Moderna failed because of small trial and size of control arm and it was not powered properly (read attached article).
The advantage between it and available treatment was not shown clearly enough.
If iScib+ has brilliant data then early approval is possible (I think likely).
An assessment of study power is essential in determining both the statistical significance and clinical relevance of any study and has serious implications for any conclusions that can be drawn. |
You've done very well, Harry! |
Pharma Looks To Redistribute CDMO Footprint. A redistribution of pharma outsourcing activities, both ex-China and also a wider shift in CDMO work from North America down... |
 Many thanks GH, but this is a road we have been on many times before. Perhaps the economy is a little worse this time around, but anyone with a bit of OXB history can recognise the patterns.
End of 2016 / beginning of 2017 we are around £2 and all is doom apart from with the insiders at OXB who all knew they were negotiating the Novartis manufacturing deal which doubled the share price by mid 2017 as kymriah gets approval. By the middle of 2018 it had doubled the share price again and then the deal with Axovant takes us as near to £10 as doesn't matter. Also a much smaller company back then with no other vectors and only facilities in Oxford.
I only mention that Novartis manufacturing contract in particular, because it's such a similar scenario to today - i.e. sat in smallcap and pretty much invisible except to our major shareholders.
Back in 2017 we could only guess the Novartis contract was coming. In 2024 we know there is a very similar one coming because Frank told us in March.
So, 2017
2024
"Recently, the Company signed a contract with a new undisclosed US-based biotechnology company for the manufacture of lentiviral vectors as the client prepares for the commercial launch of its CAR-T programme targeting multiple myeloma. Manufacturing will take place in Oxbox, the Company's Oxford-based manufacturing facility.".
They haven't told us what that is yet, or disclosed the details, but it could easily be as big and I have an inkling that the big reveal on this might be Frank's centrepiece for a week on Monday (as he does seem to like a results day with a lot more than just the results). |
Great info thanks H |
You can't get off that easily Ygor...
7 working days to go "All hail the inhaler!"
Cystic Fibrosis trial using OXB's LentiVector now live on the clinical trials database.
We know from back in 2021 that "OXB will receive an option exercise fee of $4.7 million US dollars and can qualify for payments of up to $32 million based on achievement of development, regulatory, and sales milestones.". I would say that some of that 32m will almost certainly be against the the trial starting / first patient recruited / dosed, so that will likely be a few million to OXB before the end of the year - which is always nice.
As a non-doctor / non-scientist I'm a little surprised to see that Phase 2 has a placebo arm in an experimental treatment for a disease where there isn't currently a cure - i.e. they shouldn't need a placebo to see if it works because it should be obvious? But I have read before that in all double blind trials where it's ethical to use a placebo (i.e. not cancer trials etc.) then it's normal (upon a successful trial drug gaining a licence) to immediately offer it to all the trial placebo patients for free as a thank you - so essentially they pay a time penalty but still get the treatment if it works.
Why is this good for OXB?
Well, our traditional gene therapy treatments (such as those which have gone into eyes and brains via extremely precise injection) use very little LentiVector. Professor Kingsman once referenced the quantity, then said "which is next to nothing" for those unfamiliar with the units. So OXB needed to make relatively little of it.
LentiClair is inhaling it as a mist and so they will need a lot. Obviously not for the initial 36 patients (which will already be manufactured anyway) some of whom will get a placebo instead, but should this drug be a success then OXB will be needing our biggest bioreactors and as we know already that equates to very big money - for the lifetime of the drug.
On top of this, should it work out then the early patients will be on the news / in the media and whilst Boehringer will get most glory for that (under the rule which says "he who has chequebook is king") everybody in the industry will know that Boehringer selected OXB's LentiVector because it was the best option to insert / correct that faulty gene. |
That'll do as an advent entry Harry. |
I think he means it's a very long story rather than me just being a windbag Ygor, though both points are true.
It's difficult to do OXB justice because today it's not the company it was.
When Sue and Alan Kingsman founded OXB as a spinout from the Oxford University labs they were professors at, it was a drug discovery company with the ultimate aim of keeping some drugs or sales territories inhouse to eventually become a pharmaceutical company.
None of that can ever happen now, but it's really not an unusual story. Most drugs fail in trials and almost no biotech companies turn into pharmaceutical companies for the very simple reason that the few successful ones almost always get bought out by pharmaceutical companies for huge sums of money.
Part-way through JD's term as chief (after the Kingsmans) and we are already part drug discovery biotech / part service company for others. In a nutshell that's the only way we have stayed around this long (25+ years) without ever seeing a drug (of our own) approved. We have of course been a vital part in Novartis and AZ drugs which were.
