Vir Biotechnology, Inc.and Alnylam Pharmaceuticals, Inc. announced an expansion of their existing collaboration to include the development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes the disease COVID-19. Under the agreement, the companies will utilize Alnylam’s recent advances in lung delivery of novel conjugates of siRNA – the molecules that mediate RNAi – together with Vir’s infectious disease expertise and established capabilities, to bring forward one or more siRNAs to treat SARS-CoV-2 and potentially other coronaviruses as well. The collaboration will focus on development of siRNAs that Alnylam recently identified that target highly conserved regions of coronavirus RNAs.
Alnylam has designed and synthesized over 350 siRNAs targeting all available SARS-CoV and SARS-CoV-2 genomes, which will be screened in in vitro potency assays. Potent siRNA lead candidates will be further evaluated by scientists at Vir for in vitro and in vivo anti-viral activity, leading to the selection of a development candidate (DC).
Vir will lead all development and commercialization of any selected DCs. At clinical proof of concept, Alnylam will have an option to share equally in the profits and losses associated with the development and commercialization of the coronavirus program. Alternatively, Alnylam may elect to earn development and commercialization milestones and royalties on net sales of products resulting from the collaboration in amounts agreed upon for the coronavirus program. This new program expands the companies’ existing licensing agreement announced in 2017 to now develop up to six novel siRNAs to treat infectious diseases.
“Given the scope and speed of the COVID-19 outbreak, Vir is seeking multiple approaches that combine our expertise in infectious disease with that of current and new partners to respond rapidly,” said George Scangos, Ph.D., Chief Executive Officer of Vir Biotechnology. “Alnylam has been an excellent partner, and our complementary capabilities made this a compelling opportunity to address this growing public health crisis.”
“RNAi is a powerful, natural cellular mechanism that can be harnessed to develop a broad range of innovative medicines, including anti-viral therapies. Our recent pre-clinical progress in extra-hepatic delivery of siRNAs has now been extended to the lung, and we’re encouraged that these results could potentially translate to humans,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam Pharmaceuticals. “We believe RNAi therapeutics represent a promising approach for targeting coronaviruses, like SARS-CoV-2. As the leader in RNAi therapeutics, we at Alnylam are committed to doing our part in joining other biopharmaceutical companies, like Vir, to address this emerging outbreak.”
The companies are currently collaborating on VIR-2218 (ALN-HBV02), a novel, investigational RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection, the first program to enter the clinic as a part of the infectious disease collaboration. The safety and efficacy of VIR-2218 are currently being investigated in an ongoing Phase 1/2 study.