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Ad5 nCOV - Tianjin CanSino Biotechnology

Drug Profile

Ad5 nCOV - Tianjin CanSino Biotechnology

Alternative Names: Ad5-nCOV - Tianjin CanSino Biotechnology; COVID-19 vaccine - Tianjin CanSino Biotechnology; Recombinant Novel Coronavirus Vaccine - Tianjin CanSino Biotechnology

Latest Information Update: 29 May 2020

At a glance

  • Originator Tianjin CanSino Biotechnology
  • Class 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

Highest Development Phases

  • Phase II COVID 2019 infections

Most Recent Events

  • 28 May 2020 CanSino Biotechnology plans a phase I/II trial in Healthy volunteers (In adults, In elderly) in Canada (IM) (NCT04398147)
  • 14 May 2020 The National Research Council (NRC) of Canada and Tianjin CanSino Biotechnology continue collaboration for clinical development of Ad5 nCOV for COVID-2019 infections in Canada
  • 12 May 2020 Tianjin CanSino Biotechnology plans to file CTA to Health Canada for COVID-2019 infections

Development Overview

Introduction

Ad5 nCoV, a recombinant adenovirus type 5 vector coronavirus vaccine is being developed by Tianjin CanSino Biotechnology in collaboration with Beijing Institute of Biotechnology for the treatment of COVID-19 infections. CanSinoBIO’s adenovirus-based viral vector vaccine technology platform has been applied to develop the vaccine similar to Ebola virus infection. Clinical development is underway in China.

Company Agreements

In May 2020, in continuation with the previous collaboration, The National Research Council (NRC) of Canada and Tianjin CanSino Biotechnology again announced the collaboration to advance bioprocessing and clinical development of Ad5-nCoV, a vaccine against COVID 2019 infections in Canada. According to the collaboration, NRC to advance a scale-up production process for Ad5-nCoV, using its proprietary HEK293 cell line that were designed and developed at the NRC. Both companies will utilize their respective technologies and expertise together to develop the vaccine. As a preparatory step, the Government of Canada had announced $44 million in funding to support upgrades to the NRC's facilities in Montréal to enable compliance with Good Manufacturing Practice (GMP) standards, to ensure readiness for Canadian bioprocessing of potential vaccine candidates as they become available.

Tianjin CanSino Biotechnology is utilising HEK 293 cells and the process developed by National Research Council Canada for the manufacturing of Ad5 adenovirus vector monovalent Ebola virus vaccine. [1] [2]

Key Development Milestones

In April 2020, CanSino Biologics initiated a phase II trial to evaluate the immunogenicity and safety of Ad5-nCoV in healthy adults aged above 18 years (NCT04341389; JSVCT089). The double blind trial intends to enrol approximately 500 participants in China [3] .

In March 2020, CanSino Biologics initiated a phase I trial to assess the safety, reactogenicity and immunogenicity of Ad5 nCoV in healthy volunteers (NCT04313127; JSVCT088). The open-label trial will enroll approximately 108 patients in China [4] .

In March 2020, National medical products administration (NMPA) approved IND (Investigational new drug) application for phase I study of Ad5 nCoV in healthy volunteers in China. The data from preclinical study was used to submit the IND application [5] .

As of March 2020, Preclinical studies were conducted in animal models by Tianjin CanSino Biotechnology and demonstrated strong immune response with good safety profile [5] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class 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 Phase II China IM / Injection Tianjin CanSino Biotechnology 12 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Tianjin CanSino Biotechnology Originator China
Tianjin CanSino Biotechnology Owner China
Beijing Institute of Biotechnology Collaborator
National Research Council Canada Collaborator Canada

Future Events

Expected Date Event Type Description Updated
31 May 2020 Trial Update CanSino Biotechnology plans a phase I/II trial in Healthy volunteers (In adults, In elderly) in Canada (IM) (NCT04398147) (700322291) 28 May 2020
14 May 2020 Regulatory Status Tianjin CanSino Biotechnology plans to file CTA to Health Canada for COVID-2019 infections [2] 14 May 2020

Development History

Event Date Update Type Comment
28 May 2020 Trial Update CanSino Biotechnology plans a phase I/II trial in Healthy volunteers (In adults, In elderly) in Canada (IM) (NCT04398147) Updated 29 May 2020
14 May 2020 Licensing Status The National Research Council (NRC) of Canada and Tianjin CanSino Biotechnology continue collaboration for clinical development of Ad5 nCOV for COVID-2019 infections in Canada [2] Updated 29 May 2020
12 May 2020 Regulatory Status Tianjin CanSino Biotechnology plans to file CTA to Health Canada for COVID-2019 infections [2] Updated 29 May 2020
12 Apr 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (Prevention) in China (IM) (NCT04341389) Updated 21 Apr 2020
12 Apr 2020 Trial Update Tianjin CanSino Biotechnology plans the phase II CTII-nCoV trial for COVID-2019 infections (In Volunteers, Prevention) in China (IM, Injection) (NCT04341389) Updated 14 Apr 2020
17 Mar 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in China (IM), before March 2020 [5] Updated 20 Mar 2020
17 Mar 2020 Regulatory Status National medical products administration approves IND application for phase I trial for Ad5 nCOV in COVID-19 infections (Prevention) [5] Updated 20 Mar 2020
17 Mar 2020 Trial Update Tianjin CanSino Biotechnology plans a phase I trial for COVID-19 infections (In Volunteers, Prevention) in China (NCT04313127) [5] Updated 20 Mar 2020
16 Mar 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in China (IM) (NCT04313127) Updated 27 Mar 2020

References

  1. National Research Council contribution plays key role in newly approved Ebola vaccine.

    Media Release
  2. The National Research Council of Canada and CanSino Biologics Inc. announce collaboration to advance vaccine against COVID-19.

    Media Release
  3. A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

    ctiprofile
  4. A Single-center,Open-label Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

    ctiprofile
  5. CanSinoBIO's Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China.

    Media Release
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