LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has given approval for the first-in-human study of Codagenix Inc.’s COVI-VAC, a live, attenuated whole virus COVID-19 vaccine, which is engineered to be structurally identical to wild-type SARS-CoV-2, but is much slower to replicate.
The Sanofi SA-Glaxosmithkline plc COVID-19 vaccine program is taking a step backward to recalibrate as weak interim phase I/II data showed an insufficient response in patients age 50 and older. The step is a large one, delaying a potential launch until mid-2021 at the earliest and the end of next year at the latest.
Wall Street seemed to respond with thumbs down to positive data from the phase II study called Vadis with Sellas Life Sciences Group Inc.’s nelipepimut-S (NPS, or NeuVax) in breast ductal carcinoma in situ (DCIS), but the apparent reaction likely had little to do with the trial findings.
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.
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