For the first time since August, the volume of clinical data has dipped, with 388 items of phase I, II and III data in November, a 4% decrease compared with the prior month. Again, 17% of the entries during the month are focused on vaccines and therapeutics to fight the SARS-CoV-2 virus. The same percentage held true in October. The pandemic accounted for 16% of the clinical data in September, 15% in August and 16% in July.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akari, Geron, Greenwich Lifesciences, Mitsubishi Tanabe, Prevail, Puma, Puretech Health, Scyneis, Sellas Life Sciences, Tychan.
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.
Suzhou, China-based Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of its angiogenesis inhibitor, GT-90001 (ascrinvacumab), and Opdivo (nivolumab) for advanced hepatocellular carcinoma (HCC) after preliminary data showed 40% of patients given the combo so far had partial remissions.
Both phase III studies of ublituximab, an anti-CD20 monoclonal antibody from TG Therapeutics Inc., of New York, met their primary endpoints of significantly reducing the annualized relapse rate in multiple sclerosis (MS) patients. Company stock (NASDAQ:TGTX) received a solid bump Dec. 10 as shares closed 40.85% higher at $41.72. T
New five-year breast cancer survival data from Greenwich Lifesciences Inc. ignited its stock for a wild ride that climbed nearly 1,000% upward Dec. 9, marking one of the biotech sector’s biggest single-day gains in 2020.
Wall Street is liking the prospects of Neurocrine Biosciences Inc.’s NBI-827104, in the rare pediatric indication called epileptic encephalopathy with continuous spikes and waves during sleep. San Diego-based Neurocrine is moving the orally active, brain-penetrating T-type calcium channel blocker, licensed from Idorsia Ltd., of Allschwil, Switzerland, into phase II trials.
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