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Scientists develop COVID-19 test to detect neutralizing antibodies with high sensitivity, specificity

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According to a study published in Nature Biotechnology, the sVNT is capable of detecting the functional neutralizing antibodies (NAbs) that can block the binding of the coronavirus spike protein to the angiotensin-converting enzyme 2 (ACE2) host receptor, which mimics the virus-host interaction.

The sVNT was developed by scientists from Duke-NUS Medical School, in close collaboration with National Centre for Infectious Diseases (NCID), Agency for Science, Technology and Research (A*STAR)’s Institute of Molecular and Cell Biology (IMCB) Singapore, and GenScript Biotech.

The scientists in Singapore and China validated the test across two patient cohorts, with a sample size of 250 from China and 375 from Singapore, achieving 99-100 per cent specificity and 95-100 per cent sensitivity.

“The sVNT kit can detect functional NAbs in an hour and differentiate them with binding antibodies (BAbs), without the need for live virus or a biocontainment facility.

It also has the ability to detect total receptor binding domain (RBD)-targeting neutralizing antibodies in patient samples, in contrast to most SARS-CoV-2 antibody tests published or marketed, which are isotype-specific.

This makes the sVNT accessible to the broader community for both research and clinical applications,” said Professor Wang Linfa, Director of Duke-NUS’ Emerging Infectious Diseases programme. Prof Wang is considered among the most recognised international experts on emerging zoonotic viruses and is currently serving on multiple WHO committees on COVID-19.

Infection or immunity to the virus is diagnosed by the presence of NAbs in a patient’s blood sample, which would block the RBD-ACE2 interaction.

At this critical moment of the international response to the COVID-19 outbreak, there is an urgent need for a robust serological test that detects NAbs, for accurate assessment of infection prevalence and protective immunity at the individual and population level.

Antibody tests, such as the conventional virus neutralization test (cVNT) and the pseudovirus-based virus neutralization test (pVNT), remain the only platforms for detecting NAbs. However, both require live viruses and cells, highly skilled operators, and days to obtain results. Other assays, such as the enzyme-linked immunosorbent assay (ELISA) detect Babs but are unable to differentiate between BAbs and NAbs.

The sVNT can also measure NAbs from different animals in a species-independent manner. It can therefore be a powerful tool to investigate the role of animals in the transmission of COVID-19 from natural reservoirs to intermediate hosts.

“It is an increasingly critical clinical question about what proportion of patients with COVID-19 develop antibodies to COVID-19, how long it lasts, and whether antibodies protect patients from reinfection. Neutralizing antibody is the gold-standard serological platform to determine this.

Unfortunately, the conventional virus neutralisation assay is laborious, time-consuming and requires Biosafety Level 3 for COVID-19.

The sVNT developed by Prof Wang, in collaboration with the national COVID-19 PROTECT study, makes it accessible to all hospital laboratories, and is a great advance in COVID-19 serological assays,” said Associate Professor David Lye, Director, Infectious Disease Research and Training Office (IDRTO), and Senior Consultant, NCID.

Dr Sidney Yee, CEO of A STAR’s Diagnostics Development Hub, said, “Due to the SARS outbreak in 2003, researchers in Singapore have gained important insights into that virus, which shares some similarities with SARS-Cov-2.

A STAR supported the clinical tests in this collaboration with Duke-NUS by sharing data drawn from our research experience in SARS. We are happy to have contributed to the validation of this innovative test, which will be instrumental in our fight against the global pandemic.”

We are very pleased that Prof Wang’s work has come to fruition. This is great news for scientists researching herd immunity and vaccine efficacy as they will now have access to this innovative research tool to accurately determine the level of neutralising antibodies in a population. We believe the test will shed new light on the current plaguing mysteries of COVID-19.”

Mr David Martz, Vice President, New Product Management, Life Sciences Group, Duke-NUS Medical School

The sVNT kit is commercialised by GenScript and offered worldwide under the brand cPass™ for research use only. GenScript has also filed for Emergency Use Authorisation with the US Food and Drug Administration and this filing is currently under review.

Journal reference:

Tan, C. W., et al. (2020) A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2–spike protein–protein interaction. Nature Biotechnology. doi.org/10.1038/s41587-020-0631-z.

Source: https://www.news-medical.net/news/20200725/Scientists-develop-COVID-19-test-to-detect-neutralising-antibodies-with-high-sensitivity-specificity.aspx

Biotechnology

Thermo Fisher’s $12.5B deal for Qiagen falls through, as COVID-19 test demand lights new path forward

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While many companies have faltered under the spread of COVID-19, others may be doing a little too well for some tastes—with Qiagen’s investors turning down Thermo Fisher’s multibillion-dollar takeover proposal, following rocketing demand for its testing products.

