It’s pretty hard to hit an increasingly agile moving target like the rapidly-evolving viruses that medical science is forced to contend with these days, especially when medical professionals are handicapped by using drugs that rely on somewhat antiquated approaches and technologies, many of which were initially developed over a century ago. If you think about how quickly a virus strain adapts and evolves, it is no wonder that medical science has a difficult time keeping up.
Even the more sophisticated antiviral technologies in use today often amount to little more than variations on existing approaches. The Vesicular Stomatitis Virus-Ebola Virus vaccine (VSV-EBOV) deployed in frontline clinical trials last year to combat the spread of Ebola throughout West Africa is a prime example. Given that this recombinant, replication-competent vaccine is basically just a genetically engineered virus from the same family as rabies, which has been weaponized to express Ebola glycoproteins and thus provoke an immune response in the host, the threat of the virus mutating around existing (only marginally effective) solutions and escaping containment is a persistent threat which looms large on the horizon.
More importantly, because the lion’s share of existing antiviral agents typically use a method of action that takes place within the cell, such indications are plagued by a host of unwanted side effects that can impair the host’s immune system, as well as healthy cells. Currently in the process of transitioning from a preclinical R&D company to a clinical biotech company sometime within the next 15 months, NanoViricides, Inc. (NYSE MKT: NNVC) may have the answer to this “one step forward, two steps back” problem, which is inherent among rapidly evolving viruses, as well as a comprehensive platform solution for difficult to treat viruses that have gone dangerously underserved.
NanoViricides is a unique biotechnology company focused on nanomedicine and has developed a truly revolutionary, tailorable delivery platform designed to destroy viruses both in and on the body. The company’s wholly novel nanoviricide® class of drug candidates employs a combination of cutting-edge nanotechnology and knowledge of the substantial lack of variance in the receptor site for virus-binding ligands on a virus cell’s surface, even after numerous mutations. This combination of a chemically attached virus-binding ligand (a mimic of the receptor cell surface protein) derived from the virus’s own binding site with a flexible “nanomicelle” polymer allows nanoviricides to seek out and attach to a specific virus particle in bodily fluids and then fully engulf it, using the polymer as a containment vessel. This process, using targeted, stealth ligands designed to fool the virus into thinking the nanoviricide looks biochemically like a superb infection target, ultimately renders the virus cell incapable of infecting other cells and, subsequently, dismantles it with no collateral damage to healthy cells.
As amazing as this method of action may sound when compared to existing vaccine technologies and antivirals, the real beauty of NNVC’s nanoviricide technology is its rapid-prototyping capability. The unique ability of this platform to be used for quickly developing highly optimized, virus-specific drug candidates, which can be tailored for premium pharmacokinetic characteristics, such as sustained effect and diverse routes of administration, is something which grants the company’s nanoviricide technology an enviably disruptive profile. Moreover, the platform also possesses the capacity to be utilized for broad-spectrum indications that can aggress up to 95 percent of known viruses in a cost-effective manner, including historically neglected tropical diseases like Dengue fever and Ebola/Marburg.
With the recent outbreak of the Zika virus across Latin America and the Caribbean (now considered to be pandemic), which has been linked to birth defects such as microcephaly in fetuses born to women who contract the virus, the CDC has issued a travel warning (which was echoed by the agency’s EU equivalent) focused on pregnant women and women who may soon become pregnant. Just this week a mother on Hawaii’s third largest island, Oahu, who was infected with the Zika virus when she was residing in Brazil last year, gave birth to a microcephalic child, echoing the patterns observed in Brazil. An alarming incident rate increase for Zika of over 2,200 percent in Brazil from 2014 to 2015, with over 3,500 cases last year and 46 infant casualties, has prompted growing concern from health officials worldwide, and with the Florida Department of Health reporting that, as of January 19, two cases of Zika have been identified in Miami-Dade, the three- to five-year window currently proposed by Brazilian authorities for the development of a vaccine (in record time) paints an astoundingly clear picture of the inherent potential value of NNVC’s highly-adaptable platform technology.
