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.

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.

Anaveon AG has received FDA approval of its IND application to conduct a phase I/II study of ANV-600.

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.

The FDA has cleared an IND application for GC-1130A, a treatment for mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome type A) being jointly developed by GC Biopharma Corp. and Novel Pharma Inc.

Verismo Therapeutics Inc. has received IND clearance from the FDA to conduct a phase I trial with Synkir-310 for non-Hodgkin lymphoma (NHL).

Ajax Therapeutics Inc. has received clearance for its IND application from the FDA to initiate a phase I study of AJ1‑11095, a first-in-class type II JAK2 inhibitor, for the treatment of patients with myelofibrosis.

Biotheryx Inc. has gained FDA clearance for its IND application for BTX-9341, a novel cyclin-dependent kinase 4/6 (CDK4/6) bifunctional degrader.