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Covid-19 response

Clinical trials of unbranded hyperimmune serum could begin Ãâہ¡ÃƒÆ’‚­ÃƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“within monthsâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ÂÂ, CSL chief scientific Ãâہ¡ÃƒÆ’‚­officer Andrew Cuthbertson said. An effective vaccine able to protect the entire population takes at least 12 months to Ãâہ¡ÃƒÆ’‚­develop.


Professor Cuthbertson said well-designed trials would guide decisions about who would be first in the queue for serum treatment, which is based on âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“borrowingâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ the antibodies of patients whose immune systems have fought off the viral illness.


âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Probably people who are very high risk, maybe people who are infected and getting worse and heading for the Ãâہ¡ÃƒÆ’‚­intensive care unit, possibly in the ICU. âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“It could also be used as a preventative treatment if someone coughed right into the face of a health worker.âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ÂÂ


Debate on priorities


He said priorities for eligibility in trials and for treatment would involve âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“great debateâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ÂÂ.


âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Itâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’¢Ã¢Ã¢â€š¬Ã…¾Ãƒâ€šÃ‚¢s a matter of how do we best use these precious initial vials of this medicine, because we wonâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’¢Ã¢Ã¢â€š¬Ã…¾Ãƒâ€šÃ‚¢t be able to make enough to protect the entire population âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’¢Ã¢Ã¢â‚¬Å¡Ã‚¬Ãƒâ€šÃ‚ you need a vaccine to do that.âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ÂÂ


The global pooling of expertise and resources for the manufacture of the hyperimmune treatment was announced on Monday night, with CSL subsidiary CSL Behring and Takeda joined by the German-headquartered Biotest, LFB (France), Octapharma (Switzerland) and Bio Products Laboratory (Britain).


The humanitarian alliance between commercial rivals is open to other firms and plans to work with governments.


âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“Unprecedented times call for bold moves,âââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’‚ said Julie Kim, president of Takedaâââہ¡Ãƒâ€šÃ‚¬ÃƒÆ’¢Ã¢Ã¢â€š¬Ã…¾Ãƒâ€šÃ‚¢s Plasma-Derived Therapies Business Unit.


Professor Cuthbertson said he expected clinical trials in the northern hemisphere and Australia could start in parallel, with sharing of data and insights speeding up progress.


He said local trials might require 100 to 500 donors, and would require the development of tests enabling identification of the best donors and the potency of antibodies against the illness.


CSL was in talks with the federal Health Department, regulator Therapeutic Goods Administration, research partners including the Melbourne-based Peter Doherty Institute for Infection and Immunology, and plasma collection agency the Australian Red Cross Lifeblood to get trials on foot as soon as possible.

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CSL is searching for plasma from recovered coronavirus patients as companies across the United States turn to higher payment rates and free rides to lure donors into collection centres.


The exact going rate for this plasma is not known, with CSL saying the value depends on a number of factors, including location and demand. However, plasma donations tend to pay as much as $US50, or up to $US70 to first-time donors and those with in-demand antibodies.


"Recovered COVID-19 donors are compensated at the same level as other speciality plasma programs (such as Anti-D and Rabies), which is at a slightly higher rate than normal donors," a CSL spokeswoman said....


Over the past month, collectors across the US have been urging donors to return to centres, assuring them coronavirus safety measures are in place. The sector has also launched a campaign for American donors called "The Fight is in Us" to encourage those that have beaten COVID-19 to donate.


"In support of those donors, the Global Plasma Alliance (which CSL is a member of) has partnered with ride sharing service, Uber, to provide complementary rides to and from plasma collection centres for those who are potentially eligible to donate convalescent COVID-19 plasma," a CSL spokeswoman said.


CSL is also collecting recovered donor plasma in Australia, though these donors will not get paid. It needs about 10 per cent of the 6000 Australians who have recovered from the virus to donate at least once so it can start research into a hyperimmune treatment. It said while early donations have been promising, more are needed.




