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FDA OKs Emergency Use of Regeneron’s COVID-19 Antibody “Cocktail”

REGEN-COV2 consists of two monoclonal antibodies, casirivimab and imdevimab, both designed to bind non-competitively to the receptor-binding domain (RBD) of SARS-CoV-2’s spike protein.

In MS, Gut Specific Immune Cells May Play a Protective Role

New research has deepened the understanding of how the gut microbiome influences multiple sclerosis (MS) flare-ups in patients. The work shows that specific gut immune cells—IgA B cells—travel to the brain during flare-ups. There, they seem to play a protective role, helping drive MS symptoms back into remission. This discovery could pave the way for new MS treatments that target the intestinal flora.

Breast Cancer Metastasis, and Chemo Resistance Gene Identified as Target for Nanoparticle-Based Therapy

University of Virginia Cancer Center researchers identified a gene that is responsible for the spread of triple-negative breast cancer to other parts of the body, and which can render the cancer. The scientists developed a nanoparticle-delivered antibody that demonstrated early indications in mice, which they hope could possibly address both TNBC metastasis, and resistance to treatment and estimate that this strategy of blocking the TRIM37 gene could benefit approximately 80% of TNBC patients.

Confidence in Clinical Protein Quantitation Begins with a New Generation of LC-MS

This GEN sponsored webinar will focus on demonstrating the capabilities of the new generation Thermo Scientific™ Orbitrap™ Exploris™ mass spectrometry platforms and how they can be capitalized to address challenging analytical experiments in the domain of protein quantitation. Moreover, our presenters will discuss the role of mass spectrometry in protein quantification with relation to anti-doping, infectious disease, and potential disease biomarker discovery.

Pfizer, BioNTech Seek Emergency Use Authorization for COVID-19 Vaccine

The companies said they will support their EUA application in part with final efficacy data they announced earlier this week showing BNT162b2 to be 95% effective in their nearly 44,000-patient Phase III trial, as well as positive safety data.

AstraZeneca-Oxford COVID-19 Vaccine Shows Positive Phase II Results

In the Phase II trial, AZD1222 induced immune responses in both parts of the immune system in all age groups, as well as at both the low and standard doses—though adults 70 years of age and older showed fewer adverse effects than participants in the two younger adult groups.

Researchers Discover Potential Link between COPD and the Gut Microbiome

Researchers at Centenary Institute, the University of Technology, Sydney, and the University of Queensland in Australia, report they have discovered a link between chronic obstructive pulmonary disease (COPD) and the gut microbiome. Their findings suggest that the gut microbiome should also be considered when looking for new therapeutic targets to treat lung disease.

Sea Squirt Microbiome Yields Compound Effective against Deadly Strain of Fungal Pathogen

Scientists at the University of Wisconsin-Madison have discovered an antifungal compound in the microbiome of a Florida Keys sea squirt, that efficiently targets potentially deadly, multidrug-resistant strains of the fungal pathogen Candida auris, without toxic side effects in mice. The scientists say the new molecule, named turbinmicin, represents the most tangible output to date, of the group's $30 million NIH grant to identify useful new antimicrobial drugs from bacteria living in overlooked environments.

CRISPR Technique Effectively Destroys Metastatic Cancer Cells in Living Animal

Harnessing CRISPR-Cas9 technology for cancer therapeutics has been hampered by low editing efficiency in tumors and potential toxicity of existing delivery systems. Scientists at Tel Aviv University describe a safe and efficient lipid nanoparticle (LNP) for the delivery of Cas9 mRNA and sgRNAs that use a novel amino-ionizable lipid.

Scientific Collaboration Using Innovative Remote Technologies

When COVID-19 started to spread across continents and become a global pandemic, biopharma manufacturers around the world faced two major challenges: (1) enter the race for treatment of the disease by participating in vaccine development and (2) avoid delays in the production of other essential therapeutics. This GEN webinar, sponsored by MilliporeSigma, presents two case studies from Europe and Latin America that demonstrate how the global teams across the M Lab™ Collaboration Center network used innovative remote technologies to overcome these challenges and meet important production timelines.

