Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development. Making way for the new candidate, Molecular is discontinuing development of MT-3724, which is in a phase II study for treating diffuse large B-cell non-Hodgkin lymphoma but was placed on a partial clinical hold by the FDA after a treatment-related fatality in one of the subjects.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
PERTH, Australia – Sydney-based Azura Ophthalmics Ltd. has moved into a registration trial following positive phase II results for lead candidate AZR-MD-001 in Meibomian gland dysfunction, the leading cause of dry eye disease.
Kintor Pharmaceutical Ltd. said its androgen receptor (AR) antagonist, proxalutamide, reduced mortality risk by 92% and shortened median hospital length stay by nine days vs. standard of care, based on a preliminary analysis of phase III data from 590 hospitalized COVID-19 patients in Brazil. The company expects to have final data ready by the end of this month or early April, Chief Financial Officer Lucy Lu told BioWorld.
In an unusual move for a Chinese company, Bio-Thera Solutions Ltd. terminated the clinical development of its Trop2 antibody-drug conjugate (ADC), BAT-8003, and its PD-1 monoclonal antibody, BAT-1306, a month after it halted the phase III-stage HER2-ADC candidate BAT-8001.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020.
HONG KONG – A Japanese phase III study of Chugai Pharmaceutical Co. Ltd.’s interleukin-6 inhibitor Actemra (tocilizumab) in patients hospitalized with severe COVID-19 pneumonia has read out, expanding what’s known about the drug’s use in the pandemic, which had been inconclusive until recently, though is now known to reduce mortality in the vulnerable population.
PERTH, Australia – Synthetic cannabinoid company Botanix Pharmaceuticals Ltd. announced top-line data from a phase IIa study showing that two different formulations of BTX-1801, a synthetic cannabidiol (CBD), eradicated Staphylococcus aureus (staph) in the nose, meeting study endpoints for safety and efficacy.
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