PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS).
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. At the end of November, Chinese regulators gave it a green light to move forward with an open-label, multicenter trial for lemzoparlimab, in combination with azacitidine.
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.
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