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Australia’s biggest health company, CSL, says it can produce up to 100 million doses of a COVID-19 vaccine by the end of next year if clinical trials in Australia and in high-infection areas overseas are successful.


CSL has struck a partnership with the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) and University of Queensland to fast-track the ­development of a COVID-19 vaccine, catapulting it to the forefront of the global battle to fight the coronavirus.


But CSL chief executive Paul Perrault said that while the company and UQ had won international endorsement, it was not a race against other vaccines in ­development.


“This is a race against the virus and there will be multiple vaccines to supply the globe,†Mr Perrault said. “We don’t know enough about the virus today to know how long it will be around, if there will have to be additional doses of vaccines in the future, and so it is imperative that everybody work as hard as they can collaboratively.†The agreement formalises CSL’s commitment to lend all its resources to UQ’s vaccine research effort, and comes 25 years after CSL and UQ partnered to develop the cervical cancer vaccine Gardasil.


Meanwhile, CEPI has provided UQ up to $US10.6m ($15.16m) to develop its “molecular clamp†vaccine platform, a transformative technology patented by UniQuest, UQ’s technology transfer company, that enables rapid vaccine design and production.


Already early preclinical results in mice have shown their COVID-19 vaccine candidate produces high levels of antibodies that can neutralise the virus, which has killed 383,000 people worldwide.


UQ is now on track to launch a phase 1 clinical trial next month, which will involve 120 patients, and be funded by CSL and CEPI. While initial results are promising, Mr Perrault cautioned that there was no guarantee of success.


“Research is risky, even at the best of times,†he said. “While initial results from UQ’s research are very promising there remains a number of critical milestones ahead before we can ­declare victory with an effective and safe vaccine to protect people from COVID-19.â€


The phase 1 trial will test the safety of the vaccine and also help determine the correct dosage. If that is successful, the vaccine will proceed to phase 2 trials, involving 800-1000 people.


UQ professor Paul Young said that unlike the phase 1 trial, which would be conducted in Brisbane, the phase 2 trial would be performed overseas.


“Fortunately right now in Australia the infection rate is pretty low, which is great. But to do the phase 2 efficacy study we need to do it in parts of the world or a part of the world where there are infections taking place,†Professor Young said.


“We are looking very hard with the clinical team now at which countries or cities the studies be done. It will have to be done where there are both infections but also where there is good health infrastructure and where we can gather high-quality data.â€


CSL chief scientific officer Andrew Cuthbertson said the company hadn’t budgeted the full cost of the vaccine development.


UQ vice-chancellor Peter Hoj said the vaccine development was at a “critical junctureâ€.


CEPI chair Jane Halton said multiple vaccine research efforts were needed to defeat the virus.

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Hot on the heels of its decision to acquire clinical-stage biotechnology company Vitaeris earlier this month, this morning the company announced plans to make another acquisition.


CSL has agreed to acquire the exclusive global license rights to commercialise an adenoassociated virus (AAV) gene therapy program, AMT-061 (etranacogene dezaparvovec), for the treatment of haemophilia from Nasdaq-listed gene therapy company, uniQure .


According to the release, the AMT-061 program, which is currently in Phase 3 clinical trials, could be one of the first gene therapies to provide potentially long-term benefits to patients with haemophilia B.


Management explained that one dose of AMT-061 has shown to increase Factor IX (FIX) plasma levels to a degree that reduces or eliminates the tendency for bleeding for many years. FIX is the blood clotting protein lacking in people with haemophilia B.


This means that should AMT-061’s trials be successful, appropriate candidate haemophilia B patients will be able to have a one-time treatment to restore FIX activity to functional levels capable of eliminating the need for frequent and ongoing replacement therapies.


CSL’s CEO and Managing Director, Paul Perreault, commented: “Our vision for haemophilia B patients is to offer transformational treatment paradigms that help free them from the lifelong burden of this disease. With more than three decades of providing lifesaving innovations for the global bleeding disorders community, we are well positioned to maximise the potential benefit of this therapy.â€


What is CSL paying for AMT-061?


