Pierre Fabre Laboratories (Pierre Fabre SA) has filed an IND application to the FDA to initiate a first-in-human trial with PFL-002 (VERT-002) for solid tumors, including non-small-cell lung cancer (NSCLC).
Bluesphere Bio Inc. has received FDA clearance of its IND application for BSB-1001 for patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia and myelodysplastic syndromes, in conjunction with allogeneic hematopoietic stem cell transplantation (alloHSCT).
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).
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.
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.
Abdera Therapeutics Inc. has received FDA clearance of its IND application for ABD-147, the first δ-like ligand 3 (DLL3)-targeting radiopharmaceutical for the treatment of small-cell lung cancer (SCLC) and large-cell neuroendocrine carcinoma.