Sanofi

Duvakitug phase 2b study met primary endpoints in ulcerative colitis and Crohn’s disease, showing best-in-class potential. High dose results achieved highest efficacy with any TL1A monoclonal antibody. Sanofi and Teva plan phase 3 development pending regulatory discussions.

The FDA granted fast track designation to two combination flu and COVID-19 vaccine candidates for adults 50+; one combines Fluzone High-Dose with Novavax's COVID-19 vaccine, the other uses Flublok paired with the same COVID-19 vaccine. Both aim to reduce health burdens of flu and COVID-19, especially for high-risk groups, and are undergoing phase ½ trials to evaluate safety and immune responses.

The FDA granted breakthrough therapy designation to Sanofi's BTK inhibitor tolebrutinib for nonrelapsing secondary progressive multiple sclerosis (SPMS), based on Phase 3 HERCULES trial data showing significant disability progression delay and improved safety. Sanofi is finalizing U.S. and European approval applications.

Indapta Therapeutics secures $22.5M to advance clinical trials of allogeneic NK cell therapy for cancer and autoimmune diseases. IDP-023 shows promising results in cancer trials, with plans to initiate a Phase 1 trial for multiple sclerosis in Q1 2025.

The FDA granted breakthrough therapy designation to tolebrutinib, an oral Bruton’s tyrosine kinase inhibitor, for non-relapsing secondary progressive MS. Positive phase 3 HERCULES trial results showed tolebrutinib delayed disability progression by 31% and improved disability in nearly double the participants compared to placebo. Sanofi plans regulatory submissions in the U.S. and EU, with ongoing PERSEUS study results expected by 2025.

The FDA granted breakthrough therapy designation to tolebrutinib (Sanofi) for treating non-relapsing secondary progressive multiple sclerosis (nrSPMS), based on HERCULES trial results showing a 31% reduction in confirmed disability progression (CDP) vs. placebo. Tolebrutinib, an oral BTKi, also doubled the rate of disability improvement. Liver enzyme elevations occurred in 4.1% of patients, but resolved without intervention. This designation expedites review and development for substantial clinical improvements.

The FDA granted Fast Track designation to two non-mRNA combination vaccine candidates for flu and COVID-19 prevention in individuals 50+ to address health burdens, aiming for simpler scheduling and fewer injections. The candidates include Fluzone High-Dose + Novavax COVID-19 vaccine and Flublok + Novavax COVID-19 vaccine. Both vaccines have shown efficacy and tolerability, with studies underway to evaluate safety and immune response. Combination vaccines streamline immunization, potentially boosting uptake, especially among older adults.

The FDA granted breakthrough therapy designation to Sanofi’s tolebrutinib, a BTK inhibitor for non-relapsing secondary progressive multiple sclerosis (nrSPMS). HERCULES phase 3 study results showed tolebrutinib delayed disability progression by 31% compared to placebo. Regulatory submissions are being finalized for the U.S. and Europe. Erik Wallström highlighted the need for liver function monitoring due to potential drug-induced liver injury.

The FDA granted Breakthrough Therapy designation to tolebrutinib for treating non-relapsing secondary progressive multiple sclerosis, based on HERCULES phase 3 study results showing it delayed disability progression and doubled confirmed disability improvement rates compared to placebo. Liver enzyme elevations were observed but resolved without intervention. Regulatory submissions are ongoing in the US and EU.