Tonix Pharmaceuticals Holding Corp. has received FDA clearance of its IND application to support a phase I trial with TNX-1500, an anti-CD40L monoclonal antibody. The first indication Tonix is seeking for TNX-1500 is the prevention of organ rejection in patients receiving a kidney transplant. Enrollment in the phase I study is expected to open in the third quarter of this year.
Mabwell (Shanghai) Bioscience Co. Ltd. has received approval of its IND application from Australia's Therapeutic Goods Administration (TGA) for 9MW3811 injection for tumors and pulmonary fibrosis.
Cessation Therapeutics Inc. has announced outcomes of a new study demonstrating that its anti-fentanyl monoclonal antibody treatment, CSX-1004, may provide robust and durable protection from life-threatening respiratory depression caused by high doses of fentanyl. The findings come from the company’s ongoing series of proof-of-concept studies in nonhuman primates.
Glypican 3 (GPC3) is overexpressed in hepatocellular cancers (HCC), even at very early stages. In contrast, GPC3 is not expressed in normal adult organs. One strategy in place for HCC consists in co-targeting GPC3 and CD3 with bispecific antibodies to activate the latter in order to attack GPC3-positive cancer cells.
Tonix Pharmaceuticals Holding Corp. has exercised an option to obtain an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies for the treatment or prophylaxis of SARS-CoV-2 infection.
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