TARRYTOWN, NY — For over three decades, Regeneron has been synonymous with one thing in the drug industry: antibodies. Blockbusters like Dupixent, Eylea, and Covid-19 antibodies have transformed what started as a scrappy startup into one of biotech’s biggest names.
But the billionaire co-founders who still run the $91 billion giant, CEO Leonard Schleifer and CSO George Yancopoulos, have spent nearly the last decade working on the company’s next act. They have partnered, built, and bought their way into genetic medicine, going beyond antibodies into CRISPR, RNA interference, and other technologies that manipulate the genetic code of life.
It’s an audacious bet on the future of the drug industry. And even though Regeneron’s success has come from antibodies, its leaders believe new therapies may dominate its next age.
Not only is the biotech co-developing the most clinically advanced in vivo CRISPR therapy with Intellia Therapeutics and an Alzheimer’s RNA interference drug candidate with Alnylam Pharmaceuticals, it’s also quietly working on — and increasingly excited about — some earlier, less heralded research that could change the field. Its leaders believe it can crack the delivery problem that holds back the entire space. Doing so would bring genetic medicines beyond the liver to reach more parts of the body, in the process greatly expanding the medical — and commercial — possibilities of the technology.
“While everybody else was so hyped and giving Nobel Prizes for CRISPR and all that, we realized those weren’t really the limitations,” Yancopoulos, Regeneron’s chief scientific officer, told Endpoints News during an interview at the company’s Tarrytown headquarters. “The limitations were really delivery.”
Regeneron is tapping its decades-long expertise in antibodies, attaching these proteins to standard viral vectors so they hunt for specific types of cells in the body. Research is early, with no timetable on reaching the clinic, but results in mice and non-human primates have emboldened the company’s scientific leaders on the promise of the idea. If it works, Regeneron could crack the delivery challenge that has held the entire field back for years, ultimately bringing technological breakthroughs like CRISPR and RNAi to far more diseases.
“We believe we’ve become leaders in that space,” Yancopoulos said of the delivery idea. “We will hopefully be announcing programs where we’re using biologicals to deliver genetic payloads, which we think has the chance to really continue to change the field.”
There’s still a long journey ahead into making this reality. Academics first tried the idea of attaching antibodies to viral vectors in the 1990s with moderate success, but challenges in making such a complex product have deterred industry interest. Before this idea reaches the clinic, Regeneron will need to convince regulators it has the manufacturing chops to attach these antibodies to viruses in a consistent way so batches look the same. Gene therapy experts said scaling up will be a key challenge.
Still, Regeneron carries unique credibility with its deep pockets and decades of antibody experience.
“Regeneron has certainly been the leader in designing and producing specific antibodies that could be used for this purpose,” said Barry Byrne, director of the University of Florida’s gene therapy center. “They’re the ones who will probably make this work.”
Whether using a hollowed-out virus or a lipid nanoparticle, delivering genetic cargo in the body is frustratingly hard. These carriers predominantly wind up in the liver, the body’s clearinghouse organ.
While that can address diseases caused by genes expressed in liver cells, that’s not most illnesses. The brute force approach, upping doses to try to reach other organs, comes at the expense of the liver, leading to patient deaths in some gene therapy clinical studies.
“You have to give so much vector that you’re overwhelming your liver, and your liver enzymes go crazy,” said Christos Kyratsous, co-head of Regeneron’s genetic medicines team. “That becomes the major limitation for delivering the interesting payloads.”
The delivery problem has caused the field to crowd into the same liver-based targets, such as PCSK9, to slash cholesterol. Other efforts, like the sickle cell CRISPR gene-editing program now being reviewed by the FDA, avoid delivery altogether by using an ex vivo process closer to arduous transplant surgery than a typical drug.
The delivery work is one part of a sprawling genetics strategy at Regeneron, which started in 2014 with the launch of its Regeneron Genetics Center. That has become one of the world’s largest DNA-reading efforts, having sequenced 2 million genomes and counting, leading to over 10 new genetic targets tied to diseases like obesity or liver disease.
Walking around the RGC, sequencing machines tower over and outnumber white-coated scientists toiling at lab benches. It’s far more common for its 170 employees to log on remotely to check experiments or let robotic systems whiz around to handle routine tasks like pipetting.