Under the agreement with the gene therapy company, CSL will have the exclusive global right to commercialise AMT-061.


It will pay uniQure an upfront cash payment of US$450 million, followed by regulatory and commercial sales milestone payments and royalties.


In addition, uniQure will complete the Phase 3 trial and scale up manufacture for early commercial supply under an agreed plan with CSL. The transaction remains subject to customary regulatory clearances before closing.


Mr. Perreault concluded: “Upon approval, we believe this next-generation therapy would be highly complementary to our existing haemophilia B product portfolio. We hope that it provides patients with an alternate best-in-class treatment option, building on our legacy of delivering lifesaving innovations in hematology."

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CSL is in discussions to produce hundreds of millions of doses of an experimental Covid 19 vaccine in 2021, assuming clinical trials are successful and it is approved by Australian and international regulators. The decision... to push the button on manufacturing came as the vaccine was given to people for the first time in Phase 1 clinical testing. The University of Queensland scientists behind it said on Monday the immuniser could be ready for emergency use in the new year.

CSL, which is partnering with UQ to fast-track the vaccine, will make several million antigen doses before the human trials are completed, punting on the prototype vaccine passing the three-stage proving process and being licensed.

A portion of these (doses) will be used in phase II/III clinical studies, with the remainder available as soon as marketing authorisation is granted, a company spokesman said. We anticipate producing tens of millions of doses during 2021, which would be made available subject to safety and efficacy data generated by trials as well as regulatory approval.


Initially, CSL will manufacture vaccine from its biotech manufacturing facility at Broadmeadows. Further scaling up of production to hundreds of millions of doses will be achieved in partnership with a contract manufacturer. To this end, we are in early discussion with global manufacturers regarding production.â€


Qld Premier Anna Palaszczuk emphasised the importance of the vaccine being made in Australia. That has always been the missing piece … we have to get overseas companies to do that production. (This time) it can be made here locally and distributed internationally, she said. She said this would be worth “millions if not billions†of dollars to the nation.


UQ project leader Trent Munro said the scientists had been working around the clock to meet aggressive timelines to ready the vaccine to be tested on people, a critical phase of its development. Preclinical trials on laboratory animals in May showed it delivered higher immunity levels to COVID-19 than those in people who had recovered from the disease.



Yet many new drugs fail in human testing and Professor Munro said there was no guarantee the UQ vaccine would get through.

I think it’s still early days, but everything we have seen gives us confidence that we should keep moving forward. We feel really positive … all the data we have seen is good but like any vaccine trial, this may or may not succeed.

Work that would normally take years to bring a new drug to clinical trial has been crammed into barely five months since the UQ team adapted its cutting-edge molecular clamp vaccine technology to COVID-19. Being protein based, the candidate vaccine is considered safer to test on people than formulations using live virus. The volunteers, ranging from 18 to 55, will be given two treatments four weeks apart in a randomised, double blind, placebo controlled study.


Another lead researcher, Paul Young, said the aim was to have the vaccine mass-produced and widely available by mid-2021. The drug could be released as early as January for emergency use if it performed to expectation in the human trials. Nursing homes hit by a coronavirus outbreak or situated in an area where the disease was surging would be considered for such use, public health experts say.



Only a handful of the 180-odd vaccines in development around the world are in human trials, putting the promising UQ offering in the top tier of contenders from the US, Britain and China. In the US, an RNA vaccine developed by Boston-based biotech Moderna Therapeutics completed successful phase-I human trials in May and is due to go to phase-II/III testing by the end of the month. Other US companies on the trail include pharmaceutical giants Pfizer and Johnson & Johnson; Pennsylvania-based Inovio has also reported strong immune responses in phase-1 subjects of its DNA-based vaccine. Oxford University group has human trials under way, as do Brazil and South Africa. CanSino Biologic in China has been cleared by Beijing to test its potential vaccine on the two million-strong army. Professor Young said rival research teams were not competing, and the world would need more than one vaccine.

