The A’s have it but the B’s don’t in Moderna Inc.’s pivotal phase III study of mRNA-1010, a seasonal flu vaccine for adults living in the southern hemisphere. Interim results showed the vaccine achieved superiority on seroconversion rates for influenzas A/H3N2 and A/H1N1, superiority on geometric mean titer ratios for influenza A/H3N2 and noninferiority on geometric mean titer ratios for influenza A/H1N1. However, noninferiority was not met for the endpoints against the influenza B/Victoria- and B/Yamagata-lineage strains.
Ascletis Pharma Inc. presented subgroup data from a phase II trial showing its subcutaneous PD-L1 antibody envafolimab (ASC-22) was able to functionally cure chronic hepatitis B, according to hepatitis B surface antigen decline following 24-week treatment.
Erytech Pharma AS, repositioning itself to recover from a tough phase III cancer study failure in 2021, will merge with Pherecydes Pharma SA, which specializes in precision phage therapy for treating resistant and/or complicated bacterial infections.
Bavarian Nordic A/S plans to buy two travel vaccines plus a phase III chikungunya vaccine candidate from Emergent Biosolutions Inc. for about $380 million. Emergent will receive a $270 million up-front payment and perhaps as much as $110 million in future milestone payments. The vaccines are Vivotif, for preventing typhoid fever, and Vaxchora, for preventing cholera caused by Vibrio cholerae serogroup O1. Both oral vaccines have U.S. FDA and European approvals.
Biomedical Research & Bio-Products (Bio&Bio) AG is laying plans for a phase III trial of its vaccine for preventing methicillin-resistant Staphylococcus aureus infections from sparking toxic shock syndrome, after delivering phase II data showing good safety and immunogenicity.
Zhimeng Biopharma Inc. found a global partner for its hepatitis B virus (HBV) program, licensing rights to GSK plc for CB-06, an oral small-molecule Toll-like receptor 8 agonist. Pending positive data from an ongoing phase I study, GSK will gain rights to develop, manufacture and commercialize the drug for chronic HBV infection, either for use in combination or as a sequential treatment with bepirovirsen.
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine.
Low enrollment in a phase III trial and a missed primary endpoint sent Aridis Pharmaceuticals Inc.’s shares tumbling by 35% on Jan. 26, although the company’s AR-301 (tosatoxumab) showed superior efficacy over the control group in Staphylococcus aureus ventilator-associated pneumonia (VAP) patients.
Microbiome company Finch Therapeutics Group Inc. has suffered one blow after another in the past year with dwindling cash, delayed programs, a terminated deal and three workforce reductions. The latest reduction will bring the once healthy 189-person company down to a handful of employees, and it places the lead program – the oral microbiota product, CP-101, for Clostridiumdifficile infection – on the sidelines.
Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no.