In work at Shanghai Curegene Pharmaceutical Co. Ltd., synthesis and optimization of a series of SARS-CoV-2 3CL protease (3CLpro, Mpro) inhibitors led to the identification of compounds [I], [II] and [III] as lead candidates suitable for further evaluation, based on their enzymatic IC50s (14, 12 and 8.6 nM, respectively), cellular EC50s (36, 26 and 52 nM, respectively) and human liver microsome (HLM) stability.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amplia, Apellis, Biocon, Biotech, Ipsen, Janssen, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Samsung Bioepis, Sanofi.
Details on the work leading to the discovery of the second-generation SARS-CoV-2 main protease (Mpro) inhibitor PF-7817883 (ibuzatrelvir) were disclosed recently by Pfizer Inc. The drug is in phase II clinical development for the treatment of adult individuals with COVID-19 symptoms who are not hospitalized.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.
Insilico Medicine Inc. has synthesized 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
The State University of New Jersey (Rutgers) has synthesized non-structural protein 3 (nsp3; PL-pro) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of viral infections.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon.
Moderna Inc.’s shares (NASDAQ:MRNA) sank 19% to a $64.11 low in early trading Sept. 12 as investors learned during the annual R&D Day event of a $1.1 billion reduction to R&D and the U.S. FDA’s reluctance to support an accelerated approval filing for its individualized neoantigen therapy for melanoma.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Arecor, Apollomics, Avistone, Briacell, Biogen, Biothera, Bridgebio, Eli Lilly, Eupraxia, GSK, Hightide, Innovent, Johnson & Johnson, Merck, Oneness, Regeneron, Sanofi, Telix.
Ascletis Bioscience Co. Ltd. has patented nucleoside and nucleotide analogues reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
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