Late last year, Qiagen was missing revenue targets and saying goodbye to its long-time CEO, and planned to walk away from developing its own diagnostic hardware under a multi-year reorganization that would favor tests built for Illumina’s sequencing machines.

Still, the Dutch manufacturer was coy about being acquired; Qiagen rebuffed multiple takeover offers in the last days of December—describing them all as “not compelling”—despite press reports that Thermo Fisher had been after the company for weeks, if not years. The lab equipment giant finally broke through in early March, and the two announced a $11.5 billion deal slated for early 2021—a 23% premium above the stock price at the time.  

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Five months and one global pandemic later, Qiagen found itself back in the spotlight. With the world clamoring for its COVID-19 diagnostic reagents and molecular testing supplies, the company’s shares outpaced the original offer as sales jumped nearly 20%. Thermo Fisher even sweetened the deal, adding an extra $1 billion after one of Qiagen’s hedge fund investors urged the company to hold out for more.

But it wasn’t enough. Investors rejected Thermo Fisher’s offer, with only 47% of shares signing up for the deal before the August 10 deadline, falling below the two-thirds minimum.

RELATED: Qiagen to reorganize around 15-year NGS partnership with Illumina as CEO quits

“The magnitude and duration of the global coronavirus pandemic have proven the increasingly critical importance of molecular testing to society,” Qiagen CEO Thierry Bernard said. The company previously rolled out plans to quadruple its reagent production, to support millions of COVID-19 tests per month with the necessary chemicals to help sequencing machines gain access to the virus’ RNA.

“Qiagen’s business prospects have improved significantly, as shown in our performance for the first half of 2020 and the strong outlook for the rest of this year and for 2021,” Bernard added. 

RELATED: Hedge fund urges Qiagen to rethink Thermo Fisher’s $11.5B takeover offer, as COVID-19 fuels testing demand

The New York-based investment fund Davidson Kempner—which recently increased its stake in Qiagen to 8%, making it its second-largest investor, and had pushed for a higher price of about $13.4 billion—did not take up the final offer, and said that fewer than half of the company’s shares lining up to be traded showed “widespread confidence in the long-term prospects of Qiagen.”

Instead, Qiagen will move forward with an acquisition of its own: The company plans to pick up the remaining stake of NeuMoDx Molecular, makers of a test for COVID-19 as well as a multiplexed panel that detects the novel coronavirus plus influenza and respiratory syncytial virus—an important tool for telling infections apart as the pandemic begins to collide with this year’s oncoming flu season.

The $234 million deal was first announced in September 2018, with Qiagen previously owning about 20% of NeuMoDx and agreeing to commercialize its tests and systems. Qiagen said it would deliver more details alongside its third-quarter earnings report.

Meanwhile, Thermo Fisher showed no signs of plans to come back to the table after announcing last week that its price would be its “best and final offer.”

“Thermo Fisher is a disciplined acquirer with a strong track record of executing value-creating transactions,” President and CEO Marc Casper said in a statement after the deal fell through. “We remain extremely well-positioned to deliver on our proven growth strategy and continue to generate significant returns for our shareholders.”

Source: https://www.fiercebiotech.com/medtech/thermo-fisher-s-12-5b-deal-for-qiagen-flops-as-covid-19-test-demand-lights-new-path-forward

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MicuRx gets $7.8M top-up to push new antibiotic into the clinic

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Just last week, MicuRx nabbed nearly $43 million in venture funding to expand its antibiotics pipeline and gear up for its first launch in China. Now, the Sino-American biotech is topping that up with $7.78 million from a nonprofit focused on antimicrobial resistance to push another asset into human trials.

The funding comes from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, which previously funded IND-enabling studies for the prospect, dubbed MRX-8. The cash will bankroll a phase 1 study of the drug, a novel antibiotic in the polymyxin class, and cover “related R&D activities” for phase 2 trials.

First discovered in the 1940s, polymyxins have been used for decades to fight off infections caused by gram-negative bacteria. But their side effects, including acute kidney injury and neurological issues like dizziness and prickling sensations in various parts of the body, has sidelined them in favor of newer, less toxic antibiotics.

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Become fluent in the core elements of revenue forecasting including epidemiology, competitive assessments, market share assignment and pricing. Let Biotech Primer’s dynamic industry experts teach you how to assess the value of new therapies.

