Luminex sees Q2 revenue as high as $110M

Luminex (NASDAQ:LMNX) announces Q2 2020 revenues between $109M and $110M, up more than 30% over Q2 2019.

Molecular Diagnostics revenue of ~$65M, up over 100% vs. Q2 2019.

Sample-to-answer MDx revenue of ~$30M, (+65% Y/Y).

Automated and Non-automated MDx assay revenue of ~$26M and ~$35M, respectively.

170 sold or contracted sample-to-answer systems.

Licensed Technologies Group revenue of ~$35M.

Flow Cytometry revenue of more than $7M.

The company had an additional $2M of confirmed orders that were not able to be installed due to the COVID-19.

Luminex expects to release full Q2 results on August 3.

https://seekingalpha.com/news/3589425-luminex-sees-q2-revenue-high-110m

Nanoviricides up on advancement of SARS-CoV-2 therapeutics program

NanoViricides (NYSEMKT:NNVC) surges 54% premarket on heels of excellent safety and tolerability of the drug candidates observed in animal model against SARS-CoV-2 to treat COVID-19.

The nanoviricides drug candidates tested in this study have previously shown strong effectiveness against lung infection by a SARS-CoV-2, namely, hCoV-NL63, in an animal study.

Three different drug candidates at three different dosage levels (low, medium, and high) and vehicle control were administered to separate groups of mice intravenously in the Safety/Tolerability study reported here.

Clinical observations and gross post-mortem studies have been completed. The tested drug candidates were safe and well tolerated, thereby clearing the path for further development towards a treatment for COVID-19.

No clinical signs of immune or allergic reactions were observed. Further, no observable changes in any organs including large intestine or colon on post mortem in gross histology were reported.

The Company’s “nanoviricide” drug candidates, are designed to be broad-spectrum, and therefore virus escape by mutation is unlikely.

https://seekingalpha.com/news/3589396-nanoviricidesplus-54-on-advancement-of-sars-covminus-2-therapeutics-program

Biogen completes U.S. application for Alzheimer’s drug aducanumab July 8, 2020

Despite uneven results from late-stage clinical trials, Biogen (NASDAQ:BIIB) announces that it has completed the submission of its U.S. marketing application seeking approval of aducanumab for Alzheimer’s disease (AD). It has requested Priority Review of the filing.

The company plans to discuss applications with regulators in Europe and Japan.

In March 2019, the company and development partner Eisai terminated two Phase 3 studies in AD patients with mild cognitive impairment after a futility analysis showed that the trials were unlikely to meet the primary endpoints. In December 2019, one of the studies, EMERGE, gave Biogen renewed hope when the high-dose arm met the primary endpoint. The other Phase 3, ENGAGE, failed to achieve the primary and secondary endpoints in both the low-dose and high-dose arms.

https://seekingalpha.com/news/3589404-biogen-completes-u-s-application-for-alzheimers-drug-aducanumab

Promising therapy to fight epidemic of liver disease

In an effort to combat a growing worldwide epidemic of Nonalcoholic Fatty Liver Disease (NAFLD), scientists have discovered a new target and a new therapy that has shown promising results in preclinical mouse models, according to researchers at the University of Colorado Anschutz Medical Campus.

“NAFLD is a major health issue right now, a real epidemic with no treatment. It affects about 25% of the world population,” said the study’s lead author Mercedes Rincon, PhD, professor in the Department of Immunology and Microbiology at the University of Colorado School of Medicine. “The incidence is higher in those who are obese, but it is not restricted to them.”

The study was published last week in the journal Nature Communications.

NAFLD is characterized by the accumulation of fat in the liver which can lead to fibrosis and eventually Non-Alcoholic Steatohepatitis (NASH), an advanced phase of NAFLD that can cause liver failure and death. It is now the most common form of chronic liver disease with no drugs currently approved to treat it.

The researchers focused on MCJ or Methylation-Controlled J Protein as a target for NASH. This protein lives in the mitochondria, the engine of the cells, where lipids are burned in the liver. MCJ acts as a brake on the metabolic activity of the mitochondria. Patients with NAFLD often have higher MCJ levels in their livers.

But MCJ is not critical for life under normal conditions, so Rincon’s team decided to eliminate this metabolic brake in the liver to increase fat burning and minimize the accumulation of lipids and the development of fibrosis. They used siRNA or Small Interfering RNA to silence MCJ in the liver. This is an emerging therapeutic approach that has shown success in treating some liver diseases.

