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.
DUBLIN – Shares in Pluristem Therapeutics Inc. were down 40% by midday Dec. 9 on news that it was terminating a pivotal phase III trial of its allogeneic, placenta-derived cell therapy, PLX-PAD, in critical limb ischemia (CLI), following a futility analysis, which concluded that the study would be unlikely to meet its primary endpoint.
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