical trials may be the trigger for a deal but if a potential partner is interested enough to make an offer, surely they'd either do it at the preclinical stage or wait for the initial trial results.

Regarding BioNTech, they have so many competing priorities at the moment, a vast pipeline eating up cash and developmental commitments for other products that they must meet. On top of that they have their COVID vaccine. So I don't think the Modi1 TCR is going to be on their list of priorities at the moment and they have the comfort of knowing they have first option. I'm still hoping that there's a chance of a deal although the value may not be as high as some of the valuations we see being discussed.

IMO etc. etc.

Konar/Dracula,

It's hard to see how any clinical trial results will be availiable within 12 months so Scancell's best hope of a commercial deal lies either with Avidimab/glycan mAbs or Modi1 TCR with BioNTech IMO. The other alternative of course is the sale of the whole company.

LochinvarLass,

In drug development, phase IIb/III is considered late stage. Preclinical in any shape or form is by definition early stage.

Crumbs,

If it helps, the primary outcome measure of these trials when they get into phase III will be the incidence of patients who have caught COVID (confirmed by testing) in the treatment group versus the placebo group. So just generating antibodies won't be enough to secure approval - they have to actually prove it works and is safe in tens of thousands of patients.

Crumbs,

No I genuinely don't. This/these vaccine(s) will be the most scrutinised in history. It/they will also be the ones most under attack from the anti-vax movement and I truly believe that if anything, the regulators will be more rigorous regarding safety.

Crumbs,

As far as I know, all of them are manufacturing in advance in the full knowledge that if the vaccine fails it will all be wasted. The alternative is to wait to set up phase III trials, recruit about 30,000 patients, dose them all and wait until enough of them catch COVID to prove efficacy, submit and apply for marketing approval and then start - how many thousands of lives will be lost by waiting? It's a toss up between potentially wasting money or wasting lives.

lol thanks Crumbs - you can tell what's on my mind.

Crumbs,

They haven't even finalised the product yet , according to the Sky interview they're still at the stage of adding peptides/doing away with the gold bullet. How can it be anything other than early stage? It's not a criticism, Scancell themselves have been clear - this is a second wave vaccine.

Knowlesi, I'm sure Scancell will receive funding - I'd be amazed if they didn't. Anybody aware of any credible vaccine candidate that has been refused funding?

It's easy to criticise, but UK life sciences sector is punching way above its weight at the moment in terms of the clinical trials for existing treatments and vaccines. Impossible to overstate the effort that is being put in by both academia and industry. Scancell's time will come IMO, but they're part of the second wave and it will take longer.

Wild/Chelsea,

In order to be at the front of the queue, you have to be in the race to develop the first approved vaccine . That means the vaccine must be one of the front runners in clinical trials at the moment. I agree, it would be astonishing if there was a deliberate strategy to put all the UK eggs in one/two baskets but as far as I know, there were only 2 UK vaccines that were advanced enough to join that race and they both received the funding they needed. I believe that there are 2 other vaccine projects that have already received some funding and the only others that I've read about that are awaiting funding are Scancell and Bristol - both very early stage projects. I'm sure there are others, but I haven't read about any vaccines that were able to be developed quickly enough but couldn't get funding - are either of you aware of any?

There are now 16 vaccines in the world in clinical trials broken down as follows:-

China 8 vaccines
US 2
Germany 1
Korea 1
Russia 1
Germany/US collaboration 1
UK 2

So the only other countries in the world with more shots on goal are China and the US and most countries aren't even in the game.

Of course if both the UK vaccines fail, the UK will be at the back of the queue, on the other hand, if one of them succeeds, not only will the UK be at the front of the queue but plans are already in place to make sure that the poorest countries in the world will also be supplied.

Chelsea,

Just to clarify, when the term 'a person closely associated with Martin Diggle' appears on the RNS, the word 'person' just refers to a legal entity, in this case the Vulpes Fund. ie. It isn't an individual person. So as you say the Vulpes Fund taking profit.