EpiBiome, a biotech startup tackling one of the biggest bacterial menaces plaguing the global cattle industry – bovine mastitis – has raised $6 million in Series A funding.
The accelerator program of genome sequencing company Illumina – Illumina Accelerator Boost Capital – contributed to the round alongside Matrix Capital Management, Alexandria Venture Investments, SV Tech Ventures, and China Rock Capital Management.
Bovine mastitis, which infects cows’ udders and renders their milk unfit for human consumption, is the primary reason to administer antibiotics in today’s livestock industry. The use of antibiotics in animal production is increasingly unpopular among consumers.
Recent publicity surrounding the ever-increasing threat of antibiotic-resistant bacteria has hit major media outlets and even caught the White House’s attention. In March 2015, President Obama released the National Action Plant to Combat Antibiotic-Resistant Bacteria outlining a five-year plan for conducting better data collection, boosting research efforts to find alternatives and roadmaps for maintaining the efficacy of existing antibiotics.
EpiBiome, which is developing alternatives to small-molecule antibiotics, will use the funding to invest in its engineering platform, and file additional patents for its technology.
“One of the problems is that most common chemicals used to eliminate bacteria today, like bleach, iodine, or small molecule antibiotics, are all very broad spectrum; they kill everything. Maybe 10 years ago the only good bacterium was a dead one,” CEO and co-founder Nick Conley tells AgFunderNews. “Today, we understand more about microbiomes and good bacteria.”
According to Conley, bovine mastitis costs the US dairy industry $2 billion and sets global dairy back $35 billion. It causes reduced milk production, herd culling, discarded milk due to an antibiotic residue, and costs farmers an average of $200 per cow annually to combat.
On its search for a more scalpel-like solution, EpiBiome has honed in on bacteriophages, a macromolecular bacterial virus with a bullish disposition that seeks out and destroys specific strains of bacteria.
“The phages recognize things on the surface of the bacteria, and they bind to those things, which is what gives them high specificity and allows them to kill things like e. Coli,” explains Conley. Essentially, the bacteria catch the flu. As multi-cell beings, humans can fend off a pesky virus, but the single-cell bacteria are not so lucky.
“Once they bind, they inject their DNA into the bacterial cell which then hijacks the bacteria’s own cellular machinery and puts it on a new program that is designed to make more phages. After 20 minutes the bacteria bursts and all the new daughter phages are released into the environment where they can infect new bacterial cells. It’s a natural form of antibiotics.”
The ultimate phage cocktail could be administered directly into the udder using a syringe. Because phages are self-propagating, Conley believes that far fewer applications would be required than existing antibiotic therapies. And unlike the current antibiotic-based protocol, the cow would not have to be removed from production during treatment. The naturally occurring, non-GMO phages are also promising for the organic industry, which disallows the use of antibiotics.
Shockingly, phages outnumber bacteria 10 to one. Every two days, phages wipe out roughly half of the bacteria existing on the planet. The cells cannot infect mammalian cells, meaning they pose no risk to humans.
This technology isn’t entirely novel. Scientists have known about phages and their potential for some time. A particular strain of bovine mastitis, Staphylococcus aureus, has created a roadblock for phages as it clumps together in raw milk due to a reaction with the milk’s naturally occurring immunoglobulin G. The clump renders the bacteria highly resistant to both phages and small molecule antibiotics. EpiBiome’s protein engineer discovered a biologic protein that can break up the clump, rendering staph A. defenseless against the phages.
“This is a really important piece of IP. Without it, you don’t have phages against staph aureus. It is a key barrier to entry,” says Conley. Even though phages are naturally-occurring, they are also patentable. The company already holds a few phage-based patents. Conley says this was a definite plus for attracting investors.
With the clumping conundrum resolved, EpiBiome still faces a few more challenges. Conley reports that the company will be focusing its efforts on developing a strong proof of concept in cows during the first half of 2016. Demonstrating the ability to replicate the same type of phage will be key, especially where a particular disease requires a cocktail of multiple phages to eliminate.
The regulatory landscape is also proving unpredictable. Although the FDA issued recent guidelines for live biotherapeutics for dosing humans with live bacteria, there are no guidelines for dosing patients with a bacterial virus.
“FDA-approved human therapy is more attractive to investors than something for veterinarians,” says Conley.
Food safety is an easier regulatory hurdle to overcome. The phages are destroyed during pasteurization, meaning the bacterial viruses will be absent from the milk by the time the consumer purchases it.
EpiBiome hopes to achieve GRAS status, or “generally recognized as safe,” from the FDA for its phages. The agency has already granted generic GRAS status to phages for use on food intended for human consumption. GRAS is a good start, but Conley is eager to figure out how to get EpiBiome’s phages approved as a drug in the absence of any FDA approved phage therapy as precedent.
The company is hopeful that the White House’s recent initiative will encourage the FDA to be more accommodating to antibiotic alternatives. The company is already in touch with some FDA regulators to work on the issue, and Conley describes the agency as receptive to the idea.
Beyond bovine mastitis, Conley sees phages having broad applications, including everything from aquaculture to combating destructive termites. “Our focus has really been on agriculture to date, but when you start talking about 10-year plans I’d be foolish if I didn’t mention food safety, oral and skin care, and human health.”
While there are numerous potential applications for human use, Conley thinks agtech is a hot sector and dismisses any concern over whether it may soon cool off. He does, however, stress the importance of identifying exits and being able to demonstrate viable business models.
“There will need to be acquisitions and IPOs. I think there will be and, as long as that continues, capital will continue to flow into agtech.”
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