The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Endpoints chief editor is excited about Autumn
https://twitter.com/johncendpts/status/1435328017912537095?s=21
Roll on SAR
Hey Silver
Not sure if you know the Sierra almost very nearly hit delisted from the Nasdaq and only survived by doing a 40:1 consolidation. The shares were next to worthless and they were facing doom.......
You may want to read their recent history and be sure of what you have invested in.
Wish you all the best.
Hi All
Been here over a decade, my resolve is still unwavering. The true value of this science that we own is coming to the fore. The next generation of immunotherapy is gaining validation globally. This is truly a multi billion if not multi trillion market over the duration of our patents.
GLA
Hi Afham
It would be good if we could find out when the webpage was last updated.......it is feasible that the results would have been under final production (I’m sure SAR stated the experiments had finished and results were as expected from the earlier encouraging update) and peer review. If it is now formally closed by UKRI then we should expect formal POC results to be published and maybe notification of next steps.
ATB and eyes open for a Monday RNS
Great post Krone and particularly the last paragraph.
We are one of those such companies which could well be cleaner and more selective. Sareum are about to unveil everything and it certainly feels like the stars have aligned in the kinase inhibitors space.
GLA
Yes SOG and news of our first in human trials is only weeks away.
The trial designs will be well advanced and I be bold enough to state the target indication(s) have been selected with final preclinical tests being administered now. Next will be notice of Clinical Trial Application being submitted, for which all of above will have to be complete. We know all too well Sareum are extremely thorough so CTA will be approved.
All this, as per the last RNS will be done before the year is out.
ATB
Furthermore, we have been tweaking these molecules for years making them better, safer and more selective.
We have major jurisdictions patent protection, very low toxicity (we couldn’t reach a maximum tolerable dose (MTD) in animal species eg giving them too much to kill them) and therefore considered safe. I think we were something like 30x recommended daily dose!
You will recall the leading commentator (can someone remind us who this was) who said “if you don’t have a Tyk2, you haven’t been paying attention”
GLA
Hi All
We have been developing our Tyk2 Jak1 inhibitors for years. All LTHs know this. We are the next generation of this paradigm shift in medical research.
A paper from 2014 published by the Journal of Immunology is listed on Sareum’s website. This demonstrates exactly why it is ‘massive’!
The paper refers to SAR-20347 which we know is now SDC-1801. Copied the link below for the lazy researchers......
https://www.jimmunol.org/content/193/7/3278
GLA
For those who remember, I said at the beginning of the Covid pandemic that all the large pharmaceuticals will be trying their own drugs against the virus first. As and when these don’t show efficacy or effectiveness they will be searching for novel candidates.
The effectiveness of Tyk2 kinase inhibitors have been validated in many research papers and scientific journals since the pandemic started.
The virus is not going anywhere for a while and if recent reports are anything to go by then new variants may pose even more of a threat to the efficacy of current vaccines.
IMHO we will be entering trials soon to check out just how superior we are to the only effective therapeutic currently used worldwide - dexamethasone. Furthermore, we will prove much safer than Baricitinib.
GLA
Forgot the link
https://endpts.com/fda-warns-of-heart-related-events-cancer-blood-clots-and-death-for-jak-inhibitors/
Hi All
This works differently than our treatment, SAR are targeting the cytokine storm rather than the virus itself.
Pfizer is one of several drug manufacturers hoping to develop the first antiviral pill to be taken for early signs of the illness.
The study will involve 1,140 participants and will combine the treatment, PF-07321332, with a low dose of ritonavir, which has previously been used with other antiviral medications.
Patients will receive the treatment or a placebo orally every 12 hours for five days.
PF-07321332 is designed to block the activity of the main enzyme that is needed for the virus to replicate.
If the trial is successful, Pfizer said it would file for emergency approval between October and December this year. The drug manufacturer said it could be prescribed at the first sign of infection, without requiring hospitalisation.
The company is running a separate trial involving people who are not in hospital but are at risk of becoming severely ill, which began in July.
There are no antiviral treatments for coronavirus that have been approved for use in the UK.
Gilead Sciences' remdesivir, administered intravenously, is the only approved antiviral treatment for COVID in the US.
Another COVID-19 pill, molnupiravir, by Merck and its partner Ridgeback Biotherapeutics, is already being studied in a late-stage trial in patients who are not in hospital to see if it lowers the risk of hospitalisation or death.
A separate late-stage trial is looking at whether taking molnupiravir can prevent people from being infected with COVID-19.
The prime minister, Boris Johnson, said in April that he hoped pills or capsules could be available by the autumn to help fight a possible further wave of the virus.
A government taskforce was launched to identify the most promising antiviral treatments - particularly those that can be taken at home - and support their development through clinical trials.
https://emea01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fnews.sky.com%2Fstory%2Fcovid-19-treatment-pill-administered-in-new-pfizer-clinical-trial-12396759&data=04%7C01%7C%7Cbced60de4f744b04b65608d96dabf5ac%7C84df9e7fe9f640afb435aaaaaaaaaaaa%7C1%7C0%7C637661407587633859%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=DZUWET%2FE%2FlTr3n3KsKVj08G6x%2BFwEn0gZPdUftV3R5Q%3D&reserved=0
GLA
Great summary WIP.
I would add;
Parker’s tweet that was clearly related to the UKRI proof of concept experiments which eventually claimed SDC-1801 is superior to dexamethasone and baricitinib. ‘Great news for the UK and the World’!
