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I would suggest you listen to your doctor about what medication to get and when it is appropriate to do so

In other words, you don't replicate the models. You buy the people who made them. But you are taking this discussion in a very bad place.

A smaller innovative company securing key talent is a top priority for this type of company, this isn't even an argument. It came to mind because the discussion was what to do with the extra money (I'm sure they have plenty to do as they expand core business) and I have no reson to think they are not doing what they should be. It was merely to give an example of what would be better use of any extra cash than paying dividents etc

You are missing the point.

What I meantioned is all it takes to make a new entity and recruit from the small but far more exoerienced company the necessary workforce. It would require deep pockets but is more common than you think, especially if you take into account that bigger companies do that all the time to smaller ones like every day.

That is solid dd right there. Have a nice day

On a side note (though I have no reason to think they are not doing exactly that) I do sincerely hope they are proactively doing everything they can to keep current key staff, including (and especially) technical level field staff. All it takes is a big pocket with some appetite for risk and a couple of medics with good clinical trial background and some entrepreneurial experience to kill a company this small. Again, I'm not saying there is anything wrong, just pointing out what has happened to many innovative small companies in the past.

Share buybacks at this early growth stage would be ridiculous imo and I would personally (at least) frown upon it. I also don't see what biotech they would acquire woth the money at hand without having to raise cash st the same time. Sometimes the best thing to do is nothing more than already planned (this goes to the chairman as well). Personally I care 90% about core business and everything else is an unecessary distraction.

There is no EUA, not only the FDA has said they are no longer giving them (at least not as readily as before) but also the company clearly stated they were going for full submission and approval.

Tornado I am impressed with what you have learned from previous discussion but you are slightly off.

The idea is that if there is an ifna deficiency (far more common) and in those patients the drug worked particularly well then this would be a selection biomarker so then they would focus on these patients. If they find anti ifnb1 antibodies (this is more rare) and those particular patients did not respond very well to treatment then this would be an exclusion biomarker. I guess there is a slight possibility that they find patients with anti ifnb1 antibodies and the drug worked well in those as well, but it would simply mean that the dose was high enough so that the existing antibodies could not block it completely, which I guess would be good news as well but more difficult to be a biomarker and also there are very few people with those antibodies (unlike ifna and some other ifns but not so much ifnb).

I really hope they actually do this analysis in a timely manner and it works out for you guys. However I am obviously glad I got out before this mess.

*and they only got a positive signal in those patients

Don't you have any shame?
Whatever signal they got in COPD was in the presence of steroids ( exacerbating COPD patients), they demonstrated positive target engagement biomarkers in the presence of steroids and they only got the those patients. This just to point out that steroids weren't necessarily the issue in the sprinter. Biggest issue with the COPD trial was that the results weren't great since they did not achieve statistical significance with the large majority of patients that were treated and analysed before they paused it (PEFR does really take you that far).

Moreover, they cannot do a phase 3 trial with an incomplete and incloclusive phase 2 trial and they have actually stopped the phase 2 anyway (this was after they had paused it see link below).

So best case scenario for COPD they design a second phase 2 and after that they can use partial results from the first one as supporting evidence to get the go ahead for a phase 3.

After already discussing this several times on this board, shouldn't it be clear already that any regulars who come back with "they should finish the COPD trial" are shameless BSters?

https://www.lse.co.uk/rns/SNG/full-year-results-xpi8plx12w54935.html

Whatever signal they got was in the presence of corticosteroids and they demonstrated positive target engagement biomarkers in the presence of steroids. Biggest issue was that results weren't great, since they did not achieve statistical significance with the large majority of patients that were treated and analysed before they paused it (PEFR does really take you that far).

Moreover, they cannot do a phase 3 trial with an incomplete and incloclusive phase 2 trial and they have actually stopped the phase 2 anyway (this was after they had paused it see link below).

So best case scenario for COPD they design a second phase 2 and after that they can use partial results from the first one as supporting evidence to get the go ahead for a phase 3.

https://www.lse.co.uk/rns/SNG/full-year-results-xpi8plx12w54935.html

Lol
What actually happened was that the company highlighted back then that they were surprised they got a strong signal with dexa in particular. Though, I think they saw something similar in the copd or asthma trials. So this "leak" is fake or RM a spoon or both.

*shows

This is good because it ahows the FDA recognises the value of the data produced by this platform

See below

22 February 2022

Open Orphan plc

("Open Orphan" or the "Company")



FDA Breakthrough Designation for Big Pharma RSV candidate

Vaccine candidate assessed in successful human challenge trial conducted by hVIVO

Open Orphan plc (http://www.openorphan.com) (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated 14 February 2022 (https://www.bavarian-nordic.com/investor/news/news.aspx?news=6478) from Bavarian Nordic A/S ("Bavarian Nordic") (OMX: BAVA), reporting that the US Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation for Bavarian Nordic's respiratory syncytial virus ("RSV") vaccine candidate, MVA-BN® RSV. hVIVO (http://www.hvivo.com) , a subsidiary of Open Orphan, successfully conducted a Phase 2, double-blinded, placebo controlled human challenge trial (https://otp.tools.investis.com/clients/uk/open_orphan/rns/regulatory-story.aspx?cid=2484&newsid=1505805) to assess MVA-BN® RSV using its RSV Human Challenge Study Model.

A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. A significant portion of this preliminary evidence was the successful challenge study conducted by hVIVO. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.

The challenge study conducted by hVIVO to assess MVA-BN® RSV demonstrated a significant reduction in viral load in vaccinated subjects versus placebo, thus meeting the primary endpoint of the study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.

Both the copd and asthma trials failed and have been dropped (for copd there is even an rns from last year, obviously after the first said that said it had been paused. This has been discussed 1000 times here, what you are doing is criminal.

