LONDON – Stopping people under 40 from receiving Astrazeneca plc’s COVID-19 vaccine has put an end to the serious blood-clotting syndrome associated with the product, with no new cases in the U.K. for the past four weeks, according to an expert panel of hematologists.
Sinovac Biotech Ltd. said booster shots of its Coronavac vaccine against SARS-CoV-2 induce strong immune responses in adult and elderly populations following a considerable loss of antibodies six to eight months after completing the current two-dose regimen.
SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.
Fulcrum Therapeutics Inc. shares (NASDAQ:FULC) closed at $18.77, up $10.44 or 125%, on word of positive interim results from a phase I trial in healthy adult volunteers with oral FTX-6058 for sickle cell disease (SCD). The firm has “already achieved maximal target engagement [MTE] at all three doses,” said Christopher Morabito, the company’s chief medical officer. “I don’t think we’ll exceed that.”
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Athersys, Dicerna, Healios, Innovent, Neurocrine.
While Aprea Therapeutics Inc.’s data disclosed July 21 from the phase II trial with eprenetapopt – also known as APR-246, a reactivator of mutant tumor suppressor protein p53 – plus azacitidine (AZA) whetted interest in taking aim at the “guardian of the genome,” the company’s fortune took an unexpected turn when the FDA smacked a partial clinical hold on work with the duo.
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