San Diego startup Hera Therapeutics is developing a topical antiviral drug that attacks human papillomavirus – and early studies are showing it can successfully combat three strains, including two that cause 70 percent of all cervical cancer.
The drug candidate, HTI-1968, blocked the replication of HPV-16, HPV-18 and HPV-11 cells, according to the NIAID-sponsored study. The work was conducted primarily by University of Alabama researchers Louise T. Chow and Thomas Broker. The drug could be effective against more, CEO Karl Hostetler said, but these are the only three HPV strains available for screening through the NIH.
“We believe it’s possible the drug’s pangenotypic – that is, active against all strains – but can’t prove that because these are the only three strains available right now for testing,” Hostetler said.
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Hera Therapeutics doesn’t yet know the exact steps the antiviral takes, but it essentially blocks the pathway that allows the virus to make its DNA using cellular enzymes, Hostetler said.
“It’s a nucleoside analog, and that’s all we’re wiling to say about it right now,” Hostetler said.
The nascent company has started safety testing for the drug, and hopes to file an IND by late next year. It is working with a contractor to develop a prototype to combat the sexually transmitted infection, Hostetler said.
Hostetler, a professor emeritus at University of California, San Diego, previously founded three other companies – Vical, Chimerix and Triangle Pharmaceuticals. He founded Hera Therapeutics in late 2012. It has received $2.4 million in funding to date, including $1.3 million last month. The startup is housed in the Janssen Labs accelerator in San Diego.
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HPV is painfully common, with 6.2 million Americans getting newly infected each year, according to the CDC. Nearly 4,000 women die each year from invasive cervical cancer, which is largely a result of an undetected case of the virus. However, outside of the Gardasil vaccine that’s not really available to women older than 26, or those who have already contracted it, there isn’t much in the way of HPV prevention or treatment. Hostetler expounds on why there’s been a dearth of HPV antivirals on the market:
“Over the years, there haven’t really been many antiviral drugs developed for HPV, probably because the screening process is so difficult.
Most antivirals interfere with the viral polymerase that makes the DNA or RNA. The thing about HPV is that if it does not have its own polymerase enzyme, it hijacks some of the human cell DNA synthesizing pathways to make it viral DNA, and that’s led a lot of people to believe that you couldn’t develop a nucleoside that would be selective for the virus.
HIV, for instance, has a retroviral polymerase, and AZT and tenofivir and lots of other drugs inhibit that. That’s great. But here’s a virus that doesn’t have a polymerase, so it’s been very difficult historically to find things that will selectively block it.”
However, a number of immunotherapy candidates are in clinical testing to treat HPV, so it’ll be worth watching to see which therapies shake out as medically – and commercially – viable.