US NIH licenses to C-TAP
In May 2022, under the auspices of WHO’s COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool signed two licensing agreements with the United States National Institutes of Health (NIH) for the development of 11 innovative therapeutics, early-stage vaccines and diagnostic tools for COVID-19.
The NIH licensing agreements where assessed by the C-TAP Technical Advisory Group (TAG), the final report is available here.
List of technologies offered to C-TAP by NIH and licenses:
The 11 technologies in C-TAP listed below, including full text of licensing agreements:
1. A VSV-EBOV-Based Vaccine (Vaccine Candidate)
Technology Holder: United States National Institutes of Health (NIH)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NIAID researchers, using a rhesus macaque study model, have taken the existing federally approved vaccine against Ebola virus (brand name Ervebo) and modified it to also protect against SARS-CoV-2, the virus that causes COVID-19. Ervebo uses recombinant vesicular stomatitis virus (VSV)—which is typically not harmful to people—to deliver an Ebola virus protein in a vaccine to generate immunity. The same research group that helped develop Ervebo has added an immune-generating protein from SARS-CoV-2 that provided protection in its macaque model. This is one of several examples of how NIAID scientists are testing the safe and cost-effective VSV delivery method in pre-clinical animal models to introduce proteins that generate protection from different viruses.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
2. ACE2 Dimer construct (Research Tool for Drug Development)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NIAID scientists developed a plasmid encoding human ACE2 dimers (two copies of ACE2 that are joined together). ACE2 is the protein on the surface of human cells to which the spike protein of SARS-CoV-2 must bind to infect cells. This research tool can be used in studies testing the binding of spike protein probes to ACE2 and for selecting and isolating antibodies generated against SARS-CoV-2. This tool has been used widely by scientists to study COVID-19 and can be used to study other viruses that bind to ACE2.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
3. Detection of SARS-CoV-2 and other RNA Virus (Diagnostic)
Technology Holder: United States National Institutes of Health(NIH) - National Eye Institute (NEI)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NEI researchers discovered a technique for isolating SARS-CoV-2 from patient samples that increases yield and safety while reducing cost and prep time. Key to the method is a chelating agent called Chelex 100 resin made by the company Bio-Rad that preserves SARS-CoV-2 RNA in patient samples. The RNA prep method inactivates the virus, making positive samples safer for lab personnel to handle. Once extracted, the RNA is amplified to detectable levels using reverse transcription PCR (RT-qPCR), a widely used lab technique.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
4. High-Throughput Diagnostic Test (Diagnostic)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Environmental Health Sciences (NIEHS)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: As part of the NIH Rapid Rapid Acceleration of Diagnostics (RADx) program, NIEHS researchers developed a genetic sequencing-based test that can combine thousands of biological patient samples to test them for SARS-CoV-2 infection and forecast each patient’s COVID-19 risk in a single run, helping to overcome time constraints. The method, which detects both the virus and the patient’s active genes directly from their swabs, can permit monitoring of at-risk individuals.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
5. Newcastle Disease Virus-Like Particles Displaying Prefusion-Stabilised Spikes (Vaccine Candidate)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology:NIAID researchers designed an investigational virus-like particle (VLP) vaccine for COVID-19. VLP vaccines use virus proteins to form a non-infectious particle that mimics a virus particle but does not replicate. For this vaccine, scientists combined proteins from Newcastle disease virus (which primarily infects poultry) and stabilized SARS-CoV-2 spike proteins. The vaccine candidate induced robust immunity against SARS-CoV-2 in animal models.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
6. Parainfluenza virus 3 based vaccine (Vaccine Candidate)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology:NIAID researchers have developed nasal spray vaccine candidates against COVID-19 primarily intended for infants and young children. The vaccines use a viral vector to express the stabilized SARS-CoV-2 spike protein immunogen. The viral vector is a live but weakened chimeric virus consisting of a bovine parainfluenza virus backbone with certain proteins from human parainfluenza virus type 3 (HPIV3). These nasal spray vaccines are expected to induce durable and broad systemic and respiratory mucosal immunity against SARS-CoV-2, and against childhood respiratory infections caused by HPIV3.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
7. Prefusion spike proteins (Vaccine Development)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NIAID scientists and their academic collaborators invented a molecular engineering approach for stabilising the spike protein of any coronavirus. The spike protein enables coronavirus particles to infect human cells. The strategy, based on previous related research on HIV and respiratory syncytial virus (RSV), involves locking the spike protein into a prefusion conformation, or shape. Stabilising coronavirus’ spike proteins makes them potent and precise immunogens for use in vaccines. NIH was issued a patent for this invention, which covers specific mutations to stabilise pre-fusion coronavirus spike proteins. The SARS-CoV-2 spike protein was stabilised using this patented molecular engineering approach. NIH has licensed this pivotal technology to various companies worldwide for use in their COVID-19 vaccine products.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
8. Pseudotyping Plasmid (Research Tool for Vaccine Development)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NIAID scientists developed a plasmid encoding spike proteins of SARS-CoV-2 variants. This research tool can be used to make pseudoviruses, which are harmless proxy viruses. Because SARS-CoV-2 is a potentially lethal and airborne virus, it must be handled in high-containment laboratories (Biosafety Level 3) that require special airflow, ventilation and decontamination procedures. Research on SARS-CoV-2 countermeasures can be conducted more expeditiously by using pseudoviruses in standard Biosafety Level 2 laboratories.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
9. RNASEH-Assisted Detection Assay for RNA (Diagnostic)
Technology Holder: United States National Institutes of Health (NIH) - National Cancer Institute (NCI)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NCI researchers developed a diagnostic methodology that can detect specific RNA sequences in less than 3 hours and does not require the expensive thermocycler instrument needed for PCR tests. The technology uses low-cost reagents and has potential for point-of-care applications for detection of cellular or viral RNA.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
10. Structure-Based Design of Spike Immunogens (Research Tool for Vaccine Development)
Technology Holder: United States National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NIAID scientists designed a SARS-CoV-2 spike protein immunogen for use in COVID-19 vaccines. The immunogen includes specific mutations designed to induce antibodies that can bind to SARS-CoV-2 and prevent immune evasion.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.
11. Synthetic humanised llama nanobody library and use (Research Tool for Drug and Diagnostic Development)
Technology Holder: United States National Institutes of Health (NIH) - National Center for Advancing Translation Sciences (NCATS)
License: Worldwide, non-exclusive and transparent license available here.
C-TAP categorisation after WHO technical pre-assessment: Category II
Description of the technology: NCATS scientists have built a library of antibodies called synthetic nanobodies to rapidly identify novel therapeutics. The library will help speed the identification and development of nanobodies into preclinical evaluation and clinical applications. The library’s diversity will increase the likelihood of identifying nanobodies against new SARS-CoV-2 variants, as well as future pandemic threats as they emerge. The researchers evaluated the library against the SARS-CoV-2 spike protein, which the virus uses to infect cells. They found that many types of nanobodies could block the virus spike protein, and the viral activity.
C-TAP invites interested developers anywhere in the world to express their interest in obtaining a sublicence for any of these technologies by submitting an e-mail to C-TAP-NIH@medicinespatentpool.org providing as much detail as possible as to what the developer intends to do with a sublicence.