Syndicate content

Archive

June 14th, 2020

AstraZeneca to Supply Europe with Up to 400 Million Doses of Oxford University’s Vaccine at No Profit; Company Exploring Further Additional Global Capacity to Provide Broad and Equitable Access

On June 13, 2020, AstraZeneca announced that it has reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy, and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. With today’s agreement, the IVA aims to accelerate the supply of the vaccine and to make it available to other European countries that wish to participate in the initiative. The IVA is committed to providing equitable access to all participating countries across Europe. AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The company is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic. Pascal Soriot, MBA, AstraZeneca’s Chief Executive Officer, said: “This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval. With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly. I would like to thank the governments of Germany, France, Italy, and the Netherlands for their commitment and swift response.” AstraZeneca has recently completed similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance for 700 million doses, and it agreed to a license with the Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses.

June 13th

Moderna Advances Late-Stage Development of Its Vaccine (mRNA-1273) Against COVID-19; Phase 3 study of 30,000 subjects expected to begin in July 2020 at 100 μg Dose Level

On June 11, 2020, Moderna, Inc., (Nasdaq: MRNA) a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S., and is expected to be conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease; key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. Based on the results of the Phase 1 study, the 100 μg dose level was chosen as the optimal dose level to maximize the immune response, while minimizing adverse reactions. Moderna has completed manufacture of vaccine required to start the Phase 3 study. The Company expects dosing in the Phase 3 study to begin in July. With the Phase 3 dose being finalized at 100 μg, Moderna remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Lonza.

First Map of Proinsulin’s “Social Network” Reveals New Drug Target for Type 2 Diabetes; PRDX4 Found to Play Central Role in Proper Folding of Proinsulin; May Be Target of Treatment to Preserve or Even Restore Pancreas Islet Cells in Type 2 Diabetes

Scientists at the Sanford Burnham Prebys Medical Discovery Institute in California have mapped, for the first time, the vast network of proteins that interact with proinsulin, the protein the body normally processes into insulin. The study, published in the May 2020 issue of Diabetes (https://diabetes.diabetesjournals.org/content/early/2020/05/15/db20-0245), also revealed one protein—called peroxiredoxin 4 (PRDX4)—that may be essential for proinsulin folding and insulin production. The research suggests that boosting PRDX4 levels may be a novel therapeutic approach to improving the health of people with diabetes. The article is titled “Unbiased Profiling of the Human Proinsulin Biosynthetic Interaction Network Reveals a Role For Peroxiredoxin 4 in Proinsulin Folding.” “Type 2 diabetes is a progressive condition, and, over time, the insulin-producing beta cells in the pancreas ‘burn out’ and die. Our recent work suggests that proinsulin misfolding plays a role in beta cell failure and the development of type 2 diabetes,” says Pamela Itkin-Ansari (photo) (https://www.sbpdiscovery.org/our-scientists/pamela-itkin-ansari-phd), PhD, Adjunct Associate Professor in the Development, Aging and Regeneration Program (https://www.sbpdiscovery.org/biomedical-research/programs/development-ag...) at Sanford Burnham Prebys, and senior and co-corresponding author of the study. “Our hope is that by fixing proinsulin misfolding, potentially by targeting PRDX4, we may be able to protect or even restore the health of beta cells and achieve a functional cure.”

Warburg Effect: Sugar-Tagging Helps Target Drug Compounds to Human Prostate Cancer Cells Due to Their Increased Glucose Consumption to Feed Their Chosen Glycolysis Pathway; Analog of Sea Urchin Pigment Coupled to Sugar Via Sulfur Link

Scientists of Far Eastern Federal University (FEFU) in Vladivostok, Russia, together with German and Russian colleagues, have developed a lead compound to fight chemotherapy-resistant prostate cancer. The original design came when scientists combined biologically active molecules from the chemically-modified pigment of sea urchins with glucose molecules to deliver the active drug substance into tumor cells. The Russian-German scientific paper was recognized as a best research article of the current issue of Marine Drugs. The article was published online on May 11, 2020, and is titled “Inspired by Sea Urchins: Warburg Effect Mediated Selectivity of Novel Synthetic Non-Glycoside 1,4-Naphthoquinone-6S-Glucose Conjugates in Prostate Cancer.” In their efforts in research to develop a cure for prostate cancer, the scientists decided to capitalize on the Warburg effect, which is the term used for tumor cells’ inclination to consume large amounts of "sugar,” i.e., they consume glucose compounds more intensively compared to the majority of normal cells. [Editor’s Note: The phenomenon of high sugar consumption by tumor cells is known as the Warburg effect. It results from a high glycolysis rate, used by tumors as a preferred metabolic pathway even in aerobic conditions.] The researchers believed that targeting the Warburg effect to specifically deliver sugar-conjugated cytotoxic compounds into tumor cells is a promising approach to create new selective drugs.

