Member Info for Burble

It’s deafening! Every morning I wake up, grab a coffee and then check for that shining red dot. Who knows when it’ll come, or what it’ll say. But we know it must be just around the corner.

Non-paywalled version https://www.theguardian.com/business/2023/jul/04/toyota-claims-battery-breakthrough-electric-cars

Though I am unsure whether this is linked to IKA

Berm,

Due to the changes that were made, now the globe is on a first to file system. Meaning what is written in that patent when granted, is what is covered in IP law.

Historically, in the US (and Canada and the Philippines) if you could prove that you had made the same discovery before another party, even if they had made it to the patent office & filed first, there was a window when you could effectively submit a counter claim for that IP. In pharmas, this was important because two parties could discover the same drug molecule independently for the same target. Party A may have continued to do some further research on it to understand more about the molecule & delayed patenting it (therefore extending the life of the useable part of the patent if it got through clinical trials), whilst Party B may have gone for a patent early to go for protection, even if they then had to do some further R&D to understand more about the molecule.

Using this example with a standard 20 year patent life.

Y0 - Party A discovers drug

Y5 - Continues to work on this molecule and then patents it

Y15 – Drug is approved

Y25 – Drug comes off patent (10 years of sales)

Y0 – Party B discovers drug and patents it

Y5 – Continues to work on this molecule

Y15 – Drug is approved

Y20 – Drug comes off patent (5 years of sales)

If Party A could prove that they discovered & had been working on the molecule before Party B did, then they could argue that Party B’s patent was invalid and that they should be granted the patent. In terms of sales using the above example, Party A would benefit from not patenting until it had done further research as this would lead to a longer sales before going off patent. In a first to discover world, this is beneficial. In a first to file, this is not because you may miss the opportunity to patent.

It all got very complicated because how do you prove when you did something (it is easier with tracked data logged electronic lab books etc but not everyone uses these). This all changed when the US and the rest of the first to discover, moved to the first to file system.

Now parties file a patent which is as broad/far reaching as possible. If granted – good. You then tie up loose ends, or continue to work on the areas that you have less data on without fear of someone else stealing your IP If not, then you drop the claims which you have less data on & still have something patented. Previously, you would have just continued to work on strengthening those claims because you weren’t rushed to get the IP covered.

You are correct in the fact that PTMs which were deleted do not form part of Scancell's IP. However, there is nothing stopping them doing the research on that, strengthening the data behind those and reapplying. However, now because we’re all on a first to file system, if someone else (Party C) is doing that research in the background and gets there first, tough. Party C would get the pa

It depends.

There are two different filing types which differ between the US/UK when it comes to patenting. In some jurisdictions it’s first to file, meaning whoever gets to the patent office first, gets the patent. In other places it’s first to discover, meaning if you can prove you made the same discovery earlier but didn’t file it right away, you may still have a claim.

When I worked at Pfizer, it was drummed into us that we had to document everything we did in the lab in our lab books within 24 hours of doing it because it could be pivotal in an IP dispute.

Historically the US patent office was first to develop rather than first to file (as was Canada and the Philippines). However this changed when the America Invents Act came in 2012/2013. Now every country I believe runs under the first to file system.

was driving back from glasgow yesterday and i was thinking about sclp and how trials are progressing. something that sprung to my mind was how the modi-1 trial is currently being trialled in people who are late in their disease, with limited or no options left. if you look at the agm slide 11, i would therefore probably consider these patients to be equivalent to the d14 mice. from this ******-meier chart, we see a 30% survival in these mice after a single injection of modi-1v.

better survival is seen in mice that have been injected earlier d7 or d10. i wonder whether we will eventually (whether in this trial or subsequent trials) see changes to the trial to allow people to be given modi-1 vaccines earlier in their disease journey rather than later. especially if the safety profile is as good as we think it may be.

'If this wasn’t personalized, the vaccine could probably be made for pennies' - this is what has been consistently highlighted both with respect to the Immunobody platform and Moditope platform. Both are non-personalised. Both could be made for pennies. Both could therefore be accessible to larger swathes of patients and not be restricted to those countries that can afford it.

Thoughts.

Could it be they're trying to line up a deal, by putting things out in this manner they’re seeking to get multiple interested parties - hence starting a bidding war.

Just thinking aloud here, but it seems very quiet but what is put out seems to be an advertising piece for our platforms.

Something caught my eye. I first contacted Julia Kollewe back in November of 21 after she had published an article on the use of T-cell based covid vaccines in the guardian. We have since had a number of emails backwards and forwards about the use of novel vaccine technology for infectious disease and cancer.

What is interesting, is that she has now moved over to covering financial journalism. So I wonder how long this piece of writing has been in the pipeline - I suspect longer than we may have realised. As others have asked therefore - why now? Is it because she's finished writing it and therefore it gets published? Or is there another reason why this now financial journalist is publishing this article now?

SG

No problem. Glad you’re still with us 25 years after your own personal cancer experience.

