Vir and Alnylam Expand Collaboration to Advance Investigational RNAi Therapeutics Targeting Host Factors for the Treatment of COVID-19

− Collaboration to Evaluate RNAi Therapeutics Targeting Three Host Factors Required for SARS-CoV-2 Infection, Including ACE2 and TMPRSS2 −

− Vir to Lead Development of Potential Coronavirus RNAi Therapeutic Candidates Discovered by Alnylam, with Alnylam Retaining an Option for 50-50 Participation −

SAN FRANCISCO, CA & CAMBRIDGE, MA, USA I April 02, 2020 I Vir Biotechnology, Inc. (Nasdaq: VIR) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced an expansion to their broad multi-target existing collaboration for the development and commercialization of RNAi therapeutics for infectious diseases, including SARS-CoV-2, the virus that causes the disease COVID-19. This expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with the potential for an additional host target to emerge from Vir’s functional genomics work.

Pursuant to an amendment to the collaboration 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 up to three additional host factor-targeting development candidates (DCs) to treat SARS-CoV-2 and potentially other coronaviruses as well. The two named targets include angiotensin converting enzyme-2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2). ACE2 is known to be the viral entry receptor for SARS-CoV-2 and other coronaviruses, while TMPRSS2 is believed to cleave the SARS-CoV-2 spike protein to facilitate cellular attachment. The third target is expected to emerge from Vir’s ongoing functional genomics efforts to identify novel host factors pertinent to coronaviral infection and targetable by siRNA, mAbs or small molecules.

As part of the original collaboration to advance investigational RNAi therapeutics to treat disease caused by coronavirus infection, Alnylam has designed and synthesized over 350 siRNAs targeting highly conserved regions of the SARS-CoV-2 genome. Lead siRNAs have recently been identified by scientists at Alnylam and are now being further evaluated by scientists at Vir for anti-viral activity in support of DC selection. Upon DC selection, Vir will lead development efforts – working closely with Alnylam to generate the data required to enable the potential for rapid commencement of clinical studies.

“Vir is aggressively pursuing multiple platforms and multiple therapeutic strategies to combat the COVID-19 pandemic. We are excited about our partnership with Alnylam – which has already led to identification of promising siRNAs targeting SARS-CoV-2 – and we’re pleased to now expand our efforts to evaluate the anti-viral effects of siRNAs targeting human host factors,” said George Scangos, Ph.D., CEO of Vir. “We share a sense of urgency with Alnylam in advancing these efforts as quickly as possible and with the highest priority.”

“The biopharmaceutical industry needs to advance its full armamentarium of potential treatment approaches and strategies to address the COVID-19 pandemic. To this end, we are excited about the promise of targeting host factors critical for viral infection and replication, in addition to our efforts directly targeting the SARS-CoV-2 genome,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam Pharmaceuticals. “At this time of enormous public health need, we plan to act with the utmost urgency to broaden and accelerate our efforts with Vir to develop investigational RNAi therapeutics against COVID-19, and potentially future coronavirus diseases.”

Under the collaboration and license agreement, as amended, in addition to leading development of selected DCs, Vir will lead commercialization of any products emerging from the collaboration that gain regulatory approval. At clinical proof of concept, Alnylam will have an option to share equally in any profits and losses associated with the development and commercialization of each coronavirus program. Alternatively, Alnylam may elect to earn development and commercialization milestones and royalties on net sales of any products resulting from the collaboration in amounts agreed upon for each coronavirus program. These additional targets expand the companies’ collaboration and license agreement announced in 2017, and the subsequent amendment to that agreement announced in March 2020, to now develop novel siRNAs for up to nine infectious disease targets in total, including hepatitis B virus in the Vir-2218 (ALN-HBV02) program currently in Phase 1/2 studies.

About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of five product candidates targeting hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

About Alnylam
Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), approved in the U.S., EU, Canada, Japan, Switzerland, and Brazil, and GIVLAARI® (givosiran), approved in the U.S. and EU. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its "Alnylam 2020" strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

SOURCE: Vir Biotechnology

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