Novel Mechanism That Triggers a Cellular Immune Response Is Described; Clinical Trial Planned for Pancreatic Cancer

Viruses and other disease-causing microbes influence the type of immune response their hosts will develop against them. In some cases, the predominant response involves antibodies, proteins made by the immune system that specifically recognize parts of the invading microbe and mediate its destruction. In other cases, immune cells are trained to recognize the microbe and lead the attack against it. Scientists have extensively investigated the mechanisms that lead to either an antibody or a cell-mediated response, and about 10 years ago, a novel signal was suggested as the trigger of a cell-mediated response. In the current study, Baylor researchers William Decker, PhD, Matthew Halpert, PhD, Vanaja Konduri, PhD, and colleagues present comprehensive evidence that supports this phenomenon and propose a mechanism for its action. The article was published online on April 16, 2020 in the journal of the Federation of American Societies for Experimental Biology (FASEB). The FASEB article is titled “MHC Class I and II Peptide Homology Regulates the Cellular Immune Response.” Research has shown that two factors related to microbes significantly affect the type of immune response that will predominate. On one hand, are the microbial components (parts of proteins or genetic material, called pathogen-associated molecular patterns or PAMPs), and on the other hand, is the location of the microbes, whether they tend to be inside or outside cells. Cells have means to recognize PAMPs, and some cellular proteins recognize PAMPs inside cells, while others detect PAMPs outside cells. Research on viruses has shown that when viral genetic material is detected inside cells, a cell-mediated immune response develops, while the detection of viral proteins outside the cell triggers antibody-mediated responses.

International Society for Extracellular Vesicles (ISEV) Annual Meeting (#ISEV2020), Including Exosomes, Is Now VIRTUAL (July 20-22); >600 Discussions (Plenary Addresses, Panel Sessions, Oral Abstract Talks, Poster Chats, & Educational Sessions)

The International Society for Extracellular Vesicles (ISEV) annual meeting, including exosomes (https://www.isev.org/mpage/2020Program), has become the “go to” meeting for intra- and interdisciplinary cross-fertilization of extracellular vesicle (EV) and exosome science within the EV/exosome community. It also plays a pivotal role in the training of junior scientists and trainees. Please join over 800 people who have already registered for this 3-day, live-streamed, online event. You may register for this outstanding virtual meeting at https://www.isev.org/mpage/2020Registration. Instead of spending 24 hours traveling across the world, have all the latest in EV/exosome research come to you, wherever you are! You can expect a similar amount of content as you would have experienced at the face-to-face conference. #ISEVirtual offers 5 live-streamed plenary talks, 4 live “hot-topic” panel sessions, 6 educational sessions, and 146 oral talks selected from your submitted abstracts. That’s 161 talks plus more than 470 interactive 3-minute poster pitches. That’s a total of over 600 discussions on the latest developments in EV/exosome work, all completely available online. Also, as you will be used to at the face-to-face meeting, there will also be the chance to ask questions of the speakers and panelists, interact with company sponsors, and chat with other delegates via the #ISEVirtual app. And if you can’t make it on the day? Don’t worry! ALL content will be available to view at your leisure for 60 days after the event. This is the first time in ISEV history that you’ll be able to see EVERYTHING, all from the comfort of your own home, wherever you are in the world.

June 11th

CytoDyn Initiates Phase 2 Clinical Trial with Leronlimab for Treatment of NASH (Non-Alcoholic Steato-Hepatitis); Preclinical Results Demonstrated Leronlimab Effectively Inhibited Fatty Liver Development

