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Kriya Therapeutics Establishes Operational Manufacturing Plant

The facility will focus on process development and scalable cGMP production of gene therapies.

Acupuncture Tames Cytokine Storm, Improves Mouse Survival Via Specific Neural Pathways

A team of researchers led by neuroscientists at Harvard Medical School used acupuncture to dampen potentially fatal cytokine storm inflammatory responses in mice with experimentally induced systemic inflammation. The studies showed how treatment activated different signaling pathways that triggered either a pro-inflammatory or an anti-inflammatory response, dependent upon where on the body acupuncture was applied, and the timing and intensity of treatment.

Tumor Growth Slowed Down by Restricting Amino Acid Metabolism

Over the past decade, scientists have been adopting strategies that limit the availability of serine and glycine—amino acids that are critical for cancer progression—as potential cancer therapies. Now researchers from the University of California, San Diego, and Salk Institute for Biomedical Studies have adopted a new approach by focusing on serine metabolism. Their new approach has led to a decrease in tumor progression in mice and highlights the complexity of metabolism.

U.S. Raises to $2.5B toward Its “Warp Speed” Bet on Moderna’s COVID-19 Vaccine

NIAID and Moderna are now conducting an approximately 30,000-patient Phase III trial of mRNA-1273, for which enrollment is on track to be completed in September, Moderna said.

Malaria Treatment May Be Found by Targeting the Host

An assessment of host erythrocyte signaling during infection with Plasmodium falciparum, the causative agent of malaria, suggests that targeting enzymes from the human host, rather than from the pathogen itself, could offer effective treatment. The study provides a proof of concept that human signaling kinases represent attractive targets for antimalarial intervention.

Immunotherapy Boosted to Eliminate Cancers in Mouse Model

Studies by researchers at Washington University School of Medicine in St. Louis have shown how the effects of a standard immunotherapy drug can be enhanced by blocking a protein called TREM2, resulting in the complete elimination of tumors. The results point to a potential new way to render immunotherapy effective for greater numbers of cancer patients. Investigators suggest that if further preclinical work yields positive results, it may be possible to move into clinical trials relatively easily because there are already a number of antibodies available.

Up-to-$1B KaNDy Acquisition Hits Bayer’s Sweet Spot of Women’s Health

The deal would add to Bayer’s pipeline KaNDy’s lead compound NT-814, a potential first-in-class, oral once-daily, dual mechanism neurokinin-1,3 receptor antagonist that is expected to launch a Phase III trial next year.

Digital Biopharma Operations Need Better PAT and Staff Training

Advanced analytical methods and improved staff training programs are needed to take full advantage of digital manufacturing.

Plasmid Manufacturer Scales Up Production Capacity to Serve New Therapeutics

Aldevron plans to open a new 189,000 sq. ft facility in spring 2021 to add to their existing 70,000 sq. ft of manufacturing space.

Label-Free, Non-Destructive Analytic Technique for Biological Applications

Fourier transform infrared spectroscopy helps researchers know when a batch of antibodies is ready for further processing.

Potential Prion Disease Treatment Found in Antisense Therapy

Prion disease is rapidly fatal and currently untreatable. A new study that examined the efficacy of an antisense therapy approach against prion disease in mice presented promising results for a potential treatment. Using a set of prion protein-targeting antisense oligonucleotides (ASOs), the team demonstrated therapeutic benefit including a reversal of disease and significantly extending the survival of mice, laying the basis for full scale clinical development.

Fast Tracking Drug Therapies for Viral Infections and Cancer

For the past 50 years, scientists have used man-made, synthetic, and nucleoside analogues to create drug therapies for diseases that involve the cellular division and/or the viral reproduction of infected cells. These diseases include hepatitis, herpes simplex, HIV, and cancer. Scientists at Simon Fraser University and international collaborators' new technique, can create new nucleoside analogues months earlier than with the previous method, paving the way for quicker drug discoveries.

FDA Approves Guardant Test as First Pan-Cancer Liquid Biopsy, CDx for AstraZeneca’s Tagrisso

The approval makes Guardant360 CDx the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) to identify patients with specific EGFR alterations.

Gene Therapy: What’s Up With AAV?

Join us on this GEN Live webinar, sponsored by PerkinElmer, as we discuss the state of gene therapy, the rise of AAV, and the safety issues that need to be addressed going forward.

Heart Disease Therapeutics Could Arise from Newly Discovered Mutation

New work led by Carnegie's Meredith Wilson and Steven Farber identifies a potential therapeutic target for clogged arteries and other health risks that stem from an excess of harmful fats in the bloodstream. Their findings are published by PLOS Genetics.

Synthetic Compound May Serve as Potential Anticancer Agent

Chemists at Scripps Research were able to create a synthetic version of a natural compound's complex structure in nine steps. The chemists believe the compound is in the same class as several FDA-approved anticancer drugs, with some improved properties.

COVID-19 Patients Exhibit Early Antibody Signatures Potentially Predictive of Death or Recovery

Researchers at the Ragon Institute of MGH, MIT and Harvard, and the University of Washington School of Medicine, identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, and those who didn’t survive the disease. The researchers used a systems serology technology to generate a detailed profile of SARS-Co-2-specific humoral responses in hospitalized patients. The results indicated that individuals who survived COVID-19 infection and those who died exhibited antibody responses that were primarily directed against different SARS-CoV-2 proteins.

FDA Accepts Biogen’s BLA for Alzheimer’s Candidate Aducanumab

If approved, aducanumab would be the first therapy indicated for reducing clinical decline in people with Alzheimer’s disease, and would also be the first therapy to tie improved clinical outcomes to removing amyloid beta.

Biomarker for Heart Disease Captured by Novel Nanoparticle Technology

The new University of Wisconsin-Madison method—nanoproteomics—effectively captures and measures various forms of the protein cardiac troponin I, or cTnI, a biomarker of heart damage currently used to help diagnose heart attacks and other heart diseases. The scientists maintain that an effective test of cTnI variations could one day provide doctors with a better ability to diagnose heart disease, the leading cause of death in the U.S.

Cancer Mutation in Tasmanian Devils Shed Light on Human Tumors

Researchers at Washington State University and the Fred Hutchinson Cancer Research Center in Seattle, found a single genetic mutation that leads to reduced growth of the transmissible cancer called devil facial tumor disease in Tasmanian devils. While findings hold the most immediate promise to help Tasmanian devils, their results may one day translate to human health.

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