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Exosome Diagnostics, a Bio-Techne Brand, Has Published Review Article on Exosome-Based Liquid Biopsies in Cancer in “Annals of Oncology” Journal

On February 11, 2021, Bio-Techne Corporation (NASDAQ:TECH) announced that Exosome Diagnostics, a Bio-Techne brand, has recently published a review article entitled “Exosome-Based Liquid Biopsies in Cancer: Opportunities and Challenges” (Yu, W et al.), in Annals of Oncology (https://www.annalsofoncology.org/article/S0923-7534(21)00103-4/fulltext). This review, published online on February 3, 2021, provides unique insight into liquid biopsies and the field of exosomes in the context of other liquid biopsy approaches such as cell-free DNA (cfDNA) and circulating tumor cell (CTC) analysis. The exosome field has gone through a rapid growth phase in parallel with the increasing attention over the potential of liquid biopsies. Despite recent progress of liquid biopsies for late-stage cancers, there remains a need to improve both the accuracy and utility of these tests, especially in earlier-stage cancers. This will likely require a combination of approaches that exploit biomarkers released through different processes. Exosomes are released from living cancer cells as an active metabolic process, and carry RNA, DNA, and proteins. The open-access article describes how the use of the multi-analyte component of exosomes either alone or in combination with other types of liquid biopsies will be an important tool to overcome limitations with many of the current liquid biopsies, including low signal-to-noise ratio. The inadequacies of tissue biopsy paired with the paradigm shift to molecular analysis, have driven increasing interest in the molecular profiling of biofluids, also known as "liquid biopsy." This approach offers a significant step forward because of its less invasive nature, lower cost, and real-time insights into tumor status.

Bats & Pangolins in Southeast Asia Harbor SARS-Cov-2-Related Coronaviruses, New Study Reveals

While the World Health Organization (WHO) continues its mission to Wuhan, China, investigating the origin and early transmission of SARS-CoV-2, a new study led by scientists from Duke-NUS Medical School, Singapore, and Chulalongkorn University, Thailand, shows that SARS-CoV-2-related coronaviruses (SC2r-CoVs) are circulating in animals as far away as Thailand. The study, published online on February 9, 2021 in Nature Communications, reported that high levels of neutralizing antibodies against the virus were present in both bats and pangolins found in the Southeast Asian country. The study further indicates that more SC2r-CoVs are likely to be discovered in the region. Southeast Asia with its large and diverse bat populations may be a more likely hotspot for such viruses. "This is an important discovery in the search for the origin of SARS-CoV-2, which was made possible by rapid application of cutting-edge technology through transparent international collaboration," said Supaporn Wacharapluesadee, PhD, from the Thai Red Cross Emerging Infectious Diseases Health Science Centre, Faculty of Medicine, Chulalongkorn University, Bangkok Thailand. The open-access Nature Communications article is titled “Evidence for SARS-CoV-2 Related Coronaviruses Circulating in Bats and Pangolins in Southeast Asia.” In the study, the team examined Rhinolophus bats in a Thai cave. SARS-CoV-2 neutralizing antibodies were detected in bats of the same colony and in a pangolin at a wildlife checkpoint in Southern Thailand. "Our study extended the geographic distribution of genetically diverse SARS-CoV-2-related coronaviruses from Japan and China to Thailand over a 4,800-km range. Cross-border surveillance is urgently needed to find the immediate progenitor virus of SARS-CoV-2," said Dr.

Experimental Antiviral Proves Effective at Preventing & Treating COVID-19 in Mouse Model Containing Human Lung Tissue; Scientists Also Demonstrate That Endogenous Corona Viruses in Bats Can Likely Move Directly to Humans Without Adaptation