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Further questions have been raised this week about Australia's capability to produce a vaccine quickly for mass distribution.


Some vaccine technologies, such as the mRNA technology being developed by Monash University, can't yet be manufactured in Australia.


It is because Australian medical supply and vaccine company CSL — the only company in Australia with mass vaccine manufacturing capabilities — only creates a certain type of influenza vaccine.


But it has put up its hand to move into the new areas of vaccine manufacturing.


The Prime Minister said he was confident "in the majority" of cases that CSL would be able to reproduce vaccines locally.


CSL told the ABC the UQ vaccine — which it has committed to manufacture — was its priority,


However, CSL product development vice-president Anthony Stowers said the company was committed to "leveraging [its] skills and manufacturing capabilities" to support the development of any vaccine candidate


"This includes the capacity to undertake the "downstream" aspects of vaccine production, such as processing licensed vaccine material into vials at our [facilities] in Melbourne," Dr Stowers said.


"We are exploring ways to support the manufacture of other vaccines under development and will keep discussions open."



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AAAAGGGHHHH, Just what CSL needs.

Trump has endorsed the CSL approach to Covid vaccine.

From The OZ

US President Donald Trump has thrown his support behind a therapy to fight COVID-19, which Australia’s biggest health company CSL is developing with other plasma manufactures


At a White House roundtable with Mr Trump, CSL chief executive Paul Perreault says the company is weeks away from beginning a clinical trial of plasma-based hyperimmune therapy to combat COVID-19.


Mr Trump endorsed the trial which CSL - the biggest company on the ASX - will complete as part of a global alliance it forged with Takeda and other plasma therapy manufacturers earlier this year.


The therapy focuses on using antibodies found in plasma donated from people who have recovered from COVID-19 to help others fight off the high infectious disease that has killed 670,000 across the globe, infected millions of others and exiled Victoria from the rest of Australia.


Mr Trump said the plasma-based therapy was “a more delicate way of doing thingsâ€. He has previously advocated the use of hydroxychloroquine to ward off coronavirus, despite his own public health officials saying it is ineffective.


All the never trumpers will start badmouthing the therapy and CSL will tank.


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... start badmouthing the therapy and CSL will tank.


Technicals seem to not like it:

...just look at this broad top formation that CSL has been forming for the past nine months. It appears poised to break lower under $278 and head down to $250... " - Greg Tolpigin



and the fund managers come in with their analyses:

Livewire Markets: Okay. We've got a couple of stocks that you both like. Can you tell me something you don't like right now?

Blake Henricks (Firetrail): Well, I'd say we are funding some of these purchases through something like a CSL where great business, but there is probably not the tailwinds that it has had over the last few years in the next little while. So that's a good funder for us.


Livewire Markets: Jun Bei, you got something that you are using to fund your Zip shares?

Jun Bei Liu (Tribeca): He took my stock! I was going to say CSL. We are not going significantly underweight, but CSL, it has done well and it is pretty expensive and its earnings are going to be downgraded. So that is a funder [for other Buys]...


Now $270, has not been this low since Oct 2019; and below the Covid panic, even.. So now we have total consensus it can only go down!! :sadsmiley02: ...(= if good news comes, the snapback could be dramatic) :wacko:

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Talks with AstraZeneca include CSL potentially producing its vaccine under a licensing deal at its advanced manufacturing facility at Broadmeadows in the Melbourne northern suburb.

Development of the UQ vaccine candidate remains CSL's priority, a company spokeswoman said.


However, we are currently in discussions with AstraZeneca and the Australian Government to assess whether it is possible to provide local manufacturing support for the Oxford University/ AstraZeneca vaccine, should it prove successful, while protecting our commitment to the UQ vaccine.


We are assessing the viability of options ranging from the fill and finish of bulk product imported to Australia through to manufacture of the vaccine candidate under licence.

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