Canariabio Inc.'s MAb-AR20.5 has been awarded orphan drug designation by the FDA for pancreatic cancer. MAb-AR20.5 is an IgG1k type murine monoclonal antibody that binds specifically to the circulating and tumor-associated antigen (MUC1) expressed on pancreatic cancer cells.
Boston Immune Technologies and Therapeutics Inc. (BITT) has received IND clearance from the FDA for a first-in-human trial of BITT-2101, a monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2), in patients with relapsed or refractory non-Hodgkin lymphomas (NHLs).
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.