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.
U.S. biotechs and regulators ushered in the era of gene therapy in 2023, experts at Bio Japan said, but medical reform is needed to pave the way for the “year of cell therapy” in 2024 and implement wider access to ultra-expensive cell and gene therapies.
A patent from Nanjing Mingde New Drug Research Co. Ltd. and Zhangzhou Pientzehuang Pharmaceutical Co. Ltd. details the identification of salts of interleukin-1 receptor-associated kinase 4 (IRAK-4) degradation inducers reported to be useful for the treatment of diffuse large B-cell lymphoma.
Shanghai Fosun Pharmaceutical (Group) Co. Ltd. has patented new tricyclic compounds acting as serine/threonine-protein kinase ATR inhibitors and thus reported to be useful for the treatment of colon cancer.
Adcentrx Therapeutics Inc. has received FDA clearance of its IND application for ADRX-0405 for the treatment of select advanced solid tumors. A first-in-human phase Ia/b trial of ADRX-0405 in patients with select advanced solid tumors, including metastatic castration-resistant prostate cancer, will begin enrollment and dosing this quarter.
Researchers from Kexing Biopharm Co. Ltd. have published details on the development and preclinical characterization of GB18-06, a novel nanobody, also known as variable domain of heavy-chain antibody (VHH), targeting growth differentiation factor 15 (GDF15) and being developed for the treatment of cachexia.
Repeated RNA elements have a virus-like behavior in the cells that express them. Furthermore, they could confer a novel mode of tumor expansion based on changes in cellular states. “About 10 years ago, we had identified that these repetitive elements were highly expressed in pancreas cancer,” co-senior author David Ting, associate professor of medicine and assistant physician at the Mass General Cancer Center at Harvard Medical School, told BioWorld.
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.