To test if siRNA for MCJ (called siMCJ) could be a potential therapeutic against NAFLD, mice in preclinical studies were fed a high-fat, high fructose diet. After months on the diet, the mice developed fatty liver. Then they were treated regularly with siMCJ or a placebo. The siMCJ group had lower levels of lipids and fibrosis in their livers compared to the control group. Using this treatment, similar reductions in lipid content and fibrosis were seen in another model on a low protein diet.

“We showed that MCJ-deficient mice are resistant to the development of fatty liver and NASH,” Rincon said. “Importantly, using siRNA as a therapeutic approach we show that treatment with different formulations of siMCJ after the onset of the disease reduces liver steatosis and fibrosis in multiple mouse models.”

A key aspect of this therapy is delivering it to the right part of the liver. The researchers combined the siRNA with GalNac, a sugar derivative that binds directly to hepatocytes, cells that make up the majority of the liver.

The result, the study said, is that MCJ is emerging as an alternative target for treating NASH and NAFLD.

“Currently, most leading therapeutic drugs undergoing clinical trials for NASH are small molecules given as a systemic treatment,” Rincon said. “Our data show, in contrast, that the use of siRNA to reduce the levels of MCJ in the liver may constitute an alternative therapeutic strategy.”

https://www.eurekalert.org/pub_releases/2020-07/uoca-rfp070720.php

Numerous jobs linked to increased risk of knee reconstruction

Knee replacements are a huge burden on society and individuals from all walks of life. A major global systematic review has identified the common jobs – paid and unpaid – that may be putting people unknowingly at risk.

A study by the Universities of Sydney, Oxford and Southampton reveals there is a need for targeted work health and safety practices to extend beyond physically burdensome jobs; regulators and insurance companies should take account of the high number of medium-risk occupations and that unpaid roles also rate highly.

It is the biggest meta-analysis and systematic review of the potentially debilitating knee osteoarthritis (OA) – comprising 71 studies and almost one million people – and the first systematic review into the association between job ‘titles’ and knee OA.

Increased risk was found in agriculture workers, construction workers, miners, service workers, houseworkers (i.e. housewives) and cleaners.

The findings are published today in the prestigious journal Arthritis Care and Research.

The senior author, Professor David Hunter, of the University of Sydney’s Florance and Cope Chair of Rheumatology, Institute of Bone and Joint Research in the Kolling Institute, said the research, while not focusing on the important role of exercise in combatting this common lifestyle ailment, identified the jobs that placed high-to-moderate stress on vulnerable knees.

“Knee osteoarthritis is a leading cause of loss of work and disability worldwide and can necessitate invasive surgery including total knee replacement, so preventing occupational hazards is critical,” Professor Hunter said.

“The burden is increasing, with projections of osteoarthritis that affects one in eight people jumping 50 percent within 15 years , in large part attributable to lifestyle issues such as growing rates of obesity and reduced exercise.”

Lead author Dr Xia Wang, also from the Institute of Bone and Joint Research, Faculty of Medicine and Health, said although research has previously identified frequent kneeling, squatting and heavy lifting – particularly in agriculture and construction – as risk factors, this comprehensive study highlighted occupational risks generally.

“With people working and living longer knee osteoarthritis is an area of concern even in service-focused developed nations, including in mid-risk occupations such as cleaning and full-time, unpaid housework and caring,” she said.

Findings include:

• – Floor-layers, bricklayers and carpenters have ~2.5 times increased odds compared to sedentary workers.

– Agricultural workers had up to 64% increased odds; builders and construction workers had increased odds of 63%.

– Houseworkers (unpaid) have up to 93% increased odds.

– Occupations like commerce, forestry or fishery workers, machine operators, plumbers, electricians, technicians, postmen were not found to be statistically significantly associated with knee OA.

– The following activities were identified as increased risk: excessive kneeling, squatting, standing, lifting and climbing stairs.

Dr Thomas Perry, co-lead author and postdoctoral researcher at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, said: “Our collaborative work has been critical in understanding the relationship between work-place physical activities and knee osteoarthritis. We hope these findings will help guide the future development of work-place personal protective equipment.”

