Candidate: Antiviral therapy based on company’s novel nanomedicines platform.
Type: Broad-spectrum virus-binding ligand: “It is like a ‘Venus-Fly-Trap’ for the virus,” says Anil R. Diwan, PhD, president and executive chairman.
Status: Diwan stated September 3 at a presentation during the LD 500 investor conference that the company was close to declaring a clinical candidate for treating patients infected with SARS-CoV-2.
In July, NanoViricides said it saw “excellent” safety and tolerability in a mouse model for three drug candidates it is developing against SARS-CoV-2. Three different dosage levels (low, medium, and high) of the candidates, and vehicle control, were administered to separate groups of mice intravenously, 16 mice per group. The candidates were safe and well tolerated, thereby allowing for further development towards a treatment for SARS-CoV-2, according to the company.
The candidates tested in the safety/tolerability study previously showed “strong” effectiveness against lung infection in a lethal lung infection model in rats by hCoV-NL63, which uses the same ACE2 receptor as SARS-CoV-2, and which the company said was a good surrogate model for therapeutics development against SARS-CoV-2, NanoViricides added.
NanoViricides said May 12 it has developed two drug candidates showing “very high” antiviral effectiveness in cell culture studies against multiple coronaviruses. The unnamed candidates were tested against two unrelated coronaviruses that cause human disease—hCoV-NL63 and hCoV-229E, which causes seasonal common colds in humans. NanoViricides added that it plans to study its’ candidates’ effectiveness against SARS-CoV-2, and perform animal studies for safety/toxicology.
A week earlier, NanoViricides said it signed a Confidential Disclosure Agreement with “a leading pharmaceutical company in the Asian region” to explore collaborating on the company’s COVID-19 program.
In March, NanoViricides said it completed the synthesis of “a number of” nanoviricide drug candidates for cell culture testing a few weeks after identification of virus-binding ligands, a result of the company tapping into its inventory of novel custom chemicals, including a polymer backbone that was previously manufactured in multi-kilogram quantities.
NanoViricides confirmed in January that it was developing a COVID-19 treatment, stating that it “already found some lead candidate ligands in its chemical library” that can bind to the SARS-CoV spike protein just as it binds to cognate receptor angiotensin converting enzyme type 2 (ACE2).
The company’s technology relies on copying the human cell-surface receptor to which the virus binds, and making ligands that chemically attach to a nanomicelle, to create a nanoviricide®. When a virus comes in contact with the nanoviricide, the nanomicelle polymer is designed to fuse with the virus lipid envelope. The company said it has started preparing for testing of potential candidates in cell cultures against “low-threat” coronaviruses, including ones that use the ACE2 receptor, in its own BSL-2 virology laboratory at its Shelton, CT, campus.
NanoViricides added that it is working on developing collaborations to advance its COVID-19 program should an effective drug candidate be identified. If initial work suggests a potential for developing a successful antiviral, NanoViricides said in a Form 10-Q quarterly report filed February 24, it will pursue a license allowing use for coronaviruses from the license-holder of its technology TheraCour, whose 90% owner is NanoViricides president and chairman Anil Diwan, PhD.
NanoViricides also said it acquired and expanded two low-threat circulating coronaviruses in its BSL-certified virology lab, and has already expanded them to enable testing of drug candidates. One coronavirus, NL63, uses the same ACE2 receptor on human cells as SARS-CoV-2, although it does not cause a similarly severe disease in humans. If the test candidates show effectiveness in the cell culture studies against coronaviruses, the company reasons, that would provide a strong rationale for expecting they would be effective against SARS-CoV-2.
NanoViricides added that it also successfully developed antiviral drug testing assays based on cell culture infection of low-threat coronaviruses in the BSL2 lab—a feat accomplished in a few weeks due to the expertise of senior virologist Brian Friedrich, PhD.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: