NanoViricides Searches For Coronavirus Treatment In Ligand Library: 'A Humanitarian Thing To Do'

Anil Diwan typically runs on six hours of sleep, but he’s no stranger to two-week stretches of three hours or less. He’s used to working weekends and having little leisure time between full-time fatherhood of two kids and full-time leadership at NanoViricides Inc NNVC. 

“I am not a hired CEO,” Diwan, the founding president, chairman and CEO of NanoViricides, told Benzinga. “I am the scientist that started this, and I want to see this dream to completion.”

But these days, he’s busier than usual: “It’s just work, work, work,” he said.

That’s because, in the downtime of typical candidate development, NanoViricides is rushing to complete a new project — a treatment for the novel coronavirus.

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COVID-19 Effort

NanoViricides aims to “take the load off the immune system” by luring and trapping viruses with chemicals structured like cell receptors. Its portfolio of ligands is broad spectrum, capable of attacking various indications, and easily synthesized in large quantities.

It’s somewhere in this stash of antiviral nanocides, which includes chemicals explored for the 2014 MERS and 2002 SARS outbreaks, that the company suspects it has a treatment for COVID-19.

Drawing upon its resources, NanoViricides has condensed a typically six-month process of discovery and synthesis into just three weeks, the CEO said. 

“We had a library of chemicals built already and could do modeling and come up with the ligand quickly,” Diwan said. “We were able to go real quickly to go into the initial systems.”

The lab is now testing its antiviral substances and performing cell culture assays to identify top candidates for animal studies. It will then select one to advance to human trials, he said. 

Typically, the testing cycle takes about two years, and then scale and optimization take another two years and additional tests last another 18 months. Submitting for FDA approval takes even longer. NanoViricides is declining to take the testing shortcuts — like skipping animal trials — that are being considered by peers, Diwan said. 

“What is the best path for society or institutes to take is to do anti-coronavirus testing and take it to the next step. If there is an animal model, do it there, and then say we can condense this whole optimization scheme, which is a five-year scheme, into, let’s say, three months,” Diwan said, citing precedents in the FDA’s relaxation of diagnostic testing procedures.

NanoViricides has completed molecular risk modeling and asked a partner to come up with an animal model of the infection to initiate 10-day lab testing.

“In three to four weeks, we will know which candidate is the most viable drug candidate,” Diwan said.

NanoViricides' Coronavirus Objectives

NanoViricides’ coronavirus program was driven first by empathy rather than profit, the CEO said. 

“We got into it because we thought obviously it was a humanitarian thing to do,” Diwan said. “At that time, it was still in Wuhan only and we never expected it to escalate here either ... three out of 100 people dying is not an acceptable situation.”

His primary goal is to bring down the case-fatality ratio.

“That’s not going to be done by vaccine," Diwan said. “Vaccines are not going to be available for a very long time. Drugs can be developed much faster, and drugs are needed for treatment."

The government should have "pushed for drugs before they pushed for vaccines," he told Benzinga. 

Novel Drug Development At NanoViricides 

At this juncture, NanoViricides is working solo on COVID-19, although it has reached out to the National Institutes of Health and the U.S. Army Medical Research and Development Command, the latter of which has been a past collaborator.

With its current manufacturing capacity and a payroll expansion, the company estimates that it could treat about 2,000 patients every two weeks. That’s enough, by Diwan’s calculations, to address the critical cases.

“That still gives you a substantial amount of runway in the context of the United States,” he said. “It doesn’t give you a substantial amount of runway if the entirety of India goes down.”

To scale to meet greater need, the lab would have to collaborate with pharmaceutical manufacturers, and the scaling process may take time, he said. 

If NanoViricides does enter large-scale production, the program would incur direct costs. NanoViricides has not yet assigned that cost but anticipates support from government funds or equity raises, Diwan said. 

In the meantime, low costs are being absorbed by the shingles program.

“Instead of letting people sit at their desk while they’re waiting for other things to happen when they are doing chemistry — usually there is one hour or two hours when you are waiting for something to happen — we just tell them to do something toward this program,” Diwan said.

The Lead NanoViricides Candidate

The hope is that a coronavirus cure would have broad commercial application and supplement NanoViricides’ existing portfolio, Diwan said.

“What we think is that it will even be applicable to the common cold.”

On a normal day, NanoViricides is advancing its lead program for herpes simplex virus 1 and 2. The program could address eight identified indications, which could yield a $10 to $20 billion market size, the CEO said, adding that it's a conservative estimate.

“When an effective drug is introduced against a viral disease, the market size expands,” Diwan said.

The herpicide programs are now transitioning from animal to human testing.

The lab is also crafting a treatment for shingles — a disease marked by a vaccine shortage, no treatment, and outbreaks among increasingly younger patients.

At current production rates, Diwan said he suspects it would take 10 to 15 years to vaccinate the U.S. population.

For this reason, he anticipates a “tremendous amount of need” for a shingles treatment and cites analyst estimates for $1 billion in potential market penetration. NanoViricides is preparing an IND for the candidate and expects clinical trials to begin shortly, he said. 

Nanoviricides is advancing smaller programs to address HIV, influenza, dengue fever and chicken pox. If the company succeeds on all projects, it stands to penetrate a $40 billion to $100 billion annual market, according to in-house estimates.

“[We’re] limited just by the financial resources and human resources that we can deploy,” Diwan said.

“Once we get past in one drug into clinical trials and we show efficacy in clinical trials, I believe the whole platform at that point will gain recognition and we will expand into all the indications we have already been working on.”

NanoViricides plans to support its clinical trials with its own manufacturing facilities before collaborating with peers on scale and commercialization.

This Company Made Back Pain Therapies. Now It's Out For A COVID-19 Drug.

NanoViricides' Financial Health

In the last few years, the pharmaceutical industry saw an exodus from the viral infection space, and investments in such programs began to dry up. Now, Diwan said NanoViricides has been “inundated with offers for purchase of equity.”

In the last year, the company raised more than $8.5 million in common stock offerings, completed a reverse stock split and received a $2-million loan commitment.

Diwan said the company has more than a year’s worth of cash on hand, but the board is discussing diverse methods to raise money, including a direct stock sale into the market. He suggested a shelf registration would be filed in the coming days.

“We believe we have access to the equity markets primarily because of the current threat,” Diwan said. “People are looking at investing in infectious diseases companies.”

Of course, M&A isn’t off the table, either.

“Big pharma has been keeping track of us for a long time, since about 2007,” he said.

NanoViricides remains in contact with those companies, the CEO said.

“I believe that what has happened with this pandemic is going to change that [antiviral] picture again, and I believe they are going to start exploring opportunities to acquire that space that they have lost. So I think we are in a very good place in that sense.”