Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.
With a regulatory filing expected later this year for gepotidacin based on positive data in uncomplicated urinary tract infections, GSK plc reported that the potentially first-in-class oral antibiotic hit its endpoints in a phase III trial in uncomplicated urogenital gonorrhea, the sexually transmitted disease facing a rise in incidence rate and increased antibiotic resistance.
In the first month of 2024, BioWorld reported on 252 phase I-III clinical trial updates, marking a 10% decrease from the 281 updates in December 2023, as well as a decline from 354 updates in November and 416 in October. The number of trial updates is also a 10% drop compared to January 2023, which recorded 281 updates.
Kazia Therapeutics Ltd. stopped its two-part paxalisib plus radiotherapy phase I trial early based on positive safety and promising clinical responses in patients with phosphoinositide 3-kinase pathway mutation brain metastases from solid tumors. The company plans to meet with the U.S. FDA to discuss a pivotal registrational trial.
The first – and handsomely upsized – IPO of this year by CG Oncology Inc., along with the sizeable financing Feb. 14 by Engene Holdings Inc., proved Wall Street’s interest in non-muscle invasive bladder cancer, where a number of other players also are busy.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
CSL Ltd. will review the data further to see if there is a path forward for CSL-112 (human apolipoprotein A-I) after the phase III AEGIS-II trial failed to meet the primary efficacy endpoint in reducing the risk of major adverse cardiovascular events in patients following an acute heart attack.
On the verge of top-line data from its phase IIb trial with oral small-molecule CC chemokine receptor 4 (CCR4) antagonist zelnecirnon in atopic dermatitis (AD), due around the middle of this year, Rapt Therapeutics Inc. said the U.S. FDA has imposed a clinical hold on that study with the otherwise promising drug, also known as RPT-193, in AD as well as the phase IIa trial with the same compound in asthma.
South Korean biopharmaceutical firm GNT Pharma Co. Ltd. on Feb. 13 reported positive findings from a domestic phase III trial of its neuroprotectant therapy, nelonemdaz (NEU-2000), for patients with acute ischemic stroke.
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