mRNA Treatment

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Yuli Ban
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mRNA Treatment

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Why are mRNA vaccines so exciting?
The very first vaccines for COVID-19 to complete phase 3 testing are an entirely new type: mRNA vaccines. Never before have mRNA vaccines — such as the two-dose Pfizer/BioNTech and Moderna vaccines that have now received emergency use authorization from the FDA — been approved for use in any disease. How do they differ from traditional vaccines, and what makes them so exciting?
I actually genuinely didn't realize these were such a quantum leap forward for medicine. Jeez!
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Yuli Ban
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Re: Why are mRNA vaccines so exciting?

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The mRNA vaccine revolution is just beginning
NO ONE EXPECTED the first Covid-19 vaccine to be as good as it was. “We were hoping for around 70 per cent, that’s a success,” says Dr Ann Falsey, a professor of medicine at the University of Rochester, New York, who ran a 150-person trial site for the Pfizer-BioNTech vaccine in 2020.

Even Uğur Şahin, the co-founder and CEO of BioNTech, who had shepherded the drug from its earliest stages, had some doubts. All the preliminary laboratory tests looked good; since he saw them in June, he would routinely tell people that “immunologically, this is a near-perfect vaccine.” But that doesn’t always mean it will work against “the beast, the thing out there” in the real world. It wasn’t until November 9, 2020, three months into the final clinical trial, that he finally got the good news. “More than 90 per cent effective,” he says. “I knew this was a game changer. We have a vaccine.”

“We were overjoyed,” Falsey says. “It seemed too good to be true. No respiratory vaccine has ever had that kind of efficacy.”

The arrival of a vaccine before the close of the year was an unexpected turn of events. Early in the pandemic, the conventional wisdom was that, even with all the stops pulled, a vaccine would take at least a year and a half to develop. Talking heads often referenced that the previous fastest-ever vaccine developed, for mumps back in 1967, took four years. Modern vaccines often stretch out past a decade of development. BioNTech – and US-based Moderna, which announced similar results later the same week – shattered that conventional timeline.

Neither company was a household name before the pandemic. In fact, neither had ever had a single drug approved before. But both had long believed that their mRNA technology, which uses simple genetic instructions as a payload, could outpace traditional vaccines, which rely on the often-painstaking assembly of living viruses or their isolated parts. mRNA turned out to be a vanishingly rare thing in the world of science and medicine: a promising and potentially transformative technology that not only survived its first big test, but delivered beyond most people’s wildest expectations.

But its next step could be even bigger. The scope of mRNA vaccines always went beyond any one disease.

NOT EVERYONE WAS so surprised that mRNA vaccines passed their first test with flying colours. Katalin Karikó, a Hungarian biochemist, started working with mRNA as early as 1989; her research at the University of Pennsylvania in the mid-2000s laid the foundation for both the BioNTech and Moderna vaccines (Karikó now oversees RNA pharmaceuticals for BioNTech as a senior vice president). When I ask about her take on the past year, she is characteristically blunt. “There was no nail biting. I expected the vaccines to be very potent,” she says.
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joe00uk
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Re: Why are mRNA vaccines so exciting?

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Let's just hope these celebrations aren't premature. Overconfidence like this so early on is not exactly the most encouraging sign in the world.
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Yuli Ban
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Re: Why are mRNA vaccines so exciting?

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joe00uk wrote: Wed Jun 09, 2021 12:22 pm Let's just hope these celebrations aren't premature. Overconfidence like this so early on is not exactly the most encouraging sign in the world.
There's a reason for the overconfidence. It's not like this was developed just in the past two years. People have been working on this technology for literal decades and were telling the world throughout all that time "This works; this really really works for a massive range of issues."
The health industry simply shrugged them off during all that time. Then COVID-19 forced everyone to get with the plot.

If not for COVID, we'd likely not even be talking about mRNA medical treatments on a wide scale for at least another 20 years, and not because it doesn't work.
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Yuli Ban
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Re: mRNA Treatment

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mRNA vaccine yields full protection against malaria in mice
Scientists from the Walter Reed Army Institute of Research and Naval Medical Research Center partnered with researchers at the University of Pennsylvania and Acuitas Therapeutics to develop a novel vaccine based on mRNA technology that protects against malaria in animal models, publishing their findings in npj Vaccines.

In 2019, there were an estimated 229 million cases of malaria and 409,000 deaths globally, creating an extraordinary cost in terms of human morbidity, mortality, economic burden, and regional social stability. Worldwide, Plasmodium falciparum is the parasite species which causes the vast majority of deaths. Those at highest risk of severe disease include pregnant women, children and malaria naïve travelers. Malaria countermeasures development has historically been a priority research area for the Department of Defense as the disease remains a top threat to U.S. military forces deployed to endemic regions.

A safe, effective malaria vaccine has long been an elusive target for scientists. The most advanced malaria vaccine is RTS,S, a first-generation product developed in partnership with WRAIR. RTS,S is based on the circumsporozoite protein of P. falciparum, the most dangerous and widespread species of malaria parasite. While RTS,S is an impactful countermeasure in the fight against malaria, field studies have revealed limited sterile efficacy and duration of protection. The limitations associated with RTS,S and other first-generation malaria vaccines have led scientists to evaluate new platforms and second-generation approaches for malaria vaccines.
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Yuli Ban
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Re: mRNA Treatment

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Germany-based BioNTech announced the first patient had been treated in its BNT111 cancer vaccine
Germany-based BioNTech SE announced the first patient had been treated in its BNT111 Phase 2 cancer vaccine trial. The study evaluates the Company’s therapeutic cancer vaccine candidate BNT111 in combination with Libtayo® (cemiplimab) in patients with anti-PD1-refractory/relapsed unresectable Stage III-IV melanoma.

