Resilience in risk-sharing gene therapy partnership with BridgeBio

BridgeBio Pharma and National Resilience (Resilience) have partnered on the production and development of two investigational gene therapies. 

The collaboration will focus on the production and advancement of BBP-812, an adeno-associated virus (AAV) 9 gene therapy to remedy Canavan disease, and BBP-631, an AAV 5 gene therapy for congenital adrenal hyperplasia (CAH). 

Through a cost- and risk-sharing strategy Resilience will provide production services equivalent to BridgeBio, and will be entitled to the development and approval-based milestone payments, as well as royalties for the two candidates. 

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“The cost- and risk- sharing approach allows us to assume some of the risk in the early stages of production and development with an agreement to share in the profit of the product candidates if successful,” a spokesperson for Resilience told BioProcess Insider.  

Resilience launched as a services firm in 2020 with intentions to overcome bottlenecks in the advanced therapy space. While many of its collaborations have seen Resilience act as a contract development and manufacturing organization (CDMO), the firm has also forged partnerships where it acts as a full development partner, rather than a traditional service provider. For example, in May 2022, the firm teamed with Be Bio through a similar cost and risk-sharing model.  

With BridgeBio, “Resilience will be investing partial in-kind manufacturing services for clinical and pre-commercial product candidates in return for future development milestones and royalties. The remainder of the deal will be fee-for-service,” the spokesperson added. 

Specific financials were not divulged, but as part of the deal Resilience aims to overcome manufacturing challenges for the two candidates, and – if both programs are successful – function as the main commercial manufacturer. 

“There are many challenges, but manufacturing can be one of the most complex,” we were told. “To overcome this challenge, Resilience will be responsible for the manufacturing and scalability of the production to ensure consistency and quality of these two AAV-based gene therapy product candidates, which will be done via tech transfer from BridgeBio into Resilience’s network of gene therapy sites.”