Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection (CDI) are “about as good as it gets” in the tough-to-treat patient population.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anaptysbio, Avadel, Axsome, BMS, Eli Lilly, Enlivex, Genentech, Humanigen, Innovent, Kamada, Krystal, Logicbio, Ovid, Pharming, Precigen, Rhovac, Seres.
HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. has obtained positive top-line data in its phase III study of a combination of Opdivo (nivolumab, Bristol Myers Squibb Co.) and bevacizumab in lung cancer patients.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Cstone, Everest, Ligand, Oncolys, Oncopeptides, Roche, Satsuma.
While privately held Levo Therapeutics Inc.’s phase III study of LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS) failed to meet its primary outcome measurements, the company’s CEO told Bioworld the first secondary endpoint showed a statistical significance that raised her hopes the FDA might approve the selective oxytocin-receptor agonist for the indication.
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
With Glaxosmithkline plc (GSK) having sailed through an FDA advisory panel meeting July 14 centered on its belantamab mafodotin (belantamab), an antibody-drug conjugate (ADC) for multiple myeloma (MM), others in the B-cell maturation antigen (BCMA) space such as Legend Biotech Corp. are further piquing Wall Street’s interest.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is rapidly advancing CT-P59, its antiviral antibody treatment for the COVID-19 virus, after receiving its second green light to begin phase I trials.
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