March 15, 2021 – SAN DIEGO, California
TrueBinding, Inc. announced on March 9th, 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 reducing the severity of underlying diseases in COVID-19. The TB006 treatment aims to decrease the potential acute severe deterioration in ambulatory COVID-19 patients with underlying diseases, such as diabetes, cardiovascular disease (hypertension), and cancer. TrueBinding, Inc. will expect to initiate the Phase I Trial for TB006 in patients with mild to moderate COVID-19 disease in the Spring of 2021.
Dr. Dongxu Sun, CEO of TrueBinding stated, “we are proud to achieve this important milestone despite the ongoing COVID-19 pandemic. TB006 has shown promising potential to mitigate severity of COVID-19 and underlying diseases in nonclinical studies, and we hope that TB006 can help provide better treatment options to patients with COVID-19.”
Dr. Qinhua Cindy Ru, managing director of CRC Oncology stated, “the IND clearance of TB006 marks our first regulatory milestone of our collaboration with TrueBinding, and we look forward to expanding the development of TB006.”
TB006, a monoclonal antibody, is an anti-inflammatory and anti-fibrotic agent that was developed by TrueBinding, Inc. In pre-clinical evaluations, TB006 showed promising capabilities in modulating the host immune response, reducing the post-infectious incidence of pulmonary fibrosis, which could mitigate the risk of adverse in COVID-19 patients with underlying comorbidities, including diabetes and cardiovascular diseases such as hypertension.
COVID-19 is a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a strain of virus belonging to the coronavirus family. COVID-19 can range from mild to severe disease, the latter including pneumonia, severe acute respiratory syndrome, multi-organ failure, and death. In a clinical study conducted in 44,000 COVID-19 patients, 81% experienced mild to moderate symptoms, 14% experienced severe symptoms, and 5% experienced critical symptoms.
About TrueBinding, Inc.
TrueBinding Inc. is an early 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 www.truebinding.com.
About CRC Oncology
CRC Oncology is a contract research organization (CRO) focused on reshaping the global landscape of innovative drugs and therapies for cancer treatment. CRC Oncology provides high quality development and research services by strategically driving global regulatory submissions, authoring quality eCTD dossiers, leading US clinical development, advancing quality management expertise, building and maintaining a 24/7 audit trail, providing full GxP compliance master quality management systems, and bridging global business development needs.
For more information, visit www.crconc.com.
1. U.S. Food and Drug Administration. COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. 2021, May. Retrieved from https://www.fda.gov/media/137926/download
2. Centers for Disease Control and Prevention. Clinical Care Guidance. https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html