Regeneron has inked collaborations with Decibel Therapeutics and Alnylam over the past few years, respectively working on CRISPR gene editing, gene therapy, and RNA interference to advance that RGC research. In August, Regeneron made an extraordinarily rare M&A move, agreeing to buy Decibel and its gene therapy work.
Regeneron now has six genetic medicines in its pipeline and more than 30 preclinical programs. But even as the field has generated excitement with the first US approvals for gene therapies, RNAi drugs, and mRNA vaccines all since 2017, its potential still dwarfs its current impact. The pesky delivery problem looms over the entire field.
Regeneron hopes its antibody idea can reach more organs, starting with the muscle and the brain. Preclinical data are encouraging, independent experts told Endpoints.
Regeneron’s most advanced program attaches an antibody targeting a protein found in muscle cells called CACNG1 to a viral vector. Mice and non-human primate studies showed massive boosts in reaching muscle cells, alongside big drops in entering the liver and heart compared to an unmodified version of the virus, according to data presented at this year’s American Society of Gene & Cell Therapy meeting.
“This is unlocking an entirely new space in terms of delivery and what you can actually do with all these genetic medicines,” Kyratsous said.
Christina Pacak, a University of Minnesota gene therapy researcher, called the data exciting, adding she’s hopeful for the approach.
“If we can increase safety, reduce costs, and just lower what patients are exposed to, that’s an enormous advantage,” said Pacak, who’s not involved with Regeneron’s research.
For Regeneron’s early results, other experts said they are encouraging but not industry-shaking.
“Super-beautiful data. It’s impressive,” said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology. “But it doesn’t look different magnitude-wise on either purposeful targeting or detargeting to any of the novel capsids. Competitive, but not different.”
Startups like Dyno Therapeutics, Solid Biosciences, Capsida Biotherapeutics, and Apertura Gene Therapy are all tinkering with AAVs, or adeno-associated viruses, to get beyond the liver. (Paulk sits on Dyno’s scientific advisory board.) Outside of AAVs, other startups focused on delivery include Aera Therapeutics, Ensoma, and ReCode Therapeutics.
Even as more startups take on delivery, Regeneron stands alone with its antibody idea. In a sign of its progress, its AAV-focused team has grown from the single digits about seven years ago to now several hundred people.
Outside experts repeatedly mentioned scaling up production as the key challenge to watch. Siren’s Paulk said manufacturing challenges have limited the idea’s potential for decades, as attaching antibodies can be inconsistent and finicky. Paulk said Regeneron would need to have a production trick up its sleeve to address those challenges.
“Every lot becomes a snowflake, and that becomes a challenge for the FDA,” Paulk said. “I don’t see a way this moves forward. I hope I’m dead wrong.”
David Schaffer, a bioengineering researcher at UC Berkeley, called Regeneron’s results “interesting” but noted in an email it may be “technically challenging to scale reproducibly and robustly.”
Regeneron’s leaders said they are confident in meeting that challenge. Kyratsous said they are advancing two methods of attaching antibodies to viruses, adding they’ve seen consistent results in scaling both ideas so far.
“We don’t want to over-engineer something and make something that is very cool on paper or works very well in small animal models, and you cannot scale it up for human use,” he added.
Regeneron’s leaders pointed to their experience in mass-producing antibodies and the expanding AAV team.
“We’re moving toward clinical-scale virus production,” said Leah Sabin, executive director of Regeneron’s genetic medicines unit.
Sabin said they are debating what muscle diseases to prioritize for the clinic, while a brain-targeting program is now being tested in non-human primates. The team is already mulling what tissues to target next.
“The current capsids are not good enough,” Sabin said. “They’re fine, but what would be industry-altering is having this completely new, way more efficient way to get them there.”fda preclinical genetic antibodies therapy rna dna deaths covid-19
Alzheimer’s, Now A Leading Cause Of Death In US, Is Becoming More Prevalent
Alzheimer’s, Now A Leading Cause Of Death In US, Is Becoming More Prevalent
Alzheimer’s disease is now one of the leading causes of death…
Alzheimer’s disease is now one of the leading causes of death in the United States, according to the Centers for Disease Control and Prevention.
Alzheimer’s is a degenerative and incurable brain disease that predominantly affects older people.