Single Cell Multiomics: Simultaneous Epigenetic and Transcriptional Profiling

Researchers can now capture both transcriptomic and epigenomic modalities simultaneously in the same single cells with Chromium Single Cell Multiome ATAC + Gene Expression. This technique removes the computational errors associated with linking separate datasets and maximizes possible readouts from precious samples.

X and Y: Synthorx Expands the Genetic Code to Create Optimized Biologics

GEN sat down with Marcos Milla, PhD, chief scientific officer, and Lauren Baker, VP of Scientific & Medical Affairs, to discuss the history and future direction of Synthorx’s Expanded Genetic Alphabet platform technology. We also covered the company’s development since its recent acquisition by Sanofi.

Gut Bacteria Trigger Immune Defense Mechanism to Protect against Viral Infections

Harvard Medical School researchers have, for the first time, described in mice how bacteria residing in the gut can protect against viral infections. Their work pinpointed a group of gut microbes—and a particular species—that trigger immune cells to release virus-repelling type 1 interferons. The studies further identified the molecule on the bacteria that unlocks the immune-protective cascade.

Novel Approach Offers Hope to Children with Brain Cancer

Newcastle University research has revealed that experts can identify the time, nature, and outcome of medulloblastoma relapse from the biology of the disease at diagnosis and the initial therapy received. Their breakthrough means doctors can tailor treatment for each individual child and improve prognosis.

Pfizer, BioNTech Report 95% Final Efficacy for COVID-19 Vaccine

That 95% efficacy rate is based on nearly twice as many COVID-19 cases as the 94 cases reported in early data released last week from the 43,538-participant Phase III trial (NCT04368728). That data showed the vaccine to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.

Advancing Neuronal Reprogramming

A current promising approach is the conversion of glial cells into neurons for the loss of neurons due to brain injury or neurodegeneration. Now, researchers at Helmholtz Zentrum München and Ludwig Maximilians University Munich (LMU) report they have manipulated mitochondria and the cell metabolism in mice and achieved a four times higher conversion rate and simultaneously increased the speed of reprogramming.

Antidepressant Sertraline Inhibits Cancer Growth by Blocking Metabolic Addiction

Studies in mice by investigators at KU Leuven have demonstrated how the antidepressant sertraline can help to inhibit the growth of cancer cells, by acting on a metabolic addiction to serine and glycine, which some types of cancers have developed to enable them to thrive.

Immune-Boosting Components Double the Effectiveness of Melanoma Vaccine Candidate in Phase II Trial

Researchers at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and colleagues, have shown that a vaccine created to prevent the recurrence of melanoma is about twice as effective when patients also receive two components immune-boosting components. The team tested the approach in a clinical trial, in patients treated using a vaccine candidate that is designed to target dendritic cells. The results showed that the addition of the small molecule, Flt3L boosted the vaccine's effectiveness at triggering the production of antibodies and T cells that can later fight melanoma. Adding the second component, poly-ICLC, also strengthened the dendritic cells' ability to promote antibodies as well as helper and killer T cells.

For Safer, More Targeted CRISPR Delivery, Shine a Light on Liposomes

A light-sensitive liposome delivery system has been developed that offers a high degree of spatial and temporal control of gene editing with the CRISPR-Cas9 system. Besides allowing targeted delivery, the modified liposomes may prove safer than viral vectors. Thus far, the LED-sensitive liposomes have been tested in cell lines and animal models. X-ray-sensitive liposomes could be useful in more ambitious applications.

COVID Driving Biopharma to Embrace Digital Tech Faster

The pandemic may have hastened its “digital transformation,” but biopharma still needs to find the best way of modernizing manufacturing processes.

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