Sofinnova, Forbion back $70M push across finish line for rare antifungal treatment
As the former global brand leader of Merck’s antifungal business, Francesco Maria Lavino knows his facts: There are only three classes of antifungals.
But F2G, the biotech where he’s now CEO, is confident that it can soon bring a fourth antifungal class to the market. And it’s closed $70 million in new financing to get there.
The company has yet to unveil data from its open Phase IIb study in patients with rare and resistant molds — it plans to do so at a conference in October — but the results are apparently positive enough to cement an FDA filing by the end of the year. The agency has already granted its compound, named olorofim, designations as a breakthrough therapy, qualified infectious disease product and orphan drug.
Lavino, a self-described “commercial person,” joined F2G more than a year ago and, working out of New York City, has been building out a team in the US to prepare for market launch sometime next year pending FDA approval. The biotech keeps its R&D operations in Manchester, UK, and has a small office in Vienna, bringing the total headcount to about 55.
Forbion and Sofinnova co-led the round, which follows a recent Europe and Asia deal with Shionogi that already poured $100 million cash into F2G’s bank, with promises of more in milestones.
Nanna Lüneborg, Forbion general partner, remembers doing due diligence on the company more than a decade ago while she was still at Novo Holdings. For her, the draw to F2G is “straightforward.” Rare fungal infections like invasive aspergillosis typically affect cancer patients whose immune systems are compromised from treatment, and drug-drug interactions mean existing antifungals cannot be used together with many of the standard-of-care cancer treatments these days.
“A lot of patients don’t have any suitable treatment options,” she said. She is joining F2G’s board alongside Sofinnova’s Joe Anderson.
So while F2G will encourage doctors to use an azole when it’s appropriate, Lavino believes olorofim will have a sizable role to play in salvage — with a price to reflect that.
“We are not trying to displace generic drugs that work,” he said. “We are saying when you really have no option, this is a drug that could save your patient’s life.”
The company is conducting a separate Phase III head-to-head comparing olorofim to an existing option dubbed AmBisome. The cash reserves could also fund lifecycle management, Lavino added, such as developing an inhaled version of olorofim. Further down the line, the CEO sees F2G potentially bringing in more drugs.
“At the moment we don’t want to be — we don’t believe we will be an anti-infective company actually, we want to be a rare disease company,” he said.