By Ben Adams
The new French biotech Enyo Pharma has raised a good chunk of money in its first round of financing as it looks to start human testing for a potential hepatitis B cure.
The company, which was founded in 2014, raised €22 million ($24 million) in Series A financing, led by venture capital firm Sofinnova Partners, with the money coming from an international investors' syndicate composed of Morningside Ventures and Bpifrance, through its Innobio fund.
The deal was completed just one year after Paris-based Sofinnova Partners' initial seed investment and follows Enyo's licensing several patents and creating a unique technology platform for the treatment of viral pathologies.
Enyo Pharma was created by Patrice André and Vincent Lotteau--two Inserm scientists based in Lyon, France.
The company says its main candidate EYP001, in combination with currently approved viral polymerase inhibitors--i.e., Gilead Sciences' ($GILD) curative hep C drugs Harvoni and Sovaldi--is expected to cure hep B after a 6-month treatment.
Current medicines are not curative but simply manage the disease. This means any new drug which could eradicate the condition would be highly successful--and potentially reach the dizzying sales heights seen with Harvoni and Sovaldi (which made $4.9 billion in the fourth quarter).
Its CEO and co-founder, Jacky Vonderscher, is an industry veteran with a history of developing new therapeutics, in particular for Swiss giants Roche ($RHHBY) and Novartis ($NVS).
Vonderscher says: "With over 350 million people chronically infected with the hepatitis B virus awaiting treatment, Enyo Pharma answers a huge medical need. Sofinnova Partners played a key role in the success of the fundraising, and our investors' support will allow us to develop our technology and bring patients radically novels solutions."
Could Enyo be the next Pharmasset--the small New Jersey biotech that originally developed Sovaldi before being snapped up by Gilead for $11 billion in 2011?
Gilead may seem a logical suitor, but this week John Milligan, who will become its new CEO in March, told reporters that while the company is "very interested in acquiring assets through partnerships or potentially acquisitions that can help us grow," management is looking outside of viral diseases (namely oncology and liver disease), for new tie-ups, putting Enyo likely out of the frame.
Rafaèle Tordjman, managing partner at Sofinnova, told FierceBiotech that the company will be seeking a second financing event in the next three years--so after Phase II proof-of-concept testing--but said Enyo and the VC had been talking to pharma firms already.
"We have a number of scenarios in mind outside of this funding route," she said. "... It's clear we need to find the next Sovaldi for hepatitis B. I think there is scope for a Big Pharma company to get involved. It's an exciting field and drug and the goal of curing hepatitis B is a hot one, and we know Big Pharma firms are interested in the area."
Sovaldi went from being synthesized in 2007 to approval in 2013--just 6 years--with human testing only beginning in 2010. It then went on to make more than $10 billion in its first 12 months on sale.
Whether EYP001 can pull off the same remarkable speed remains to be seen, but Tordjman said she is targeting the same kind of rapidity and expects Enyo to be seeking regulatory approval in four or 5 years' time maximum.
On potential patient numbers, hep C has around half the prevalence of hep B, with WHO estimating that around 3% of the world's total 7.4 billion population has been infected, with more than 170 million chronic carriers who are at risk of developing liver cirrhosis and/or liver cancer, compared to the 350 million with chronic hep B.
While there is no hep C vaccine, there are immunization programs against hep B--but this will not help those already infected, and the patient pool awaiting a cure remains huge.
Despite still being early stage, pricing is already on the VC's mind, but it has not been scared off by recent concerns over drug costs.
"If we succeed in finding a cure, then this is a big jump compared to what's on the market," Tordjman explains. "We will target maximizing the efficacy of the drug for the patient, and that will mean a high price. Even with pricing pressures--and we're used to this is the U.S. and Europe--we know that if we have a big efficacy, we'll have a big price."
Enyo says it has designed a new therapeutic approach toward infectious diseases, as its technology does not target the constituents of the virus--as most existing antivirals do--but targets the infected individual's cellular functions which are central in the virus replication.
By disrupting the interactions between viral and human proteins, the company says its preclinical testing shows its technology impedes the virus' activation.
The new funds raised will be used to accelerate the deployment of the biotech's programs, and help it begin Phase 1 clinical trials for EYP001 in Q3 and Q4.
There are already a number of big pharma companies in the hep B space, with Gilead already marketing Viread (tenofovir disoproxil fumarate)--which made just over $1 billion in sales last year--with older treatments in the form of Bristol-Myers Squibb's ($BMY) Baraclude (entecavir) and Roche's Pegasys (peginterferon alfa-2a).
Earlier this month, Gilead presented data showing its next gen, once-daily hep B treatment tenofovir alafenamide (TAF) was as effective as Viread--but crucially was safer for patients.
Gilead is seeking regulatory approval for TAF in the U.S. and Europe in the first quarter, but TAF will not be able to cure the disease.