Tellus Therapeutics to develop first treatment for newborns with white matter brain injury

DURHAM, NC – Tellus Therapeutics, Inc., a biopharmaceutical company developing TT-20 as a treatment for white matter injury (WMI) and myelin repair in premature babies, today announced a seed investment from Xontogeny, LLC to advance their lead program through IND-enabling work.

Founded in October 2018, Tellus is translating breakthrough science licensed from Duke University that originated in board-certified neonatologist Eric Benner’s research laboratory in collaboration with Simon Gregory, PhD. Dr. Benner’s work identified compounds in breast milk that induce the regeneration of myelin-producing oligodendrocytes and repair WMI in animal models of perinatal brain injury.

“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 Chris Garabedian, Founder, Chairman and Chief Executive Officer of Xontogeny. “All of us at Xontogeny are looking forward to working with the Tellus team to effectively deploy this seed investment towards reaching our key milestones.”

In the United States, one in ten babies is born preterm and at significant risk for brain injury and life-long cognitive and neurological impairments. Neonatal WMI is the most common brain injury leading to neurodevelopmental disability in survivors of preterm birth. Tellus’s lead candidate, TT-20, is derived from a class of molecules found in breast milk, which promote oligodendrocyte differentiation in postnatal neural stem cell populations. The mechanism of action is reparative and independent of the cause of WMI, thereby providing an advantage over neuroprotective approaches that target only injury prevention. Current medical response consists solely of supportive care, as no treatments are currently approved to treat newborns with white matter brain injury. TT-20 has demonstrated an impressive efficacy and safety profile in models of WMI, supporting its potential as a breakthrough candidate to address this unmet medical need in babies born prematurely.

“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, President and Chief Executive Officer, Tellus Therapeutics. “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. This is especially important for the development of TT-20 and pioneering a regulatory path for ‘First-in-Neonates’ programs that leverages advances in clinical tools and regulatory guidance.”

WMI is the most prevalent form of preterm neonatal cerebral injury and is a strong predictor of poor neurologic outcomes in preterm neonates, leading to adverse neurodevelopmental outcomes including cerebral palsy, intellectual disability, and neurosensory impairments. WMI is characterized by diffuse, subtle changes in the white matter (myelin) microenvironment due to global hypomyelination. This disease process is driven by a reduction in the number of oligodendrocyte progenitor cells (OPCs) that can result from postnatal infections that induce systemic inflammation, including necrotizing enterocolitis or spontaneous intestinal perforations. There are currently no FDA-approved treatments for WMI. The exposure of breast-fed newborns to naturally-occurring molecules supports development as a therapeutic for neonates in which safety is paramount.

In addition to Jason Kralic as President and Chief Executive Officer, 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, CEO of Xontogeny, Fred Callori, SVP of Corporate Development of Xontogeny, Eric Benner and Jason Kralic.

About TT-20

TT-20 has demonstrated an impressive efficacy and safety profile in models of WMI, supporting its potential as a breakthrough candidate to address the unmet medical need in babies born prematurely. TT-20 is derived from a class of naturally-occurring molecules in breast milk, which promote oligodendrocyte differentiation in postnatal neural stem cell populations. The mechanism of action is reparative and independent of the cause of WMI, thereby providing an advantage over neuroprotective approaches that target only injury prevention. Systemic administration of the breast milk-associated compounds rescues perinatal WMI and reverses motor deficits in mice. TT-20 is in late preclinical development having initiated drug product formulation, IND-enabling work and preparation for a pre-IND meeting in the next year.

About Tellus Therapeutics, Inc.

As a preclinical stage life sciences start-up company, Tellus is focused on planning, funding and executing development programs to demonstrate safety and efficacy of new therapeutic interventions in critically ill newborns. Founded in October 2018, Tellus is translating breakthrough science licensed from Duke University that originated in board-certified neonatologist Eric Benner’s research laboratory in collaboration with Simon Gregory. Dr. Benner’s work identified compounds in breast milk that induce the regeneration of myelin-producing oligodendrocytes and repair WMI in animal models of perinatal brain injury. Tellus’ goal for its lead asset (TT-20) is to provide a treatment for every baby born at risk for brain injury and improve neurodevelopmental outcomes for affected children. For more information, please visit: www.tellustherapeutics.com.

About Xontogeny, LLC

Based in Boston, MA, Xontogeny seeks to accelerate the development of life science technologies by providing entrepreneurs with funding options as well as the leadership, strategic guidance and
operational support necessary to increase the probability of success in early drug and technology development. Through a differentiated approach, the Xontogeny team partners with founding scientists and entrepreneurs to support their vision while allowing a more efficient development model that benefits company founders and early equity holders. For more information visit: www.xontogeny.com.

Forward-Looking Statements

This press release contains “forward-looking statements” concerning the development of Tellus Therapeutics, Inc. products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Tellus Therapeutics, Inc. undertakes no obligation to update any forward-looking statements for any reason.

Corporate Contact:
Jason Kralic, PhD
Tellus Therapeutics, Inc.
jasonkralic@tellustherapeutics.com

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