Pharmabcine Inc. has received approval from the human research ethics committee (HREC) in Australia for a phase Ia/b trial of PMC-309, a monoclonal antibody against the human V-domain Ig suppressor of T-cell activation (VISTA) ligand.
Insilico Medicine Inc. struck an out-licensing deal with Exelixis Inc. for its small-molecule USP1-inhibitor candidate called ISM-3091, the company said on Sept. 12, standing to gain $80 million in up-front payments.
Hanchorbio Inc. and Shanghai Henlius Biotech Inc. have entered into a strategic framework agreement for collaboration to combine Hanchorbio’s protein engineering expertise and proprietary Fc-based designer biologics (FBDB) technology platform with Henlius’ integrated product development and commercialization capabilities.
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.
Ideaya Biosciences Inc. has announced FDA clearance of an IND for a GSK-sponsored phase I/II trial of GSK-101 (IDE-705), a small-molecule inhibitor of Polϴ helicase, in combination with GSK's PARP inhibitor niraparib tosylate monohydrate for the treatment of tumors with BRCA or other homologous recombination mutations or homologous recombination deficiency.
As a cytokine used in the field of immuno-oncology, interleukin-2 (IL-2) can produce durable and even complete responses in some patients, as well as induce immune memory against tumors. However, its rapid metabolism within the body means it has a short serum half-life, so it needs to be given in high doses, which can trigger severe side effects.
Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.
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.
Interleukin-4 (IL-4) plays an important role in regulating inflammation. While several antibody-based options targeting IL-4 have been reported, strategies based on small molecule inhibitors have proven difficult to find.
