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Archive - 2020

Date

May 26th

Merck and IAVI Collaborate to Develop Vaccine Against SARS-CoV-2; New Collaboration to Leverage Complementary Expertise and Capabilities with rVSV Technology to Advance Novel Vaccine Candidate

On May 26, 2020, Merck (NYSE: MRK), known as MSD outside the United States and Canada, and IAVI (https://www.iavi.org/), a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, announced a new collaboration to develop an investigational vaccine against SARS-CoV-2 to be used for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology (image depicts VSV;see larger image below) that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO® (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort. Under the agreement, IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved. “COVID-19 is an enormous scientific, medical, and global health challenge. Merck is collaborating with organizations around the globe to develop anti-infectives and vaccines that aim to alleviate suffering caused by SARS-CoV-2 infection,” said Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories.

Biomarkers for ALS Found in Early Teeth; Analysis of Tooth Data from Birth to Ten Years of Age Indicates ALS Patients Metabolize Metals Differently from Others; Amazing Finding May Spur Early Diagnosis & Aid Treatment Development

Mount Sinai scientists have identified biological markers present in childhood that relate to the degenerative and often fatal neurological disease called amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, according to a study published online on May 21, 2020 in the Annals of Clinical and Translational Neurology in May (https://onlinelibrary.wiley.com/doi/full/10.1002/acn3.51006). The open-acccess article is titled "Early Life Metal Dysregulation in Amyotrophic Lateral Sclerosis." The researchers found the markers in the teeth of patients who went on to develop ALS as adults. They used lasers to map growth rings that form daily in the teeth and discovered evidence in the growth rings formed at birth and within the first 10 years of life that patients with ALS metabolized metals differently than patients without the disease. ALS is a condition that usually manifests when someone is in his/her 50s or 60s. The cause is not known, and there is no test to predict its onset. Genetic studies have not revealed a great deal yet, and while experts believe environmental factors play a significant role in the development of the disease, there have been no clear indications of which ones. “This is the first study to show a clear signature at birth and within the first decade of life, well before any clinical signs or symptoms of the disease,” said senior author Manish Arora, BDS, MPH, PhD, Edith J. Baerwald Professor and Vice Chair of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai. “We hope in the long term, after validation of this work in larger studies, that this will lead to preventive strategies.

Merck to Acquire Themis; Merck Will Apply its Industry-Leading Vaccine Development Capabilities to SARS-CoV-2 Vaccine Program Originated by Themis and Institut Pasteur, Using Measles Vector Platform

On May 26, 2020, Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Themis, a company focused on vaccines and immune-modulation therapies for infectious diseases and cancer, announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire privately-held Themis. Themis has a broad pipeline of vaccine candidates and immune-modulatory therapies developed using its innovative measles virus (image) vector platform based on a vector originally developed by scientists at the Institut Pasteur, a world-leading European vaccine research institute, and licensed exclusively to Themis for select viral indications. In March 2020, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-19. “Building on the pioneering work of the Institut Pasteur, the Themis team has established specialized expertise that complements Merck’s own capabilities in the discovery, development, manufacturing, and global distribution of vaccines,” said Dr. Roger M. Perlmutter, MD, PhD, President, Merck Research Laboratories. “We are eager to combine our strengths both to develop an effective COVID-19 vaccine in the near term and to build a pandemic preparedness capability directed toward emerging agents that pose a future epidemic threat.” The planned acquisition builds upon an ongoing collaboration between the two companies to develop vaccine candidates using the measles virus vector platform, and is expected to accelerate the development of Themis’ COVID-19 vaccine candidate.

Promising Drug for Treatment of Severe Lung Inflammation in COVID-19 Patients: Montefiore-Einstein Scientists Lead Two Clinical Trials of Leronlimab, Humanized Monoclonal Antibody from CytoDyn

Montefiore Health System and Albert Einstein College of Medicine in the Bronx, New York, are the first sites in the nation to begin evaluating an investigational drug in two separate, FDA-approved clinical trials: one to treat mild-to-moderate cases of COVID-19, and the other to treat severely ill COVID-19 patients. The sites are hopeful that the drug, leronlimab, may prevent the “cytokine storm” that inflames and fatally damages the lungs and other organs of many COVID-19 patients. Harish Seethamraju (photo), MD, an organ transplant specialist and a member of the Department of Medicine at Montefiore and Einstein, researched leronlimab early in the pandemic and realized its potential for treating his transplant patients who had COVID-19. He then obtained “compassionate use” permission from the Food and Drug Administration (FDA) so that he and his colleagues could use leronlimab on 10 severely ill COVID-19 patients, six of them transplant patients from various organ transplant programs. “By calming the overactive immune systems of these patients, leronlimab halted the inflammation and blood clotting that are so damaging to the lungs, liver, and kidneys of severely ill COVID-19 patients,” said Dr. Seethamraju. All 10 patients had extremely high blood levels of CCL5 (also known as RANTES), which is an inflammatory molecules known as a cytokine. This is why the extreme inflammatory response is known as the “cytokine storm.” Leronlimab interfered with those CCL5/RANTES molecules, preventing them from directing immune cells to swarm into and inflame the lungs and other organs.