Early symptoms include memory loss and lapses in judgment, but at a later stage these can progress to problems with a wider range of functions too, such as balance, breathing and digestion.
As Statista's Anna Fleck details below, while heart disease, cancer and Covid-19 claimed by far the highest numbers of lives in 2021 (which was the latest available data), Alzheimer’s disease ranked in a high seventh place with 119,399 deaths that year, equating to 31 people per 100,000 population.
You will find more infographics at Statista
The rate of people dying of Alzheimer’s disease in the United States more than doubled between the years 2000 and 2019, according to the Alzheimer’s Association's latest report.
Where an average of 17.6 people per 100,000 died from the form of dementia at the turn of the millennium, the figure had climbed to 37 per 100,000 people nearly two decades later.
You will find more infographics at Statista
According to the Alzheimer’s Association, this is likely the result of an aging population, since age is the predominant risk factor for Alzheimer’s dementia. However, they note, it could also reflect a rise in the number of formal diagnoses of the disease or even in the number of physicians who are reporting Alzheimer’s as a cause of death.
The charity’s analysts forecast that by 2025, the number of people aged 65+ with Alzheimer’s dementia in the U.S. could reach 7.2 million, and up to 13.8 million by 2060, if there were to be no medical breakthroughs in that time to prevent, slow or cure the disease.
On that note, pharmaceutical companies have a number of drugs in development, targeting different symptoms, from inflammation to synaptic plasticity/neuroprotection pathways.
According to AgingCare, neurological damage and muscle weakness can lead to patients finding it difficult to manage even simple movements such as swallowing food without assistance. This is the most common cause of death among Alzheimer's patients, since it can result in the inhalation of food or liquids to the lungs, which in turn can lead to pneumonia, since it more difficult to fight off bacterial infections.
The Alzheimer’s Association stresses the importance of seeing a doctor when someone develops Alzheimer’s symptoms. This is because an early diagnosis allows for treatment from earlier on, which may be able to lessen symptoms for a limited time as well as to make more time for people to plan for the future.
God bless nana.
American Pandemic ‘Samizdat’: Bhattacharya
American Pandemic ‘Samizdat’: Bhattacharya
Authored by Jay Bhattacharya via RealClear Wire,
On May 15, 1970, the New York Times published…
On May 15, 1970, the New York Times published an article by esteemed Russia scholar Albert Parry detailing how Soviet dissident intellectuals were covertly passing forbidden ideas around to each other on handcrafted, typewritten documents called samizdat. Here is the beginning of that seminal story:
Censorship existed even before literature, say the Russians. And, we may add, censorship being older, literature has to be craftier. Hence, the new and remarkably viable underground press in the Soviet Union called samizdat.
Samizdat – translates as: “We publish ourselves” – that is, not the state, but we, the people.
Unlike the underground of Czarist times, today’s samizdat has no printing presses (with rare exceptions): The K.G.B., the secret police, is too efficient. It is the typewriter, each page produced with four to eight carbon copies, that does the job. By the thousands and tens of thousands of frail, smudged onionskin sheets, samizdat spreads across the land a mass of protests and petitions, secret court minutes, Alexander Solzhenitsyn’s banned novels, George Orwell’s “Animal Farm” and “1984,” Nicholas Berdyayev’s philosophical essays, all sorts of sharp political discourses and angry poetry.
Though it is hard to hear, the sad fact is that we are living in a time and in a society where there is once again a need for scientists to pass around their ideas secretly to one another so as to avoid censorship, smearing, and defamation by government authorities in the name of science.
I say this from first-hand experience. During the pandemic, the U.S. government violated my free speech rights and those of my scientist colleagues for questioning the federal government’s COVID policies.
American government officials, working in concert with big tech companies, defamed and suppressed me and my colleagues for criticizing official pandemic policies – criticism that has been proven prescient. While this may sound like a conspiracy theory, it is a documented fact, and one recently confirmed by a federal circuit court.
In August 2022, the Missouri and Louisiana attorneys general asked me to join as a plaintiff in a lawsuit, represented by the New Civil Liberties Alliance, against the Biden administration. The suit aims to end the government’s role in this censorship and restore the free speech rights of all Americans in the digital town square.
