Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Just watched today’s WHO press briefing. Pretty inconsequential other than maybe the last couple of minutes where they talk about sharing of data between trials.
They didn’t mention any specifics but the two most obvious for us are REMAP-CAP and Solidarity - that would really help differentiate IFN B1a as both a stand alone treatment and IV administration. Here’s hoping!
The patent in Oil’s link below refers to the method for determining a patient’s responsiveness to Interferon treatment. Correct me if I’m wrong but I don’t believe it protects against Rebif being used IV.
This one is interesting too...
https://patents.justia.com/patent/20170246254
... as it protects the lyophilised form. I quote:
‘The invention further concerns a lyophilised formulation or an aqueous pharmaceutical composition according to the invention for use in the prevention of vascular leakage in ARDS...’
The questions I don’t know the answer to are:
1) does Rebif count as ‘an aqueous pharmaceutical composition according to the invention’?
2) Can Rebif be injected intravenously and is that what they are doing in the trials? It is designed for subcutaneous injection.
Even if they are injecting Rebif intravenously, I would think that a combination of the diagnostic and the lyophilised form (freeze dried so it can be transported easily and lasts much longer) must be superior to Rebif.
So imo it will come down to 1) whether they license our diagnostic for use with Rebif and 2) our manufacturing capability.
But first we need results confirming that IFN B1a works.
I agree, that would be incredibly helpful!
My guess is that the analysis of the interim data proved that the HIV drugs didn’t work but showed an improvement of some kind when combined with IFN-B1a. Otherwise they wouldn’t have left the website like it is.
They’re probably finalising what they need to do next (which may or may not involve the HIV drugs) and will update it / us when they have agreed it.
My hope is that the Faron team have been close enough to the programme to understand the outstanding issues, hence releasing the paper on administration routes just in time (for the protocol to be adjusted to take it into consideration). I remember it saying something about administration routes being wrongly considered the same in terms of pharmacological effect.
Maybe I’m joining too many dots, we’ll see.
gkb - I was referring to this WHO page...
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
Whilst it doesn’t reference Traumakine directly, we know:
i) Traumakine was included in the Solidarity trial (RNS etc)
ii) The Lopinavir/Ritonavir with Interferon beta-1a arm of Solidarity was the only one with IFN B1a so that must be the one Traumakine was in
iii) From the link above, the WHO Solidarity page states that they have cancelled the Lopinavir/Ritonavir arm but kept the Lopinavir/Ritonavir with Interferon beta-1a arm (in the Treatment options under study section in black background).
I agree it’s opaque, but there is nothing to suggest that Traumakine is no longer part of the study, and if it had been pulled I am pretty sure Faron would have had to issue an RNS.
Traumakine is still in the WHO Solidarity trial (IFN-B1a has not been pulled according to WHO website) and REMAP-CAP.
Given that Traumakine’s entry to each of these trials was signalled in separate RNSs, I would expect they would have to release another if Traumakine was pulled from either.
So in this instance I believe no news is good news.
The free float must be shrinking but I just looked on the FT website and they say Hargreaves Lansdown hold 2.36m shares (just over 5%) using data to 01/07/2020.
As far as I’m aware they don’t have a fund that would take a stake in a company as small as Faron so I reckon this is all their individual clients‘ holdings (including mine!) wrapped up under their Custodian agreement (ie they wouldn’t show up as individual investors on the Faron share register)
So still a fair amount of our stock held by PIs on AIM imo.
The ‘Traumakine to be part of WHO’s Solidarity trial’ RNS was on 27/04, a couple of weeks after that article. So it might just be a timing thing.
The Lopinavir/Ritonavir with IFN-B1a arm was the only arm with IFN-B1a (published on the WHO website) and we know we are involved in Solidarity.
But it’s all very opaque!
Solidarity page now updated following the weekend’s news.
They have removed the Lopinavir/Ritonavir arm but interestingly have kept the arm for Lopinavir/Ritonavir with IFN-B1a. Seems contradictory to some of the other reports so maybe it will be updated further.
But no matter how you read it we’re still very much in the game.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
They are using Traumakine (administered IV) and Merck’s Rebif (sub-cutaneous injection). Both IFN-B1a
That’s why the article the team published a few days ago is so important.
https://ccforum.biomedcentral.com/articles/10.1186/s13054-020-03048-5
Tumbleweed. And more tumbleweed. So what's next?
Will it be WHO (likely) or REMAP-CAP (less likely?) or Faron (somewhere in between?) who blinks first on Traumakine?
Or will we get some data on the 1st expanded cohort (CRC) on Clevegen?
Here we all are, hoping we've caught on to the next Nokia story out of Finland before the rest of the world has noticed.
But some interesting people have noticed, including Giles Hargreave and his team - the Hargeave Hale VCT has a stake - and he is one of the most astute small company investors around.
Tears, oh yes, definitely. Me too I expect.
Ultimately Markku is the reason I'm here. I could almost see a tear the first time i saw him speak (about the patients). i was hooked and had to find out more.
He is genuinely passionate about the science, Faron and the people this will help. It's very personal too, especially the Traumakine story.
It's a rare thing and (it seems) a very special family.
Having joined the webcast yesterday and watched the Proactive video today I'm amazed at how much this small team achieves so fast, from the science to the clinic and commercially.
Some additional points from my notes...
Traumakine
- Harvard and Stanford involved (plus others) in Hibiscus. Not just big ICUs but heavyweight med schools.
- Loan from Business Finland is to create their own IFN Beta 1a master bank, but they don't intend to manufacture themselves. That's a good thing as far as i'm concerned as I would rather they stay focused.
Clevegen
- Two of the ten cohorts (Uveal melanoma and Thyroid) can give an accelerated path to market as a 1st Line treatment as there is no existing standard of care.
- They are all (including myeloid research pioneer prof. Alberto Mantovani) clearly exited and in violent agreement about the potential here. 'Completely novel mode of action', 'first in class', 'excellent patent protection'.
I still believe Markku is after a single mega-deal for Clevegen. We'll have to wait and see but we're well funded now so there's no rush.
I'm here for the long term and increasingly confident.
Looks like the jury is still out on the safety of hydroxychloroquine.
RandomIsation to hydroxychloroquine is suspended in UK REMAP-CAP sites for now, but it looks likely that it may resume as the RECOVERY trial had been allowed to reinstate it after urgent interim analysis.
https://www.remapcap.org/covid19publications
We've been told that we need a partner to progress with Phase 3 Traumakine trials. Positive results in the Covid trials will give us much more leverage for the deal, so they will come first IMO.
Traumakine manufacturing is the big hole in our knowledge - we have no idea if / how we can meet Covid demand without this piece of the puzzle.
Of course, if we can't meet the demand, we can always add it to the damages in the arbitration with Rentschler! And this process might be one reason that we're not hearing much on the whole TK manufacturing issue.
Pure speculation on my part.
Yes, it would have to be RNS'd.
But they will know the timeline for Clevegen results so could set this up in advance if they thought it was likely to be material, whereas Traumakine (Covid) trial news is pretty much out if their control now.
I've just noticed that Interferon Beta-1a is now listed separately from lopinavir/ritonavir on the WHO Solidarity trial site.
So maybe it's a leg of the trial in its own right now.
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments