By GREGORY ZELLER //
A pre-clinical-stage biopharmaceutical company is being fast-tracked toward a potential Alzheimer’s treatment, after taking a decidedly slow road.
Stony Brook-based Avanti Biosciences Inc. actually launched in 2009, but was “dormant for a few years,” according to founder Gian Luca Araldi, “kind of an empty shell.”
It was only in the last two years, when “I had some ideas I wanted to develop on my own,” that Araldi – a former senior director at Forest Laboratories and the founder of East Setauket biotech consultancy U.S. Pharma Services – brought Avanti back to life.
The reborn biotech is very much in startup mode, starting with what its CEO called a “completely changed business model.” Avanti Biosciences’ focus now is on catechins – “flavonoid” antioxidants that, in large concentrations, can inhibit an enzyme that helps trigger Alzheimer’s disease, Down syndrome and other neurodegenerative conditions.
Catechins, which are a major component of green tea, can fritz DYRK1A, an enzyme that modulates tau phosphorylation. Tau proteins, of course, stabilize microtubes throughout the central nervous system, but as everyone knows, if you add a phosphoryl group to a tau molecule – phosphorylation – the protein’s enzymes go haywire.
Just a few years of graduate-level chemistry and the thick science comes clear (Araldi earned duel doctorates in organic chemistry and pharmacy from the University of Parma in Italy). But for the 5.1 million Americans estimated by the Alzheimer’s Foundation of America to suffer from the progressive (and currently irreversible) neurodegenerative disease, the skinny is simple: a new potential treatment.
To that end, Avanti Biosciences in August won a $1.93 million Small Business Innovation Research grant from the National Institutes of Health’s National Institute on Aging, specifically to support the re-startup’s small-molecule Alzheimer’s disease research.
Araldi, who has personally staked about $25,000 to launch and later revive the company, said the first-ever outside funding will support research conducted in tandem with New York’s Staten Island-based Institute for Basic Research in Developmental Disabilities and scientists at the University of California-San Diego. The UCSD School of Medicine is the home base of Steve Wagner, a neurosciences professor who sits on Avanti Bioscience’s Scientific Advisory Board alongside Stony Brook University Distinguished Chemistry Professor Iwao Ojima.
The research, according to Avanti Biosciences, aims to “attenuate and potentially reverse pathogenesis for Alzheimer’s disease and other neurodegenerative diseases.”
Araldi translates: “We hope to stop the development of Alzheimer’s.”
And the early-stage biotech doesn’t only have Alzheimer’s disease in its sights. Araldi, who also earned an MBA from Long Island University and was named an entrepreneur in residence of the Long Island Bioscience Hub in 2015, noted a “strong rationale” for using catechin-derived therapies to treat other neurological conditions.
The startup also has early designs for new pharmaceutical treatments for Down syndrome and hyperinsulinemia hyperammonemia syndrome, a rare autosomal-dominant disease linked to hypoglycemia, childhood-onset epilepsy, learning disabilities and seizures. Like Avanti Bioscience’s Alzheimer’s treatments, they are in the “discovery” phase, according to the company, with preclinical development and various clinical phases to follow.
Araldi, who noted established connections between Down syndrome and early-onset Alzheimer’s disease, said the collaboration would focus first on those two ailments – “the same molecule to treat both conditions” – while preparing for future development of HHS therapies and “a pipeline of drugs that target not only the brain and the central nervous system, but diseases in the periphery of the body.”
“We are looking at rare diseases … where the use of these catechins has already been demonstrated to be effective in both human and animal [models],” the CEO said, noting Avanti Biosciences is already laying early groundwork for future studies with the Children’s Hospital of Philadelphia, where the Congenital Hyperinsulinism Center is a sanctioned HHS Center of Excellence.
But the three-year SBIR grant announced in August will look to build on the company’s existing catechin patent – covering use of the antioxidant specifically as a neurological-disorder treatment – and bring a product to Phase 1 clinical trials by 2021.
“Our business strategy right now is we are looking for more funding through the NIH to get this project off the ground,” Araldi said, noting three fresh grant applications he’s planning to submit in January. “Hopefully, once we are mature enough, then we will seek partnership with another pharmaceutical company, or eventually seek investments from venture capitalists.
“We just want to see if these ideas are working, and then we can expand.”
For now, the startup – which upon its 2015 resurrection was approved by the Long Island High Technology Incubator for participation in SBU’s Incubator Without Walls initiative – is “delighted to have been granted this funding from the NIA,” according to its founder, whose quarter-century of executive-level biopharma experience includes 113 international patents and oversight of major clinical-development programs at GlaxoSmithKline and other major-league manufacturers.
“This underscores the great need for innovative, effective treatments for this disease,” Araldi said. “And it recognizes the potential benefits that our compounds may provide for patients with Alzheimer’s disease.”
Avanti Biosciences Inc.
What’s It? Preclinical biopharma brewing up natural treatments for neurological disorders
Brought To You By: International pharmaceutical veteran, finance ace and corporate-resurrection specialist Gian Luca Araldi
All In: $25,000, self-invested by Araldi, covering startup formation, patent applications and some materials
Status: Fast-tracking toward clinical trials for potential Alzheimer’s disease therapies