Lawyers in the Missouri v. Biden case took sworn depositions from many federal officials involved in the censorship efforts, including Anthony Fauci. During the hours-long deposition, Fauci showed a striking inability to answer basic questions about his pandemic management, replying “I don’t recall” over 170 times.
Legal discovery unearthed email exchanges between the government and social media companies showing an administration willing to threaten the use of its regulatory power to harm social media companies that did not comply with censorship demands.
The case revealed that a dozen federal agencies pressured social media companies Google, Facebook, and Twitter to censor and suppress speech contradicting federal pandemic priorities. In the name of slowing the spread of harmful misinformation, the administration forced the censorship of scientific facts that didn’t fit its narrative de jour. This included facts relating to the evidence for immunity after COVID recovery, the inefficacy of mask mandates, and the inability of the vaccine to stop disease transmission. True or false, if speech interfered with the government’s priorities, it had to go.
On July 4, U.S. Federal District Court Judge Terry Doughty issued a preliminary injunction in the case, ordering the government to immediately stop coercing social media companies to censor protected free speech. In his decision, Doughty called the administration’s censorship infrastructure an Orwellian “Ministry of Truth.”
In my November 2021 testimony in the House of Representatives, I used this exact phrase to describe the government’s censorship efforts. For this heresy, I faced slanderous accusations by Rep. Jamie Raskin, who accused me of wanting to let the virus “rip.” Raskin was joined by fellow Democrat Rep. Raja Krishnamoorthi, who tried to smear my reputation on the grounds that I spoke with a Chinese journalist in April 2020.
Judge Doughty’s ruling decried the vast federal censorship enterprise dictating to social media companies who and what to censor, and ordered it to end. But the Biden administration immediately appealed the decision, claiming that they needed to be able to censor scientists or else public health would be endangered and people would die. The U.S. 5th Circuit Court of Appeals granted them an administrative stay that lasted until mid-September, permitting the Biden administration to continue violating the First Amendment.
After a long month, the 5th Circuit Court of Appeals ruled that that pandemic policy critics were not imagining these violations. The Biden administration did indeed strong-arm social media companies into doing its bidding. The court found that the Biden White House, the CDC, the U.S. surgeon general’s office, and the FBI have “engaged in a years-long pressure campaign [on social media outlets] designed to ensure that the censorship aligned with the government’s preferred viewpoints.”
The appellate judges described a pattern of government officials making “threats of ‘fundamental reforms’ like regulatory changes and increased enforcement actions that would ensure the platforms were ‘held accountable.’” But, beyond express threats, there was always an “unspoken ‘or else.’” The implication was clear. If social media companies did not comply, the administration would work to harm the economic interests of the companies. Paraphrasing Al Capone, “Well that’s a nice company you have there. Shame if something were to happen to it,” the government insinuated.
“The officials’ campaign succeeded. The platforms, in capitulation to state-sponsored pressure, changed their moderation policies,” the 5th Circuit judges wrote, and they renewed the injunction against the government’s violation of free speech rights. Here is the full order, filled with many glorious adverbs:
Defendants, and their employees and agents, shall take no actions, formal or informal, directly or indirectly, to coerce or significantly encourage social-media companies to remove, delete, suppress, or reduce, including through altering their algorithms, posted social-media content containing protected free speech. That includes, but is not limited to, compelling the platforms to act, such as by intimating that some form of punishment will follow a failure to comply with any request, or supervising, directing, or otherwise meaningfully controlling the social media companies’ decision-making processes.
The federal government can no longer threaten social media companies with destruction if they don’t censor scientists on behalf of the government. The ruling is a victory for every American since it is a victory for free speech rights.
Although I am thrilled by it, the decision isn’t perfect. Some entities at the heart of the government’s censorship enterprise can still organize to suppress speech. For instance, the Cybersecurity and Infrastructure Security Agency (CISA) within the Department of Homeland Security can still work with academics to develop a hit list for government censorship. And the National Institutes of Health, Tony Fauci’s old organization, can still coordinate devastating takedowns of outside scientists critical of government policy.
So, what did the government want censored?
The trouble began on Oct. 4, 2020, when my colleagues and I – Dr. Martin Kulldorff, a professor of medicine at Harvard University, and Dr. Sunetra Gupta, an epidemiologist at the University of Oxford – published the Great Barrington Declaration. It called for an end to economic lockdowns, school shutdowns, and similar restrictive policies because they disproportionately harm the young and economically disadvantaged while conferring limited benefits.