This is going to hit mainstream news later in the day for sure. That said, it's the contracts that matter in the end.

(Cont 3, that was a lengthy one)
Challenge studies could still prove to be important in the future to speed the development of 'next-generation' Covid-19 vaccines and antiviral drugs.

"This data underline just how useful a tool lateral flow tests can be to pick up people when infectious and the importance of wearing a face covering in crowded, enclosed spaces."  

Dr Mariya Kalinova, Principal Investigator on the study and Medical Director of hVIVO, said: "Closely observing and examining COVID-19 infection disease progression in volunteers during the SARS-CoV-2 characterisation study has revealed several important insights which will benefit public health going forward. Results uncovered new insights into the average incubation period for COVID-19 infection as well as disparities in viral loads between the nose and mouth, which endorses proper mask wearing guidance. Most importantly, there were no serious or adverse events, which proves a SARS-CoV-2 challenge is safe and well tolerated."

Dr Sir Michael Jacobs, consultant in infectious diseases at the Royal Free London, said: "We have vast experience of safely managing highly transmissible infections at the Royal Free Hospital and we are really pleased to have been able to play our part in this landmark study.

"The trial has already provided some fascinating new insights into SARS-CoV2 infection, but perhaps its greatest contribution is to open up a new way to study the infection and the immune responses to it in great detail and help test new vaccines and treatments."

'Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge' by Killingley, B. et al. is available on the Research Square pre-print server and has been submitted for peer-review. DOI: 10.21203/rs.3.rs-1121993/v1 https://www.researchsquare.com/article/rs-1121993/v1

(Cont 2)
Human challenge studies could prove to be the fastest way to compare old and new vaccines and therapies."

Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said: "The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. Importantly the study demonstrated that SARS-CoV-2 challenge studies are safe and well tolerated by the volunteers with no serious symptoms and no Serious Adverse Events (SAEs).  The study's results have provided useful insights which could be used to inform public health decisions on COVID-19 symptoms and virus detection going forward, including isolation periods for infectious individuals, the use of LFTs, and establishing the human challenge platform to investigate further aspects of COVID-19.

"While the characterisation study was focused on the original SARS-CoV-2 strain, and there are differences in transmissibility between it and the other variants, the same factors will be responsible for protection against it, meaning the findings remain valuable for variants such as Delta or Omicron.  These data provide a clear platform to now utilise the human challenge model to expedite product efficacy testing for new vaccines or antivirals"

Professor Christopher Chiu, Professor of Infectious Diseases from the Institute of Infection at Imperial College London and Chief Investigator on the trial, said: "First and foremost, we've shown that our challenge infection model was safe and well tolerated in healthy young adult participants. People in this age group are believed to be major drivers of the pandemic and these studies, which are representative of mild infection, allow detailed investigation of the factors responsible for infection and pandemic spread.

"Our study reveals some very interesting clinical insights, particularly around the short incubation period of the virus, extremely high viral shedding from the nose, as well as the utility of lateral flow tests, with potential implications for public health." 

Professor Sir Jonathan Van-Tam, Deputy Chief Medical Officer at Department of Health and Social Care, said: "Human challenge studies have been performed using other pathogens for decades, including flu and Respiratory Syncytial Virus (RSV). They need full independent ethical review and very careful planning - as has been the case this time. Every precaution is taken to minimise risk.

"Scientifically these studies offer real advantage because the timing of exposure to the virus is always known exactly, therefore things like the interval between exposure and the profile of virus shedding can be accurately described.

"This important study has provided further key data on COVID-19 and how it spreads, which is invaluable in learning more about this novel virus, so we can fine-tune our response. Challenge studies could still prove to be important in the future to speed the deve

(Cont)

the Company should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals. The Company is already developing a Delta strain of the COVID-19 virus in partnership with Imperial College London and funded by the Wellcome Trust, which could be used in future trials.

The data published today supports the safety of the infection challenge model which could theoretically provide a 'plug and play' platform for testing therapies and vaccines using the original COVID-19 strain as well as variants of the virus.

The characterisation study results and the insights they provide into COVID-19 infection have potential implications for public health. During the study, the average incubation period was 42 hours, which is considerably shorter than existing estimates of five to six days. Results also showed that while virus was detected significantly earlier in the throat, peak levels of virus were far higher in the nose, implying a potentially higher risk of viral shedding from the nose. This underlines the importance of proper facemask use to cover both the mouth and nose. Additionally, insights into the timeline of infection, with viable virus seen after nine days and 12 days for some, support the isolation periods advocated in most guidelines.

Lateral flow tests (LFTs) were also shown to be a good indicator of whether someone was harbouring viable virus. Positive LFTs correlated well with lab-confirmed detection of virus from swabs throughout the course of infection, including in those who were asymptomatic. However, the tests were less effective in picking up lower levels of virus at the very start and end of infection.

The challenge virus used in the study was produced under hVIVO's supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London. The Human Challenge Programme is funded by the UK Government, who commissioned Imperial College London to act as the clinical study sponsor. The study was conducted by hVIVO at the Royal Free Hospital, under the supervision of the Company's highly trained scientists and medics.

Cathal Friel, Executive Chairman of Open Orphan, said: "I am delighted that the world's first COVID-19 characterisation study has completed with no serious adverse events or serious symptoms, demonstrating that a COVID-19 human challenge study is safe in healthy young adults. The results, which have been made public today, have provided invaluable insights into COVID-19 disease progression.

"Crucially, we have now successfully established a COVID-19 Human Challenge Model which could be instrumental in accelerating the development of future COVID-19 therapeutics. New variants, such as Omicron, often mean that vaccines and antivirals have to be quickly re-evaluated to ensure effectiveness. Human challenge studies could prove to be the fastest way to com