Migration Pattern Study Reveals an Eden for Ancient Humans and Animals

Pinnacle Point, a series of archaeological sites that overlook a now submerged section of South Africa's coastline and one of the world's most important localities for the study of modern human origins, was as much of an Eden for animals as it was for early humans. Jamie Hodgkins, PhD, Assistant Professor of Anthropology at the University of Colorado Denver, and her team drilled ancient herbivore teeth to find that many local animals stayed put in the ecologically rich ecosystem, which may explain why humans flourished there, too. Their study was published in a Quaternary Science Reviews special issue: The Palaeo-Agulhas Plain: a Lost World and Extinct Ecosystem this month (link to in-press article below). The title of the article is “An Isotopic Test of the Seasonal Migration Hypothesis for Large Grazing Ungulates Inhabiting the Palaeo-Agulhas Plain.” Home to some of the richest evidence for the behavior and culture of the earliest clearly modern humans, the submerged shelf called the Palaeo-Agulhas Plain (PAP) once formed its own ecosystem. Co-author Curtis Marean, PhD, Arizona State University, has worked with teams of scientists for decades to reconstruct the locale back into the Pleistocene, the time period that spanned from 2.6 million to 11,700 years ago. In this study, the researchers looked specifically at antelope migratory patterns at Pinnacle Point. This series of cave sites that sit on the modern South African coast offers archaeological materials from humans who were living and hunting there back to 170,000 years ago. "During glacial cycles, the coastal shelf was exposed," said Dr. Hodgkins. "There would have been a huge amount of land in front of the cave sites. We thought it was likely that humans and carnivores were hunting animals as they migrated east and west over the exposed shelve."

May 25th

Novavax Initiates Phase 1/2 Clinical Trial of COVID-19 Vaccine; Vaccine Contains Antigen Derived from SARS-CoV-2 Spike Protein, and Includes Novavax’ Patented Saponin-Based Matrix-M™ Adjuvant

On May 25, 2020, Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX CoV2373 includes Novavax’ proprietary Matrix M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020. “Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID 19 pandemic,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.” The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX CoV2373, both adjuvanted with Matrix M and unadjuvanted. The trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix M and without. The Phase 2 portion is expected to be conducted in multiple countries, including the United States, and would assess immunity, safety, and COVID 19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVX CoV2373 during the pandemic.

May 24th

CytoDyn to Hold Conference Call Tuesday, May 26, to Provide Updates on Leronlimab for COVID-19 (Phase 2, 3, & eIND), Cancer (Metastatic Triple-Negative Breast Cancer, Phase 2 for 22 Solid Tumor Cancers), HIV (BLA, Monotherapy), NASH, GvHD, and MS

CytoDyn Inc.(OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, has announced that Nader Pourhassan, PhD, President and Chief Executive Officer, and Jacob Lalezari, MD, Chief Science Officer, will host an investment community conference call on Tuesday, May 26, 2020, to provide a comprehensive update on several recent clinical and regulatory developments. Management will dedicate approximately 30 minutes to address questions from analysts and investors. Date of the Conference Call: Tuesday, May 26, 2020, Time: 1:00 pm PDT / 4:00 pm EDT. Dial-In: 877-407-2986 US / 201-378-4916 International. A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download, and install any necessary software. The webcast can also be accessed via the following link: https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/38.... A replay of the conference call will be available until June 26, 2020. To access the replay, interested parties may dial 877-660-6853 (US) / 201-612-7415 (international) and enter conference identification number 13702767.

