NanoViricides™ is on the cutting-edge of nanobiotechnology, with a rapidly developing portfolio of indications designed to treat some of the most daunting viruses known to man and do so in a wholly new and compelling fashion, to which said viruses may never be able to effectively adapt. The company’s core technology exploits the very mechanism and features of a virus which allow it to bind to a cell. By focusing on the receptor binding molecules on the surface of a virion itself, which are chemically similar even among viruses of varied protein signature and which rarely change as a virus mutates, the company’s nanoviricides actually cover up and block a virus’ multiple binding sites.
By using virus-binding ligands that are derived from the virion’s own cell surface receptor binding sites, which are covalently attached to nanomicelle polymers as a backbone carrier (an aggregation of surface tension lowering molecules with polymer strands that can unfold and encompass a virion, potentially also carrying active pharmaceuticals), the company’s nanoviricides provide an unrivaled versatility when it comes to how they work and how they can be administered. Nanoviricide technology represents a real breakthrough in how we handle viral infections and because the technology may be capable of optionally attacking the viral genome itself and eradicating the virus, as well as smuggling active pharmaceutical ingredients in, right up to the surface of the virus, there is considerable upper limit potential here as well.
This platform technology is being developed along two distinct vectors. Firstly, for providing solutions to highly targeted and virus-specific applications, as is suitable for treating HIV, Influenza and Avian (bird) Flu, like the A(H5N1) and A(H7N9) strains that have crossed over into humans. Secondly, for providing broad-spectrum nanoviricidal indications which could prove extremely effective at combating some of the most rapidly changing tropical diseases, such as Ebola. The company’s virus-specific nanoviricides function in such a targeted manner that the non-specific (side) effects which are typically experienced with most anti-viral agents on the market today, impacting both the virus and healthy host cells, are essentially eliminated. The PEG-based (polyethylene glycol) polymer used also means an optimum safety threshold with very limited immune reactions and foreseeably easy clearance via the FDA.
The company’s broad-spectrum nanoviricides have the potential to address up to 95% of known viruses, providing the same kind of shotgun approach that allows various classes of antibiotic to treat multiple forms of bacteria, because they exploit a feature that is common to all bacteria. Furthermore, the company’s proprietary Accurate-Drug-In-Field™ (or ADIF) technology could quickly become the go-to field solution for containing outbreaks, giving healthcare providers the ability to dynamically respond to outbreaks around the world, using stockpiled nanomicelles as their primary weapon. This key technological advantage offers healthcare providers the ability to have the first dosages of a treatment drug up and running in as little as three weeks, with a window as short as three months possible for being able to roll out enough of the drug in order to treat people external to the outbreak zone and really contain the virus.
The capacity of ADIF technology to generate a drug targeted at a specific virus, without having to understand its molecular biology or even have a specific identification, has enormous biodefense potential, and represents a true frontline solution for combating novel viruses, in addition to its obvious ability to help put handles on an outbreak of a known virus. The capacity to rapidly develop a field solution that can simply and completely gum up the ability of virtually any virus to bind to host cells could mean one of the only universally effective ways to head off a future biological catastrophe at the pass. And because the mechanism of action in a nanoviricide is wholly different than that of typical vaccines, which rely on stimulating the host’s immune system, nanoviricidal indications could prove to be highly successful even in patients with compromised or weakened immune systems.
This novel mechanism of action not only future-proofs the company’s technology due to its ability to fool practically any virus that emerges, effectively coating the virus in nanoviricide and eventually destabilizing/dismantling it without the help of the host’s immune system, it is also backed up by considerable IP, given that all of the company’s candidates are based on the highly-tailorable TheraCour® polymeric micelle technology created by Anil R. Diwan, PhD, NNVC’s President and founder. The biomimetic capabilities of such nanoviricides, which mimic existing biochemical processes, take full advantage of such properties as addressing and encapsulation, as well as lipid fusion, not just blocking a few sites, but engulfing the virus particle in its entirety and initiating its decomposition. With exclusive worldwide license to this technology and two broad international patent applications covering everything from manufacture to materials, as well as the methods and fields of use, NNVC is in a very strong IP position and intends to file patent applications on each separate drug as they go along.