Now we are 100% service provider to others, which I never saw coming - but I don't mind because it's regular money with much less risk.
So I would say it's impossible to do a share price story which means anything.
Drug discovery with any company is a cycle of hope, hype, reality and repeat - until you either get a winner or run out of money. Covid delays ran quite a few companies out of money which might otherwise have made it. Fortunately OXB had their cash pile but have still had to cut their cloth to suit. |
Come on CousinIT, when it comes to OXB Harry is a more reliable source of information than ChatGPT. |
Talk about war and peace! 😂 |
Harry....quite a big buy came in this afternoon which was encouraging to see. Perhaps your next advent calendar story should be a brief history of the OXB share price since listing! |
Wednesday, and working day 8 on the advent calendar countdown.
Not wanting to do an ambassador's chocolates here and spoil you all (especially those who have already bought popcorn for this afternoon's xTalks webinar), today's calendar door opens on current events and the Biosecure act just voted through by the US lower house.
Still has to pass the senate and yes horses will be traded (I'm trying to avoid the gulag again and you all know what I mean $$$) but this potentially has huge implications for OXB (and any other specialist CDMO outside of China).
Literally, you are CEO of ABC right now and need XYZ. Do you go the China route and risk delays, penalties and falling foul of the world's policeman or do you look around for someone else outside of China to hedge your bets with? For very specialist CGT CDMO there isn't a lot of choice. It means more work for OXB and more work means more money.
As for today's featured partner in the advent calendar countdown, it's going to be a quick reminder of one covered only recently (Oxford University labs) and their Lassa Fever programme.
A reminder of the relevant OXB link
"Two new adenoviral vector agreements with Oxford University have been signed, including a Clinical Supply Agreement for the manufacture and supply of adenoviral vectors for a vaccine against the Lassa virus". |
Just a quick reminder of an earlier post, re the presentation tomorrow for those who want to tune in.
Harry S Truman 19 Aug '24 - 19:49 - 8512 of 8599
AAV team presenting Wednesday September 11th 4pm on Webinar Hosted by Xtalks.
Stimulating though that sounds, maybe a scientist amongst us might want to take one for the team and report back with the larger print summary? |
Remember that top 5 stocks to own story the other day? (Motley Fool and a guy who didn't seem to know that much about OXB seeing as it was his pick).
Today Peel Hunt (and remember they are no longer house broker - so no obligations / duty here)
The UK shares to own as interest rates fall
Peel Hunt sees one of the biggest impacts being in healthcare and life sciences, where valuations are built on future cash flows. The run of rate rises has diminished their appeal, leading to one of the sector’s most testing periods since the financial crisis.
The bank said: “As we turn the corner, it would be reasonable to assume that a more stable inflationary environment will also see some risk-appetite return for higher growth companies.”
In Peel Hunt’s coverage, the Buy-rated stocks that could see support include FTSE 250-listed PureTech Health and Syncona and the smaller duo of Oxford BioMedica and hVIVO.
Perhaps a little premature to jump to a conclusion based upon two separate news stories a week or so apart, but it seems possible to me that slowly, slowly the investment market is being warmed up for our revaluation after the interims. |
Thanks Tuco,
I was struck with the idea of "the 10 days of interims" (a bit like the 12 days of Christmas). So we've done Sardocor and today CARGO, and my list of clients where OXB have given us at least a good hint of a name is about 22 in number so it should be possible, but we will see.
You know yourself what one good commercial partner has been worth to us in Novartis. The number of partners OXB has these days makes eventual multiple commercial supply contracts like that pretty much inevitable, but to my mind it's just the question now of how big that income stream becomes / is forecast to become before someone else wants it more than we do. |
Morning all in the land of opportunity and sunshine.
For today's entry in the boredom relief interim results advent calendar challenge (I can't compete with mass prisoner releases organised by professional comedians) I present a recent Nature article entitled "Editor’s pick: Cargo Therapeutics".
Seems a very positive article to me, but I was drawn to this passage "Bicistronic and tricistronic CARs are hard to make, for two reasons. First, the vectors require long sequences, which can impair viral packaging, disrupt transduction and reduce CAR expression. Ports says Cargo carefully screened for transduction efficiency and high-quality lentiviral titers before selecting CRG-023. The other challenging issue is T cell exhaustion. “You put two or three CARs in the same cell, there’s concern that the cell may get overactivated and undergo exhaustion and activation-induced cell death,” says Neelapu. While a legitimate concern, says Ports, “we’re simply just not seeing it. We see that the total level of CAR receptor expressed is comparable to monospecific CARs.”.".
