Generation Bio Announces Strategic Reorganization

CAMBRIDGE, Mass., Nov. 29, 2023 (GLOBE NEWSWIRE) — Generation Bio Co. (Nasdaq:GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced a strategic reorganization to prioritize investment in the development of its cell-targeted lipid nanoparticle (ctLNP) delivery system for wholly-owned programs in extrahepatic cell types. Generation Bio intends to continue to develop ctLNP for immune cells as part of its collaboration with Moderna and to develop its immune-quiet DNA (iqDNA) for its lead hemophilia A and other programs.

“Our ctLNP platform has demonstrated uniquely selective ligand-targeted delivery to T cells with minimal off-target uptake. We believe there is a clear path to developing our own programs using ctLNP to reach extrahepatic targets and are realigning our investments to support this,” said Geoff McDonough, M.D., chief executive officer of Generation Bio. “We also remain focused on developing the iqDNA platform for our lead program in hemophilia A as well as for other programs in the liver and beyond. To allow us to reach critical development milestones for these platforms under current market conditions, we are taking the difficult but necessary steps to align our investments with our strategy and to extend our cash runway.”

Dr. McDonough continued: “We are deeply grateful to all our employees who have demonstrated incredible dedication to each other, to our community, and to the millions of people whose lives we aim to significantly improve by pursuing our mission. We are focused on supporting our departing employees through this difficult transition, and on beginning the next stage of our journey.”

The reorganization actions and financial impacts are as follows:

  • Streamlining R&D to develop wholly-owned ctLNP programs for extrahepatic cell types
  • Continuing to develop immune cell programs with Moderna
  • Continuing to develop the iqDNA platform for its lead hemophilia A and other programs
  • Extending cash runway into the second half of 2027

The company will reduce its total workforce by 40%, while preserving core R&D capacity. Several of Generation Bio’s leadership team members will also depart as part of the reorganization.

About Generation Bio

Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral genetic medicine platform incorporates novel iqDNA; a unique ctLNP delivery system; and a highly scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis, or RES, to produce iqDNA. This approach is designed to enable multi-year durability from a single dose, to deliver large genetic payloads, including multiple genes, to specific tissues and cell types, and to allow titration and redosing to adjust or extend expression levels in each patient. RES has the potential to expand Generation Bio’s manufacturing scale to hundreds of millions of doses to support its mission to extend the reach of genetic medicine to more people, living with more diseases, around the world.

For more information, please visit www.generationbio.com.