1ST Biotherapeutics, Inc., Announces FDA Clearance of IND Application for Phase 1/2 Study of FB849 to Treat Patients with Advanced Solid Tumors
– Initiation of Phase 1/2 Clinical Trial Expected in Q1, 2023
1ST Biotherapeutics, Inc., a clinical-stage biotechnology company focused on the development of novel small molecule therapeutics in neurodegenerative diseases, immuno-oncology, and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate FB849, a small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with advanced solid tumors. Harnessing multiple components in the immune system while avoiding interfering with essential immune function is a significant challenge in immuno-oncology. FB849 as a highly selective HPK1 inhibitor has the potential to overcome these challenges.