Zumutor Biologics Inc. has received FDA clearance of its IND application for ZM-008 to enter a first-in-human phase I study for the treatment of multiple solid cancers. A phase I study is anticipated to begin in the fourth quarter, and will include evaluation of ZM-008 followed by pembrolizumab.
Cessation Therapeutics Inc. has obtained IND clearance from the FDA to initiate a first-in-human trial of CSX-1004 for the prevention of fentanyl overdose. The trial in healthy volunteers is expected to begin next month.
Newly formed Mage Biologics Inc. is set to receive investment of $28 million from TVM Capital Life Science and Tillotts Pharma AG. Mage plans to advance to clinical proof of concept a novel, orally administered, humanized monoclonal antibody (MAb) for an initial indication of ulcerative colitis.
The U.S. Department of Defense (DOD) has awarded Evotec SE’s subsidiary Just-Evotec Biologics Inc. a contract valued up to US$74 million for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting orthopoxviruses.
Zymedi Co. Ltd. has signed a clinical cooperative research and development agreement (CRADA) with the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), to develop ZMA-001 for the treatment of pulmonary arterial hypertension (PAH).
Domain Therapeutics SA has nominated a novel drug candidate, DT-7012, an anti-CCR8 monoclonal antibody depleting tumor-infiltrating regulatory T cells (Tregs).
CSPC Pharmaceutical Group Ltd. has announced clinical trial approval by China’s National Medical Products Administration (NMPA) for the antibody drug JMT-203, being developed by the company’s Shanghai JMT-Bio Technology Co. Ltd. subsidiary for cancer cachexia.
Iaso Biotechnology Co. Ltd. has received FDA approval of the company’s IND application for IASO-782 injection for use in U.S. clinical trials for autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (AIHA).
Alentis Therapeutics AG has received FDA clearance of the company’s IND application for ALE.C04, a first-in-class monoclonal antibody developed to specifically target exposed Claudin-1 (CLDN1) on cancer cells.
RSS
