We’re back with our second installment of Excedr’s monthly news roundup. We’ve tailored this roundup to focus on cutting-edge research and study, as well as COVID-19 updates, FDA approvals, and more. We also have a monthly news roundup focused on fundraising, M&A, IPOs, and more for those of you who love keeping up with the nitty-gritty of the financing side of biotech.
Our love for science means we’re always on the lookout for interesting publications and articles, but we know keeping up can be difficult at times. We hope splitting up the two newsletters makes finding what matters most to you as easy as possible.
Interested in our other blog posts? We’ve got informative pieces on different lab equipment and more, check it out!
COVID-19 has pushed scientists and researchers to approach studies and clinical trials much differently. Many believe a shift in how information is shared will benefit the science community, opting for transparency and real-time data sharing around the globe. As the world grapples with the virus, researchers continue to work around the clock, in hopes of finding an effective and safe vaccine as quickly as possible. While we dedicate a portion of this monthly roundup to COVID-19, we’ll also be highlighting some significant publications in biotechnology, including genomics, neuroscience, and more.
AstraZeneca resumes UK COVID-19 trial after participant develops severe reactions
Earlier this month, AstraZeneca had to pause its COVID-19 trials in the UK due to a suspected adverse reaction in a participant. The company released a statement four days later that it would resume the trials, but only in the UK. AstraZeneca is also conducting trials in the U.S., Brazil, and South Africa. They have not disclosed the illness that occurred in the participant who was in the vaccine arm of the trial, although their CEO, Pascal Soriot, told a group of investors that the symptoms matched up with transverse myelitis, a serious condition that causes inflammation in the spinal cord and can lead to a number of serious problems. Although it isn’t uncommon for trials to be put on pause, this is the second time such a hold has been placed on the UK trial. STAT News reported the statement released by AstraZeneca.
Moderna to receive reports of vaccine efficacy by as early as November
The CEO of Moderna is expected to know by November whether or not their COVID-19 vaccine works, FiercePharma reports. The company was able to reach human testing for its vaccine candidate in record time and is expecting efficacy data come November. Although they are behind Pfizer and BioNTech, it looks like they are beginning to catch up, as this tortoise-and-the-hare story unfolds. Along with the expectations that they could see results as early as November, Moderna also released their trial protocol for their phase 3 study, meaning a successful Q4 may be in store.
Pfizer and Moderna publish clinical trial protocols amid growing concerns
Pfizer and Moderna, both considered front-runners in the race for a COVID-19 vaccine, published their Phase 3 clinical trial protocols earlier this month amid concerns over political interference. Pressure from academia and industry observers prompted the two companies to provide transparency regarding their clinical trials in attempts to calm a growing skepticism over vaccine efficacy. While it is typical for pharmaceutical companies to withhold details in order to gain a competitive edge, many believe the secrecy needs to be dropped, especially when it comes to anything regarding COVID-19, reports Fiercebiotech.
Measuring wastewater to understand infection dynamics in community
A recent study published in Nature Biotechnology earlier this month highlighted the effectiveness of measuring SARS-CoV-2 RNA concentrations in wastewater. The measurements were taken in New Haven, Connecticut, and focused on the primary sewage sludge of the metropolitan area during the COVID-19 outbreak in the spring. By measuring the concentrations, community infection dynamics could be determined, adjusting for the time lags between clinical test results and hospitalizations. The immediate results from wastewater testing were able to provide advanced notice of infection dynamics, accounting for delays between specimen collection and the reporting of test results.
Historic FDA approvals could happen in Q4, here’s what to look out for
The last three months of 2020 are going to end up being among the most important in the FDA’s history, according to Biopharma Dive. It’s very possible that two of the leading vaccine makers will be seeking emergency approval this fall, meaning the Food and Drug Administration will be in for an extraordinary series of decisions. They face an unprecedented amount of pressure to approve a vaccine as early as possible, without enough data to go off of. President Trump has gone so far as to publicly pressure the regulator to approve a vaccine before the coming election this November, further complicating the urgency behind finding a solution to the global pandemic. Among the issues surrounding the possible approval for a SARS-CoV-2 infection vaccine is the FDA’s business-as-usual, which includes a number of experimental therapies scheduled for a tentative approval. All in all, Q4 will be an incredibly important last stretch to this insane year.
While research efforts remain focused on the coronavirus outbreak, other developments have quietly continued. With interest and investment in basic research and R&D continuing to grow, many projects carry on.
