Huddled over work stations in a lab cluttered with test tubes, petri dishes and cardboard boxes labeled "biohazard," the co-founders of Stony Brook-based Codagenix Inc. are working on what they see as the future of vaccination.
Hoping to improve upon current production methods that date to the late 1800s, the company is using specialized computer software to genetically sequence viruses that drugmakers can then use to manufacture vaccines against viruses such as influenza.
"Our goal is to be the game changer in the flu industry," said Robert Coleman, Codagenix chief operating officer and assistant professor of biology at Farmingdale State College.
Since 2012 Codagenix has been awarded three federal research grants totaling $1.6 million from the National Institutes of Health. The grants -- two of which were awarded this month -- have enabled the small startup to make strides, but chief scientific officer Steffen Mueller said the company needs significantly more financing to take its work to the next level.
BRIDGING FUNDING GAP
Following successful low-dosage trials on ferrets -- the test animal of choice for flu vaccines -- Codagenix estimates it needs an additional $2 million to reach the early stages of FDA-approved clinical trials on humans. With money from private investment, the startup could be ready for human vaccine testing in 12 to 18 months.
For biotech companies such as Codagenix, born out of academic institutions, the gap between research-grade testing and full-blown commercialization can be massive, leaving many unable to make the leap, said Joseph Scaduto, founder of Traverse Biosciences, a Stony Brook-based startup working to commercialize a drug to control canine periodontal disease.
"We're all trying to bridge this valley of death," he said.
"Grant money is wonderful, but it needs to complement and supplement private investment," Scaduto said. Time constraints created by patent lives -- typically 20 years -- add additional pressure on businesses hoping to commercialize scientific breakthroughs and new products. "The patent clock is ticking," he said.
Codagenix filed its utility patent in 2008, and Coleman and Mueller said even with an injection of private investment it would take another six to seven years before vaccines made with their method would be commercially available.
Officially launched in 2011, the company was built on research and technology developed by Stony Brook University professor Eckard Wimmer and is based at the Long Island High Technology Incubator, a nonprofit affiliate of the university.
In addition to winning over investors, the company must win acceptance from the scientific community for its new vaccine methodology. The current method of creating vaccines relies heavily on the gradual mutation of viruses through trial and error.
Instead, Coleman likens the Codagenix process to making an exact copy of a Ferrari -- the wild virus -- but instead of a top-of-the-line engine under the hood, a subpar motor powers the new copycat -- the attenuated virus. In effect, the new copy is identical except for its most dangerous components, making it ideal for safer mass production of vaccines in the event of a pandemic.
Flu shots today contain roughly 10 billion particles of influenza. Using Codagenix's attenuated virus method, vaccines would only contain 10,000 particles, making the manufacturing of vaccines in a hurry more efficient.
"We say it's not so important to make more; what you have to make is a more efficient vaccine where you can use less ," Mueller said.
Even with preliminary science on their side, capital investment will be paramount in speeding the clinical trial process along and catching the eye of big pharma, said Mark Lesko, executive director of Accelerate Long Island, a group that promotes high-tech company growth on Long Island.
"A lot of angel investors select themselves out of the biotech space," said Lesko. "The time to achieve a return on investment is usually very long in biotech."
Codagenix executives said they met earlier this month with potential investors in Seattle, whom they declined to identify.
Until investments come through, the company intends to continue preclinical testing and research on other viruses such as dengue, and it will expand its work to include bacterial vaccinations as part of a partnership with Farmingdale State.
Despite challenges, "there's a growing group of early-stage entities emerging from the academic institutions," Scaduto said. "We have the opportunity to capitalize on the assets we have in the region."