Sanofi

Sanofi's two non-mRNA combination vaccine candidates for flu and COVID-19 received Fast Track designation in the US. Both candidates combine licensed vaccines with proven efficacy and favorable tolerability. Phase 1/2 studies are ongoing to evaluate safety and immune response.

AQEMIA, a techbio teaching atomic scale physics to generative AI for innovative medicine, announces $100 million in funding and global expansion starting in London. The $38 million funding round led by Cathay Innovation supports clinical trial preparations and drug discovery platform advancements.

Despite headwinds, the techbio sector continues to attract significant investment and drive innovation, exemplified by the 2024 launch of Xaira, backed by over $1 billion, aiming to design novel therapeutic proteins using advanced AI. The sector is maturing through strategic consolidation, significant capital deployment, technical diversification, and steady clinical validation, as illustrated by 25 techbio organizations, including notable players like Isomorphic Labs, Generate:Biomedicines, Recursion Pharmaceuticals, and Schrödinger Inc., all leveraging AI for drug discovery. Emerging players such as Archon Biosciences, AION Labs, and Antiverse are also making strides, while established companies like Insilico Medicine and Ginkgo Bioworks continue to expand their platforms and partnerships.

Sarclisa-based combinations showed significant benefits in newly diagnosed multiple myeloma patients, with higher MRD negativity rates and improved PFS in both transplant-ineligible and eligible patients, according to studies presented at ASH 2024.

Sanofi's Phase III LUNA 3 trial of rilzabrutinib for persistent or chronic immune thrombocytopenia (ITP) met its primary endpoint, showing a 23% durable platelet response in therapy-treated adults. The study involved a 24-week treatment period with rilzabrutinib 400mg twice daily or placebo, followed by a 28-week open-label period. A 65% platelet response rate was observed in the therapy group versus 33% in the placebo group, with significant improvements in secondary endpoints like decreased bleeding and need for rescue therapy. The therapy is under regulatory review in the EU and US.

The phase III IMROZ trial found that adding isatuximab to bortezomib, lenalidomide, and dexamethasone (VRd) significantly reduced disease progression or death by 40% and doubled sustained MRD negativity rates in transplant-ineligible newly diagnosed multiple myeloma patients ≤ 80 years old, establishing isatuximab/VRd as a new standard of care.

Sanofi's phase 3 LUNA 3 study of rilzabrutinib, an oral BTK inhibitor for immune thrombocytopenia (ITP), showed durable platelet response in 23% of patients vs. 0% in placebo. Rilzabrutinib also demonstrated significant improvements in bleeding reduction, rescue therapy use, and quality of life measures.

Sanofi's Phase III LUNA 3 trial of rilzabrutinib for immune thrombocytopenia met primary endpoint, showing 23% durable platelet response. Rilzabrutinib demonstrated a 65% platelet response rate, compared to 33% for placebo, with significant improvements in secondary endpoints and quality of life measures. The therapy is under regulatory review in the EU and US.

CD40 targeted therapies, currently in late-stage clinical trials, show promise across various diseases. First approval expected by 2027, with over 20 therapies in development. Key players include Amgen, Sanofi, and GenMab.