Brii Biosciences Ltd. made strides toward getting its SARS-CoV-2 neutralizing monoclonal antibody combination therapy, BRII-196/BRII-198, to market with positive interim phase III data that show high-risk outpatients may benefit from the combination therapy up to 10 days following symptom onset.
Coherus Biosciences Inc. and partner Shanghai Junshi Biosciences Co. Ltd. continued to build their case for the anti-PD-1 antibody toripalimab, popping the lid off positive interim data from the pivotal, combination phase III study called Choice-01 in first-line advanced squamous or non-squamous non-small-cell lung cancer (NSCLC).
Innovent Biologics Inc.’s PCSK9 inhibitor, IBI-306, intended for the treatment of heterozygous familial hypercholesterolemia (HeFH), has met its primary endpoint in a phase III study in Chinese patients.
Following an interim analysis of phase III gastric cancer data, Innovent Biologics Inc. said it’s planning to seek an expanded label the company’s Eli Lilly and Co.-partnered PD-1 inhibitor, Tyvyt (sintilimab), in the indication. According to Innovent, a combination of the drug with chemotherapy met the primary endpoint of overall survival in the study, delivering a statistically significant improvement in the measure vs. placebo, also with chemotherapy.
Clinical data in 2021 has risen by about 9.2% in comparison with the same timeframe in 2020. As of mid-August, BioWorld has tracked a total of 2,400 entries of clinical data, which is up from the 2,197 entries last year. The gap has decreased from about 26% in mid-April, suggesting a steady slowdown in activity.
Astrazeneca plc and Daiichi Sankyo Co. Ltd. are pushing forward with a challenge to Roche Holding AG with breast cancer drug Enhertu (trastuzumab deruxtecan) after it demonstrated superiority over the Swiss firm’s Kadcyla (trastuzumab emtansine) in a head-to-head trial.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
While overall clinical trial activity appears to be slowing, June was the busiest month for the year, and, in fact, all of last year, with a total of 436 items of news related to phase I, phase II and phase III research.
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia.
While phase I-III clinical trial data continue to rise above the same timeframe in 2020, the gap is closing and a smaller percentage of this year’s reports are focused on the COVID-19 pandemic.
