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SCB 2019

Drug Profile

SCB 2019

Alternative Names: 2019-nCoV S-Trimer vaccine - Clover Biopharmaceuticals; Protein-based COVID-19 S-trimer vaccine - Clover Biopharmaceuticals; recombinant 2019-nCoV S protein subunit-trimer vaccine - Clover Biopharmaceuticals; Recombinant S subunit trimer vaccine - Clover Biopharmaceuticals; Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine - Clover Biopharmaceuticals; S-trimer COVID-19 vaccine; S-Trimer vaccine - Clover Biopharmaceuticals; SCB-2019

Latest Information Update: 29 Apr 2020

At a glance

  • Originator Clover Biopharmaceuticals
  • Class Adjuvants; Recombinant proteins; Subunit vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 28 May 2020 Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (IM) in June 2020 (NCT04405908)
  • 27 Apr 2020 Clover Pharmaceuticals signs partnership agreement with Coalition for Epidemic Preparedness Innovations (CEPI) for development of COVID-2019 vaccine
  • 27 Apr 2020 Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections in Australia

Development Overview

Introduction

SCB 2019 is a recombinant S-trimer subunit vaccine being developed by Clover Biopharmaceuticals for prevention of COVID-2019 infections. The company is utilising its patented Trimer-Tag© technology to construct a recombinant protein subunit-trimer vaccine (S-Trimer) and is expected to produce the vaccine via a rapid mammalian cell-culture based expression system. Coronaviruses are positive single-stranded RNA (ssRNA) viruses with a trimeric spike (S) protein on its viral envelope. The trimeric S protein of 2019-nCoV is responsible for binding to host cell surface receptor ACE2 and subsequent viral entry. Preclinical studies are underway in China.

Timer-Tag is a drug development platform which produces covalently-trimerized fusion proteins targeting trimerization-dependent pathways. The platform takes advantage of the C-prodomains of collagen proteins which are capable of efficient self-trimerization. It allows any secreted protein (cytokines, soluble receptors, Fab of mAbs) to be made as covalently linked homo-trimers with greatly increased avidity to their disease-causing targets.

Clover Biopharmaceuticals seeks to advance the development of recombinant subunit-trimer vaccine via partnerships and collaborations (Clover Biopharmaceuticals website, February 2020).

Company Agreements

In April 2020, the Coalition for Epidemic Preparedness Innovations entered into a collaboration with Clover Biopharmaceuticals Australia (the wholly-owned subsidiary of Sichuan Clover Biopharmaceuticals,(China) for developing a COVID-19 vaccine. As per the agreement, CEPI will provide initial US$3.5m to Clover Biopharmaceuticals to support preparation and initiation of a phase I trial of Clover’s protein-based COVID-19 S-Trimer vaccine in Australia. [1]

In March 2020, Clover Biopharmaceuticals and Dynavax Technologies Corporation entered into a research and development agreement to develop a vaccine for COVID-2019 infections. Under the terms of agreement, Dynavax will provide technical expertise and the company’s proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018. Financial details of the agreement were not disclosed. [2]

In February 2020, Clover Biopharmaceuticals entered into a research collaboration with GlaxoSmithKline for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer). GSK will provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies. Having one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China, Clover could potentially rapidly scale-up and produce large-quantities of the coronavirus vaccine. [3]

Clover Biopharmaceuticals received exclusive worldwide rights from GenHunter Corporation to utilise Trimer-Tag© technology for the development of drug candidates (Clover Biopharmaceuticals website, December 2017).

Key Development Milestones

As at January 2020, early research and development is ongoing for the subunit trimer vaccine for the prevention of COVID-2019 infections [4] .

Financing information

In May 2020, Dynavax Technologies announced its intention to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. It expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the common stock being offered in the offering. The company intends to use the net proceeds to fund activities, associated with the ongoing commercialisation of adjuvanted Hepatitis B vaccine (recombinant) [see Adis Insight Drug Profile800020941], to advance its CpG 1018 vaccine platform, including any scale up efforts in support of a potential COVID-19 vaccine by Dynavax and its collaborators, and for general corporate purposes, including working capital [5] .

Patent Information

Clover Biopharmaceuticals has patent protection for Trimer-Tag technology platform in the US, Europe, Japan and China (Clover Biopharmaceuticals website, January 2020)

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation unspecified
  • Class Adjuvants, Recombinant proteins, Subunit vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical China IM / unspecified Clover Biopharmaceuticals 24 Mar 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Clover Biopharmaceuticals Originator China
Clover Biopharmaceuticals Owner China
GenHunter Corporation Technology Provider USA
Coalition for Epidemic Preparedness Innovations Funder Norway
GlaxoSmithKline Collaborator United-Kingdom
Dynavax Technologies Collaborator USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Clover Biopharmaceuticals - Unspecified - 03 Feb 2020

Future Events

Expected Date Event Type Description Updated
20 Jun 2020 Trial Update Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (IM) in June 2020 (NCT04405908) 03 Jun 2020

Development History

Event Date Update Type Comment
28 May 2020 Trial Update Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections (Prevention) (IM) in June 2020 (NCT04405908) Updated 03 Jun 2020
27 Apr 2020 Licensing Status Clover Pharmaceuticals signs partnership agreement with Coalition for Epidemic Preparedness Innovations (CEPI) for development of COVID-2019 vaccine [1] Updated 29 Apr 2020
27 Apr 2020 Trial Update Clover Biopharmaceuticals plans a phase I trial for COVID-2019 infections in Australia [1] Updated 29 Apr 2020
24 Mar 2020 Licensing Status Clover Biopharmaceuticals and Dynavax Technologies enter into research and agreement for recombinant S subunit trimer vaccine [2] Updated 27 Mar 2020
24 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in China (IM) [2] Updated 27 Mar 2020
25 Feb 2020 Licensing Status GlaxoSmithKline and Clover Biopharmaceuticals agree to co-develop Recombinant S subunit trimer vaccine for COVID-2019-infections [3] Updated 27 Feb 2020
03 Feb 2020 Patent Information Clover Biopharmaceuticals has patent protection for Trimer-Tag© technology in USA, Europe, Japan and China (Clover Biopharmaceuticals website, February 2020) Updated 04 Feb 2020
28 Jan 2020 Licensing Status Recombinant subunit trimer vaccine is available for licensing as of 03 Feb 2020 before February 2020 (Clover Biopharmaceuticals, website, February 2020)http://www.cloverbiopharma.com/index.php?m=content&c=index&a=lists&catid=44 Updated 04 Feb 2020
28 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in China (unspecified route) before January 2020 [4] Updated 04 Feb 2020
28 Dec 2017 Licensing Status Clover Biopharmaceuticals in-licenses Trimer-Tag© technology from GenHunter Corporation worldwide (Clover Biopharmaceuticals website, December 2017) Updated 04 Feb 2020

References

  1. CEPI Announces COVID-19 Vaccine Development Partnership With Clover Biopharmaceuticals Australian Subsidiary.

    Media Release
  2. Dynavax and Clover Biopharmaceuticals Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with CpG 1018 Adjuvant.

    Media Release
  3. Clover and GSK Announce Research Collaboration to Evaluate Coronavirus (COVID-19) Vaccine Candidate with Pandemic Adjuvant System.

    Media Release
  4. Clover Initiates Development of Recombinant Subunit-Trimer Vaccine for Wuhan Coronavirus (2019-nCoV).

    Media Release
  5. Dynavax Technologies Announces Proposed Public Offering of Common Stock.

    Media Release
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