By GREGORY ZELLER //
A fresh $3 million in public and private investments has set Codagenix Inc. on the trail of another nefarious disease.
Already developing vaccines for Zika virus, the mutating menace Influenza A and a host of other viral villains, Codagenix will now focus its vaccine-creation might on Respiratory Syncytial Virus through a $1.5 million Phase II Small Business Innovation Research grant from the National Institutes of Health and another $1.5 million in private funding from Mamaroneck-based VC firm Topspin Partners, a frequent Codagenix supporter with strong Long Island ties.
Codagenix’s tech involves software that redesigns viruses at the genomic level – essentially “re-coding” virus genes to produce weaker strands that serve as low-dose vaccines. Working with the NIH’s National Institute of Allergy and Infectious Diseases, the Broad Hollow Bioscience Park resident used its platform to develop a vaccine candidate for RSV, a common cause of the common cold that tends to put a serious licking on newborns and the elderly.
The live-attenuated RSV vaccine candidate is now awaiting clinical trials – with $2 billion in market potential in the offing, Codagenix noted Thursday, making the $3 million buy-in a fairly sound bet.
Multiple RSV vaccine candidates were actually generated by Codagenix’s synthetic-biology design platform, with “pre-clinical safety and immunogenicity … demonstrated in multiple publications in 2016 and 2017,” the biotech said.
One lead candidate will be the focus of the Phase 1 clinical trial, which will attempt to demonstrate the same safety and immunogenicity in “aged volunteers,” according to the Farmingdale-based firm, launched in 2012 by Stony Brook University assistant research professor Steffan Mueller and Farmingdale State College biology professor J. Robert Coleman.
With clinical trials of the company’s influenza vaccine set to wrap up in the first quarter of next year and the Phase 1 RSV trial slated to commence in the second half of 2018, Codagenix is “very much looking forward to adding a second clinical-stage compound to our pipeline with RSV,” Coleman, the biotech’s chief operating officer, said Thursday.
Respiratory Syncytial Virus is the No. 1 cause of bronchiolitis and pneumonia in American children younger than 1 year, according to the U.S. Centers for Disease Control and Prevention. The virus leads to more than 2 million outpatient visits and 57,000 hospitalizations annually for children under 5, but it’s even harder on the elderly: Each year, RSV is responsible for 177,000 hospitalizations and more than 14,000 deaths in patients 65 and older.
The key to stopping the contagious virus in its tracks, according to Mueller, is working with a live-attenuated vaccine candidate – essentially, a vaccine created by reducing the virulence of a pathogen but still keeping it viable, precisely the formula employed by Codagenix’s proprietary software.
“It is Codagenix’s position that only a live vaccine will work to protect against RSV,” Mueller, the company’s chief science officer, said in a statement. “The elderly have significant amounts of RSV-specific antibodies but still get sick. Why? Because they lack RSV-specific T-cells to protect them – (and) these types of protective T-cells can best be engendered via a live vaccine.”
The $3 million in public/private funding is the latest in a series of investments landed by the 2012 startup. Codagenix has a raised a total of $10 million since securing its first outside investment in 2015, including U.S. Department of Agriculture stipends funding research into vaccine candidates for the infectious Foot and Mouth Disease virus and swine flu.
Topspin, which helped fuel the now-concluded Long Island Emerging Technologies Fund and has privately backed numerous Island-based ventures, seeded the startup to the tune of $100,000 in 2014, then came back with a fresh $2 million stake in 2015.
Government health agencies and private investors keep coming back to Codagenix because the biotech’s software-based rational design algorithm is unlike any previous vaccine platform, according to Coleman, making it the ideal weapon in the fight against pathogenic E. coli, Dengue fever and other ailments.
“Our disruptive genome-recoding technology intends to shake up the vaccine industry’s status quo,” Coleman said. “And we are demonstrating that our platform provides a rational means to design vaccines against a range of targets, yielding candidates suitable for full clinical development.”