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Research programme: anti-viral monoclonal antibody therapeutics - Celltrion

Drug Profile

Research programme: anti-viral monoclonal antibody therapeutics - Celltrion

Latest Information Update: 04 Jun 2020

At a glance

  • Originator Celltrion
  • Class Antivirals; Monoclonal antibodies
  • 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 Yes

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 31 May 2020 Positive pharmacodynamics data from a preclinical study in COVID-2019 infections released by Celltrion
  • 31 May 2020 Celltrion plans additional preclinical efficacy and toxicity studies in COVID-2019 infections (Parenteral)
  • 03 Apr 2020 Celltrion plans a clinical trial for COVID-2019 infections in July 2020

Development Overview

Introduction

Monoclonal antibodies for the prevention and treatment of COVID-2019 infections are being developed by Celltrion, selected by the Korea Centers for Disease Control (KCDC). The company has identified the library of antibodies sourced from the blood of recovered patients in Korea, which are thought to be involved in neutralising the virus and may contribute to recovery from COVID-2019. These antivirals will be designed to train the immune system to make antibodies that recognise and block the spike protein that the virus uses to enter human cells. Preclinical development is underway in Korea.

Celltrion plans to develop a ‘super antibody’ or an 'antibody cocktail therapy,' to target potential mutations of SARS-CoV-2 that can attach and neutralise all kinds of coronavirus related strains, such as those causing COVID-19 and SARS.

Celltrion is actively engaged in licensing in/out through strategic partnerships with the industry, academia, and research centers to expand its pipelines. Through these partnerships, the company plans to boost the effectiveness of new drug R&D projects and revitalize the bio ecosystems in and outside of Korea (Celltrion website, March 2020).

Key Development Milestones

Celltrion, in conjunction with Chungbuk National University College of Medicine, released favourable preclinical data highlighting the effectiveness of its antiviral antibody in the treatment of COVID-2019 infections, in May 2020 [1] .

In April 2020, Celltrion completed the selection of potent therapeutic antibody candidates for neutralising the SARS-CoV-2 virus after screening the antibodies which exhibited the ability to bind to the virus spike protein. Out of the 38 potent neutralising antibodies, Celltrion captured 14 powerful neutralising antibodies against SARS-CoV-2. Earlier, in the same month, the company reported the initiation of the second phase of development for an antiviral treatment for COVID-2019 infections, following the completion of the first phase of securing 300 different types of antibodies that bind to the antigen [2] [3] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Antivirals, Monoclonal antibodies
  • Target Coronavirus spike glycoprotein
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J05A-X (Other antivirals)

  • EPhMRA code

    J5B (Antivirals, excluding anti-HIV products)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - - Preclinical South Korea Parenteral / unspecified Celltrion 31 May 2020
COVID 2019 infections - Prevention Preclinical South Korea Parenteral / unspecified Celltrion 31 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Celltrion Originator South-Korea
Celltrion Owner South-Korea
Chungbuk National University Collaborator South-Korea
Korea Centers for Disease Control and Prevention Collaborator South-Korea

Scientific Summary

Pharmacodynamics

Summary

Favourable preclinical data demonstrated a 100-fold reduction in the viral load of SARS-CoV-2, following administration of anti-COVID-2019 antibody, with improvement in lung lesions indicative of a restoration to normal activity level in animal models. The antibody was superior to placebo, wherein improved recovery in terms of clinical symptom scores inclusive of runny nose, cough and body aches was demonstrated by the former, following the first day of treatment. Significant clinical remission was noted, following the fifth day. High-dose group samples reflected a dip in the viral load by 100-fold. Inflammation returned to normal lung tissue histopathology within six days along with a shortened recovery time for both high and low antibody dosages, whereas sustained levels of lung inflammation and other complications were revealed for the placebo group [1] .

Future Events

Expected Date Event Type Description Updated
01 Jul 2020 Trial Update Celltrion plans a clinical trial for COVID-2019 infections in July 2020 (700320129) [3] 09 Apr 2020

Development History

Event Date Update Type Comment
31 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in South Korea (Parenteral) before May 2020 [1] Updated 04 Jun 2020
31 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections in South Korea (Parenteral) before May 2020 [1] Updated 04 Jun 2020
31 May 2020 Scientific Update Positive pharmacodynamics data from a preclinical study in COVID-2019 infections released by Celltrion [1] Updated 04 Jun 2020
31 May 2020 Trial Update Celltrion plans additional preclinical efficacy and toxicity studies in COVID-2019 infections (Parenteral) [1] Updated 04 Jun 2020
03 Apr 2020 Trial Update Celltrion plans a clinical trial for COVID-2019 infections in July 2020 [3] Updated 09 Apr 2020
01 Apr 2020 Active Status Review Peer QC and QC feedback incorporated, MOA modified to Immunostimulants Updated 01 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in South Korea (Parenteral) [4] Updated 01 Apr 2020
23 Mar 2020 Phase Change Early research in COVID-2019 infections in South Korea (Parenteral) [4] Updated 01 Apr 2020

References

  1. Celltrion Announces Positive Pre-clinical Results for COVID- 19 Antiviral Antibody Treatment, Showing Improvement in Recovery Time.

    Media Release
  2. Celltrion Completes Neutralisation Test on Candidate Monoclonal Antibodies (mAbs) for COVID-19 Antiviral Antibody Treatment.

    Media Release
  3. Celltrions COVID-19 Antiviral Treatment Enters the Next Phase of Development.

    Media Release
  4. Celltrion Accelerates Development of COVID-19 Antiviral Treatment and Aims to Launch Rapid Self-testing Kit.

    Media Release
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