Results of a futility analysis prompted Regeneron Pharmaceuticals Inc. to continue the phase III study of its virus-neutralizing monoclonal antibodies, a REGN-10933 and REGN-10987 cocktail for treating hospitalized COVID-19 patients who are seronegative and need low-flow oxygen.
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus. Volunteers who received the vaccine in the phase III experiment produced high-tier antibodies, with a neutralizing antibody positive conversion rate of 99.52% after two doses, the company said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Chiesi, Codiak, Emergent, Hepion, Lipocine, Neurorx, Nicox, Protalix, Regeneron, Sinopharm.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Arcturus, Intra-Cellular, Nanology, VBL.
Shares of Aprea Therapeutics Inc. (NASDAQ:APRE), a company focused on developing therapies that reactivate the mutant tumor suppressor protein p53, fell 78.1% to $5.50 on Dec. 28, just north of its cash balance, after a pivotal trial of its lead candidate missed its endpoint, leaving the asset's future hazy and likely scuttling plans the company had for a first quarter 2021 NDA filing.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Algernon, Aprea, Gannex, Inovio, Lysogene, Novavax, Taiwan Liposome.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Dynavax, Evaxion, Macrogenics, Modag, Oramed, Palvella, Rakuten, Revive, Serum Institute of India, Spectrum, Supernus.
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd.
HONG KONG – Shanghai Junshi Biosciences Co. Ltd.’s toripalimab has reached its prespecified primary endpoint of progression-free survival at the interim analysis of a phase III study in non-small-cell lung cancer (NSCLC), as efforts to expand approval of the anti-PD-1 antibody into other cancer types are underway.
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