The nationwide and global response to the COVID-19 pandemic is relying on numerous research initiatives around the country to find treatments, vaccines, and more. Below we highlight just some of the many exciting initiatives involving our alliance members. Working on other efforts? Let us know!
Academia
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Johns Hopkins University: Arturo Casadevall and collaborators at Johns Hopkins and beyond have worked around the clock to develop a convalescent serum therapy to treat COVID-19 using blood plasma from recovered patients. If early promising studies on the therapy done in China are confirmed by U.S. trials, thousands of survivors might soon line up to donate their antibody-rich plasma.
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University of Pennsylvania Perelman School of Medicine: Penn Medicine is a participant in the Phase I safety and immunogenicity clinical trial of INO-4800, a DNA vaccine designed to prevent COVID-19 infection. Approved by the U.S. Food and Drug Administration (FDA) on April 6, Phase I clinical testing of the vaccine started immediately, with first dosing planned to begin in up to 40 healthy volunteers the same day.
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Northwestern University McCormick School of Engineering: NSF awarded a $200,000 Rapid Response Research grant to scientists at Northwestern University who are working on a self-sanitizing face mask that would deactivate viruses on contact. Led by Jiaxing Huang, materials professor at Northwestern's McCormick School of Engineering, the scientists are developing an "accessory" embedded with virus-killing agents. It would attach to an existing mask and render virus particles inert before they make contact with the air. The device could be a sheet or sticker that could be wrapped or glued to the outside of a mask.
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University of California at San Francisco: Researchers have initiated a study to test the effectiveness of 120 available antibody test kits (or serology tests) to examine potential immunity to SARS-CoV2. Blood tests for antibodies can compliment the standard swab test and determine whether a patient is in the early or late stages of the infection.
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University of Texas at Austin: A team at UT is investigating drug delivery methods that can repurpose existing drugs into more effective forms. The team first focused on the antiviral niclosamide, which is more potent than chloroquine, lopinavir and remdesivir. The research team has developed novel drug delivery technologies to overcome its current delivery limitations. The team has increased the drug’s solubility and is currently performing oral studies.
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Baylor College of Medicine: One of 50 sites participating in a clinical trial for treatment of patients with severe COVID-19 pneumonia with the drug Tocilizumab (TCZ). It will be tested alongside placebo in a randomized, double blind, controlled study. This drug is being tested because it could potentially target the body’s severe “cytokine storm” response to the virus.
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Stanford University, UCSF, CZI BioHub: A collaboration is planning to study the spread of COVID-19 in the Bay Area. Researchers will recruit 4,500 Bay Area residents who previously came up negative for the virus, testing them one time each month with both a serological test that detects antibodies and a polymerase chain reaction (PCR) test, which detects the presence of infection. Using viral genome data, the research teams hope to glean insight on the chain of transmission within the area as well as any evidence about how that the virus traveled into the community from outside the region.
Industry, Academia and Government Partnerships
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AbCellera, Lilly, and DARPA: AbCellera and Eli Lilly and Company announced they have entered into an agreement to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera's rapid pandemic response platform, developed under the DARPA Pandemic Prevention Platform (P3) Program, and Lilly's global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies.
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AdvaMed, STERIS, 3M, HHS: The Advanced Medical Technology Association released the following statement from President and CEO Scott Whitaker on STERIS’s Emergency Use Authorization (EUA) from FDA for certain V-PRO® Low Temperature Sterilization Systems to allow health care providers to decontaminate N95 respirators on site: “ . . . The ability to quickly decontaminate protective masks . . . truly is a game changer for our heroes on the front lines treating patients with COVID-19. STERIS’s fast, innovative work, in partnership with 3M, is yet another example of the medical technology community mobilizing to save lives. We appreciate the FDA’s quick work to authorize this leap forward in our fight against the coronavirus.”
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Alnylam & Vir Pharmaceuticals: Alnylam and Vir are attempting to decrease the amount of available ACE2. On March 4, Vir and Alnylam expanded an existing collaboration to include development and commercialization of RNA interference (RNAi) therapeutics against SARS-CoV-2, which has since been expanded again. They will leverage Alnylam’s advances in lung delivery of novel conjugates of siRNA, the molecules that mediate RNAi, with Vir’s infectious disease expertise and capabilities. They are focused on developing siRNAs Alnylam recently identified that target highly conserved regions of coronavirus RNAs. Essentially, Vir and Alnylam’s overall approach is to silence a protein that causes a disease that is the result of an overproduction of the protein. In the case of COVID-19, the focus is on silencing the ACE2 receptor, with the rationale that without it, the virus won’t be able to infect cells.
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BD and BioMedomics: These partners have released a new point-of-care serology test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection.
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Johnson & Johnson and BARDA: Johnson & Johnson has teamed up with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine against coronavirus. J&J is pooling money and resources with BARDA in an attempt to accelerate the progress of a vaccine candidate into phase 1 development. Having selected a lead candidate from the constructs it began working on in January, J&J has teamed up with BARDA to provide the resources needed to move the vaccine forward quickly. The partners have committed more than $1 billion to novel coronavirus vaccine R&D. J&J plans to start testing its COVID-19 vaccine in humans by September at the latest, post data by the end of 2020, and go on to land an emergency use authorization early next year. In trying to hit that timeline, very short by historical standards, J&J will commit personnel and infrastructure around the world to the vaccine program. Other teams at J&J will work in parallel to ensure there is the capacity to make the vaccine widely available if it clears the tests of its safety and efficacy.
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NIAID, Gilead Sciences, Northwestern University, University of Chicago Medicine, Cedars-Sinai Medical Center (many other sites enrolling/enrolled): A large-scale research effort sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) is putting remdesivir to the "gold standard" test in medicine: a controlled clinical trial. Patients hospitalized with COVID-19 are being randomly assigned to receive either infusions of remdesivir or a placebo, in addition to standard care, including breathing support. 75 sites worldwide to [are planned to] participate.
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Pfizer, BioNTech: In this collaboration, BioNTech’s COVID-19 mRNA vaccine program, BNT162, will be accelerated by the development, regulatory, and commercial capabilities that Pfizer offers. Both companies will implement multiple research and development sites, including in the United States and Germany, to house the activities identified by the collaboration agreement.
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Regeneron and U.S. Department of Health and Human Services: Regeneron used its proprietary VelociSuite technologies to produce fully human antibodies against the novel coronavirus from genetically edited mice. This time it took Regeneron a little over a month from when it expanded a collaboration with the U.S. Department of Health and Human Services (HHS) to focus on the novel coronavirus to isolate all those neutralizing antibodies for further screening. Regeneron is preparing for clinical-scale production with the goal of making hundreds of thousands of low prophylactic doses per month by the end of summer. Regeneron is also working with the HHS’ Biomedical Advanced Research and Defense Authority to ramp up manufacturing capacity even further.
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Sanofi & GlaxoSmithKline: Sanofi and GSK announced that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the U.S. GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.
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Vanderbilt University Medical Center, AstraZeneca: Vanderbilt University Medical Center is teaming up with academic, governmental, and corporate partners in an unprecedented, fast-tracked global effort to develop antibody-based treatments to protect people exposed to the 2019 novel coronavirus disease, COVID-19. Researchers from the Vanderbilt Vaccine Center (VVC) have rapidly responded to this outbreak by building a comprehensive “toolkit” to identify and analyze antibodies isolated from the blood of survivors for their ability to neutralize SARS-CoV-2. “Our goal is to prepare antibodies for human clinical trials by this summer,” said James Crowe, MD, director of the Vanderbilt Vaccine Center.