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May 24th, 2020

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.

Weizmann Scientists Demonstrate Self-Synthesis & Self-Assembly of 30S Subunit of Ribosome

As the cell's protein factory, the ribosome is the only natural machine that manufactures its own parts. That is why understanding how the machine itself is made, could unlock the door to everything from understanding how life develops to designing new methods of drug production. An intensive, long research effort at the Weizmann Institute of Science in Israel has now demonstrated the self-synthesis and assembly of the small subunit of a ribosome-the 30S subunit--on a surface of a chip. Professor Roy Bar-Ziv, PhD, and Staff Scientist Dr. Shirley Shulman Daube, PhD, of the Institute's Chemical and Biological Physics Department have been working on this project for around seven years. One of the main challenges to such a project is the sheer number of different molecules the cell must produce to make the subunit: The core is a long strand of RNA, and 20 different proteins must be attached to the strand. These get organized by the weak chemical forces between the protein molecules and the RNA--repelling at some points and attracting at others--and the whole structure thus relies on the proper manufacture and organization of each component. Add to that another six proteins that are not part of the structure, but act as chaperones to assist in the assembly. That makes at total of a least 27 different genes--one to encode the RNA and each protein component or chaperone--that must work together to make the subunit. Together with postdoctoral fellow Michael Levy, PhD, who led the current study, and research student Reuven Falkovich, the team produced the subunits on tailored chips that Dr. Bar-Ziv has developed in his lab. Ultimately, they succeeded in mimicking the natural process of synthesizing the parts and assembling them into the ribosome subunits.

AstraZeneca Receives Over $1 Billion in US BARDA Investment to Support Development & Production of Oxford mRNA Vaccine (AZD1222); First Agreements to Supply 400 Million Doses, with Total Capacity of 1 Billion Doses Through 2020 and into 2021

OnMay 21, 2020, AstraZeneca announcedthat it is advancing its ongoing response to address the unprecedented challenges of COVID-19, collaborating with a number of countries and multilateral organizations to make the University of Oxford’s potential vaccine (an adenovirus vector carrying mRNA coding for the virus Spike protein; the vaccine was first called ChAdOx1 nCoV-19, and is now known as AZD1222) widely accessible around the world in an equitable manner. The Company has concluded the first agreements for at least 400 million doses and has secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020. AstraZeneca aims to conclude further agreements supported by several parallel supply chains, which will expand capacity further over the next months to ensure the delivery of a globally accessible vaccine. AstraZeneca today received support of more than $1 billion from the US Biomedical Advanced Research and Development Authority (BARDA) for the development, production, and delivery of the vaccine, starting in the fall. The development program includes a Phase III clinical trial with 30,000 participants and a pediatric trial. In addition, AstraZeneca is engaging with international organizations such as the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the World Health Organization (WHO), for the fair allocation and distribution of the potential vaccine around the world. AstraZeneca is also in discussions with governments around the world to increase access. Furthermore, AstraZeneca is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.

Researchers May Have Uncovered Achilles Heel of Viruses; Many Inhibit Host STING Protein to Thwart Immune Response; Efforts to Block This Inhibition & Activate STING May Aid Efforts to Fight Variety of Viral Infections, Including Herpes & Coronaviruses

Viruses have an exceptional ability to circumvent the body's immune system and cause diseases. The majority of people recover from a viral infection such as influenza, although the current COVID-19 pandemic demonstrates how dangerous viruses can be when there is no effective vaccine or treatment. Professor and virologist Søren Riis Paludan, PhD, from the Department of Biomedicine at Aarhus University, Denmark, has been leading a research partnership amongst Aarhus University, the University of Oxford, and the University of Gothenburg, which has brought us one step closer to understanding the tactics used by viruses when they attack the immune system. Dr. Paludan heads a laboratory that carries out research into the immune system's ability to fight diseases caused by the herpes virus, influenza viruses, and, most recently, SARS-CoV-2, a coronavirus. In the new study, which has just been published online on May 8, 2020 in the scientific journal Journal of Experimental Medicine, the researchers have investigated how the herpes simplex virus circumvents the immune system in order to cause infections of the brain. This is a rare infection, but one which has a high mortality rate among those who are affected. The open-access JEM article is titled “HSV1 VP1-2 Deubiquitinates STING to Block Type I Interferon Expression and Promote Brain Infection.” "In the study, we found that the herpes simplex virus is capable of inhibiting a protein in the cells, known as STING (image)(stimulator of interfereon genes) (https://en.wikipedia.org/wiki/Stimulator_of_interferon_genes), which is activated when there is a threat.