RELATED: Big Pharma joins forces on $1B fund to shore up struggling antibiotics makers

However, the rise of multidrug-resistant strains of gram-negative bacteria, such as Pseudomonas aeruginosa, and Acinetobacter baumannii, has “forced” doctors to put polymyxins back in the mix, Swiss researchers wrote in a 2017 study.

MicuRx believes that MRX-8 could be even better than two commonly used polymyxins, polymyxin B and colistin, thanks to its safety profile. The drug showed “improved renal safety” in monkey studies, as well as better efficacy than polymyxin B in “certain nonclinical models of Gram-negative infections, such as urinary tract and lung infection in animal models,” the company says. Now, it has the cash to try to prove that out in humans.

Besides MRX-8, MicuRx has two other programs in its pipeline: contezolid, an oral antibiotic against gram-positive bacteria that has been filed for approval in China, and contezolid acefosamil, an oral and intravenous antibiotic for gram-positive bacteria. Both programs are in phase 2 studies in the U.S.

The funding comes a month after a laundry list of Big Pharma companies joined forces on a $1 billion fund to bolster the development of much-needed antibiotics.

Despite the rise of antibiotic-resistant bacteria, very few antibiotics have been approved over the last 30 years. Multiple pharma companies, including Novartis, AstraZeneca and Eli Lilly, have bowed out of antimicrobials research, while smaller biotechs trying to fill the gap have struggled to stay afloat. In the span of one year, antibiotics makers Aradigm, Achaogen, Melinta and Tetraphase all filed for bankruptcy protection; all but Melinta had approved products.

The new fund, known as the AMR Action Fund, should be up and running by the fourth quarter and aims to see two to four new antibiotics through approval by 2030.

Source: https://www.fiercebiotech.com/biotech/micurx-gets-7-8m-top-up-to-push-new-antibiotic-into-clinic

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Scholar Rock’s experimental SMA therapy nabs speedy review voucher

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The FDA has handed Scholar Rock a rare pediatric disease designation voucher, which can allow the biotech a speedy review of its leading of spinal muscular atrophy (SMA) hopeful SRK-015.

The drug targets the progressive, rare genetic disease that leads to motor function impairments in young children. For decades there were no treatments, but there are now three, all coming in the past few years.

The latest, Roche’s Evrysdi, a survival motor neuron-2 splicing modifier, was approved in the past week, and allows patients to take the drug at home. The other two drugs are Biogen’s Spinraza, an antisense oligonucleotide, and Novartis’ gene therapy Zolgensma.

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Become fluent in the core elements of revenue forecasting including epidemiology, competitive assessments, market share assignment and pricing. Let Biotech Primer’s dynamic industry experts teach you how to assess the value of new therapies.

Those companies have been battling for market share and working to grow sales, as Spinraza sales reached $2.1 billion last year, while Zolgensma generated $361 million during its launch year.

Scholar Rock’s SRK-015 works as a selective inhibitor of the activation of myostatin, and say its drug “may promote a clinically meaningful increase in muscle strength.” It’s a similar theory behind research in another devastating childhood disease, Duchenne Muscular Dystrophy (DMD), although both Roche and Pfizer have in the past tried and failed in this approach.

The biotech will hope to have better luck in SMA, and says it is “on track” report six-month interim efficacy and safety data from the ongoing TOPAZ phase 2 clinical trial of its med, in patients with Type 2 and Type 3 SMA, in the fourth quarter. Top-line data for the 12-month treatment period are expected in the first half of 2021.

There are four main types of SMA, with Type 2 affecting older babies and toddlers, with symptoms less severe than Type 1. Type 2 SMA can shorten life expectancy, but most children with it survive into adulthood.

Type 3 meanwhile usually develop symptoms after 18 months of age, but this is very variable and sometimes it may not appear until late childhood or early adulthood. It doesn’t impact life expectancy.

Now, the Scholar Rock has that rare pediatric disease designation for its rare drug. Under this program, a biopharma that gains approval for a rare pediatric disease can grab a voucher that can be redeemed to receive a priority review of a new, separate marketing application for a different drug.

Recently, these have become hot property and sold off for $100 million-plus to another buyer, given the seller a quick cash grab and the buyer a potentially quicker approval.

We’ll have to wait and see whether the biotech decides to hold on to the voucher for its other programs, many of which are partnered with an array of biopharmas. 

Source: https://www.fiercebiotech.com/biotech/scholar-rock-s-experimental-sma-therapy-nabs-speedy-review-voucher

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