LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection. The World Health Organization (WHO) has just released guidelines for assessing the ethical acceptability, saying such trials would allow for more rapid and standardized testing, accelerating development and enabling candidates to be prioritized.
HONG KONG – Israeli biopharma Redhill Biopharma Ltd. is looking to extend access to its new investigational drug, opaganib (Yeliva, ABC-294640), following the drug’s initial success from a compassionate-use study treating six patients in Israel hospitalized with moderate to severe COVID-19 symptoms.
BEIJING – CAR T specialist Wuhan Bio-Raid Biotechnology Co. Ltd. said its BRD-01, an anti-CD30 CAR T therapy candidate, has been granted IND approval by China’s NMPA. It is the first CD30 candidate to enter the clinic stage amid an increasingly heated CAR T race dominated by candidates targeting CD19 and BMCA.
PERTH, Australia – Australian stem cell company Mesoblast Ltd.’s shares were up nearly 39% on the news that its allogeneic cell therapy showed an 83% survival rate in ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) treated at New York’s Mount Sinai Hospital.
Two phase III studies in China testing Gilead Sciences Inc.’s antiviral drug, remdesivir, in patients with COVID-19 infection have been halted after Chinese authorities reported a lack of eligible patients. Other studies, including trials sponsored by the Foster City, Calif.-based company, remain ongoing.
HONG KONG – Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, published results in New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis.
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. reported interim data showing that lead candidate paxalisib (formerly GDC-0084) saw a positive overall survival signal in its phase II glioblastoma trial, and the company raised AU$7.2 million (US$4.4 million) days after the data were released.
Indian scientists have discovered a previously unknown mechanism underlying life-threatening sepsis and proposed a new treatment strategy centered upon cell-free chromatin (cfCh), they reported in the March 4, 2020, edition of PLOS ONE.