New Device Quickly Detects Lithium Ions in Blood of Bipolar Disorder Patients; Advance Should be Boon for Bipolar Patients Taking Lithium

Lithium carbonate is used for treating bipolar disorder, a mental health condition that causes extreme mood swings. But using this drug requires caution because the therapeutic concentration range of lithium ions in blood is narrow and close to the toxic range. Japan’s Pharmaceuticals and Medical Devices Agency warns doctors to regularly examine lithium ion concentration levels in the blood of patients given the drug. However, existing examination methods require a large amount of blood, special operations, and large, expensive devices. These methods can be performed only by certain testing laboratories. The present study led by Takeshi Komatsu, a doctoral student at Hokkaido University’s Graduate School of Chemical Sciences and Engineering, and Professor Manabu Tokeshi, PhD, of the University’s Faculty of Engineering was conducted to address this problem by developing a user-friendly, low-cost method. The study was published online on April 14, 2020 in ACS Sensors. The open-access article is titled “Paper-Based Device for the Facile Colorimetric Determination of Lithium Ions in Human Whole Blood.”The researchers succeeded in making a colorimetric paper-based device that allows point-of-care testing in one step. The device consists of two paper-based elements linked to each other: a blood cell separation unit and a colorimetric detection unit. High-purity cotton blotting paper and a blood cell separation membrane, which are both available on the market, are used as a substrate for each unit, respectively. Hydrophobic ink was coated on the device to allow easy liquid handling.

May 20th

DNA Vaccines Protect Against SARS-CoV-2 in Rhesus Macaques, Science-Published Study Reports; Companion Study Suggests Initial Infection with SARS-Cov-2 Protects Against Re-Infection Following Repeat Exposure to the Virus

With nearly 5 million confirmed cases globally and more than 300,000 deaths from COVID-19, much remains unknown about SARS-CoV-2, the virus that causes the disease. Two critical questions are whether vaccines will prevent infection with COVID-19 and whether individuals who have recovered from COVID-19 are protected against re-exposure to the virus. Now, a pair of new studies, led by researchers at Beth Israel Deaconess Medical Center (BIDMC), suggests the answer to these questions is yes, at least in animal models. Results of these studies were published on May 20, 2020 in Science. The titles of the two open-access articles are “DNA Vaccine Protection Against SARS-CoV-2 in Rhesus Macaques,” and “SARS-CoV-2 Infection Protects Against Rechallenge in Rhesus Macaques.” “The global COVID-19 pandemic has made the development of a vaccine a top biomedical priority, but very little is currently known about protective immunity to the SARS-CoV-2 virus,” said senior author Dan H. Barouch (photo), MD, PhD, Director of the Center for Virology and Vaccine Research at BIDMC. “In these two studies, we demonstrate in rhesus macaques that prototype vaccines protected against SARS-CoV-2 infection and that SARS-CoV-2 infection protected against re-exposure.” In the first study, the team found that six candidate DNA vaccines--each formulation using a different variant of the key viral protein--induced neutralizing antibody responses and protected against SARS-CoV-2 in rhesus macaques. Dr. Barouch and colleagues, who began working toward a COVID-19 vaccine in mid-January when Chinese scientists released the SARS-CoV-2 genome, developed a series of candidate DNA vaccines expressing variants of the spike protein, the part used by the virus to invade human cells and a key target for protective antibodies.

INOVIO's COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models; Article Published in Nature Communications

On May 20, 2020, INOVIO (NASDAQ:INO) announced the publication of the preclinical study data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2. The open-access study was published in the peer-reviewed journal Nature Communications and is titled, "Immunogenicity of a DNA Vaccine Candidate for COVID-19" and authored by INOVIO scientists and collaborators from The Wistar Institute, the University of Texas, Public Health England, Fudan University, and Advaccine. Kate Broderick (photo), PhD, INOVIO's Senior Vice President of R&D and the Team Lead for COVID-19 vaccine development, said, "These positive preclinical results from our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA medicines platform, but also build on our previously reported positive Phase 1/2a data from our vaccine against the coronavirus that causes MERS, which demonstrated near-100% seroconversion and neutralization from a similarly designed vaccine INO-4700. The potent neutralizing antibody and T cell immune responses generated in multiple animal models are supportive of our currently on-going INO-4800 clinical trials." INO-4800 targets the major surface antigen Spike protein of SARS-CoV-2 virus, which causes COVID-19 disease. The studies demonstrated that vaccination with INO-4800 generated robust binding and neutralizing antibodies, as well as T cell responses in mice and guinea pigs.