The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
Definitely hoping for Imutex news this side of Christmas, but in Elrico's post the other day (thanks for sharing by the way Elrico) CF indicated that DIM would be the next spin off and that this wouldn't be until next year.
Can we assume then that we won't get any news on Imutex until after that, or that Imutex news is imminent but it involves a sale rather than it being 'spun out'?
To say I'm frustrated by the lack of news on Imutex would be an understatement!
Just to be clear Ivy, that's not what I was trying to suggest or imply by sharing that link. Saw it on the SNG board and thought it might be an interesting read for those who've followed ORPH for a while, as a CRO involved in testing covid and non-covid vaccines for the likes of Pfizer and other big pharmas.
Posted on the SNG board today:
https://www.bmj.com/content/375/bmj.n2635
The lack of news on the Covid challenge studies is frustrating, as is the share price, but having read report that I would much rather ORPH prioritised its reputation and high quality over speed.
- are we likely to see a cash dividend before Christmas as previously mentioned?
- are CHIM conversations still ongoing with Chinese government?
- any news from Antwerp/Benelux as mentioned in previous presentation?
- ETA for TB challenge model?
- Can we still expect upcoming malaria contracts?
I didn't see Troajan's thread before I posted it either, threads/messages seem to disappear and reappear all the time on LSE.
ORPH have shared this interview on Twitter this morning with Yamin ‘Mo’ Khan:
https://www.youtube.com/watch?v=mZvdOAZZUFM
There was also the comment from CF back in August about something very positive coming soon in Antwerp/Benelux.
Looks like the Telegraph article from the weekend has been 'repurposed' for the American version of the The Sun, and syndicated to other News Corp titles, the New York Post and news.com.au
https://www.the-sun.com/health/3887694/lab-london-infecting-humans-covid/
https://nypost.com/2021/10/19/inside-the-only-facility-infecting-humans-with-covid-for-pay/
https://www.news.com.au/world/coronavirus/health/london-lab-prepares-to-pay-volunteers-to-be-infected-with-covid19-in-world-first/news-story/9f635ec82e87cee6ad0d445618b40061
Great to see more news coverage inside and outside the UK.
Cheers Chazzy, I hadn't seen the article to be fair - thanks to Yogi77 for spotting it.
The source is today's Telegraph as Yogi77 mentioned in the original message in this thread.
This link might not work without a subscription:
http://digitaleditions.telegraph.co.uk/data/760/reader/reader.html?social#!preferred/0/package/760/pub/760/page/102/article/230042
By December 2019, Open Orphan had acquired hVivo. Covid struck two months later and the rest is history. Open Orphan will be profitable this financial year for the first time ever, its share price has more than quadrupled and it remains the only company in the world doing human challenge studies at a commercial level.
So what next? Friel says work is being done on designing more trials in other infectious and respiratory diseases, from malaria to strep throat to tuberculosis. Friel also wants Open Orphan to list on the Nasdaq in the next 12 months, although the company will keep its dual listing.
“We would be mad to drop our Aim listing,” he says. “I feel in a way, given the company’s history from a world first in 1947, to a world first today, that the circle has been rounded.”
The company has its roots in 1947 when the British government realised that influenza killed more allied soldiers than the Germans in the Second World War, and decided to set up the Salisbury Common Cold and Flu Clinic. For decades it carried out cutting-edge research doing the world’s first human challenge studies. “Britain was way ahead of the rest of the world,” Friel says.
That came to an end in 1987, but a couple of years later two former employees set up a company doing the same sort of work, calling it Retroscreen. In 2008, it caught the attention of the fund manager Neil Woodford, who backed the business, changed its name to hVivo and floated it on the stock market. Woodford pumped £120m into the company between 2010 and 2017, but never made any cash out of it. Then his investment empire collapsed after a series of risky bets.
“Our feeling was that if Woodford had put in £120m, there has got to be something in the asset,” says Friel, whose speciality is taking on distressed companies and turning them around.
So where does Open Orphan fit into all of this? Friel started the company just over two years ago, initially as a pharma services business helping American drug developers to launch treatments for rare diseases in Europe. But just before the float, Friel stumbled across a struggling clinical trials company called Venn Life Sciences, based in Dublin. It was “going nowhere”, had never made a profit in its 15 years and was on the verge of bankruptcy.
“We had heard through Venn that European pharma companies were starting to increase their spend on vaccines and antivirals. Everyone kept saying the vaccines business is dead and it’s all moved to India and China, but we kind of had a feeling.”
Friel decided he could fix it. He paid off its debts and Open Orphan did a reverse takeover of Venn in June 2019. “Then we said, oh dear what sort of a mess had we got ourselves into?”, he recalls. “It was actually in far worse shape than we had realised.”