Shareguard

Whilst NWBio is indeed in Phase III trials, there are definitely a number of things to consider when you compare the two companies and their technologies. NWB DCVax technology requires the patient's blood to be harvested through a standard blood draw. Subsequently the patients white blood cells are matured, activated and loaded with antigens in the lab. This is costly and not an overnight thing - so has considerable staff input and overheads attached. There is also the question of where does this happen? Is it at a central processing plant or will they be installing satellite labs to do this (each will require regulatory compliance and sign off on batches by a regulatory approved qualified person). Then their DCVax is administered in one of two ways. For some patients this will be as an intradermal injection. For patients with inoperable tumours, this will be intra-tumour - meaning the patient will need to be sedated and the injection done using imaging guidance.

So you have the following steps:

- Patient presents in clinic with tumour

- Tumour sampled

- Tumour genetic profile is created - turn-around time for this can be days/weeks. This may also require both technicians and bioinformaticians to identify key antigens to target.

- Patient specific antigen constructs generated

- Patient then has to be in an appropriately staffed/equipped hospital to do blood harvest

- Transport of blood to a lab

- Manipulation and maturation of that sample using patient specific antigens - few days/weeks wait

- Qualified person required to sign off on each batch

- Delivery back to patient

- Injection intradermally/imaging guided intra-tumour injection

Scancell on the other hand have a different approach

Immunobody - targets CD8 cells

- Immunobody vaccine batch created

- Qualified person signs off on batch of immunobody vaccine

- Patient presents in clinic with tumour

- Tumour possibly sampled

- Patient has needle free injection

- Patient goes home

Moditope - targets CD4 cells

- Moditope vaccine batch created

- Qualified person signs off on batch of moditope vaccine

- Patient presents in clinic with tumour

- Tumour possibly sampled

- Patient has needle free injection

- Patient goes home

Yes I am oversimplifying things, but whilst cancer vaccine technology is heating up, espeically post the success of covid vaccine. I think there is a high focus on personalised medicine. It's expensive, involves many moving parts. Scancell are taking a different approach and one that I and many other LTHs believe will be successful for a broader range of patients. Thats; not to say that personalised medicines won't work for some, they will and people will benefit from that. But I don't see it being a widespread technology unless supply chains are shortened and prices come down.

As of yesterday, Modi-1 was a year old. The first ever patient dosed by the drug (two vimentin peptides) was dosed a year ago. I sat last night and briefly thought about that person, how unknowingly they made history. I also wondered how they’re doing now, whether Modi-1 had been able to have an effect on their disease.

Agree, of all ministers I’ve ever had to deal with, George Freeman is passionate about the life science sector and really pushing for us to lead the charge in a lot of things. He knows his stuff too, unlike some of the previous science ministers.

Just an observation, apart from a brief AGM update about the advantages that the SCIB1+ amendment to the SCOPE trial would provide (this has yet to be implemented) we're now a week short of a year since the last proper SCIB1 RNS update (https://www.lse.co.uk/rns/SCLP/phase-2-scope-trial-of-scib1-vaccine-expanded-5aan68mrmnyo27s.html).

My guess is as good as yours as to when we will next get an update. I wonder how recruitment for this has been progressing and how patients are getting on.

I hope not referring to me! I’m stuck with a fourth bout of covid and this time manifesting itself as migraine like symptoms. I’ll catch up over the weekend when I’m back to normal.

I’m definitely starting to think that something is going on behind the scenes which is why we seem to have gone quiet. Not even a post on Twitter to highlight the Liverpool Echo news. 🤔

For me the stand out in this article is the following:

‘ it is the easiest treatment I've ever had. There have been no real side-effects. And this is one of the remarkable things, that it has been a total breeze compared to other cancer treatments, such as chemotherapy and radiotherapy.’

This is from a patient who has experienced a lot through their cancer journey, they’ve been walked to a cliff edge and faced the harsh reality of life with cancer. Only to be given a second chance.

As a healthcare professional, they have seen the effects that other treatments have on other patients. So this quote to me is the real stand out. We know that Modi-1 has been well tolerated. Even if it only works in a sub population, in the patients it does work in this would be a welcome relief.

That would be fun!

Likewise, sending you best wishes CW!

My 2p worth. If I were in the driving seat with regard to investor relations, I would look to have a quarterly update RNS, doesn’t have to be massive but similar to how other industries report. Something along the lines of:

Ongoing activities.
Trials:
Modi-1
18 patients recruited of which 3 in the last quarter.
X TNBC,
Y Ovarian
Z renal
3/15 sites currently recruiting

SCIB1
18 patients recruited, of which 3 since last quarter.
6/8 sites recruiting.

Doesn’t need to be anything huge or massively detailed. But it would at least put investors at ease that things were progressing and stop the guessing game that ends up going on where information comes out from other boards or by the strong research by the likes of Bermuda or other regular posters here.

We for instance haven’t had a proper update from the SCIB-1 phase 2 trial since June last year (excusing the AGM).

It really wouldn’t be difficult to do and just build it into a regular reporting schedule.

8 weeks for high-risk melanoma is why I keep banging on about the USP of SCIB-1 (and Modi-1 too) being off the shelf products. They’re cheaper to produce, no waiting around and in this example would get to work two months earlier than bespoke made therapies.