FDA Grants Clearance of IND Application to TB006 Alzheimer’s Disease (AD) Treatment
04/23/2021
TrueBinding, Inc. announced on April 23, 2021 that the U.S. Food and Drug Administration (FDA) has granted clearance of the Investigational New Drug (IND) application to proceed with the clinical development of its lead product candidate, TB006, for the treatment of Alzheimer’s Disease. The TB006 treatment aims to reduce the aggregation of amyloid-β (Aβ) and tau proteins and to mitigate neuroinflammation, which contribute to the manifestation of Alzheimer’s Disease. TrueBinding, Inc. will expect to initiate the Phase I Trial for TB006 in healthy volunteers in the Summer of 2021 (NCT04920786).
Dr. Dongxu Sun, CEO of TrueBinding, stated, “We are proud to achieve another important milestone for TB006. TB006 has shown promising potential to mitigate Alzheimer’s Disease in animal model studies, and we believe that TB006 can provide better treatment options to AD patients.”
About TB006
TB006 is a monoclonal antibody against Galectin-3, a novel drug target discovered by TrueBinding, Inc. In pre-clinical evaluations, Galectin-3 was shown to intrinsically promote the aggregation of Aβ and Tau proteins. In AD in vivo model studies, TB006 showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance, which show potential therapeutic effect of TB006 in addressing underlying pathology and ameliorating the course of AD.
About Alzheimer’s Disease
Alzheimer’s Disease (AD) is a chronic progressive neurodegenerative disorder and is the leading cause of dementia among older adults.[1] AD is hypothesized to be caused by toxic oligomers in the brain involving two major proteins, amyloid beta (Aβ) and tau.
Abnormal tau aggregates to form neurofibrillary tangles (NFT). Aβ also aggregates and accumulates between neurons.[2] Glial cells, particularly microglia are considered a major source of proinflammatory molecules correlated to the propagation of neuroinflammation. Galectin-3 is involved in the sustained release of proinflammatory molecules, such as cytokines and chemokines which contribute to the toxic environment in the brain that drives the progression of AD [3].
About TrueBinding, Inc.
TrueBinding Inc. is a clinical stage biotherapeutics development company focused on creating molecules for applications in immuno-oncology and other disease areas with unmet medical needs, such as neurological disorders and neurodegenerative diseases. TrueBinding has discovered novel, uncharacterized ligands to receptors of known checkpoint inhibitor pathways for potential therapeutic development.
For more information, please visit https://www.truebinding.com/
References
1. Centers for Disease Control and Prevention. Clinical Care Guidance
2. National Institute on Aging. Alzheimer’s Disease Fact Sheet. 2019.
3. Boza-Serrano, A., Ruiz, R., Sanchez-Varo, R. et al. Galectin-3, a novel endogenous TREM2 ligand, detrimentally regulates inflammatory response in Alzheimer’s disease. Acta Neuropathol. 2019; 138:251–273. DOI:10.1007/s00401-019-02013-z