Tessera Therapeutics received FDA clearance to begin a Phase I/II clinical trial of TSRA‑196, its in‑vivo gene‑editing candidate for alpha‑1 antitrypsin deficiency, and received HREC approval in Australia. The clearance enables first‑in‑human testing of Tessera’s site‑specific genome integration approach using engineered vector platforms. In parallel, Nature Biotechnology published a review on targeted in‑vivo delivery of genome editors that outlines design frameworks for delivery systems and highlights the importance of tissue tropism, immune profiling and payload design. Together, the regulatory clearance and the review reflect converging progress on delivery science—an industry bottleneck for translating genome editors into systemic therapies.