Eilean Therapeutics LLC has announced clearance by the Human Research Ethics Committee in Australia for a first-in-human phase I trial of balamenib (ZE63-0302), an oral small-molecule inhibitor of the menin-KMT2A interaction.
Creative Medical Technology Holdings Inc.'s Immcelz (CELZ-101) has been awarded orphan drug designation by the FDA. Immcelz is aimed at preventing allograft rejection in patients undergoing pancreatic islet cell transplantation.
Jacobio Pharmaceuticals Group Co. Ltd. has received FDA approval of its IND application for JAB-30300, allowing it begin a phase I/IIa trial in the U.S. in advanced solid tumors.
Ariceum Therapeutics GmbH has received approval from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a phase I trial (CITADEL-123) of 123I-ATT-001, its iodine-123 labeled PARP inhibitor, in patients with recurrent glioblastoma. The study is expected to begin in the U.K. in June of 2024.
Arthex Biotech SL has received FDA clearance to initiate the phase I/IIa Arthemir study of ATX-01 for the treatment of myotonic dystrophy type 1 (DM1).
Clearmind Medicine Inc. has received approval from Israel’s Ministry of Health to initiate a phase I/IIa trial of CMND-100 oral capsules for alcohol use disorder (AUD). The multinational trial in healthy volunteers and AUD subjects will be conducted in Israel and the U.S.
Trawsfynydd Therapeutics Inc. has received approval to initiate a first-in-man phase I trial of the novel best-in-class COVID-19 treatment, TRX-01, an inhibitor targeting the SARS-CoV-2 viral main protease (3CL, Mpro).
Elicera Therapeutics AB has received approval from the Swedish Medical Products Agency to start a phase I/II study of chimeric antibody receptor (CAR) T-cell therapy ELC-301 in patients with refractory or relapsed B-cell lymphoma.
The Foundation for the National Institutes of Health (FNIH) has announced the online publication of the first playbook designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.