Harbour Biomed Ltd. has received FDA clearance of its IND application to commence a phase I trial of HBM-9033 in advanced solid tumors. Developed in collaboration with Medilink Therapeutics (Suzhou) Co. Ltd., HBM-9033 is an antibody-drug conjugate that specifically targets human mesothelin (MSLN), an upregulated tumor-associated antigen in various solid tumors, including mesothelioma, ovarian cancer, lung cancer, breast cancer and pancreatic cancers. The fully human monoclonal antibody in HBM-9033, generated from the Harbour Mice platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN.
Oncusp Therapeutics Inc. has received IND clearance from the FDA to begin clinical trials with CUSP-06, a cadherin-6 (CDH6)-targeting antibody-drug conjugate designed for the treatment of multiple solid tumors. CDH6 is overexpressed in cancers including ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. A phase I trial will pave the way for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Beigene Co. Ltd. has divulged antibody-drug conjugates (ADC) comprising HER3 (erbB3) targeting antibody linked to an effector molecule through a linker reported to be useful for the treatment of cancer, metabolic diseases, neurodegeneration and inflammation.
Jiangsu Hengrui Medicine Co. Ltd. and Shanghai Hengrui Pharmaceuticals Co. Ltd. have disclosed antibody-drug conjugates (ADC) comprising human monoclonal antibodies targeting ROR1 covalently linked to exatecan through a linker. They are reported to be useful for the treatment of cancer.
Mabwell (Shanghai) Bioscience Co. has received approval from China's National Medical Products Administration (NMPA) for its clinical trial application for 7MW-3711 for advanced malignant solid tumors.
Mabwell (Shanghai) Bioscience Co. Ltd. has received clearance by China’s National Medical Products Administration (NMPA) for its clinical trial application for 9MW-2921 for advanced solid tumors.
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimedbio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs.
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs).
Bivictrix Therapeutics plc has released promising final data from a second in vivo efficacy study of its lead clinical candidate BVX-001, a first-in-class Bi-Cygni antibody-drug conjugate (ADC) for the treatment of acute myeloid leukemia (AML).