BioNTech and Genevant Sciences Sign Strategic mRNA-Focused Partnership in Rare Diseases

BioNTech AG and Genevant Sciences announced that they have entered into a collaboration to develop five mRNA therapeutic programs for rare diseases with high unmet medical need. The companies have also agreed a series of exclusive licenses covering the application of Genevant’s delivery technology to five of BioNTech’s oncology programs. Genevant is eligible to receive significant commercial milestones for the oncology licenses.

The collaboration in rare diseases will combine Genevant’s industry-leading lipid nanoparticle (LNP) delivery technology with BioNTech’s cutting-edge mRNA drug discovery platform to develop best-in-class therapeutics. Both companies have established GMP-grade manufacturing capabilities and infrastructure.

Under the terms of the agreement, Genevant and BioNTech will pursue the co-development and co-commercialization of five mRNA programs. Genevant and BioNTech will share all future costs and profits for these programs on a 50/50 basis. The companies aim to initiate clinical development in 2020.

In addition to its strengths in cell and gene therapies and protein therapeutics, BioNTech is an industry leader in mRNA therapy development with extensive scientific expertise, manufacturing infrastructure, broad academic networks, and a deep understanding of mechanisms of action and clinical applications for this technology. It also has an innovative, scalable, ‘just-in-time’ manufacturing capability to produce its tailored treatments for patients.

“This partnership with Genevant will allow us to access a highly potent, clinically validated LNP delivery platform,” said Prof. Ugur Sahin, Co-Founder and Chief Executive Officer of BioNTech. “Genevant’s liver-targeted platform complements our existing capabilities for dendritic cell-specific delivery of mRNA encoded antigens used in the development of our cancer vaccine pipeline.”

Genevant’s LNP platform is the only clinically-validated LNP delivery technology, the safety and efficacy of which has been evaluated in over 400 patients across multiple clinical programs. Genevant’s delivery technologies can facilitate therapeutic approaches covering a broad spectrum of payloads. Genevant has begun development on numerous programs across multiple RNA modalities.

“This 50/50 partnership to develop rare disease mRNA therapeutics recognizes the critical importance of both best-in-class nucleic acids and their delivery in RNA drug development,” said Paris Panayiotopoulos, Executive Chairman of Genevant. “BioNTech’s impressive molecular design expertise and Genevant’s leadership in RNA delivery are the ideal combination for developing cutting edge mRNA therapies for rare disease patients who have limited or no treatment options today.”