Tscan Therapeutics Inc. has received FDA clearance of its IND application for TSC-203-A0201, a T-cell receptor (TCR)-engineered T-cell therapy (TCR-T) targeting preferentially expressed antigen in melanoma (PRAME). PRAME is expressed in melanoma and other solid tumors, including head and neck cancers and non-small-cell lung cancers. TSC-203-A0201 is specific for patients with HLA type A*02:01.

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.

KRAS-mutated tumors were once untreatable. In fact, KRAS was something of a poster child for so-called undruggability. Several laboratories are investigating strategies to address other mutations and uses beyond non-small cell lung cancer (NSCLC) and colorectal cancer. If you can't bind KRAS to block it, use a glue or combine multiple weapons. This is the idea behind two new approaches that target cancers caused by this proto-oncogene.

Xnk Therapeutics AB has entered into a research collaboration with the Karolinska University Hospital to evaluate the suitability of the company's preclinical autologous natural killer (NK) cell therapy candidate XNK-02 as a novel therapy for treatment of acute myeloid leukemia (AML).

Verismo Therapeutics Inc. has entered into a licensing agreement with the University of Pennsylvania for worldwide exclusive rights for two newly discovered anti-CD19 binders, the result of a sponsored research agreement between the two parties.

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.

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.