My selections from that quoted paragraph with annotations:- (next gen) "CARs are hard to make, for two reasons. First, the vectors require long sequences, which can impair viral packaging, disrupt transduction and reduce CAR expression." AND (god bless OXB) "Cargo carefully screened for transduction efficiency and high-quality lentiviral titers" AND (regarding problems) “we’re simply just not seeing it".
Where am I going with this one? I'm pleased you asked.
Whilst research licences are usually free, once a go / no go decision has been made then a contract is needed and CARGO Therapeutics has been a contracted secret squirrel partner of OXB since June 24, 2022 (you can find that in their 8-K forms).
In 2022 it seems initially just for lead product Firi-cel (CRG-022), but as of March 4, 2024 they came back and amended the contract as "Oxford Biomedica manufactures and supplies to the Company certain lentiviral vectors (“Vectors”) and grants to the Company a non-exclusive royalty-bearing license under certain of Oxford Biomedica’s intellectual property rights for the research, development, manufacture and commercialization of T-cells transduced with such Vectors (“Licensed Products”).".
Seb only told us about this on 20th September 2023 in the interims (hence my previous point about them saving up good news for the interims presentations) see this link where he says:-
"I am taking here three names, some that we know very well and you don't. Cargo is one. The agreement has not been made public yet. It's the first time that we're using publicly their logo and some information here, although we had signed with them back last year, first agreement on the early programme. We're currently in phase two, extremely successful. I'll let you look at the successes of Cargo, but we're extremely happy to support them."
The usual caution here that I may simply be seeing what I want to see, but an editor's pick in Nature talking about the challenges / successes with a next gen CAR (CRG-023) and OXB as the tech partner / manufacturer for the vectors.
CRG-022 is most relevant as in people / in Phase 2 means big news (good or bad) soon (soon being a relative term in biotech), but more importantly I think, showing OXB able and selected to support the coming better mousetrap in CRG-023. |
Just looked in. It appears that Harry is back to form and responding to each and every post. At length I guess from previous form. Has the share price improved since my last visit? I don't know - or care. |
Thanks Harry but the technology is a bit beyond me. I'm still at the stage where is vector can be described as a mosquito where the insect is the delivery system and the malaria that it's carrying gets delivered once it lands on its target! |
Hello again Ygor,
That sounds like a storm response to me (CRS) which is a known common issue when an immune system which hasn't previously "seen" a problem suddenly "sees" it.
Not specifically ours, but an explanation to 3rd gen. |
Harry...I was really thinking of a chart for the vector diagram. The kind of thing you'd see hanging on the wall of a better-class science lab. Numbered vectors running vertically down the left hand side with an explanation besides each one of them. All ruled off of course. Anyway, I get your drift on the direction of flight. As an aside, I can tell you that the melanoma that was overwhelming my daughter by the day like some medieval disease was stopped in it tracks by T-Cell immunotherapy. The only problem with it is that once the T-cells wake up they operate like a Gatling gun and can start attacking parts of the body that you'd rather they didn't. The name of the game then is a regular wide spectrum of blood tests to make sure everything is working as it should.Let there be no doubt, however, that this treatment is a game changer. |
Ygor,
I'm not a scientist and can't explain the science of generational vectors to you other than to say it's a bit like biplane, monoplane, swept wing, afterburner. Each one improves over the last - in our case with with safety / capacity / manufacturing. I only really need to know what the vectors do (e.g. deliver genetic information to target cells) and that they do it well, but the science of how they achieve it is for people with very specific science degrees.
This is OXB's 4th generation
Random point here:- It was May '23 when OXB launched their 4th generation and at that point 6,000+ people had been treated with LentiVector.
Look at the OXB website page rather than that datasheet and scroll down near to the bottom. Last time they updated the website it was 8,000+ patients.
Another 2,000 patients in 16 months? If we were a US company we would have planes up towing banners with that written on it. |
You obviously remember the same legal case where he had fallen out with his manager over money and his spending habits were aired in court. I forget the exact figure now, but he had spent something like 300k on flowers and the judge enquired as to whether he considered that a little excessive. He replied no, adding that he liked flowers. Amazingly talented but a tad crackers. I think Johnny Depp is one of the biggest spenders, which takes some doing in a world where people like Travolta have a 707 parked outside the house. |
Register for streaming realtime charts, analysis tools, and prices.
Hot Features
Premium