The Declaration endorsed a “focused protection” approach that called for strong measures to protect high-risk populations while allowing lower-risk individuals to return to normal life with reasonable precautions. Tens of thousands of doctors and public health scientists signed on to our statement.
With hindsight, it is clear that this strategy was the right one. Sweden, which in large part eschewed lockdown and, after early problems, embraced focused protection of older populations, had among the lowest age-adjusted all-cause excess deaths of nearly every other country in Europe and suffered none of the learning loss for its elementary school children. Similarly, Florida has lower cumulative age-adjusted all-cause excess deaths than lockdown-crazy California since the start of the pandemic.
In the poorest parts of the world, the lockdowns were an even greater disaster. By spring 2020, the United Nations was already warning that the economic disruptions caused by the lockdowns would lead to 130 million or more people starving. The World Bank warned the lockdowns would throw 100 million people into dire poverty.
Some version of those predictions came true – millions of the world’s poorest suffered from the West’s lockdowns. Over the past 40 years, the world’s economies globalized, becoming more interdependent. At a stroke, the lockdowns broke the promise the world’s rich nations had implicitly made to poor nations. The rich nations had told the poor: Reorganize your economies, connect yourself to the world, and you will become more prosperous. This worked, with 1 billion people lifted out of dire poverty over the last half-century.
But the lockdowns violated that promise. The supply chain disruptions that predictably followed them meant millions of poor people in sub-Saharan Africa, Bangladesh, and elsewhere lost their jobs and could no longer feed their families.
In California, where I live, the government closed public schools and disrupted our children’s education for two straight academic years. The educational disruption was very unevenly distributed, with the poorest students and minority students suffering the greatest educational losses. By contrast, Sweden kept its schools open for students under 16 throughout the pandemic. The Swedes let their children live near-normal lives with no masks, no social distancing, and no forced isolation. As a result, Swedish kids suffered no educational loss.
The lockdowns, then, were a form of trickle-down epidemiology. The idea seemed to be that we should protect the well-to-do from the virus and that protection would somehow trickle down to protect the poor and the vulnerable. The strategy failed, as a large fraction of the deaths attributable to COVID hit the vulnerable elderly.
The government wanted to suppress the fact that there were prominent scientists who opposed the lockdowns and had alternate ideas – like the Great Barrington Declaration – that might have worked better. They wanted to maintain an illusion of total consensus in favor of Tony Fauci’s ideas, as if he were indeed the high pope of science. When he told an interviewer, “Everyone knows I represent science. If you criticize me, you are not simply criticizing a man, you are criticizing science itself,” he meant it unironically.
Federal officials immediately targeted the Great Barrington Declaration for suppression. Four days after the declaration’s publication, National Institutes of Health Director Francis Collins emailed Fauci to organize a “devastating takedown” of the document. Almost immediately, social media companies such as Google/YouTube, Reddit, and Facebook censored mentions of the declaration.
In 2021, Twitter blacklisted me for posting a link to the Great Barrington Declaration. YouTube censored a video of a public policy roundtable of me with Florida Gov. Ron DeSantis for the “crime” of telling him the scientific evidence for masking children is weak.
At the height of the pandemic, I found myself smeared for my supposed political views, and my views about COVID policy and epidemiology were removed from the public square on all manner of social networks.
It is impossible for me not to speculate about what might have happened had our proposal been met with a more typical scientific spirit rather than censorship and vitriol. For anyone with an open mind, the GBD represented a return to the old pandemic management strategy that had served the world well for a century – identify and protect the vulnerable, develop treatments and countermeasures as rapidly as possible, and disrupt the lives of the rest of society as little as possible since such disruption is likely to cause more harm than good.
Without censorship, we might have won that debate, and if so, the world could have moved along a different and better path in the last three and a half years, with less death and less suffering.
Since I started with a story about how dissidents skirted the Soviet censorship regime, I will close with a story about Trofim Lysenko, the famous Russian biologist. Stalin’s favorite scientist was a biologist who did not believe in Mendelian genetics – one of the most important ideas in biology. He thought it was all hokum, inconsistent with communist ideology, which emphasized the importance of nurture over nature. Lysenko developed a theory that if you expose seeds to cold before you plant them, they will be more resistant to cold, and thereby, crop output could be increased dramatically.
