Sana CEO Steve Harr actively questions whether the company's groundbreaking science can translate into a scalable, commercially viable therapy. This internal pressure focuses the team on solving not just the scientific challenges ("does it work?"), but also manufacturing ("can you scale it?") and the commercial model required for a true cure.
Unlike broad delivery systems like LNPs, Sana's Fusagen technology uses a modified viral component as a "logic gate." It is engineered to bind to a specific cell target, which then triggers a conformational change that fuses the payload directly into the cell's cytoplasm. This two-step mechanism aims for higher specificity and lasting effect.
A key innovation in Sana's diabetes cell therapy is overcoming the dual immune response. While knocking out MHC expression hides cells from the adaptive system (T-cells), this triggers an attack from the innate system (NK cells). Sana's solution is to overexpress CD47, effectively creating a "don't kill me" signal for both.
Despite promising data, Sana's CEO provides a sober timeline for their type 1 diabetes cell therapy. While clinical proof-of-concept ("does it work?") is expected within 12-18 months, even a "super optimistic" commercial launch would not happen until later this decade. This highlights the lengthy process of scaling manufacturing and navigating regulatory pathways.