Using a new research model containing human lung tissue, scientists at the University of North Carolina (UNC)-Chapel Hill showed that the broad spectrum, experimental drug EIDD-2801 proved effective at preventing and treating SARS-CoV-2 infection. Publishing their work online on February 9, 2021 in Nature, scientists at the UNC School of Medicine and UNC Gillings School of Global Public Health found that the orally administered experimental drug EIDD-2801 halts SARS-CoV-2 replication and prevents infection of human cells in a new in vivo lab model containing human lung tissue. The Nature article is titled “SARS-CoV-2 Infection Is Effectively Treated and Prevented by EIDD-2801.” Separate phase 2 and 3 clinical trials are ongoing to evaluate EIDD-2801 safety in humans and its effect on viral shedding in COVID-19 patients. The number of new COVID-19 cases continues to rise in many parts of the world, with the highest incidence in the United States. Although some highly efficacious vaccines have been authorized for emergency use, it may take considerable time to reach target vaccination levels needed for herd immunity due to the logistics of vaccine manufacturing, shipping, storage, and distribution as well as public acceptance. Also, SARS-CoV-2 variants have emerged which appear to have increased transmissibility and have added more challenges to ensure vaccine viability. Therefore, alternative treatments and preventive approaches that can be widely and rapidly implemented are urgently needed to curb the risk for COVID-19-related hospitalization and death in multiple settings including nursing homes and long-term care facilities.

Researchers Identify New Molecular Mechanism Related to Severe Anaphylaxis; Mutation in KARS Gene Linked to Life-Threatening Reaction to Paper Wasp Venom

Anaphylaxis is a systemic allergic reaction that can affect the skin, the gastrointestinal tract, the respiratory system, and the cardiovascular system. The most severe form of anaphylaxis is anaphylactic shock, which features hypotension and can cause death. This reaction can have several causes, such as allergic reactions to food, medicines, or insect venom. The molecular mechanisms that cause the severity of these kinds of reactions is still unknown. In a study led by researchers at the University of Barcelona (UB) and IDIBAPS (August Pi i Sunyer Biomedical Research Institute), researchers analyzed the mutation of a gene detected in a patient who suffered from recurrent anaphylactic shocks caused by the allergy to paper wasp venom (Polistes dominula). The results, published online on December 29, 2020 in the Journal of Allergy and Clinical Immunology, revealed a new molecular mechanism that can control the degree of severity in an anaphylactic reaction (see image below). The study was led by UB and IDIBAPS researchers Margarita Martín, PhD, and Rosa Muñoz-Cano, MD, PhD. Both are members of the Asthma, Allergic and Adverse Reactions Network (ARADyAL) of the Carlos III Institute. The article is titled “Mutation in KARS: A Novel Mechanism for Severe Anaphylaxis.” Researchers carried out the biochemical, functional, and structural characterization of mutations in the KARS gene (which codes for lysyl-tRNA synthetase, LysRS), detected in the patient. “The study combines clinical data from the patient with severe anaphylaxis and carrier of a mutation in the KARS gen, with biochemical, functional, and structural data that show an anomalous function of the LysRS protein, coded by this gene,” notes Dr. Martín.

Expression of Specific Genes in Placenta May Help Predict Baby's Risk for Schizophrenia; Further Confirmation of Placenta's Role in Early Life Development of Schizophrenia Lays Groundwork for Possibly Eventually Preventing the Mental Disorder

A genetic scoring of schizophrenia-related genes in the placenta can predict the size of a baby's brain at birth and its rate of cognitive development, which, dependent on other factors, may lead to schizophrenia later in life, according to a study published on February 8, 2021 in PNAS. Researchers at the Lieber Institute for Brain Development (LIBD) and the University of North Carolina (UNC) School of Medicine used MRI scans at UNC from newborns and cognitive development measures for the first two years of life to uncover the finding. They noted that this was most significant in males. The open-access PNAS article is titled “Placental Genomic Risk Scores and Early Neurodevelopmental Outcomes.” "By identifying the specific genes activated in the placenta that appear to be unique for schizophrenia risk, we have zeroed in on a set of biological processes that could be targeted to improve placental health and reduce schizophrenia risk," says Daniel R. Weinberger, MD, CEO & Director of the LIBD. "To date, prevention from early in life has seemed unapproachable, if not unimaginable, but these new insights offer possibilities to change the paradigm." Dr. Weinberger notes that that most of the children with higher schizophrenia gene scoring in the placenta will not develop schizophrenia because other genetic and environmental factors will compensate for these placental effects later in development. But, he says, in principle, individuals who have other schizophrenia genetic risk factors and early life complications during pregnancy may not be able to compensate and will develop the illness, particularly if they are males.

