HCW Biologics Inc. has received clearance of its IND application from the FDA to initiate a first-in-human phase I trial to evaluate HCW-9302 in patients with moderate to severe alopecia areata.
Ocugen Inc. has received IND clearance from the FDA for OCU-500, an inhaled mucosal vaccine for COVID-19. The National Institute of Allergy and Infectious Diseases (NIAID) will sponsor and conduct a phase I trial of OCU-500 administered via inhalation into the lungs and intranasally as a spray.
To realize the promise of cell therapy for neurodegenerative disorders, S.Biomedics Co. Ltd. is looking to expand clinical trials of TED-A9, its stem cell therapy for Parkinson’s disease (PD), to the U.S., having reaped positive results from a domestic phase I/IIa trial in November 2024.
Axcynsis Therapeutics Pte Ltd. has gained IND clearance from the FDA for AT03-65 for the treatment of patients with CLDN6-positive solid tumors. Axcynsis is planning to initiate a phase I trial in the U.S. during the current quarter in patients with advanced CLDN6-positive solid tumors.
Quanta Therapeutics Inc. has gained IND clearance from the FDA for QTX-3544, an oral multi-KRAS inhibitor with G12V-preferring activity and dual ON/OFF state.
Simcere Zaiming Pharmaceutical Co. Ltd. has announced clinical trial approvals in China and the U.S. for its CDH6-targeting antibody-drug conjugate (ADC), SIM-0505, for advanced solid tumors. A global clinical study will evaluate SIM-0505 in various malignant tumors, including ovarian cancer and renal cancer.
Epirium Bio Inc. has obtained IND clearance from the FDA for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin dehydrogenase (15-PGDH) enzyme inhibitor.
RSS
