Kintor Pharmaceutical Ltd. said it's "actively initiating" multiregional phase II/III trials to test a combination of GT-90001 (ascrinvacumab) and Opdivo (nivolumab) for advanced hepatocellular carcinoma.
Australian biopharma Immutep Ltd. saw its stock price jump 165% Dec. 10, as the company reported that adding its eftilagimod alpha (IMP-321, “efti”) to paclitaxel resulted in what the company called a “promising and improving” trend toward increased overall survival in women with metastatic hormone receptor-driven breast cancer.
PERTH, Australia – The University of Queensland (UQ) and CSL Ltd. are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase I trials. The response means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However, there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present, the partners said.
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. saw its stock drop 15% on the news that its allogeneic mesenchymal cell therapy, rexlemestrocel-L (Revascor), failed to meet the primary endpoint of a reduction in hospitalizations in its phase III advanced chronic heart failure trial.
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
New phase III data on Takeda Pharmaceutical Co. Ltd.'s TAK-620 (maribavir) for the treatment of transplant recipients with tough-to-treat cytomegalovirus (CMV) infections met the trial's primary endpoint, setting the company up to file an NDA for the oral antiviral in the first half of next year.
HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks.
PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion.
LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222. Significantly, efficacy increased to 90% in the prime-boost arm of the trial, in which volunteers received half a dose, followed by a full dose. In addition to greater protection, that will make supplies go further.
HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints.
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