ATB
That’s a good article Jiffy - but your chosen extract of ‘crap’ puts readers off.
If we take the time to read the article in detail it gives some great insight into where we (the world) are heading especially with the WHO ‘solidarity trials’
My favourite paragraph in the article is;
*There are other European studies too. One already underway will also be going after useful repurposed drugs. It’s called—deep breath, here we go—Randomised, Embedded, Multi-Factorial, Adaptive Platform Trial for Community-Acquired Pneumonia. (Yes, that’s Remap-Cap.) It has already chalked up a rare win by getting good results with the drugs tocilizumab and sarilumab, inhibitors of an inflammatory molecule called interleukin-6; block that and you get an anti-inflammatory, immunosuppressive effect.*
We have (IMHO) probably the best available kinase inhibitor of IL-6 which is superior to dexamethasone and Baricitinib.
Come on SAR get the ‘consultation with experts’ wrapped up and our SDC-1801 into covid trials.
GLA
How good would an auction be between the global giants wanting our TYK2s!
You will notice I stated plural, as IMHO a large pharmaceutical will take both on so as not to leave any door open for a competitor.
GLA
Hi All - looks like Pfizer are getting positioned for more deals.......plenty of vaccine cash swelling the vaults and a pipeline that needs expanding.
What did one prominent commentator mention recently........”if you don’t have a Tyk2, you haven’t been paying attention......”
https://endpts.com/albert-bourla-picks-a-new-dealmaker-to-lead-the-hunt-for-more-drugs-to-swell-pfizers-pipeline/
GLA
Hi All - as per my earlier post regarding spread of delta in vaccinated people, Sky is reporting the below today:
UK COVID cases up by nearly a fifth in a week and rising in the vaccinated
Coronavirus cases in the UK have risen by nearly a fifth in a week, according to a real-world data from an app.
According to ZOE COVID Study, which tracks positive cases in millions of users, on average there are currently 51,961 new daily symptomatic virus cases in the UK.
This is up 19% from the 43,693 new cases recorded last week and is based on PCR and lateral flow testing data.
A significant portion of these are in vaccinated people - some 15,309 new daily cases are in this group.
This figure has been rising steadily for the last week and now some 29.4% of the total new daily cases are in the vaccinated.
Vaccines do not provide 100% protection from disease but do protect against severe disease and hospitalisations.
The government has plans to give booster doses to the most vulnerable in the population from 6 September, although no firm details on who may be eligible have been announced.
New cases are highest in the 18-35 age groups, closely followed by the 0-18 year olds, the data shows.
Professor Tim Spector, lead scientist on the ZOE COVID Study app, said the rise in cases is down to the nation "eagerly declaring freedom" and removing most restrictions and giving the virus the "opportunity to spread".
Stay safe
I truly hope that SAR get in the clinic soon with our potential covid therapeutic.
GLA
https://news.sky.com/story/covid-latest-news-live-reading-and-leeds-festival-offering-jabs-this-weekend-amid-warning-schools-returning-will-cause-significant-virus-surge-12389178
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam
Posted: 10 Aug 2021
Hi All - this is a worrying development of the ongoing covid pandemic for which the scientists are still trying to understand infection and transmission.
This research has been lodged with The Lancet for publication and as of now is NOT PEER REVIEWED. It is pre-publication paper.
The research was funded by Wellcome.
More than ever, the rushed vaccines are being shown as not being the answer. The world needs urgent therapeutics as well as updated vaccines. The virus will continue mutating bringing further challenges for vaccine development not to mention restrictions, suffering and economic carnage.
Abstract - Background: Data on breakthrough SARS-CoV-2 Delta variant infections are limited.
Methods: We studied breakthrough infections among healthcare workers of a major infectious diseases hospital in Vietnam. We collected demographics, vaccination history and results of PCR diagnosis alongside clinical data. We measured SARS-CoV-2 (neutralizing) antibodies at diagnosis, and at week 1, 2 and 3 after diagnosis. We sequenced the viruses using ARTIC protocol.
Findings: Between 11th–25th June 2021 (week 7–8 after dose 2), 69 healthcare workers were tested positive for SARS-CoV-2. 62 participated in the clinical study. 49 were (pre)symptomatic with one requiring oxygen supplementation. All recovered uneventfully. 23 complete-genome sequences were obtained. They all belonged to the Delta variant, and were phylogenetically distinct from the contemporary Delta variant sequences obtained from community transmission cases, suggestive of ongoing transmission between the workers. Viral loads of breakthrough Delta variant infection cases were 251 times higher than those of cases infected with old strains detected between March-April 2020. Time from diagnosis to PCR negative was 8–33 days (median: 21). Neutralizing antibody levels after vaccination and at diagnosis of the cases were lower than those in the matched uninfected controls. There was no correlation between vaccine-induced neutralizing antibody levels and viral loads or the development of symptoms.
Interpretation: Breakthrough Delta variant infections are associated with high viral loads, prolonged PCR positivity, and low levels of vaccine-induced neutralizing antibodies, explaining the transmission between the vaccinated people. Physical distancing measures remain critical to reduce SARS-CoV-2 Delta variant transmission.
Funding: Wellcome (106680/B/14/Z and 204904/Z/16/Z).
Declaration of Interest: None to declare.
Ethical Approval: The study was approved by the Institutional Review Board of HTD and the Oxford Tropical Research Ethics Committee, University of Oxford, UK.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733
GLA and come on SAR we need our SDC-1801 into trials considering we are superior to Dexamethasone and Baricitinib.