I hope it is not a surprise to readers to learn that Lysenko was wrong about the science. Nevertheless, Lysenko convinced Stalin that his ideas were right, and Stalin rewarded him by making him the director of the USSR’s Institute for Genetics for more than 20 years. Stalin gave him the Order of Lenin eight times.
Lysenko used his power to destroy any biologist who disagreed with him. He smeared and demoted the reputations of rival scientists who thought Mendelian genetics was true. Stalin sent some of these disfavored scientists to Siberia, where they died. Lysenko censored the scientific discussion in the Soviet Union so no one dared question his theories.
The result was mass starvation. Soviet agriculture stalled, and millions died in famines caused by Lysenko’s ideas put into practice. Some sources say that Ukraine and China under Mao Tse-tung also followed Lysenko’s ideas, causing millions more to starve there.
Censorship is the death of science and inevitably leads to the death of people. America should be a bulwark against it, but it was not during the pandemic. Though the tide is turning with the Missouri v. Biden case, we must reform our scientific institutions so what happened during the pandemic never happens again.
Dr. Bhattacharya is the inaugural recipient of RealClear’s Samizdat Prize. This article was adapted from the speech he delivered at the award ceremony on September 12 in Palo Alto, California.
Disney World finally brings back parking trams
The theme park giant very rarely gives back things it has taken away from ticketholders, but people will be happy with this change.
Walt Disney made a lot of changes at its theme parks during the covid pandemic.
Many of them were unpopular but necessary. Health checks, masks and social distancing were beyond the company's control. Moving to only digital ordering at many casual eateries and limiting park attendance were also logical, given the need to keep people safe from the virus.
During the pandemic, however, the company also made some changes at Disney World that people did not like and that had nothing to do with covid. Walt Disney (DIS) - Get Free Report dropped the FastPass system and replaced it with the paid Genie+ and Lightning Lane offerings.
Disney World also added a reservation system during the pandemic to manage crowd levels at its parks, while it also stopped so-called park hopping. Now, the company has largely restored park hopping to the way it worked prepandemic and reservations are needed only in certain situations.
Also during the pandemic Disney World dropped another popular customer convenience. After nearly three years, the company finally restored something that Disney World visitors had missed a lot.
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Disney World made careful choices
Disney World has some very large parking lots. On a crowded day at any of its four theme parks, people who don't arrive early can end up parking very far away from each park's entrance. It's possible to walk to the entrance at Hollywood Studios, Animal Kingdom and Epcot or to the monorail or ferry boats at Magic Kingdom, but the walk can be a long one.
Walking is, of course, a major part of any Disney World visit. Having customers make a long trek before they even enter a park has never made much sense.
During the covid days, however, limited crowds allowed people to park closer to the entrances. That enabled people to walk to the entrances and made parking trams an unnecessary luxury.
Disney removed the trams partly because they weren't needed and partly because they created a covid risk. In the social distancing days, having people fighting for space to queue up for a ride to the entrance required policing and seemed like a bad idea even when things returned to closer to normal.
Now, Disney has finally fully brought parking trams back to Disney World.
Disney World brings back parking trams
Disney had promised that its parking-lot trams would return, but actually bringing them back took longer than expected.
"After more than 1,100 days and nine months after a self-imposed deadline, parking lot trams have returned to Epcot and Disney’s Hollywood Studios – marking a full return of the service," BlogMickey.com reported. "Parking-lot-tram service returned to Magic Kingdom and Disney’s Animal Kingdom last year, but Disney only brought back service to Epcot and Hollywood Studios today (Sept. 21),"
The website implies that the reluctance to bring the service back could have been labor-related or it may have been Disney not wanting to spend the money. The trams have a driver and each park has attendants helping keep the lines orderly (although the system is not as organized as most Disney lines).
Disney World has mostly returned to how it operated before covid. The company has kept parts of the reservation system and digital ordering is still encouraged.
In addition, the company continues to manage attendance and has kept capacity at lower numbers than it did before the pandemic. Disney has also increased the number of days that it sells admission to at least one of its four Florida parks at the lowest price on its dynamic pricing scale.
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