Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices.
Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer.
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
Shenzhen Zhongge Biotechnology Co. Ltd. has divulged stimulator of interferon genes protein (STING; TMEM173) agonists reported to be useful for the treatment of cancer, Alzheimer’s disease, pulmonary fibrosis, heart failure, infections, psoriasis, Sjögren’s syndrome and systemic lupus erythematosus, among others.
Shenzhen Genuine Biotech Co. Ltd. has disclosed tyrosine-protein phosphatase non-receptor type 11 (PTPN11; PTP-2C; SHP-2) allosteric inhibitors reported to be useful for the treatment of cancer.
OS Therapies Inc. has announced the development and in vitro concept data for two novel tunable antibody-drug conjugate (tADC) therapeutic candidates leveraging the company’s proprietary Silinker technology.
UL16 binding protein 6 (ULBP6) is a molecule belonging to the stress-induced NKG2D ligand family and its expression is up-regulated on the surface of cancerous cells, binding to the immune-activating NKG2D receptor on natural killer (NK) and T cells, thus promoting immune evasion.
The University of Michigan has published details on the discovery and preclinical characterization of a new potent and selective proteolysis targeting chimera (PROTAC) degrader of BRD9, CW-3308. Synthesis and optimization of two different cereblon ligands led to the discovery of a novel series of highly potent BRD9 degraders, with CW-3308 selected as the lead candidate.
Metastatic solid tumors may be curable now. Among the most profound results presented over the weekend at the European Society for Medical Oncology (ESMO) 2024 Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma.
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