Professor Cyrus Cooper, director of the MRC Lifecourse Epidemiology Unit, University of Southampton, said: “Further evaluation of this issue will ensure that occupational risks of knee osteoarthritis – the commonest joint disorder worldwide – are minimised.”

https://www.eurekalert.org/pub_releases/2020-07/uos-njl070720.php

LSU Health New Orleans discovers new class of safer analgesics

Researchers at LSU Health New Orleans Neuroscience Center of Excellence and colleagues have discovered a new class of pipeline drugs to relieve pain and reduce fever without the danger of addiction or damage to the liver or kidneys. The research is published online in the European Journal of Medicinal Chemistry. Current drugs have unwanted side effects. Opioids can not only cause addiction; recent studies have shown they can be no more effective at relieving pain than non-narcotic drugs. Non-steroidal anti-inflammatories (NSAIDs) can cause kidney damage. Acetaminophen is an effective drug, but overuse can result in liver damage.

The research team, led by Drs. Hernan A. Bazan, a professor in the Department of Surgery and Program Director of the Vascular Surgery Fellowship at Ochsner Clinic, and Surjyadipta Bhattacharjee, a post-doctoral researcher at the LSU Health New Orleans Neuroscience Center of Excellence, set out to discover what causes the liver damage associated with acetaminophen and then create a drug structurally similar to acetaminophen — as effective, but without liver toxicity. Along with the chemistry team led by Professor Julio Alvarez-Builla, Department of Organic Chemistry at the University of Alcala in Madrid, they tested 21 different compounds as acetaminophen analogs.

Senior author Nicolas Bazan, MD, PhD, Boyd Professor and Director of LSU Health New Orleans Neuroscience Center of Excellence says, “The new chemical entities reduced pain in two in models without the liver and kidney toxicity associated with current over-the-counter analgesics that are commonly used to treat pain — acetaminophen and NSAIDs. They also reduced fever in a pyretic model. This is particularly important in the search for an antipyretic with a safer profile in the COVID-19 pandemic and its associated kidney and liver disease in critically ill SARS-CoV-2 patients.”

Acute and chronic pain management is one of the most prevalent and costly public health issues worldwide. According to the Centers for Disease Control and Prevention, an estimated 50 million — 20.4% of U.S. adults had chronic pain and 8.0% of U.S. adults had high-impact chronic pain in 2016.

“Given the widespread use of acetaminophen, the risk of hepatotoxicity with overuse, and the ongoing opioid epidemic, these new chemical entities represent novel, non-narcotic analgesics that exclude hepatotoxicity, for which development may lead to safer treatment of acute and chronic pain and fever,” adds Dr. Nicolas Bazan.

Other LSU Health New Orleans members of the research team included William C. Gordon, PhD, Professor of Neuroscience and Ophthalmology; Dennis Paul, PhD, Professor of Pharmacology; Scott Edwards, PhD, Associate Professor of Physiology and Neuroscience; Bokkyoo Jun, PhD, Research Instructor; and Amanda R. Pahng, PhD, a post-doctoral fellow in Dr. Edwards’ lab. The research team also included Drs. Carolina Burgos, Javier Recio, and Valentina Abet, at the University of Alcala in Madrid; Jessica Heap, a third-year medical student at the Tulane University School of Medicine and Alexander Ledet, a first-year MD/PhD candidate at the Albert Einstein College of Medicine in New York.

The intellectual property behind these new technologies, which are part of this discovery, have been licensed from LSU Health Sciences Center New Orleans to the life science startup South Rampart Pharma, LLC that is currently developing this new drug in late pre-clinical stages. Drs. Hernan A. Bazan, Carolina Burgos, Dennis Paul, Julio Alvarez-Builla, and Nicolas G. Bazan are named inventors on a patent assigned to LSU Health Sciences Center describing the synthesis and characterization of the novel non-hepatotoxic acetaminophen analogs (PCT/US2018/022029). The company expects to file the first FDA IND (Investigational New Drug) application by early third quarter 2020.

“Our primary goal is to develop and commercialize new alternative pain medications that lack abuse potential and have fewer associated safety concerns than current treatment options, and this peer-reviewed paper describes the discovery of the initial library of compounds as well as several proof of concept animal and molecular studies,” says Dr. Hernan Bazan.

