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.
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.
Virus is associated with sickness, but oncolytic virus therapies, which harness viruses to attack and kill cancer cells, may soon change the standard of treatment for cancer, including those long deemed uncurable like malignant glioma.
Ligachem Bioscience Inc., of Daejeon, South Korea, and Osaka, Japan-based Ono Pharmaceutical Co. Ltd. agreed to two antibody-drug conjugate (ADC) deals that could reach $700 million (₩943.5 billion) combined.
Immunotherapy company Cartherics Pty Ltd. raised AU$15 million (US$10.3 million) in an oversubscribed series B round that will support the first clinical trial for lead chimeric antigen receptor natural killer therapy CTH-401 for ovarian cancer, and to expand its pipeline to include other diseases.
Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China.
Investigators at Nanjing Medical University and The University of Texas MD Anderson Cancer Center recently published data from their research that aimed to identify novel immunotherapy targets in triple-negative breast cancer (TNBC).
Research into the regulation of gene expression experienced a significant breakthrough with the discovery of microRNA, small RNA molecules that do not code for proteins but control their translation. This finding has earned its authors Victor Ambros and Gary Ruvkun the 2024 Nobel Prize in Physiology or Medicine.
One of Australia’s newest biotech investment funds is set to triple investments on the back of its success and strong investor demand. The three-year old Merchant Biotech Fund (MBF) invested in several high growth ASX-listed and private life sciences companies and finished the past financial year up more than 70%. It is up 10% for the current financial year, Portfolio Manager Reece O'Connell told BioWorld.
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
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