Nanalyze

When Will There Ever Be a Cure for HPV?

While the American people may not all agree on politics, religion or the benefits of a U.S.-Mexican border wall, there’s one thing that brings nearly a quarter of the population together: HPV. At present, 79 million Americans are infected with the Human Papilloma Virus (HPV), with another 14 million becoming infected every year. HPV is that wonderful disease that causes either completely benign (but hilariously embarrassing) genital warts, or life-threatening types of cancer. More than 170 possible viruses can be labeled as HPV, while 99% of all cases of cervical cancer are caused by HPV. On top of that, a whole spectrum of other nasty cancers can arise from an HPV infection, many of which occur in areas typically used for adult entertainment. Each year in the United States, more than 13,000 women will be diagnosed with cervical cancer, and of those women, 4,000 will die. But it’s not just the ladies that bear the brunt of the problem as you can see in the below table from the CDC on cancers that are probably caused by HPV.

Update 2/15/2019 – We previously implied that males somehow got off easy. They don’t, at least not in the case of HPV. One of our readers gently suggested we change this as we were using an old source of data. We included the most recent data we could find from the CDC which can be seen in the above table.

How HPV Works

Like other sexually transmitted viruses, HPV spreads through sexual contact of the genitals and other mucous membranes. The virus burrows into the deepest layer of the epithelium and sits nice and snug inside the DNA of a host’s epithelial cells. Unlike other viruses that destroy cells from the inside by growing into massive numbers and bursting out of the cells, these viruses will spread when the epithelial cells of the genital regions peel off and start dying, which releases the viral particles. The particles then go on to infect other bodies. The virus spreads not only by sexual intercourse, but also through contact with warts on the foot. If you’re a tree-hugging hippie that loves to walk barefoot, just remember that these warts can break down and release viral particles for someone else to pick up. Not to mention, these viruses can survive for months at low temperatures without a host.

These guys live on your junk. Credit: The Spinoff

Two types of high-risk HPV, HPV-16 and HPV-18, are responsible for 70% of all cervical cancer cases. These cancer-causing viruses work by tweaking the cellular genetic code and pressing the gas on the cell division stage, forcing epithelial cells to grow like crazy. The logic behind this step is that with more epithelial cells in the cervical region, the more viruses are produced and can spread even further. The virus codes for proteins that cause the cells to ignore any signs for slowing down, and the DNA of the cells starts turning into a catastrophic mess. At this point, the cells start transforming into malignant cancerous growths that will eventually spread to vital organs and lymph nodes. Warts are formed from a similar process, except the infected tissues never go beyond anything more than a benign precancerous growth.

HPV and the Challenges of a Cure

Most cases of HPV are asymptomatic, which means that there are no tell-tale genital warts to ward off prospective Tinder dates. On top of that, there is no approved way to detect HPV in a person who shows no symptoms, which allows the disease to spread like wildfire unnoticed. It can take 15 to 20 years for a woman to develop cervical cancer, and even fewer than 10 years if the host has a compromised immune system, such as from HIV. Other risk factors that exacerbate the disease are smoking and co-infection with other sexually transmitted diseases like good old-fashioned herpes.

The Progression of Cervical Cancer. Credit: The Chinese University of Hong Kong

Click for company websiteCompanies like IncellDx, a San Francisco-based startup founded in 2009 with a total funding of $9 million, is working on improving diagnostics for HPV. The company has developed the HPV OncoTect 3Dx system, which allows users to quantify certain mRNA strands as biomarkers for cervical cancer from cervical cells, as well as determining if rapid proliferation of cancer cells is occurring. But the FDA has yet to approve the assay, and so it’s still not clear if there will be a reliable test in the future for checking on the HPV status of an individual.

Currently, three HPV vaccines are available on the market – Cervarix, Gardasil, and Gardasil 9. One problem with adoption has been the historical controversy about the vaccines as a result of conflicting beliefs, and other possibly politically or financially motivated issues. To be most effective, the vaccines must be administered to young girls before they are sexually active to make disease control effective, since these vaccines can’t prevent the symptoms of HPV after it has infected the host. And the vaccines will only work on the virus types that they’re targeting. Since there are more than 170 viruses under the HPV umbrella, these vaccines will not protect against all of them.

