NanoViricides ramps up SARS-CoV-2 drug development efforts
NanoViricides, a US-based developer of antiviral therapies based on a novel nanomedicines platform, has been targeting the novel coronavirus SARS-CoV-2 that causes COVID-19. The company has completed the synthesis of a number of nanoviricide drug candidates for testing just a few weeks after identification of virus-binding ligands.
The company previously confirmed that it is working on a drug to treat SARS-Cov-2 virus infections, and had already completed the important milestone of finding potential virus-binding ligands that mimic the ACE2 interaction with SARS-CoV (2002) using molecular modelling. SARS-CoV-2 is closely related to SARS-CoV, and uses the same human cellular receptor. The company has now also completed the next two milestones — namely synthesis of test candidates and development of anti-CoV assays for testing them.
Viruses are known to escape antibody drugs and vaccines via mutations, but the NanoViricides platform technology enables development of a drug that a virus is unlikely to escape by mutation. This is because the company develops biomimetics that are designed to interfere with the virus binding to its cognate cellular receptor, and are further capable of disabling the virus from binding to cells. Coronaviruses mutate less rapidly than other RNA viruses such as influenza and HIV.
NanoViricides has now acquired and expanded two different, low-threat circulating coronaviruses in its BSL2 certified virology lab, and has already expanded them to enable testing of drug candidates. One of these coronaviruses, NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2, although it does not cause a similar severe disease in humans. Another coronavirus being tested uses a different but somewhat related receptor (in terms of biophysics).
Investigating against both of these strains will allow the company to examine which of the test candidates has more broad-spectrum effectiveness. If its test candidates are effective against these cell culture studies against coronaviruses, then that would provide a strong rationale that they may be expected to be effective against the current SARS-CoV-2.
The company has also developed antiviral drug testing assays based on cell culture infection of the low-threat coronaviruses viruses. Development of an assay to test the effectiveness of a drug candidate is an important milestone in the drug development process — one which was completed in just a few weeks due to the extensive experience and expertise in medium throughput drug testing antiviral assays development of its senior virologist. Testing of drug candidates against these coronavirus strains is expected to begin shortly in the BSL2 virology lab.
The company acknowledges that it does not presently have any collaboration established for further testing of its drug candidates against SARS-CoV-2; it is currently working to establish such collaborations. There is also no assurance that successful results against these forms of coronavirus will lead to similar results against SARS-CoV-2, nor that successful results against SARS-CoV-2 will lead to successful clinical trials or a successful pharmaceutical product — which is true of every drug development effort against SARS-CoV-2 at present.
Meanwhile, the US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) stating that serving science company Thermo Fisher Scientific’s diagnostic test can be used immediately by CLIA high-complexity laboratories in the US to detect nucleic acid from SARS-CoV-2, but not for any other viruses or pathogens.
The authorised test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time to result also includes time for sample preparation and instrument analysis.
“The authorisation of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” said Thermo Fisher Chairman, President and CEO Marc N Casper.
“In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease.”
The EUA test is optimised for use on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide. The test has not been FDA cleared or approved; however, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition in the case when the secretary of the US Department of Health and Human Services (HHS) declares a public health emergency.
Thermo Fisher currently has 1.5 million tests available to ship under the EUA label and expects to quickly ramp up to reach 2 million tests per week. Based on availability of raw materials and an installed instrument base, the company expects to scale production up to 5 million tests per week during the month of April. The available tests will initially be distributed to approximately 200 labs in the US and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access.
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