On June 11, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced initiation of the company’s Phase 2 clinical trial for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2 trial is designed to test whether leronlimab may control the devastating liver fibrosis associated with NASH. As previously reported, the CytoDyn’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating non-alcoholic fatty liver disease (NAFLD), a common precursor to non-alcoholic steatohepatitis (NASH). These data, along with previous findings showing that leronlimab inhibits liver fibrosis, suggests the potential of leronlimab to control both the early and late stages of NASH. There are currently no U.S. Food and Drug Administration (FDA)-approved treatments for NASH and it is expected to be the number one cause of liver transplant by 2020. About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH. Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented, “We are excited to continue to advance the evaluation of leronlimab for a potential therapeutic benefit for NASH, a disease with an increasing prevalence in the U.S. Our strategic plan to execute a multi-pathway approach to exploring all potential benefits of leronlimab has led to cancer, COVID-19 and now, potentially, NASH, along with other immunologic indications.” This trial is a 90-patient, multi-center, randomized, double-blind, placebo-controlled Phase 2 three-arm study of the safety and efficacy of leronlimab in adult patients with NASH.

CytoDyn Has Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication; Primary End-Point Announcement Is Next

On June 11, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the company has met its 75 patient enrollment for its Phase 2 clinical trial entitled “Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19.” This Phase 2 trial evaluates clinical improvement of several symptoms over a 14-day period, including changes in multiple clinical baseline metrics after days 3, 7, and 14. CytoDyn expects the evaluation clinical patient data to be available two weeks after the last patient is enrolled. Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75. Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn, commented, “Based upon our understanding of clinical outcomes from severe and critically ill COVID-19 patients, we are guardedly optimistic about the potential results from the mild-to-moderate patients. Furthermore, CytoDyn will do an interim analysis of patient data in the Phase 3 trial for severe and critically ill COVID-19 patients and we hope to have these important results in 2 to 3 weeks.” CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country. SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious.

Two Publications to Appear in Science (Monday, June 15) Highlighting Potential of Regeneron’s REGN-COV2 Anti-Viral Antibody Cocktail to Protect Against SARS-CoV-2 Escape Mutants

On June 11, 2020, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the journal Science has accepted for publication two papers describing the creation of Regeneron’s novel two-antibody cocktail, REGN-COV2, and its potential to diminish risk of viral escape by effectively binding to the virus's critical spike protein in two separate, non-overlapping locations. The publications will be available online on Monday, June 15. On June 11, 2020, Regeneron also announced that REGN-COV2 has entered human clinical trials (https://investor.regeneron.com/news-releases/news-release-details/regene...). "Our work inventing novel antibodies has shown that individual antibodies, no matter how good, are likely not enough against the devastating virus that causes COVID-19 and the ways it seeks to 'escape' being neutralized," said George D. Yancopoulos, MD, PhD, Co-Founder, President, and Chief Scientific Officer at Regeneron. "The concept that drug cocktails can prevent viral escape has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses. We now report the fundamental realization that this can also be true for antibody-based therapies, supporting our hope that our REGN-COV2 cocktail can be a potent weapon against COVID-19, while preventing the emergence of viral drug-resistance." The first Science article paper, entitled "High-Throughput Effort Using Both Humanized Mice and Convalescent Humans Yields SARS-CoV-2 Antibody Cocktail," describes Regeneron's parallel efforts using both humanized VelocImmune® mice and blood samples from recovered COVID-19 patients to generate a large and diverse collection of antibodies targeting multiple different regions of the critical receptor-binding domain (RBD) of the SARS-CoV-2 spike protein.

Regeneron Begins First Clinical Trials of Anti-Viral Antibody Cocktail REGN-COV2 for the Treatment and Prevention of COVID-19; Two-Antibody “Cocktail” Designed to Help Protect Against Viral Escape

On June 11, 2020, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced initiation of the first clinical trial of REGN-COV2, its investigational dual antibody cocktail for the prevention and treatment of COVID-19. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure (such as healthcare workers or first responders), and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate). The placebo-controlled trials will be conducted at multiple sites. "We have created a unique anti-viral antibody cocktail with the potential both to prevent and treat infection, and also to preempt viral “escape,” a critical precaution in the midst of an ongoing global pandemic," said George D. Yancopoulos, MD, PhD,, Co-Founder, President and Chief Scientific Officer of Regeneron. "REGN-COV2 could have a major impact on public health by slowing spread of the virus and providing a needed treatment for those already sick – and could be available much sooner than a vaccine. The antibody cocktail approach may also have long-term utility for elderly and immuno-compromised patients, who often do not respond well to vaccines. Ultimately, the world needs multiple solutions for COVID-19, and the innovative biopharma industry is collectively working hard to help as many people as possible with a variety of complementary approaches." Regeneron scientists evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune® mice, which have been genetically-modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.