Vast Therapeutics Lands $15M Series A, $300K from CF Foundation

Posted by on Jan 7, 2019

DURHAM, N.C. – Vast Therapeutics  is celebrating the new year with Series A funding in excess of $15 million from Shionogi & Co., Ltd. (TYO: 4507) of Japan and a $300,000 award from the Cystic Fibrosis Foundation.

The Durham company, which changed its name in mid-2018 from Novoclem Therapeutics, will use the CF award to support toxicology studies this spring. The Series A funding will support bringing the molecule BIOC51 to first-in-human clinical trials later in the year, according to John Oakley, Vast’s chief financial officer. The company anticipates submitting an lnvestigational New Drug application in 2019.

BIOC51 is a synthetically derived powder mixed with a saline solution that is inhaled through a nebulizer to deliver nitric oxide to the site of infections in the lungs. This technology augments the body’s defenses and the work of antibiotics to enhance their infection-fighting capabilities.

“BIOC51 has eradicated every bacterial pathogen that we have tested in vitro to date,” said Mark Schoenfisch, Ph.D., Vast’s president and scientific officer, in a company news release, “including over 20 species of both Gram-positive and Gram-negative bacteria, 29 distinct strains of Pseudomonas aeruginosa, and 35 antibiotic-resistant strains deemed superbugs by the Center of Disease Control and World Health Organization because of their severe threat to public health. BIOC51 has proven effective in reducing the bacterial load of nontuberculous mycobacteria (NTM) in a murine [rodent] infection model.”

Product candidate licensed from UNC-CH

BIOC51 is a licensed technology from Schoenfisch’s lab at the University of North Carolina at Chapel Hill.

“Nitric oxide is the primary molecule that macrophages (white blood cells) use to attack bacteria or other pathogens in the body. It’s something your body has the capacity to make on its own,” explained Kyle Kimble, JD, Ph.D., Vast’s director of intellectual property whose Ph.D. is in analytical chemistry. He said Vast sees its approach as biomimetic, meaning a synthetic method that mimics a biochemical process. It gives the body more of its own type of ammunition to fight invaders.

P. aeruginosa are strains of bacteria common in the environment and a major cause of lung infections in people with cystic fibrosis and others with impaired immune systems. About half of all people with CF have Pseudomonas and more than 60 percent of adults with CF have Pseudomonas, according to the CF Foundation. The infections often become chronic, resistant to antibiotics, lower patients’ quality of life and can lead to death.

These bacteria form biofilms in the lungs, which are like cocoons that shield the colonies of bacteria from the body’s own immune system and antibiotic medications. According to Kimble, BIOC51 has shown to break down these biofilms. This not only allows the nitric oxide it releases to work, but the process also allows the antibiotics to work better. Thus, BIOC51 is not competitive with antibiotics, but instead delivers an additive effect to the standard of care. Ultimately, Vast hopes it will make significant inroads into the serious global public health issue of antibiotic resistance.

Shionogi best known in US for Crestor

Shionogi is a Japanese pharmaceutical company best known for developing Crestor, the statin (lipid-lowering) medication widely used to reduce cardiovascular disease (CVD) and to treat those at risk for (CVD). It is particularly known in Japan as a producer of antimicrobial and antibiotic medications.

“The partner, Shionogi, is very exciting to us,” said Oakley. “Their reputation in the industry, their knowledge of anti-infectives – we feel like fits well and is certainly a validation of our technology. They were as interested in partnering with us as we were in partnering with them. They have done this many, many times. We think their resources will be invaluable.”

Shionogi has an equity investment as a minority shareholder in Vast, and owns some licensing rights.

Vast is a subsidiary of KNOW Bio, LLC, a Research Triangle Park-based incubator for platform-based medical technology and biotechnology companies, formerly known as Novoclem Therapeutics, Inc., and headed by CEO Anne Whitaker. Neal Hunter, serial entrepreneur and co-founder of Cree, Inc., is managing director of KNOW Bio and now CEO of Vast Therapeutics. Oakley said the leadership change was a mutual and amicable decision representing the new stage in the evolution of this pre-clinical stage company.

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