Transmitted by the same species of mosquito that carries Dengue fever (as well as now being thought to be sexually transmissible), Zika virus, whose symptoms are relatively mild, was initially not considered to be a major threat, even as the number of cases quickly shot up in Brazil. However, an increasingly apparent correlation with birth defects like microcephaly and possibly even the paralytic central nervous system malady, Guillain–Barré syndrome, has turned a lot of heads in the medical community, especially considering the lifelong impairment for children born with such birth defects.
NanoViricides’ development pipeline currently boasts a number of promising primary candidates, from an injectable, as well as orally-administered Influenza candidate (FluCide) aimed at the $33 billion plus vaccine market, to indications for HIV/AIDS, and Herpes. FluCide is quite interesting given the CDC’s own recent acknowledgment that the 2014 to 2015 flu vaccine set record efficacy lows, with a paltry 23 percent reduction to risk of getting the flu. The recent presentation by the CEO of NNVC, Eugene Seymour MD, MPH at Biotech Showcase 2016, illustrated how the company is currently moving full speed ahead with human trials for its lead virucidal herpes (of the eye/cornea) keratitis (inflammation of the cornea) treatment, HerpeCide™. Human clinical trials are currently on-track to begin late this year or in early 2017, and commercially-available HerpeCide would be a most welcome addition to the healthcare system’s existing biomedical arsenal, as ocular herpetic disease in general is a serious challenge for both optometrists and patients.
Herpes keratitis is the leading cause of infectious blindness in the Western world and ultimately requires a corneal transplant when it has progressed to the stage of blindness. Corneal transplant is a difficult procedure that can often fail and the procedure can cost as much as $24,400 on average, according to actuarial intelligence giant Milliman. The major herpes viruses that cause ocular disease (simplex and zoster) quite often bring about immunologic reactions in the host that outlive any active infection as well, meaning that the latent demand for a real solution is considerably larger than the baseline market metrics would indicate.
There are a variety of topical (as well as oral) treatments available, such as GlaxoSmithKline’s (NYSE: GSK) Viroptic (trifluridine), which carries significant toxicity risk, or Pfizer’s (NYSE: PFE) Vira-A (vidarabine), although it has been largely displaced by Aciclovir, due to the former indication’s administration via IV being cumbersome. Oral Aciclovir is available under many different generic brand names, such as GSK’s Zovirax and Eli Lilly’s (NYSE: LLY) Lovir, but side effects like dizziness, nausea, and vomiting, as well as more severe problems such as neurotoxicity in dialysis patients, has continued to daunt this segment of the broader $2 billion plus annual market for herpes simplex virus treatments.
NanoViricides recently completed a transition to its new c-GMP-capable, state-of-the-art production and testing facilities in Connecticut, and has thus graduated into a select handful of small biopharma developers with its own in-house, clinical-quality drug manufacturing footprint. With the capacity to see candidates from design through to scaling up of production for IND submissions and human clinical trials, NNVC now also has the muscle to handle commercial-scale manufacturing when (and if) its candidates are eventually licensed. This logistical capacity, combined with the company’s smart weapon nanoviricide platform, means that NNVC’s most advanced candidates, like HerpeCide and FluCide, stand an excellent chance of seeing eventual commercialization.
This is great news considering that NNVC’s anti-Herpes candidate has shown such great progress in HSV-1 animal model studies thus far, with an over 85 percent survival rate (compared to zero for untreated animals), as well as a marked ability to reduce virus production in cell cultures. Shown to be superior to topical treatment with an Aciclovir formulation, the company’s HerpeCide candidates could emerge as not only a leading treatment in the space, but a real solution for patients dealing with the disease and potentially facing blindness.
For more information, visit www.nanoviricides.com