Fibrogen Inc. has received IND clearance from the FDA allowing the company to initiate a phase I trial of FG-3165, a galectin-9 (Gal9)-targeted monoclonal antibody under development for treatment of solid tumors characterized by high levels of Gal9 expression.
Avirmax Biopharma Inc. has received IND approval from the FDA to initiate a phase I/IIa trial for its gene therapy treatment targeting wet age-related macular degeneration (AMD), including polypoidal choroidal vasculopathy (PCV).
Gyre Therapeutics Inc. has announced IND clearance for Gyre Pharmaceuticals’ F-230 tablets by China’s National Medical Products Administration (NMPA). F-230 is a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).
Actym Therapeutics Inc. has obtained IND clearance from the FDA to begin a phase I trial of ACTM-838. The first-in-human study will enroll patients in the U.S. and Australia with advanced solid tumors who have failed prior lines of therapy and have no clinically beneficial treatment options.
Full-Life Technologies Ltd. has received IND clearance by the FDA, allowing it to conduct clinical trials of 225Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer.
Georgiamune Inc. has gained FDA clearance for its IND application for GIM-531, a first-in-class oral regulatory T cell (Treg) inhibitor that enables the restoration of a strong immune response against cancer.
JJP Biologics Sp. z o.o. has received clearance from the EMA to conduct a first-in-human study of its CD89 antagonist, JJP-1212, for IgA-mediated autoimmune and fibrotic diseases. A phase I study in healthy participants will be conducted in Poland.
Be Biopharma Inc. has announced the FDA’s clearance of its IND for BE-101, an autologous potentially first-in-class B-cell medicine in development for the treatment of hemophilia B.
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