After chatting with some investment bankers, Open Orphan looked at hVivo, another struggling clinical trials company. “If we put these two together we thought we might just have something,” Friel says.
By pure luck, hVivo’s chief scientific officer, Andrew Catchpole, had a special interest in coronaviruses. Two years earlier he had tried and failed to get pharmaceutical companies interested in doing coronavirus challenge studies because he thought they had the potential to be incredibly dangerous.
“They laughed and said, Andrew you’re smoking dope, you do understand coronaviruses are pretty harmless,” Friel says. hVivo’s previous management team, who Friel has mostly replaced in favour of promoting “long-suffering staff that had been there a long time but been ignored”, took a similarly dim view of Catchpole’s ideas.
If accepted, they are paid about £3,000 to £4,000 as a tax-free reimbursement. Rooms are kitted out with televisions and PlayStations to keep participants occupied during their quarantine, which usually lasts about two weeks.
“We have had so many pharmaceutical companies, big and small, approaching us about doing Covid trials to test new treatments and vaccines – about 100,” Friel says.
“But the bigger story for us is that big pharma and governments are now not only chasing Covid, they are putting huge resources into vaccine development and programmes for influenza, respiratory syncytial virus (RSV), which is one of the biggest killers of children under 12 months in the developed world, and human rhinovirus (HRV). A few weeks ago we signed a deal for a challenge study with GSK in asthma.”
In the last year alone, Open Orphan has worked with Janssen, Pfizer and Boehringer Ingelheim, conducting human challenge trials in RSV. In July, Pfizer’s chief executive announced “stunning” results from an RSV vaccine phase II study in London, showing it was 95pc effective – that was Open Orphan’s study.
So why the sudden focus on flu and RSV? It is widely believed that there are really only five viruses or bacteria in the world that can result in a pandemic. Flu, RSV, HRV, coronavirus and tuberculosis/antimicrobial resistance.
Every pharma company in the world, backed up by national health authorities, is now looking to develop vaccines and treatments in this space, so that if another pandemic arises, they have the resources, and infrastructure, to tackle it. The infectious disease market is expected to grow from $30bn ($22bn) a year today, to $250bn by 2025.
Human challenge studies work particularly well with antiviral and monoclonal antibody treatments, vaccines and prophylactics. They are also quicker and cheaper to run than field trials. The average number of volunteers in a human challenge study is 100, with a trial duration of about three months from signing the contract to getting the final, definitive data.
Field trials, by contrast, involve 10,000 to 20,000 patients and can take two to three years. Pfizer, for example, paid Open Orphan £4m to do a human challenge study. It will now spend roughly £100m for a field study. “They have to do a field study to get regulatory approval, all vaccines must do this, but before they spend that £100m, they know that it works,” Friel says.
It also means smaller pharma companies that don’t have the money to do a field study, can pay for a challenge one, prove their drug works and then sell it to big pharma.
“Suddenly our small little niche business, which was doing one or two challenge studies a year, has started 10 this year,” Friel says. “Next year it will do 15. The world has woken up to the fact that we need to restock the shelves with vaccines and antivirals.”
Inside the London lab company infecting humans with Covid
Open Orphan is the only company in the world running human challenge studies with coronavirus
Julia Bradshaw
Step into the foyer of the Whitechapel Hotel in the East End of London and it seems no different from any other business in the capital. But venture further in, and it becomes clear that something very strange is going on in this former textile factory.
Biohazard signs on each floor warn observers not to enter. Next to the double beds in the bright and modern en suite rooms are white trolleys containing swabs, vials, gloves and other medical paraphernalia. Peepholes on the doors are not there so that guests can look out into the corridor. Instead, they are reversed for safety reasons.
This former hotel, a victim of the Covid pandemic, has been transformed into a 19-bed quarantine facility used to house volunteers taking part in human challenge studies – specialist clinical trials where people are infected with a virus or bacteria to see how they respond to experimental vaccines or treatments.
They are being run by Open Orphan, a tiny, Aim-listed company whose fortunes have been transformed by coronavirus. “The pandemic has been good to us,” says Cathal Friel, the company’s executive chairman.
Open Orphan was flung into the spotlight in March 2020. As the world went into lockdown, it announced bold plans to design a taxpayer-funded human challenge study that would infect people with Covid to see how they responded to treatments and vaccines. It was, and remains, a world-first. “The world came flocking to our door, big pharma, small pharma, asking if we could help,” Friel says.
That trial design has taken more than a year to put together. It’s a delicate procedure. The virus has to be isolated from the “wild”, grown in labs, and manufactured at a special standard so that all the molecules are identical. The minimum dose necessary to infect people must also be determined.
