A top-line Alzheimer's trial readout, once expected to catalyze value for the Vtv Therapeutics Inc. candidate azeliragon this year, instead hurried a 22.6% decline in company shares (NASDAQ:VTVT) to $2.30 after the phase II study found the drug yet again failed to deliver a statistically significant difference in cognitive decline vs. a placebo in people with mild probable Alzheimer’s disease (AD) and type 2 diabetes (T2D).
Positive results from the triple-combination arm of Biolinerx Ltd.’s phase IIa study of motixafortide as a combination therapy in incredibly tough-to-handle stage IV pancreatic cancer point toward a next study, yet the stock took a battering.
DUBLIN – Could a tyrosine kinase inhibitor approved for treating canine cancer offer clinical benefits in Alzheimer’s disease? That’s the bold claim AB Science SA is making, after unveiling top-line data from a phase IIb/III trial in which it reported that a subgroup of patients on a twice daily 4.5-mg/kg dose of oral masitinib experienced “a significant treatment effect” as compared with placebo after 24 weeks.
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway.
New approaches to trials, digitalization and the effective use of technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and devices are developed.
Three months after completing what it said was the largest development and commercialization deal by a Chinese biotech, I-Mab Biopharma Co. Ltd. is moving the monoclonal antibody at the heart of the deal deeper into the clinic.
Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of GT-90001 (ascrinvacumab) and Opdivo (nivolumab) for advanced hepatocellular carcinoma.
Australian biopharma Immutep Ltd. saw its stock price jump 165% Dec. 10, as the company reported that adding its eftilagimod alpha (IMP-321, “efti”) to paclitaxel resulted in what the company called a “promising and improving” trend toward increased overall survival in women with metastatic hormone receptor-driven breast cancer.
PERTH, Australia – The University of Queensland (UQ) and CSL Ltd. are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase I trials. The response means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However, there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present, the partners said.
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