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Research programme: RNA interference therapeutics - Alnylam Pharmaceuticals/Vir Biotechnology

Drug Profile

Research programme: RNA interference therapeutics - Alnylam Pharmaceuticals/Vir Biotechnology

Latest Information Update: 09 Mar 2020

At a glance

  • Originator Alnylam Pharmaceuticals
  • Developer Alnylam Pharmaceuticals; Vir Biotechnology
  • Class Anti-infectives; Antivirals; Small interfering RNA
  • Mechanism of Action RNA interference
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research Coronavirus infections; COVID 2019 infections; Infections

Most Recent Events

  • 05 Mar 2020 Alnylam Pharmaceuticals and Vir Biotechnology expands collaboration to develop and commercialise RNA interference therapeutics for COVID-2019 infections and Coronavirus infections
  • 05 Mar 2020 Early research in Coronavirus infections in USA (Parenteral)
  • 05 Mar 2020 Early research in COVID-2019 infections in USA (Parenteral)

Development Overview

Introduction

Various small interfering RNA (siRNA) therapeutics are being developed by Alnylam Pharmaceuticals and Vir Biotechnology, for the treatment of infectious diseases including COVID-2019 infections and infections caused by other coronaviruses. Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc conjugate technology will be used to develop the candidates. Early research development is underway in the US.

Company Agreements

In March 2020, Vir Biotechnology and Alnylam Pharmaceuticals expanded their existing collaboration to include the development and commercialisation of RNAi therapeutics targeting SARS-CoV-2, the virus that causes COVID-19 infections and other coronaviruses as well. Under the agreement, the companies will utilise Alnylam’s advances in lung delivery of novel conjugates of siRNA. Vir Biotechnology will lead all development and commercialization of any selected development candidates. At clinical proof of concept, Alnylam will have an option to share equally in the profits and losses associated with the development and commercialisation of the coronavirus programme. Alternatively, Alnylam may elect to earn development and commercialisation milestones and royalties on net sales of products resulting from the collaboration in amounts agreed upon for the coronavirus programme. Earlier, in October 2017, Alnylam Pharmaceuticals had entered into an exclusive license agreement with Vir Biotechnology for development and commercialisation of RNAi therapeutics for infectious diseases. Under the terms of the agreement, the companies will advance the development of Alnylam’s HBV programme, including ALN HBV02, and initiate a research collaboration for the development and advancement of up to four additional RNAi therapeutic programmes for the treatment of other infectious diseases. Alnylam is eligible to lead the development of a candidate, ALN HBV02, through to IND filing, and subsequently, Vir Biotechnology will be responsible for progressing the development of the candidate through a human proof-of-concept (POC) study; the developmental activities will be co-funded by both the companies. Following which, Vir Biotechnology is entitled to fund and conduct all development through completion of phase II studies. Alnylam retained the right to opt into a profit-sharing arrangement prior to initiation of phase III development. Vir Biotechnology is entitled to fund all research and developmental costs for the four additional infectious disease programmes, and Alnylam retained a product-by-product option on each programme to opt into a profit-sharing arrangement following human POC studies. Alnylam is also eligible to receive more than $1 billion in potential milestone payments related to the successful advancement of ALN HBV02 and other infectious disease programmes, as well as tiered royalties on products ultimately commercialised by Vir Biotechnology, provided Alnylam opts to decline its co-development and profit share option on a per-product basis. [1] [2]

Key Development Milestones

As of March 2020, RNA interference therapeutics are in research stage for the treatment of infectious diseases including COVID-2019 infections and infections caused by other coronaviruses [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Anti-infectives, Antivirals, Small interfering RNA
  • Mechanism of Action RNA interference
  • WHO ATC code

    J (Anti-infectives For Systemic Use)

  • EPhMRA code

    J (General Anti-Infectives Systemic)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Research USA Parenteral / unspecified Alnylam Pharmaceuticals, Vir Biotechnology 05 Mar 2020
Coronavirus infections - - Research USA Parenteral / unspecified Alnylam Pharmaceuticals, Vir Biotechnology 05 Mar 2020
Infections - - Research USA Parenteral / unspecified Alnylam Pharmaceuticals, Vir Biotechnology 19 Oct 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Alnylam Pharmaceuticals Originator USA
Alnylam Pharmaceuticals Owner USA
Vir Biotechnology Licensee USA

Future Events

Expected Date Event Type Description Updated
31 Dec 2018 Regulatory Status Alnylam plans to file one or more new clinical trial applications in Infections 2018 [3] 12 Jan 2018

Development History

Event Date Update Type Comment
05 Mar 2020 Licensing Status Alnylam Pharmaceuticals and Vir Biotechnology expands collaboration to develop and commercialise RNA interference therapeutics for COVID-2019 infections and Coronavirus infections [2] Updated 09 Mar 2020
05 Mar 2020 Phase Change Early research in Coronavirus infections in USA (Parenteral) [2] Updated 09 Mar 2020
05 Mar 2020 Phase Change Early research in COVID-2019 infections in USA (Parenteral) [2] Updated 09 Mar 2020
05 Mar 2020 Trial Update Vir Biotechnology plans preclinical trials for COVID-2019 infections and Coronavirus infections [2] Updated 09 Mar 2020
07 Jan 2018 Regulatory Status Alnylam plans to file one or more new clinical trial applications in Infections 2018 [3] Updated 12 Jan 2018
19 Oct 2017 Licensing Status Alnylam and Vir Biotechnology enters into a license agreement for development and commercialisation of RNAi therapeutics for infectious diseases [1] Updated 28 Oct 2017
19 Oct 2017 Phase Change Early research in Infections in USA (Parenteral) Updated 28 Oct 2017

References

  1. Alnylam and Vir Form Strategic Alliance to Advance RNAi Therapeutics for Infectious Diseases.

    Media Release
  2. Vir and Alnylam Expand Collaboration to Advance RNAi Therapeutics for the Treatment of Coronavirus Infection, Including COVID-19.

    Media Release
  3. Alnylam Announces 2018 Corporate Goals.

    Media Release
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