###

The research was supported by FEDER funds, Comunidad de Madrid, Ministerio de Economia, Industria y Competitividad, Instituto de Salud Carlos III, and Universidad de Alcalá.

https://www.eurekalert.org/pub_releases/2020-07/lsuh-lhn070620.php

U.S. Commits $2 Billion for Covid-19 Vaccine, Drug Supplies

The federal government awarded $2 billion to two drugmakers to support development and manufacturing of an experimental drug and a potential vaccine against Covid-19.

Novavax Inc. said it would receive $1.6 billion from the federal government to fund clinical studies of its experimental coronavirus vaccine and establish large-scale manufacturing of doses. With the funding, Novavax said it would deliver 100 million doses of its vaccine for use in the U.S., possibly by the end of this year.

Regeneron Pharmaceuticals Inc. said it has received a $450 million federal contract to manufacture thousands of doses of its experimental Covid-19 treatment that the government will distribute at no cost to the public if the drug is authorized for use by regulators.

Shares of Novavax soared nearly 29% to $102.24 Tuesday morning. Shares of Regeneron rose 3.5% to $648.90.

The new funding shows the federal government is taking steps to try to ensure that more effective tools against the pandemic are ready by fall and winter. But there is no guarantee that the drug and vaccine will work safely in clinical trials.

The exact number of treatment courses covered by the Regeneron contract is uncertain, the company said, in part because clinical trials have yet to show what the most effective dose will be.

Regeneron is testing its drug, a combination of two antibodies, as both an antiviral treatment for people already infected, and as a method of providing temporary preventive treatment against new infections. The Tarrytown, N.Y., company said Monday it is advancing the drug into later-stage studies.

The contract will cover 70,000 to 300,000 treatment doses as an antiviral treatment. If used preventively, a lower dose of the drug would be needed and the estimated treatment doses would range from 420,000 to 1.3 million, Regeneron said. Initial doses could be ready as soon as late summer, and the total contracted amount of drug should be manufactured in the fall, the company said.

The U.S. government will receive nearly all of its supply until the contracted amount of drug is completed, a Regeneron spokeswoman said. The company will keep a small portion of the drug for clinical trials, she said.

The contract was awarded as part of the government’s Operation Warp Speed initiative and will be funded by divisions of the Department of Health and Human Services and the Department of Defense, Regeneron said.

Regeneron was previously awarded $167.5 million in federal funding to help develop its Covid-19 drug.

Regeneron is working to set up other manufacturing arrangements, potentially with nongovernmental organizations or other pharmaceutical companies, to meet demand for the drug outside of the U.S., if it is authorized for use, the spokeswoman said.

Operation Warp Speed is a federal initiative to accelerate the development and manufacturing of drugs and vaccines for Covid-19. The government also is backing vaccines developed by Moderna Inc., AstraZeneca PLC and Johnson & Johnson.

Novavax, of Gaithersburg, Md., started testing its vaccine, NVX–CoV2373, in May in a small study in Australia, for which initial results are expected by the end of July. The new federal funding will support a pivotal, “phase 3” study with up to 30,000 participants beginning in the fall, Novavax said.

“We’ve got all the tools to allow us to get the vaccine made in large scale,” Novavax Chief Executive Stanley Erck said in an interview. “We just need data to show it works.” He said the company has seen promising results of its experimental vaccine in animal tests so far.

Novavax’s vaccine contains proteins resembling those found on the surface of the new coronavirus, which are supposed to trigger an immune response to the virus once injected. Novavax manufactures the proteins in insect cells.

Novavax, founded in 1987, has no products on the market. It is developing vaccines against influenza and other viruses.

The company’s efforts have gotten a boost from the Coalition for Epidemic Preparedness Innovations, an Oslo-based nonprofit that has pledged as much as $388 million in funding for Novavax’s coronavirus vaccine.

The CEPI funding is helping the company run clinical trials and begin ramping up production of doses. In return, Novavax has pledged to expand manufacturing outside the U.S. and to participate in a global allocation system for doses. Novavax manufactures portions of its developmental vaccines in the U.S. and Sweden, and recently acquired a manufacturing plant in the Czech Republic.

https://www.marketscreener.com/NOVAVAX-INC-58256108/news/U-S-Commits-2-Billion-for-Covid-19-Vaccine-Drug-Supplies-Update-30888921/?countview=0