BNT111 is the lead product candidate from BioNTech’s FixVac platform that targets a fixed combination of mRNA-encoded, tumor-associated antigens with the objective of triggering a strong and precise immune response against cancer.

BNT111 is an intravenous therapeutic cancer vaccine candidate encoding for a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as an RNA-lipoplex formulation.

The BNT111-01 trial, which is being conducted in collaboration with Regeneron, was reviewed and approved by the regulatory authorities in Spain, Germany, Italy, Poland, and the United Kingdom, the USA, Australia.
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Yuli Ban
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Re: mRNA Treatment

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If this pans out (and it's almost certainly going to), it'll make the widespread availability of mRNA vaccines one of the single biggest events in all human history. Right on par with antibiotics and penicillin.
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Yuli Ban
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Re: mRNA Treatment

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CureVac COVID vaccine let-down spotlights mRNA design challenges
Two vaccines made using messenger RNA (mRNA) have proved spectacularly successful at warding off COVID-19, but a third mRNA-based candidate has flopped in a final-stage trial, according to an initial report released this week. Researchers are now asking why — and some think that choices about the type of mRNA chemistry used might be to blame. Any insight could help to guide the future design of mRNA vaccines against COVID-19 or other diseases.

The company behind the beleaguered trial, CureVac, based in Tübingen, Germany, announced preliminary data on 16 June from a 40,000-person trial, which showed that its two-dose vaccine was just 47% effective at preventing disease.

CureVac’s mRNA vaccine was expected to be cheaper and to last longer in refrigerated storage than the earlier mRNA vaccines made by Pfizer–BioNTech and Moderna. Many had hoped that it could help to expand the reach of mRNA-based vaccines in lower-income countries, and European countries were expecting to order hundreds of millions of doses.

“I’m definitely surprised — and also disappointed,” says Philip Santangelo, a biomedical engineer at the Georgia Institute of Technology in Atlanta who has worked with many mRNA-focused companies, including CureVac.

He and others suspect that CureVac’s decision not to tweak the biochemical make-up of its mRNA, as Pfizer–BioNTech and Moderna did, might be behind its poor performance — although it is too early to know for sure.
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Yuli Ban
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Re: mRNA Treatment

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mRNA vaccine technology moves to flu: Moderna says trial has begun
Moderna has given out the first doses of an mRNA-based influenza vaccine to participants in an early-phase clinical trial, the company announced Wednesday.
Moderna ultimately plans to test the vaccine on about 180 people in the Phase I/II randomized, stratified, observer-blind trial. The trial will look at safety, different doses, and immune responses.
The vaccine, called mRNA-1010, is designed to target four lineages of influenza viruses that circulate seasonally each year, just like the current quadrivalent flu vaccines on the market. The four virus lineages are those identified by the World Health Organization as the ones to target for disease prevention each year—seasonal influenza type A lineages H1N1 and H3N2 as well as influenza type B lineages Yamagata and Victoria. If mRNA-1010 is shown to be effective against the yearly plague in later-stage trials, Moderna aims to eventually bundle it with three other mRNA-based vaccines to create a yearly one-stop shot.
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Yuli Ban
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Re: mRNA Treatment

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Moderna’s Next Act Is Using mRNA vs. Flu, Zika, HIV, and Cancer
The biotech has reached a $100 billion market cap. But after Covid, the challenges get even bigger.
A year ago, Moderna Inc. was an unprofitable company with no marketed products and a promising but totally unproven technology. None of its experimental drugs and vaccines had ever completed a large-scale trial. Experts were divided on how well the mRNA-based Covid-19 vaccine it was about to enter in a Phase III trial would stack up against older, more established vaccine technologies.
This year, Moderna could deliver 1 billion doses of its Covid shot and bring in $19 billion in revenue. It’s become the rare biotech to hit the big time without being gobbled up by, or splitting profits with, a larger, more established company. Its market value—which hit $100 billion for the first time on July 14th—exceeds that of stalwarts such as Bayer AG, the German inventor of aspirin, and biotech peers such as Biogen Inc., founded three decades prior.

The speed with which Moderna and its primary mRNA competitor, a partnership between Pfizer Inc. and BioNTech SE, devised their shots has made a major contribution to the fight to end the pandemic. With strong efficacy, steady supply, and no show-stopping safety scares (officials are carefully monitoring rare heart inflammation cases in teenagers and young adults), mRNA shots have become the vaccines of choice, at least in countries that can get them.

But for Moderna Chief Executive Officer Stéphane Bancel, the Covid vaccine is just the beginning. He’s long promised that if mRNA works, it will lead to a giant new industry capable of treating most everything from heart disease to cancer to rare genetic conditions. Moderna has drugs in trials for all three of these categories, and Bancel says his company can also become a dominant vaccine maker, developing shots for emerging viruses such as Nipah and Zika, as well as better-known, hard-to-target pathogens such as HIV.
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