Roivant Sciences Ltd.’s Immunovant Inc. unit unveiled phase II data in Graves’ disease with batoclimab, whetting appetites on Wall Street for the results with next-generation prospect IMVT-1402 from two potentially registrational trials that are enrolling now.

Onco3r Therapeutics BV has obtained clinical trial application (CTA) approval by the Belgian regulatory authorities for its SIK3 inhibitor O3R-5671. A first-in-human trial will be conducted in Belgium and is expected to open enrollment in the coming weeks. Final data are expected in the first half of next year and will inform subsequent patient trials across a range of autoimmune diseases, which are planned to commence next year.

Jynneos, a current vaccine against orthopoxviruses such as smallpox and mpox virus, elicits only modest antibody responses, highlighting the need to search for more immunogenic vaccines or treatments. The global outbreak of mpox virus infections in 2022 lent urgency to this challenge.

Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.

“The impoverished laboratory environment in which mice and rats are maintained has been very good at increasing experimental replicability,” Steven Austad told the audience at the 12th Aging Research & Drug Discovery Meeting (ARDD) in Copenhagen last week. “But at the cost of sacrificing translational relevance.”

Effective vaccines against Staphylococcus aureus remain out of reach: 10 candidates that showed promise in preclinical animal models have failed in clinical trials. Researchers at Third Military Medical University and collaborators reasoned that one of the reasons might be that 70%-80% of the population has developed antibodies to the pathogen.