Market Potential for an HPV Cure

According to the World Health Organization (WHO), an estimated 311,000 female deaths occurred from HPV-induced cervical cancers with an additional 570,000 new cases reported in 2018. And the Centers for Disease Control (CDC) estimates that the total economic cost of HPV is $4 billion annually in the United States alone. In the same study, the authors suggest that vaccination for HPV for girls at the age of 12 could potentially save as much as $21,779 per year of the vaccinated person’s life. Quick back-of-the-envelope math comes out to be a market potential of $12.4 billion annually if there were a cure for HPV. Let’s take a look at some possible immunotherapies and vaccines in the pipeline.

Potential Cures for HPV

Click for company websiteFounded in 1983, Inovio Pharmaceuticals (NASDAQ: INO) is a small Pennsylvania biotechnology company working to develop vaccines to treat HPV-induced cervical cancer with a market cap of just under $450 million. Their lead candidate, VGX-3100, is currently under investigation in a Phase 3 clinical trial that began in 2017 and works by harnessing the patient’s own immune system to combat both HPV infections and precancerous cells. VGX-3100 is administered in a unique process that involves both intramuscular injection and electroporation, a technique that sends electrical pulses to the site of injection to increase uptake.

Inovio Pharmaceuticals Product Pipeline. Credit: Seeking Alpha

Inovio recently closed a licensing agreement with ApolloBio, Chinese biomedical company, for a $23 million upfront payment to further develop the treatment.

Click for company websiteFounded in 2002, New Jersey-based Advaxis (NASDAQ: ADXS) is a very small biotechnology company that has a market cap of around $25 million following an IPO in 2005. Advaxis relies on a novel immunotherapy platform that uses recombinant protein antigens harvested from attenuated Listeria monocytogenes bacteria cells (rather than from viral proteins) to activate and alert the immune system to target HPV-associated cancer cells. Axalimogene filolisbac is Advaxis’ lead candidate for treating cervical cancers generated from HPV, and is currently under Phase 3 clinical trials.

Click for company websiteFounded in 2011, Vienna-headquartered Hookipa Pharma has received a total of $101.2 million in funding after raising funds through a Series C round in 2017. The startup is focused on a novel platform that uses arenaviruses, which are single-stranded RNA viruses that typically infect rodents, as vectors to elicit an immune response. (Our response: yuck!) HB-201 and HB-202 are two programs that rely on the TheraT vector for treating HPV-associated head and neck cancers, which both recently completed preclinical trials. TheraT is designed to elicit a strong T cell response and turns cold tumors into hot targets for the immune system to attack.

Founded in 2012 as Hera Therapeutics, Antiva Biosciences is a biopharmaceutical company based in the San Francisco area that has raised a total of $56.3 million after a Series C round in 2018. The company was initially spun out of UC San Diego. Antiva Biosciences is focusing their antiviral technology on a topical intravaginal cream designated ABI-1968, which completed Phase 1a clinical trials to evaluate its safety profile.

Antiva Biosciences Product Pipeline. Credit: Antiva Biosciences

The cream was well-tolerated at all doses applied during the trial.

Click for company websiteFounded in 2014, Maryland-based PathoVax is a biotech startup spun out of Johns Hopkins University that’s raised $5.8 million in funding so far. PathoVax uses a proprietary vaccine technology that relies on a virus-like particle known as RGVax. Preclinical trials show promising results, as RGVax is able to protect against up to 27 HPV subtypes.

Click for company websiteFounded in early 2018, Philadelphia-based Virion Therapeutics is a startup spun out of the Wistar Institute and has recently raised $5 million in Series A funding. The company’s technology is founded on anti-HPV cancer vaccines that work by inhibiting a checkpoint in the immune response that causes T-cells to become dormant. Virion is developing this platform by delivering the inhibitor using non-human primate adenovirus vectors to increase the efficacy of delivery.

Conclusions

The HPV vaccine industry is a lucrative business, which can bring on a whole host of challenges that go beyond the science and medicine. Merck, the makers of Gardasil, is bringing in $1.7 billion on sales alone with this vaccine. But that has always been the case with the pharmaceutical industry, and saving lives with cures should still be a financially sustainable enterprise. Indeed, we can’t all match the altruism of Jonas Salk, the medical inventor of the polio vaccine who refused to patent his work and gave up a potential of $7 billion. But until robots take over mundane labor and universal basic income lets everyone play eSports all day instead of working, we can thank profit-driven companies for working hard on the task of discovering the cure for HPV, ridding the world of genital warts and cervical cancer, and making a few billion bucks in the process.

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