Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
After raising $42 million in a series C1 round, Lanova Medicines Ltd. is advancing its lead phase III antibody-drug conjugate LM-302 that targets Claudin 18.2, as well as LM-299, an anti-PD-1/VEGF bispecific antibody, and LM-108, an anti-CCR8 monoclonal antibody. “Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in phase I clinical trials with best-in-class potential,” Lanova founder and CEO Crystal Qin said.
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.
Jiangsu Hengrui Medicine Co. Ltd. and Shanghai Hengrui Pharmaceutical Co. Ltd. have disclosed new GTPase KRAS (G12D mutant) inhibitors reported to be useful for the treatment of cancer.
The anti-HER2 biparatopic antibody (bpAb) KJ-015 was rationally designed at Shanghai Bao Pharmaceuticals Co. Ltd. by leveraging published antibody-antigen structures to share common light chain with two Fab arms, resulting in functionally balanced high affinity for two HER2 nonoverlapping epitopes.
Investigators from the University of Michigan and affiliated organizations published data from a study that aimed to investigate the role of cyclin-dependent kinase 12 (CDK12) in prostate cancer (PCa). Both in vivo and in vitro systems were developed to test the impact of Cdk12 ablation in the context PCa.
Starting with a study of how mutations affect sensitivity to 10 molecularly targeted drugs, researchers have laid the foundations for a prospective, systematic approach to understanding the genetic mechanisms behind cancer drug resistance. These insights will inform the development of drugs that avoid resistance emerging. For existing drugs, it will be possible to better tailor treatment and to identify second-line therapies for patients whose tumors become resistant.
Astellas Pharma Inc. gained U.S. FDA approval of first-in-class claudin 18.2-targeted treatment Vyloy (zolbetuximab-clzb), now indicated as a first-line therapy for adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
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