For a virtual biotech with one drug just entering the clinic, little South San Francisco-based Antiva Biosciences has carved out a very big mission for itself.
Led by ex-BayBio chief Gail Maderis, the biotech is targeting precancerous lesions caused by HPV with an experimental topical therapy. They’ve mapped out a clinical development plan that can, in a relatively short period of time, offer some solid evidence of its potential. And this morning their venture syndicate has come up with a $22 million round designed to provide enough support to land key data readouts.
Antiva’s ABI-1968 began its first human study just days ago, on its way to tackling cervical intraepithelial neoplasia, a precancerous condition that confronts millions of women worldwide.
“It is a topical cream that is delivered intravaginally with two mechanisms of action: antiviral and an antiproliferating agent,” says Maderis. It’s designed to tackle all forms of precancerous abnormal cell growth that lead to cervical cancer.
The molecule was invented by a professor at UCSD, Karl Hostetler, an infectious disease expert who has a long and distinguished track record in antivirals.
“We are conducting a Phase Ia in healthy volunteers in Australia,” says Maderis, focusing on safety and tolerability. If all goes well, the company will move forward into a Ib trial in the summer, which will be in high grade disease. And while safety is still a big focus, the biotech believes it can get a solid look at efficacy that should be a likely predictor of larger data readouts.
“The Phase Ib study will be treating patients with FDA approval endpoints,” she adds. “We should get some good data on the efficacy of the drug. We are also developing the same drug for anal neoplasia, with a Phase I also in the summer.”
A Phase II trial will likely have to wait until 2019.
Canaan Partners and Sofinnova Ventures, two big players on the West Coast, got the company up and running, providing the early financing needed for much of the preclinical work. They are in the C round announced this morning. But Maderis says its new backers also illustrate the business plan at Antiva.
Brace Pharma Capital, the venture arm of Brazil’s largest pharma company, EMS, led the round. Another new investor, NS Investment, is based in Korea. Osage University Partners and Alexandria Venture Investments also joined in.
The international signature in the syndicate underscores Antiva’s interest in forming regional partnerships in Latin America and Asia as they begin to lay the global groundwork that will be needed to pave out what they hope will one day be a very large rollout.
Says Maderis: “We are starting to plant the seed to look to geographies in the world where HPV disease has the most prevalence.”
If their topical therapy works, Antiva will look to deliver a new therapy that can be easily applied, at home.
Antiva was left with a very large opening, says Canaan’s Wende Hutton, after the introduction of new HPV vaccines a decade ago seemed to answer this particular unmet medical need. But the vaccines proved to be a commercial letdown, and the threat of HPV remains a major threat to women – and men – around the world. Surgical interventions, adds Hutton, are not always feasible.
“HPV is an epidemic and it’s a sad thing that women, even if screened, don’t have access to surgical therapy,” says Hutton.
I suggested to Maderis that in most cases like this, a small, venture backed biotech would eventually look to either a buyout or a licensing pact with a big player which would be able to market a therapy to a big group like this.
“Those are two good options,” she said with a cheerful laugh.
It’s early days for Antiva. But there are a few shortcuts that could be available to the company. One in particular would be looking for an accelerated approval on anal neoplasia, where there’s a big unmet need for men. The cervical side of the equation would likely need to go all the way through a big Phase III.
The seven staffers at Antiva have a big job ahead.
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