Dose-limiting toxicities in a phase I/II study led Theseus Pharmaceuticals Inc. to quit work with lead compound THE-630, a pan-variant KIT Inhibitor for gastrointestinal stromal tumors (GIST), but the company plans to nominate another such candidate in the same indication during the first half of 2024. Meanwhile, the firm is prioritizing THE-349, a fourth-generation EGFR inhibitor for non-small-cell lung cancer, due for an IND application in the fourth quarter of this year.
Lifetech Scientific Corp.’s fully degradable iron-based absorbable coronary scaffold showed its safety and efficacy to treat non-complex coronary lesions that have not been previously treated with an interventional device during a three-year, first-in-humans trial.
Although shares of TG Therapeutics Inc. took a hit on word of positive phase III data in multiple sclerosis (MS) from competitor Genentech, a unit of Roche Holding AG, the results may not end up affecting much the market showdown between the CD20 players.
First Wave Biopharma Inc. is taking apart the top-line data from its phase II study of adrulipase for treating nutrition deficiencies in cystic fibrosis patients and seems unsure exactly what it found. The company said that while the initial data found the enhanced enteric microgranule delivery formulation of adrulipase was safe, well-tolerated and was an improvement over other formulations, the preliminary data also indicate that “it is likely the primary efficacy endpoint was not achieved.”
Awak Technologies Pte Ltd. and Singapore General Hospital (SGH) plan to launch a pre-pivotal clinical trial for their automated wearable artificial kidney peritoneal dialysis (Awak PD) device. Awak PD is a wearable and portable PD device designed for patients with end-stage kidney disease to have dialysis on the go. The research team is now recruiting subjects for the single-site, prospective, single-arm study.
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.
Nodthera Ltd. claims to be first to demonstrate it is possible to modulate the NLRP3 inflammasome in the brain, after showing there were reductions in inflammatory and disease-specific biomarkers in blood and cerebrospinal fluid after seven days of daily administration of its lead product, NT-0796, an oral NLRP3 inhibitor.
As investors continue to weigh VRDN-001’s chances against Tepezza (teprotumumab, Horizon Pharmaceuticals plc) in thyroid eye disease, Viridian Therapeutics Inc. popped the lid off positive preliminary data from the ongoing phase I/II trial with the intravenous full antagonist antibody to the insulin-like growth factor 1 receptor.
Seven deaths and five respiratory-related, treatment-emergent adverse events in a group of 40 aged and very unwell cancer patients rang alarm bells for ADC Therapeutics SA. The company has voluntarily paused enrollment in its phase II Lotis-9 study of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) for treating previously untreated diffuse large B-cell lymphoma in those who are considered frail or unfit.
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.
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