[CytoDyn press release] [CytoDyn]

May 22nd

Findings on Mechanism for Intestinal Inflammation May Offer Targets for Treating Ulcerative Colitis, Crohn’s Disease, and Similar Conditions; Results Show Two-Thirds of IBD Patients Have Low Cyld Protein; Cyld Inhibits Formation of Inflammasomes

Ulcerative colitis (UC) and Crohn’s disease are marked by runaway inflammation in the gut that permanently damages the intestines, but why inflammation becomes excessive in patients with these conditions is unclear. A new study led by researchers from the University of Texas (UT) Southwestern, published online on May 18, 2020 in Nature Immunology, offers clues to the mechanism behind this phenomenon, providing several new potential targets to treat these often devastating conditions. The article is titled “Deubiquitination of NLRP6 Inflammasome by Cyld Critically Regulates Intestinal Inflammation.” Approximatley 1.6 million Americans suffer from these and other inflammatory bowel diseases (IBDs). While a variety of medications are used to treat these conditions, including corticosteroids, immunomodulators, and biologics, up to a third of patients do not respond to these drugs, and the medications often lose efficacy over time for those who do respond, says Venuprasad Poojary (photo) (https://profiles.utsouthwestern.edu/profile/189208/venuprasad-poojary.html), PhD, Associate Professor of Internal Medicine and Immunology at UTSW. New medications are urgently needed to help patients avoid invasive treatments such as surgeries. But efforts to develop pharmaceuticals for these conditions have been stymied because the mechanisms behind chronic gastrointestinal inflammation aren’t well understood, Dr. Poojary says. To help flesh out this mechanism, Dr. Poojary and his colleagues started by focusing on a single gene called Cyld, which previous studies have shown is often mutated in patients with various IBDs.

Austrianova & Cells for Cells Announce Publication of Peer-Reviewed Article on Novel Method to Produce Stem Cell Exosomes

On May 21, 2020, Austrianova (http://www.austrianova.com) and Cells for Cells (http://www.c4c.cl/) announced that the companies, and their academic partners, have just jointly published a ground-breaking, peer-reviewed, scientific publication on a novel, cost- and time-saving method to generate extracellular vesicles (EVs) from encapsulated mesenchymal stem cells (MSCs). These EVs are known to mediate many of the therapeutic effects of stem cells. The authors show that Austrianova’s proprietary Cell-in-a-Box® encapsulation technology can be used to produce and deliver EVs from encapsulated MSCs, as demonstrated using Cells for Cells’ proprietary MSCs. The article, which was co-authored with academic partners at the University of the Andes, Chile, and the University of Veterinary Medicine, Vienna, Austria, was published online on May 21, 2020 in Frontiers in Pharmacology (https://www.frontiersin.org/articles/10.3389/fphar.2020.00679/full). The open-access article is titled “Semipermeable Cellulose Beads Allow Selective and Continuous Release of Small Extracellular Vesicles (sEV) from Encapsulated Cells.” Currently, EVs have to be purified from cell culture conditioned media using tedious, costly, and time-consuming protocols that are difficult to perform under Good Manufacturing Practices (GMP) conditions. The Cell-in-a-Box® encapsulation technology allows efficient enrichment of EVs at high concentration because they are released from the encapsulated cells via the semipermeable pores, which selectively enable the release of small particles, but not of the MSCs. Moreover, Cell-in-a-Box® provides 3D culture conditions for the MSCs.

May 21st

Three Eminent Columbia University Medical Center Researchers Elected to National Academy of Sciences

On April 27, 2020, it was announced that prominent Columbia University Iriving Medical Center researchers Angela Christiano, PhD, Molly Przeworski, PhD, and Lorraine S. Symington, PhD, had been elected to the National Academy of Sciences in recognition of their distinguished and continuing achievements in original research. Dr. Przeworski was also elected this month to the American Academy of Arts & Sciences, which recognizes and celebrates excellence of scientists, artists, scholars, and leaders in the public, non-profit, and private sectors. The National Academy of Sciences announced the election of Dr. Christiano, Dr. Przeworski, and Dr. Symington, with 143 other new members (http://www.nasonline.org/news-and-multimedia/news/2020-nas-election.html). Dr. Christiano (https://www.genetics.cumc.columbia.edu/profile/angela-christiano-phd) is the Richard and Mildred Rhodebeck Professor of Dermatology and Professor of Genetics and Development at Columbia University Vagelos College of Physicians and Surgeons. She is also Vice Chair of Research in the Department of Dermatology. Dr. Christiano's research has focused on understanding the genetic and molecular mechanisms that underlie inherited skin and hair disorders in humans. Her longstanding research program has been focused on determining the genetic and immunologic mechanisms underlying alopecia areata, an autoimmune form of hair loss. Her laboratory’s research has identified potential therapeutic targets for this disorder, including JAK inhibitors that are now in widespread clinical development by several large pharmaceutical companies and will likely represent the first class of FDA-approved drugs for alopecia areata.