New X-Ray microscopy technique sheds light on neural circuits
Researchers at Harvard Medical School, Boston’s Children Hospital, and the European Synchrotron Radiation Facility (ESRF) have demonstrated a new x-ray microscopy technique that could help accelerate efforts to map neural circuits and even the brain itself. The findings were reported in Nature Neuroscience earlier this month, describing how x-ray holographic nano-tomography (XNH) “can be used to image large volumes of mouse brain and fruit fly nervous tissue at high resolutions.” The researchers believe that the technique will aid in the discovery of neural circuits in the human brain, laying a foundation for understanding neurological disorders. Harvard Medical School covers the techniques capabilities and advantages over current approaches based on electron microscopy.
Colorectal cancer post-treatment blood test outperforms previous detection methods
Clinical Genomics (CG) has announced the publication of the NOVA clinical trial in the Cancer Epidemiology, Biomarkers & Prevention Journal. The publication is said to further enforce the performance of COLVERA, a “breakthrough blood test for the clinical presence of colorectal cancer (CRC) recurrence in patients amenable to curative intent”. Clinical Genomics published the findings with the intent of further proving the importance of the blood test for post-treatment CRC patients. Furthermore, the data support the claim that COLVERA was shown to be more sensitive than a carcinoembryonic antigen (CEA). The study’s lead author, Benjamin Musher, M.D., is quoted stating “COLVERA outperformed CEA in detecting recurrences of colorectal cancer after definitive therapy. COLVERA therefore represents an important advance over the current standard of care for colorectal cancer surveillance.” This is big news for Clinical Genomics, as a more sensitive assay during a patient’s post-treatment observation could lead to improved patient outcomes in recurring colorectal cancer.
Can modular synthesis enable molecular innovation and combat antibacterial resistance?
An article published in Nature earlier this month covers a study by Li et al. that provides examples of how modular chemical synthesis can enable molecular innovation. The study could lead to a bolder pursuit of modular, complex small molecules as engines for pushing the boundaries of chemical biology and drug discovery. The study is an attempt at tackling a dilemma that is centuries in the making, the development of resistance to antibiotics by microorganisms. While these organisms had plenty of time to develop mechanisms of resistance to antibiotics, humans do not have the pleasure to take as much time to figure out a solution. Li et al. hope their report on modular synthesis of a specific family of antibiotics, streptogramin, has provided access to certain derivatives that could not have previously been prepared.
Epigenetic variations may be able to identify factors in genetic diseases, more present in the human genome than previously thought
Reported by GenomeWeb, researchers led by Andrew Sharp at the Icahn School of Medicine set out to determine the pervasiveness of epivariatons, or epigenetic variations, by analyzing methylation profiles of more than 23,000 people. Their study, reported in the American Journal of Human Genetics earlier this month, uncovered nearly 4,500 epivariations, some of which affect the promoters and expression of genes associated with human disease. These findings have led them to believe that epivariations are an overlooked contributor to genetic disease, and are more common in the human genome than previously thought. Moreover, the researchers believe that epivariatons present in patients with overt genetic disease will be identified as causative factors in some conditions.
How CRISPR can help support new therapeutic strategies
Gene-editing technology is moving along swiftly, despite how difficult it can be to stay on course due to various reasons, such as intellectual property issues. Nonetheless, the progress in gene editing, which has come about from innovative workarounds, brings a lot of hope to people who live with and suffer from incurable genetic diseases. Companies have developed a number of novel CRISPR compositions that “can deliver higher specificity, efficiency, and fidelity.”Many of the remedies being produced by this research tool are moving forward into the clinic as component suppliers expand their product offerings. GEN News provides insight on biotech companies making the most of their options.
Psychedelics show great potential in treating serious psychiatric conditions
A recent discovery published in Cell and reported by ScienceDaily has shown how psychedelics bind to key brain cell receptors. For the first time, scientists were able to solve “the high-resolution structure of these compounds when they are actively bound to the 5-HT2A receptor (HTR2A) on the surface of brain cells.” The discovery has led to the exploration of more precise compounds that could eliminate hallucinations while providing strong therapeutic effects. One such psychedelic compound, psilocybin, was granted breakthrough status by the FDA to treat depression. The co-senior author Bryan L. Roth, MD, PhD states “millions of people have taken these drugs recreationally, and now they are emerging as therapeutic agents.” While the publication does not provide the whole picture, the researchers are confident that further study will prove fruitful, showcasing the therapeutic benefits of certain psychedelic compounds in future treatments.