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Among a spate of COVID-19-related therapy developments to start the week, Kiniksa Pharmaceuticals Inc. produced positive phase II data of its monoclonal antibody, mavrilimumab, in treating non-mechanically ventilated patients with severe COVID-19 pneumonia and hyperinflammation.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements. George Gao, the director of China’s CDC, stated that Chinese vaccines “don’t have very high protection rates” at the National Vaccines and Health conference in the southwestern city of Chengdu on Saturday.
After climbing nearly 37% since the start of the week, shares of Greenwich Lifesciences Inc. (NASDAQ:GLSI) gained another 6% on April 9 as it disclosed new data bolstering the case for its cancer immunotherapy candidate, GP2. The data, to be presented at the American Association for Cancer Research annual meeting on Saturday, showed that when HER2-positive breast cancer patients had GP2 added to standard-of-care Herceptin (trastuzumab, Roche Holding AG) following breast cancer surgery, no recurrences of their cancer were observed, even after a median follow-up of five years.
CAJICA, Colombia – Following the start of phase III trials for its COVID-19 vaccine, Soberana 02, Cuban researchers have started phase III trials for Abdala (CIGB-66), another vaccine candidate developed in the island country.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Celcuity, Cytodyn, Mersana, Oncoinvent, Redhill, Tenax.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial. The multicenter Inpatient Treatment with Anti-Coronavirus Immunoglobulin trial was sponsored and funded by the National Institute of Allergy and Infectious Diseases. It aimed to demonstrate the drug’s safety, tolerability and efficacy in hospitalized adults at the onset of COVID-19 progression, the companies said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Aurinia, Beigene, BMS, Connect, Eli Lilly, Galderma, Global Blood, GT, Immunitybio, Incyte, Laurent, Merck, Ocuphire, Portage, Secura.
Cambridge, Mass.-based Agios Therapeutics Inc.’s encouraging phase III data from a pair of trials with allosteric activator mitapivat in pyruvate kinase deficiency brought more attention to the space, where Rocket Pharmaceuticals Inc. – at a much earlier stage – is trying a gene therapy called RP-L301.
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