Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function.
China’s Center for Drug Evaluation has cleared Jacobio Pharmaceuticals Group Co. Ltd.’s KRAS G12C inhibitor, glecirasib (JAB-21822), to begin a phase III pivotal study for pancreatic cancer.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
The trophoblast cell surface antigen 2 (TROP2) class chalked mix news by way of Astrazeneca plc and Daiichi Sankyo Co. Ltd. as the pair disclosed phase III data from the closely watched Tropion-Lung 1 trial with datopotamab deruxtecan (dato-dxd) against non-small-cell lung cancer.
Microba Life Sciences Ltd. has started dosing patients in a phase I trial of its gut microbiome-derived therapeutic, MAP-315, for ulcerative colitis, the major form of inflammatory bowel disease (IBD).
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
Aslan Pharmaceuticals Pte. Ltd. announced variegated results from its phase IIb TREK-AD trial testing eblasakimab, its biologic tested for moderate to severe atopic dermatitis (AD), that drew an equally mixed reaction from the market.
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