A specific change in the virus genome of SARS-CoV-2 coronavirus, previously associated with increased viral transmission and the spread of COVID-19, is shown to be more infectious in cell culture in new research by scientists published in the journal Cell.
A small yet effective change in the ‘spike’ protein of the virus, which the virus uses to enter human cells, is made by the D614G, the variant in question.
The lead author of the study and a theoretical biologist at Los Alamos National Laboratory, Bette Korber noted, ” We had observed a strikingly repetitive pattern and the D614G variant first came to our attention in early April. The D614G variant became the prevalent form soon after it was introduced into a region even when local epidemics had many cases of the original form circulating, all over the world.”
The tracking of this highly recurrent pattern, a shift in the viral population from the original form to the D614G variant, was enabled by the geographic information from samples from the GISAID COVID-19 viral sequence database. At every geographic level: city, county, and sub country, this occurred.
Supporting these initial results, there were two independent lines of experimental evidence included in the paper. At the La Jolla Institute, Professor Erica Ollmann Saphire, Ph.D., and Duke University Professor David Montefiori, Ph.D., led these additional experiments which showed that the virus’s infectivity in the laboratory is increased by the D614G change. The paper also included more extensive sequence and clinical data and improved statistical models, and these new experiments. To determine the full implications of the change, more in Vivo work remains to be done.
Overall, the mutation rate of the SARS-CoV-2 virus is low (much lower than the viruses that cause HIV-AIDS and influenza). The D614G variant appears as part of a set of four linked mutations that appear to have emerged once and then moved together around the world as a regular set of variations. An author of the study, Will Fischer of Los Alamos commented, “By careful observation of sequence data alone, this increase in infectivity was detected and in such a short time, our experimental colleagues could confirm it with the live virus.”
The Gates Foundation-supported Coronavirus Immunotherapy Consortium (CoVIC) lead, Saphire said, “According to the clinical data in this paper from Sheffield, there wasn’t a corresponding increase in the severity of illness, even though patients with the new G virus carried more copies of the virus than patients infected with D.”
Korber noted, “The importance of maintaining social distancing and wearing masks is highlighted here these findings suggest that the newer form of the virus may be even more readily transmitted than the original form.”
On the bioRxiv site in an April 2020 preprint, research partners from the University of Sheffield, Duke University, and Los Alamos National Laboratory, initially published work on this analysis. Observations of COVID-19 patients from Sheffield that suggested an association of the D614G variant with higher viral loads in the upper respiratory tract were also included in that work.
Korber said, “Through the GISAID viral sequence database, researchers worldwide are rapidly making their viral sequence data available making it possible to track SARS-CoV-2 evolution globally.” Korber and the research team were able to identify the emergence of the D614G variant as there are tens of thousands of sequences available through this project currently.
In order to encourage collaboration among influenza researchers, GISAID was established, however, the consortium established a SARS-CoV-2 database early in the epidemic, making it the de facto standard for sharing outbreak sequences among researchers globally.
The Medical Research Council (MRC) part of UK Research & Innovation (UKRI the National Institute of Health Research (NIHR); the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Interagency Agreement No. AAI12007-001-00000, and the Los Alamos Laboratory Directed Research and Development program; a FastGrant, from Emergent Ventures, in aid of COVID-19 research; private philanthropic support, as well as the Overton family; CoVIC, INV-006133 of the COVID-19 Therapeutics Accelerator, supported by the Bill and Melinda Gates Foundation, Mastercard, Wellcome; Genome Research Limited, operating as the Wellcome Sanger Institute; supported the study, “Tracking changes in SARS-CoV-2 Spike: evidence that D614G increases infectivity of the COVID-19 virus”.
The study included additional authors: H. Yoon, S. Gnanakaran, C.C. LaBranche, S.P. Whelan, A. Moon-Walker, H. Tang, L.G. Perez, C. McDanal, T.I. de Silva, T.M. Freeman, C.M. Evans, D.G. Partridge, K.M. Hastie, B. Foley, T. Bhattacharya, M.D. Parker, E.E. Giorgi, N. Hengartner, W. Abfalterer, J. Theiler.
Thermo Fisher’s $12.5B deal for Qiagen falls through, as COVID-19 test demand lights new path forward
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.
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.
“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.
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.”
MicuRx gets $7.8M top-up to push new antibiotic into the clinic
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.
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.
Scholar Rock’s experimental SMA therapy nabs speedy review voucher
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.
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.
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