HFB200604 / HiFiBiO - LARVOL DELTA

Application of HiFiBiO Drug Intelligence Science (DIS®) Translational Platform to Guide the Clinical Development of HFB200604, a Phase I BTLA Agonist Monoclonal Antibody (FOCIS 2025) - "HFB200604 clinical evaluation is guided by DIS® single immune cell profiling of autoimmune diseases and focused on indications with reduced HVEM expression and BTLA signaling, where deregulated BTLA function can be restored through BTLA agonism. Based on the enrichment of a BTLA activation signature, we have prioritized autoimmune diseases where B and T cells exhibit lower levels of pathway activation.In conclusion, DIS® interrogation of patient datasets supports HFB200604 as a promising therapy to treat autoimmune diseases where BTLA suppressive functions are not fully engaged."

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Immunology • Inflammatory Arthritis • Lupus • BTLA • IFNG • IL17A • TNFA

HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200604, a Best-in-Class BTLA Agonist Antibody for the Treatment of Inflammatory and Immunology Diseases (Businesswire) - "HiFiBiO Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604....HiFiBiO plans to begin a single ascending dose (SAD) Phase 1 clinical study in a healthy volunteer cohort, followed by a multiple ascending dose (MAD) study in patients with selected inflammatory and immunology diseases identified through the HiFiBiO DIS platform."

IND • Immunology

HiFiBiO Therapeutics to Present Phase 1 Clinical Trial Data for Two Novel Immuno-Oncology Antibodies at the 2024 Annual Congress of the European Society for Medical Oncology (HiFiBiO Press Release) - "HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO), taking place September 13-17 in Barcelona, Spain....The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069)....HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September."

IND • P1 data • Immunology • Inflammation • Solid Tumor