RESEARCH TRIANGLE PARK – Tellus Therapeutics is pushing ahead with developing its neonatal brain injury treatment after landing crucial seed funding this week.
The Durham-based biotech company focused on neonatal health announced that it had secured an undisclosed sum from Boston-based Xontogeny to advance its lead TT-20 program.
The program targets diffuse white matter injury (DWMI) in preterm infants less than 32 weeks gestational age.
“We are excited to team up with Tellus to support them in pursuing their mission to provide a treatment for every baby born at risk for brain injury and improve neurodevelopmental outcomes for affected children,” said Xontogeny’s founder and CEO Chris Garabedian.
The funds are expected to cover a pre-investigational New Drug Application meeting in late 2021, along with Tellus’ filing for a “First-in-Neonate” clinical trial in 2022. Additionally, Tellus is funding “a pipeline development targeting other neonatal unmet needs.”
Founded in 2018, Tellus is focused on developing safe and effective treatments for unmet needs in newborns.
Each year, about one in 10 babies in the United States is born prematurely. The result: a significantly increased risk for white matter (myelin) injury, leading to life-long neurological impairments, including deficits in cognitive function and autism-spectrum disorders.
DWMI is the most prevalent form of preterm neonatal cerebral injury and is a strong predictor of poor neurologic outcomes. There are currently no FDA-approved treatments.
To combat this, Tellus is developing novel small molecules derived from human maternal breast milk as a form of treatment in newborns. The company’s lead molecule has been shown to promote myelination and subsequent reversal of motor deficits in animal models of white matter injury.
In December 2019, Tellus received a $250,000 loan from the North Carolina Biotechnology Center to develop its treatment.
“Both the financial and intellectual capital provided by NCBiotech has been tremendously helpful to Tellus,” Kralic said at the time, adding that FDA designation applications were covered by the loan.
“[It’s] a prime example of how [this] funding has facilitated our ability to achieve research and development, and company milestones.”
NCBiotech also funded an internship for Tellus earlier this year.
“We are excited for Tellus, and the investment by Xontogeny is certain to accelerate the development of the company’s very promising and needed new therapy targeting DWMI,” said Ken Janoski, senior director of investments for NCBiotech’s Emerging Company Development group.
“Knowing Chris Garabedian and Xontogeny as we do, we believe Xontogeny to be a great fit for Tellus, an excellent investment partner to support Tellus in its development. Notably, too, if Tellus’ new drug is eventually approved, the biggest winners will be those small children suffering from DWMI.”
Last October, the FDA granted Orphan Drug and Rare Pediatric Drug designations for its TT-20 program.
Tellus is now eligible for a priority review voucher, which can be used to obtain FDA review of a New Drug Application.
“We are thrilled to have Xontogeny as a collaborative partner and appreciate their seed investment to develop a pipeline of products with the potential to improve care, outcomes and lives of patients and their families,” said Jason Kralic, Tellus’ president and CEO.
“The Tellus team is pleased that the Xontogeny team shares our goal of rapidly advancing our technology with efficient capital deployment and a focus on designing and executing a successful development program.”
In addition to Kralic, the Tellus management team includes Eric Benner as chief scientific officer, Austin Schwartz as VP of Operations, Jaron Ballentine as VP of Commercial Strategy, and Alex Ruckdaeschel as an independent director.
The board of directors will be comprised of Chairman Chris Garabedian; the CEO of Xontogeny, Fred Callori; the senior vice president of corporate development with Xontogeny, Eric Benner; and Kralic.
(C) N.C. Biotech Center