NanoNewron, a biotechnology company developing innovative biologics for central nervous system diseases, has been awarded a $2.5 million NIH STTR Phase 2 grant to advance its NN-840 program targeting Alzheimer's disease. The non-dilutive funding will support IND-enabling studies for the company's TNF-alpha inhibitor designed to cross the blood-brain barrier, with an Investigational New Drug application submission expected next year.
Breakthrough Blood-Brain Barrier Technology
The NN-840 program represents a novel approach to treating Alzheimer's disease by combining potent TNF-alpha inhibitor antibodies with NanoNewron's proprietary NewroBus™ technology. This innovative humanized nanobody targets transferrin receptor 1 (TfR1) to enable efficient transcytosis across the blood-brain barrier, dramatically enhancing the delivery of biologic therapeutic agents to the central nervous system.
"At NanoNewron, we believe that TNF-α plays a key pathogenic role in Alzheimer's," said Luciano D'Adamio, PhD, MD, Professor at Rutgers University and Chief Scientific Officer of NanoNewron. "We developed potent TNF-alpha inhibitor antibodies to be used to treat Alzheimer's and, since these antibodies cannot cross the blood-brain barrier by themselves, we combined them with our NewroBus™ technology."
Promising Preclinical Results
The NN-840 compounds have demonstrated encouraging results in animal models when administered subcutaneously, showing high inhibition of TNF-alpha activity inside the brain with excellent tolerability. These bi-functional humanized nanobodies combine robust TNF-alpha inhibitory activity with blood-brain barrier permeability, targeting neuroinflammatory pathways after efficiently crossing into the brain.
"This breakthrough could finally allow targeted biologics to reach the brain in effective concentrations, something that has long limited progress in Alzheimer's research," D'Adamio explained.
Addressing Unmet Medical Need
The grant award validates NanoNewron's innovative approach to addressing the significant unmet need in Alzheimer's disease treatment. Current therapies only offer temporary symptom improvements and modest cognitive decline slowdown, according to company leadership.
"There is still a dire need for more effective treatments for Alzheimer's Disease. Despite decades of research, the current treatments only offer temporary improvements in symptoms and just a modest slowdown of cognitive decline," said Dr. Marco Taglietti, Chief Executive Officer of NanoNewron. "The product and the underlying technology developed at NanoNewron promise to transform the treatment of Alzheimer's in the same way that TNF-alpha inhibitors transformed the treatment of systemic inflammatory diseases such as Crohn's Disease or Rheumatoid Arthritis."
Academic-Industry Collaboration
The STTR mechanism strengthens the collaboration between NanoNewron and Rutgers University, where the initial research was conducted with funding from a previous STTR Phase I NIH grant. The company was founded by Dr. D'Adamio, who holds the Herbert C. and Jacqueline Krieger Klein Endowed Chair at Rutgers University since 2017.
"Dr. D'Adamio's innovations have the potential to make a positive impact for so many families around the world, and it's another example of the contribution and commitment of Rutgers University to advance the treatment of serious diseases," said Deborah Perez Fernandez, PhD, MBA, executive director of the Office for Research Technology Transfer unit of Rutgers University.
Development Timeline and Next Steps
The NN-840 compounds are currently advancing through preclinical evaluation in humanized models, with IND-enabling studies now beginning. The company expects to submit its Investigational New Drug application next year, representing a critical milestone toward clinical trials for this potential game-changing treatment for Alzheimer's disease and other CNS neurodegenerative conditions characterized by elevated TNF-alpha levels.