Now, with the framework in place, the first volunteers ever to take part in a human challenge study for Covid will be dosed in London in the second half of next year, pending approval from regulatory and ethics authorities.
The company’s headquarters, which are in the Queen Mary Innovation Centre (QMIC) across the road from the former Whitechapel hotel, houses its labs along with a further 24-bed quarantine facility.
Builders are upgrading it to a higher level of biosecurity, category three, needed for the Covid trials next year. On the ground floor, a former Costa Coffee shop – another Covid casualty – has been turned into a screening centre where volunteers have their blood taken to see if they are eligible to take part in any one of Open Orphan’s ongoing studies in other disease areas.
I'm not trying to 'spread' anything, the lack of progress with Imutex and Flu-v just baffles me when clearly there is a huge need for it.
Likewise in the Telegraph today:
"Officials fear that this winter could see up to 60,000 flu deaths – the worst figure in Britain since the 1968 Hong Kong Flu pandemic – without strong uptake of vaccines.
There is also concern about the effectiveness of this year’s jabs, because the lack of flu last year made it harder for scientists to sample the virus and predict the dominant strains."
If only there was a universal flu vaccine...
Questions
300k samples - can you confirm who has ownership of these? Is it POLB, DIM, ORPH?
- When POLB was spun out of ORPH, the company got a non-exclusive licence to access the data which remains property of ORPH. ORPH is aiming to be fully services rather than products. DIM is another discussion, not for JS to comment on this. Diving into the data will uncover great insights and opportunities over the next few years. POLB is not paying ORPH for access to the dataset, but ORPH shareholders have stake in POLB in lieu of payment and will be realising the value in this way instead.
Other than possible AI partnership announcement, what other news is expected before year end, and what are the realistic milestones for next 12 months?
- In active discussions about licencing programs, one or two expected by year end, "have to be clever" in terms of what we bring in and we are doing due diligence. Internal newsflow includes manufacturing POLB-001 and progressing towards in-human trials. Next year we'll be talking about "outputs" from AI and machine learning work. Gaining momentum now after "whirlwind" couple of months since IPO. 2022 will be a "blowout" year
Closed periods and lock-in periods - current situation?
- ORPH shareholders have 9 month lock in as planned, ORPH shareholders regarded as "sticky" in terms of length of shareholding, aiming to convince shareholders that peak value has not yet been reached and we are building on this. "We are in this for the long haul, a lot of value yet to be built"
Aside from in-licencing deals, any other sources of revenue?
- POLB is focused on therapeutics but also in talks with some diagnostics companies. Diagnostics firms are interested in biomarkers expressed early in the disease cycle and which can be used to identify patients/diseases early on from a diagnostics point of view. Great time to be launching this type of company, especially with US government funding many developments and research
Made a few notes as CF and JS were presenting just now. Great to hear more on how things are going and that we can expect a fair bit of news in the next few months, including some by the end of the year. I didn't note down everything as some of it was covered in the presentation a few weeks ago - feel free to add anything I missed!
- CF repeated the comparison to Evotec in Germany, and c. 10x increase in share price
- POLB is fully funded, no more fundraising, outlicensing deals expected "very early on"
- Five or six projects in the first six months
- JS will be investing personal cash in POLB in the near future
- POLB-001 will be in the clinic next year
- Company is "actively in-licensing additional assets"
- "Plan to be a partnering engine" for big pharma
- Big pharma is looking to companies like POLB to repopulate their pipelines with infectious disease assets
- "the deal-making environment is so rich right now" in terms of the appetite for $100m+ partnerships between Big Pharma and smaller biotechs
- Post-covid, there will be demands on pharma to come up with better solutions for minimising flu hospitalisations/deaths, whereas high numbers of these were previously just accepted
- POLB-001 is well placed to capitalise on this, a "potential blockbuster"
- The team at Hvivo identified P38 immune pathway as cause of cytokine storm in severe influenza, POLB-001 acts as inhibitor for P38 without damaging bodies' own tissue or immune system
- Immediate market for Influenza of c. $800m+
- POLB-001 is currently Phase II ready
- POLB has patent protection on POLB-001 until 2038
- Human trials intended to generate data to make partnership with pharma possible
- Potential for POLB-001 to be eligible for fast tracking
- AI and machine learning - using human challenge studies to test vaccines and antivirals, giving access to unique data - this data cannot be collected in a normal field trial and is ideally suited to identifying drug targets
- Unmatched clinical utility in this data
- POLB currently in discussions with AI and machine learning partners on how to mine this data; news expected on this by the end of the year
- 300k samples ready to be analysed to identify pathways with clinical utility, and select brand new drugs and those that can be repurposed