Research programme: RNA interference therapeutics - Alnylam Pharmaceuticals/Vir Biotechnology
Latest Information Update: 28 Nov 2021
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
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Research Coronavirus infections; COVID 2019 infections
- No development reported Infections
Most Recent Events
- 28 Nov 2021 No recent reports of development identified for research development in Infections in USA (Parenteral)
- 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)
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.
As at November 2021, no recent reports of development had been identified for research development in Infections in USA (Parenteral).
Company Agreements
In February 2022, Alnylum Pharmaceuticals notified Vir Biotechnology that the development of ALN COV was discontinued due to the availability of highly effective vaccines and alternative treatments for COVID-2019 infections. The company announced that it has no further obligations to work on the COVID-related targets and Vir Biotechnology will not have further rights to such targets under the exclusive agreement. Earlier 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. The expansion includes up to three additional targets focused on host factors for SARS-CoV-2, angiotensin converting enzyme-2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2) with the potential for an additional host target to emerge from Vir’s functional genomics work. 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. Upon candidate selection, Vir will lead development efforts and work closely with Alnylam to generate the data required to enable the potential for rapid commencement of clinical studies. 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 to treat SARS-CoV-2 and potentially other coronaviruses. In addition to leading development of selected candidates, Vir will lead commercialisation 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 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 | - | - | No development reported (Research) | USA | Parenteral / unspecified | Alnylam Pharmaceuticals, Vir Biotechnology | 28 Nov 2021 |
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 |
|---|---|---|
| 28 Nov 2021 | Phase Change - No development reported | No recent reports of development identified for research development in Infections in USA (Parenteral) Updated 28 Nov 2021 |
| 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
-
Alnylam and Vir Form Strategic Alliance to Advance RNAi Therapeutics for Infectious Diseases.
Media Release -
Vir and Alnylam Expand Collaboration to Advance RNAi Therapeutics for the Treatment of Coronavirus Infection, Including COVID-19.
Media Release -
Alnylam Announces 2018 Corporate Goals.
Media Release
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