The scoop: After years operating under the radar, Ansun Biopharma (formerly NexBio) is building momentum behind a portfolio of biologic drugs for viral infections, headlined by DAS181, a first-in-class therapy in midstage testing for parainfluenza and influenza. At the moment there are no approved treatments for parainfluenza, which isn’t usually a serious infection but can be life-threatening in people with compromised immune systems, such as those undergoing hematopoietic stem cell transplant. That’s why the FDA has awarded its breakthrough therapy designation as well as fast-track status for DAS181 in this indication.
What makes Ansun fierce: Armed with an $85 million series A fundraising earlier this year, the company is in the final stages of preparation for phase 3 testing of its Paradase formulation of DAS181 in hospitalized, immunocompromised patients with parainfluenza virus, a group estimated to have a mortality rate of 13% to 63% if the infection reaches the lower respiratory tract. Between 55,000 and 200,000 hospitalized patients are diagnosed with parainfluenza virus infections every year, the company says.
Ansun is also planning testing in influenza, reckoning that DAS181 could provide a new treatment option, including for drug-resistant, potentially pandemic strains such as H7N9, H5N1 and H1N1. Flu remains a major cause of death worldwide, leading to severe disease in 3 million to 5 million people every year and causing around 650,000 deaths.
DAS181 is a recombinant sialidase fusion protein, delivered by inhalation, that’s designed to cleave and block sialic acid receptors used by viruses to penetrate cells lining the respiratory tract, preventing viral replication. That means it works differently from—and could complement—current antivirals used for flu, such as Roche’s oral neuraminidase inhibitor Tamiflu (oseltamivir), which was launched 20 years ago but, despite generic competition in some markets, remains a big earner for the company with sales of more than $500 million last year.
Tamiflu, however, isn’t effective for some pandemic variants of the virus. A phase 2 clinical trial of DAS181 in otherwise healthy adults with influenza A or B showed a significant decrease in viral load with the drug—known as Fludase for this indication—and the U.S. government has provided around $100 million in funding to help bring the program forward, in the hope that it may be useful for pandemic stockpiling.
A couple of years ago, Ansun reported that DAS181 also seems to block the attachment of two other respiratory pathogens—respiratory syncytial virus and human metapneumovirus—which could open new avenues of research for the drug. And following DAS181 in its pipeline are four more drug candidates in preclinical development, headed by ANSXEV68 for human polyomaviruses BK and JC, which are generally benign but can cause serious infections in immunocompromised people and have also been linked to some cancers.
Investors: Sinopharm Healthcare Fund, Lilly Asia Ventures, Yuanming Capital, Lyfe Capital, Oceanpine Capital, VI Ventures, Matrix Partners China, 3E Bioventures Capital, Joincap Investment