Synthetic Polymer Activates STING (Stimulator of Interferon Genes), Which Boosts the Innate Immune System to Fight Cancer

A new nanoparticle-based drug can boost the body’s innate immune system and make it more effective at fighting off tumors, researchers at the University of Texas Southwestern (UTSW) have shown. Their study, published online on February 8, 2021 in Nature Biomedical Engineering, is the first to successfully target the immune molecule STING (stimulator of interferon genes) (image) (https://en.wikipedia.org/wiki/Stimulator_of_interferon_genes) with nanoparticles that can switch on/off immune activity in response to their physiological environment. The article is titled “Prolonged Activation of Innate Immune Pathways by a Polyvalent STING Agonist.” “Activating STING by these nanoparticles is like exerting perpetual pressure on the accelerator to ramp up the natural innate immune response to a tumor,” says study leader Jinming Gao (https://profiles.utsouthwestern.edu/profile/76088/jinming-gao.html), PhD, a Professor in UTSW’s Harold C. Simmons Comprehensive Cancer Center and a Professor of Otolaryngology--Head and Neck Surgery, Pharmacology, and Cell Biology. For more than a decade, researchers and pharmaceutical companies have been trying to develop drugs that target STING. Discovered in 2008, the STING protein helps mediate the body’s innate immune system--the collection of immune molecules that act as first responders when a foreign agent, including cancer DNA, circulates in the body. Research has suggested that activating STING can make the innate immune system more powerful at fighting tumors or infections. However, results from earlier clinical trials involving first-generation compounds targeting STING for activation failed to demonstrate an impressive clinical effect.

First-in-Human Clinical Trial Supports HIV Vaccine Approach by IAVI and Scripps Research; Experimental Vaccine Primes Immune System As First Stage in Production of "Broadly Neutralizing" Antibodies Directed at Difficult-to-Access Conserved Epitopes

A phase 1 clinical trial testing a novel vaccine approach to prevent HIV has produced promising results, the International AIDS Vaccine Initiative (IAVI) (https://www.iavi.org/) and Scripps Research announced on February 3, 2021. (See video summary at https://www.eurekalert.org/multimedia/pub/255392.php). Researchers reported that the vaccine showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the fast-mutating virus; the targeted response was detected in 97 percent of participants who received the vaccine. "This study demonstrates proof of principle for a new vaccine concept for HIV, a concept that could be applied to other pathogens, as well," says William Schief, PhD, a professor and immunologist at Scripps Research and Executive Director of Vaccine Design at IAVI's Neutralizing Antibody Center, whose laboratory developed the vaccine. "With our many collaborators on the study team, we showed that vaccines can be designed to stimulate rare immune cells with specific properties, and this targeted stimulation can be very efficient in humans. We believe this approach will be key to making an HIV vaccine and possibly important for making vaccines against other pathogens." Dr. Schief presented the results on behalf of the study team at the Fourth International AIDS Society HIV Research for Prevention (HIVR4P) virtual conference (https://www.hivr4p.org/) on February 3, 2021. The study sets the stage for additional clinical trials that will seek to refine and extend the approach--with the long-term goal of creating a safe and effective HIV vaccine. As a next step, IAVI and Scripps Research are partnering with the biotechnology company Moderna to develop and test an mRNA-based vaccine that harnesses the approach to produce the same beneficial immune cells.

Nasally Administered Exosomes Enriched for CD24 on Their Surface Appear to Be Quickly Effective Treatment for Moderate-to-Severe COVID-19 in Small Study in Israel

