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Crumbs where you say 'pity Modi 1s potency in that Ovarian cohort is not by itself game changer' - remember that this is a phase 1 trial. The data that comes from this, will help understand what Modi-1 is doing in different cohorts. You will see as we progress through further trials that the inclusion/exclusion criteria may be adjusted accordingly.
I would say given the aggressive nature of ovarian cancer and the fact many patients relapse quickly. A 44% disease control rate in ovarian cancer patients is quite the opposite - these are patients who have limited options left, have failed front line therapy and are on a steep glide path sadly. So a 44% disease response rate may be a game changer for these patients if this is reflected in larger studies.
Just remember, this is a small cohort of patients so far, larger studies will give a truer picture of what is happening.
DarkPrince - I would say quite the opposite!
Take a look at the 3 year results data from the Phase 1 (KEYNOTE-001) trial for Keytruda. ‘ At 36 months, investigator-assessed objective response according to immune-related response criteria was achieved for 41 of 101 treatment naive patients (41% [95% CI 30·9–50·8]; median duration of response was 16·7 months [95% CI 12·6–not reached]) and 102 of 449 previously treated patients (23% [18·9–26·9]; 33·3 ([22·5–not reached]).’
Our patients have exhausted treatment options.
Keytruda made it through Ph1-3 trials and is currently making $21bn in 2022 sales.
(Reference https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30500-9/fulltext#seccestitle150)
‘The platform has generated revenues and the antibodies continue to yield compelling results which have led to a new 6-month evaluation by a leading Biotech company. Additional in-house data has illustrated the potential of our antibodies as chimeric antigen receptor T cell (CART) therapies providing the data for a deal with a cell therapy company.’
I wonder whether this is a hint that a deal should cross the line for this before H2 2024
Something I have sensed from my current work, this government believes that mRNA (and oligonucleotides in general) are the next big thing. They’re investing heavily, pushing for mRNA tech. I and many others worry that there’s a high chance they’re putting their eggs in a single basket. The industry knows that personalised treatments, whilst effective, are going to costly to produce and have other pain points in supply chains and manufacturing. There is also a huge issue currently with delivery technologies for mRNA technology, with lots of legal wrangling over the lipid nano particle technology used to deliver it.
An off the shelf vaccine which doesn’t use the large pharma’s LNP IP has a real disruptive potential and wouldn’t surprise me if one of two scenarios happens. Either quietly purchased on the side by a company before others get proper wind of it. Or a bidding war between big pharma.
HexaBody® technology platform - ( Burble has Glymab platform anything to do with this ?)
Not specifically, but hexabody technology could be applied to any antibody. So the antibody that genmab licensed could have hexabody technology applied to it. In a very similar way to how our own Avidimab could be applied to any antibody. It is a platform technology with broad applications.
Basically it seems it is a single amino acid change within the Fc region of the antibody (similar to our finding with Avidimab). This causes clustering of six bound antibodies (hexamerisation) to occur on the surface of the cell. Once hexamerisation occurs, this results in improvements in downstream effects but also complement-dependent cytotoxicity. Basically, as a technology platform it can convert antibodies into potent cytotoxic antibodies.
As this is a platform technology and genmab have other Fc engineered antibodies, it wouldn't surprise me in the slightest if the were one of the first to license or purchase avidimab.
Front page of the guardian today. https://www.theguardian.com/society/2023/jul/07/skin-cancer-cases-reach-record-high-in-uk-with-sharp-rise-among-older-adults?CMP=Share_iOSApp_Other
Means the market for melanoma treatments is going to rise. SCIB1+ can be used to treat a broader amount of patients. Hopefully approval for this gets over the line soon. I know the HMRA is facing delays in approving studies and amendments. But hopefully this amendment to the SCOPE study will get over the line soon.
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?
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.