Nanoviricides as a tool have the potential to effectively combat some of the most daunting viruses in existence that have defied medical science for decades or more, like the constantly and rapidly changing Influenza virus, better known as the common cold, for which existing vaccination regimens have proven to be only marginally effective. With the CDC’s own data openly acknowledging the widely ranging effectiveness of vaccination against various strains of Influenza and with other daunting viruses on the loose like dengue (fever), which was just recently the subject of an epidemic declaration in Brazil by the country’s Health Minister, as well as HIV, herpes, and even Ebola now spreading around the globe, the demand for a wholly new and clinically effective approach is greater than ever before.
Currently, the company has six commercially significant drug development programs in various stages, including both an injectable and oral version of an Influenza drug, aptly named FluCide®. Injectable FluCide™ saw a good safety report profile come out back in January of this year, showing no direct adverse clinical effects observed after a 4,200mg/kg total intravenous dosage over 14 days in a GLP-like toxicology study in rats, which was conducted by Bioanalytical Systems (NASDAQ: BASI). This injectable version of FluCide is in IND-enabling studies at the moment and represents the most advanced of all of the company’s pipeline candidates. With this latest study confirming earlier results of a non-GLP toxicology study in mice and also showing positive findings in different influenza A strains, posting similarly high marks for safety and toxicology, FluCide is now clearly ready to move on to the next step. Commissioning operations are currently in the offing and are slated to take place at the company’s new state-of-the-art cGMP-compliant manufacturing and R&D facility in Connecticut, which was acquired in January this year.
The company’s strong cash-in-hand position and $36.4 million in current assets plus restricted cash reported at the close of 2014, on a burn rate in the neighborhood of $2 million a quarter, NNVC feels very comfortable having grabbed this important 18k square foot facility, which has all the lab, as well as cGMP-compliant raw materials handling/dispensing and clean room suites needed, to make and package clinical-scale quantities of the company’s nanomedicines. More importantly, the acquisition is a much more economically sustainable option than leasing and the company is confident that this facility, combined with their strong financial position, will ably carry them into human clinical studies on at least one of their promising candidates, and quite possibly allow for one other drug to reach the IND development stage.
The company’s anti-HSV (herpes simplex virus) drug candidates have demonstrated greater than 99.9% inhibition in cell culture against two distinct, different strains of herpes. The incredible effectiveness of the company’s anti-herpes drug candidates reported in April this year – where it blew the current standard of care, acyclovir, out of the water, with lethally infected HSV-1 H129c strain mice showing substantially complete survival – is a clear indication of how promising these anti-HSV candidates truly are. NanoViricides will seek rapid drug approval from the FDA for its anti-herpes candidates and the company is especially confident considering that acyclovir used at two times the concentration needed for humans has only showed a less than a 58% survival rate. What’s more, the anti-herpes candidates from NanoViricides demonstrated a significant reduction in disease severity alongside the extremely high survival rate, potentially making it a shoe in for FDA fast track. NNVC has also seen some powerful results in EKC (epidemic kerato-conjunctivitis), or severe pink eye disease, with their EKC-Cide™ candidate, and ongoing work in HIV/AIDS has also been quite promising, with sustained viral load reduction in HIV-1 even after treatment with HivCide™ was stopped, according to a recent mouse model study.
Also worth mentioning here is how the company’s rapid design platform has led to several EbolaCide™ candidates being developed in recent months, with positive results from the company’s collaborating BSL-4 facility in January showing broad-spectrum efficacy against both Ebola and the closely related Filoviridae family hemorrhagic fever virus, Marburg. Given the recent Ebola outbreak in West Africa, the largest in the planet’s history according to CDC data, with two reported cases having been officially imported to the U.S. during the outbreak, NNVC’s EbolaCide candidates could be just the thing that the CDC and WHO have been looking for in order to help stop the next outbreak before it happens.
Mimicking natural host cell receptors and tricking a virus to bind to nanoviricidal nanomicelles, effectively encapsulating the virus and making it non-infectious, is a potentially disruptive, game-changing technology for the roughly $27.6 billion global antiviral market, which is on track to hit upwards of $36.44 billion by 2019 according to recent analysis published by Mordor Intelligence. The space is projected to grow at a CAGR of around 5.71% over the next several years through 2019, and NanoViricides is positioned to capture significant market share if their revolutionary nanomedicines pan out as hoped.
Take a closer look by visiting www.nanoviricides.com