On February 6, 2021, the Jerusalem Post reported that 29 of 30 moderate-to-severe COVID-19 patients, who were administered a treatment developed by Tel Aviv’s Sourasky Medical Center (Ichilov Hospital) as part of a Phase I trial, recovered from the disease and were released within three to five days, according to a hospital statement on Friday, February 5. The 30th patient also recovered, but it took longer than five days. The Post said that the patients were given Professor Nadir Arber’s EXO-CD24 COVID-19 treatment, which is based on CD24-enriched exosomes and is meant to fight the cytokine storm that is associated with many of the world’s COVID-19 deaths. Professor Arber (photo) is Director, Health Promotion Center and Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center. CD24 is a signal transducer molecule (https://en.wikipedia.org/wiki/CD24). “This protein is located on the surface of cells and has a well-known and important role in regulating the immune system,” explained Dr. Shiran Shapira, Head of the Laboratory of Molecular Biology at the Sourasky Medical Center and who works in Professor Arber’s lab, according to the Post. Dr. Shapira has been conducting research on the CD24 protein for over two decades, i24 News reported. The EXO-CD24 COVID-19 treatment “is based on exosomes that the body is releasing from the cell membrane and uses for intercellular communication. We enrich the exosomes with the CD24 protein, which is known to play an important role in regulating the immune system," according to Dr. Shapira, i24 News reported. The Daily Mail said that Professor Arber spent years developing EXO-CD24 for the possible treatment of ovarian cancer before trialing it on coronavirus patients.

Anticancer Drug (Bevacizumab/Avastin) May Improve Outcome for Severe COVID-19 Patients

Treating severe COVID-19 patients with the anticancer drug bevacizumab may reduce mortality and speed up recovery, according to a small clinical study in Italy and China that was led by researchers at Karolinska Institutet in Sweden between February and April 2020. On average, blood oxygen levels, body temperature and inflammatory markers significantly improved in patients treated with a single dose of bevacizumab in addition to standard care. The research was published online on February 5, 2021 in Nature Communications. The open-access article is titled “Efficacy and Tolerability of Bevacizumab in Patients with Severe Covid-19.” “To reduce COVID-19 mortality, we aim to develop an effective therapeutic paradigm for treating patients with severe COVID-19,” says corresponding author Yihai Cao, MD, PhD, Professor of Vascular Biology at the Department of Microbiology, Tumor, and Cell Biology at Karolinska Institutet. “Our findings suggest that bevacizumab, plus standard care, is highly beneficial for patients with severe COVID-19 and should be considered as a potential first-line therapeutic regimen for this group.” Bevacizumab (Avastin) is a medication that has been used to treat various types of cancer since 2004. It works by slowing the formation of new blood vessels by inhibiting a growth factor known as VEGF. Many patients with severe COVID-19 have elevated levels of VEGF as well as symptoms associated with this marker, including excess fluid and disorganized blood vessels in the lungs. Against this background, the researchers designed a clinical trial to investigate the effect of combining bevacizumab with standard care for treating patients with severe COVID-19.

Missouri Researcher Studies Exosomes in Effort to Help Night-Shift Workers and to Address Various Sleep Disorders Caused by Misalignment of Biological Clocks in the Brain and Peripheral Tissues

Angel Freeman began working for University of Missouri (MU) Health five years ago. She monitors patients’ brainwaves and looks for abnormalities consistent with a stroke or seizure. Freeman works the night shift, sometimes clocking 60 hours during the week, including overtime. She said she appreciates the freedom and challenges of working nights--she and three co-workers perform without a supervisor, which pushes them to take more initiative and sharpens their skills. But she often struggles with sleep on the days she’s not working. The first day after a week of night shifts, she has an uncomfortable decision to make: If she comes home in the morning and goes to bed, she is up all night; if she stays up all day and goes to sleep at a normal time, she cannot sleep all night. The lack of sleep and general lethargy has left her without the energy to exercise, and Freeman estimates that she has gained 10 to 12 pounds this year. “I would like to say it is related to quarantine, but it’s not,” she said. Her experience is not an outlier. MU researcher David Gozal, MD, an international expert in the field of sleep medicine, said night-shift workers are more likely to suffer from insomnia, diabetes, obesity., and a wide variety of other health problems. Night shifts and other non-traditional work hours also put workers at risk for developing additional physical and mental disorders. “To be a shift worker is not a good thing [for the body to undergo regularly], yet our modern society is increasingly dependent on shift workers,” Dr. Gozal said. “If you look how things were two centuries ago, shift work was virtually non-existent,” he added. Dr. Gozal’s research on exosomes is a crucial step toward making sense of the misalignment process.

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