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Research programme: vaccines - Bharat Biotech

Drug Profile

Research programme: vaccines - Bharat Biotech

Alternative Names: Malaria vaccine - Bharat Biotech; Methicillin-resistant Staphylococcus aureus vaccine - Bharat Biotech; Non-typhoidal salmonella vaccine -Bharat Biotech; NTS conjugate vaccine - Bharat Biotech; Papilloma virus vaccine - Bharat Biotech; Pertussis vaccine - Bharat Biotech; PvR II; Tetanus vaccine - Bharat Biotech

Latest Information Update: 04 Nov 2017

At a glance

  • Originator Bharat Biotech
  • Developer Bharat Biotech; Center for Vaccine Development
  • Class Bacterial vaccines; Conjugate vaccines; Viral vaccines
  • Mechanism of Action Duffy antigen binding protein modulators; 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

  • No development reported Human papillomavirus infections; Malaria; Methicillin-resistant Staphylococcus aureus infections; Pertussis; Salmonella infections; Tetanus

Most Recent Events

  • 04 Nov 2017 No recent reports of development identified for preclinical development in Malaria in India (Parenteral)
  • 04 Nov 2017 No recent reports of development identified for preclinical development in Methicillin-resistant-Staphylococcus-aureus-infections in India (Parenteral)
  • 04 Nov 2017 No recent reports of development identified for research development in Human-papillomavirus-infections in India (Parenteral)

Development Overview

Introduction

Bharat Biotech is developing vaccines for the prevention and treatment of various bacterial and viral infections. A lead candidate from this programme, PvR II, is an antimalarial vaccine against Plasmodium vivax. PvR II targets the Duffy antigen binding protein, which enables P. vivax to bind to receptors on the red blood cells, providing the sole invasion pathway for this parasite. Preclinical development include vaccines for malaria and methicillin-resistant Staphylococcus aureus (MRSA) infections. Early research was underway for vaccines against human papillomavirus (HPV), non-typhoidal Salmonella infections, acellular pertussis, and a meat-free vaccine for tetanus. However, no recent reports of development have been identified for preclinical development in malaria and MRSA infections. Also, no recent reports of development have been identified for research development in HPV infections, pertussis, tetanus and Salmonella infections.

Vaccines for Chikungunya virus, Japanese encephalitis, Zika virus infection and typhoid have advanced into clinical development [see Adis Insight Drug profiles 800049688; 800035886; 800038671; 800053031; 800024027 respectively].

Company Agreements

PvR II is being developed in collaboration with the International Centre for Genetic Engineering and Biotechnology (ICGEB), with funding provided by numerous national and international partners, including the Government of India's Department of Biotechnology, the WHO Tropical Disease Research Division, and the Indo-US Vaccine Action Programme, which is an alliance between the Department of Biotechnology, the US National Institutes of Health, and the PATH Malaria Vaccine Initiative. Additionally, development involves a technical collaboration with GlaxoSmithKline Biologicals.

Bharat is collaborating with the Center for Vaccine Development at The University of Maryland on the development of a conjugate vaccine for the prevention of non-typhoidal Salmonella infections [1] .

Key Development Milestones

In February 2016, Bharat Biotech announced that the preclinical in vivo studies are underway for ZikaVac®. The company is developing the vaccine as recombinant, using surface antigens of the Zika virus, and inactivated forms for Zika virus infections. The process development of the product was achieved at 40 litres pilot scale [2] .

In June 2012, Bharat Biotech and The University of Maryland Center for Vaccine Development received a $US4 million Strategic Translation Award from The Wellcome Trust for the clinical development of Bharat's conjugate vaccine for invasive non-typhoidal Salmonella infections. Bharat plans to begin clinical trials of the vaccine in 2015 [1] .

Patent Information

Bharat Biotech files a global patent for Zika vaccine candidates [2] .

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Bacterial vaccines, Conjugate vaccines, Viral vaccines
  • Target Duffy antigen binding protein
  • Mechanism of Action Duffy antigen binding protein modulators; Immunostimulants
  • WHO ATC code

    J07A (Bacterial Vaccines)

    J07A-J (Pertussis vaccines)

    J07A-M (Tetanus vaccines)

    J07A-X (Other bacterial vaccines)

    J07B-M (Papillomavirus vaccines)

    J07B-X (Other viral vaccines)

    P01B (Antimalarials)

  • EPhMRA code

    J7C (All Other Vaccines)

    J7D5 (Tetanus vaccines)

    J7E (Viral Vaccines)

    P1D (Anti-Malarials)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Human papillomavirus infections - - No development reported (Research) India Parenteral / unspecified Bharat Biotech 04 Nov 2017
Malaria - - No development reported (Preclinical) India Parenteral / unspecified Bharat Biotech 04 Nov 2017
Methicillin-resistant Staphylococcus aureus infections - - No development reported (Preclinical) India Parenteral / unspecified Bharat Biotech 04 Nov 2017
Pertussis Acellular - No development reported (Research) India Parenteral / unspecified Bharat Biotech 04 Nov 2017
Salmonella infections For invasive non-typhoidal Salmonella infections Prevention No development reported (Research) India, USA Parenteral / unspecified Bharat Biotech, Center for Vaccine Development 04 Nov 2017
Tetanus Meat-free vaccine - No development reported (Research) India Parenteral / unspecified Bharat Biotech 04 Nov 2017

Commercial Information

Involved Organisations

Organisation Involvement Countries
Bharat Biotech Originator India
Bharat Biotech Owner India
Center for Vaccine Development Collaborator USA

Development History

Event Date Update Type Comment
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for preclinical development in Malaria in India (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for preclinical development in Methicillin-resistant-Staphylococcus-aureus-infections in India (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for research development in Human-papillomavirus-infections in India (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for research development in Pertussis in India (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for research development in Salmonella-infections(Prevention) in India (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for research development in Salmonella-infections(Prevention) in USA (Parenteral) Updated 04 Nov 2017
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for research development in Tetanus in India (Parenteral) Updated 04 Nov 2017
01 Oct 2012 Phase Change Early research in Human papillomavirus infections in India (Parenteral) Updated 18 Oct 2012
01 Oct 2012 Phase Change Early research in Pertussis in India (Parenteral) Updated 18 Oct 2012
01 Oct 2012 Phase Change Early research in Tetanus in India (Parenteral) Updated 18 Oct 2012
01 Oct 2012 Phase Change - Preclinical Preclinical trials in Methicillin-resistant Staphylococcus aureus infections in India (Parenteral) Updated 18 Oct 2012
18 Jun 2012 Phase Change Early research in Salmonella infections (prevention) in India (Parenteral) Updated 28 Aug 2013
18 Jun 2012 Phase Change Early research in Salmonella infections (prevention) in USA (Parenteral) Updated 19 Oct 2012
19 Mar 2009 Phase Change - Preclinical Preclinical trials in Malaria in India (Parenteral) Updated 18 Oct 2012

References

  1. Bharat Biotech and University of Maryland Accelerate Development of New Life Saving Conjugate Vaccine for Invasive Non-Typhoidal Salmonella (iNTS) .

    Media Release
  2. Bharat Biotech Unveils ZIKAVAC(R) First Vaccine Candidate for Zika Virus.

    Media Release
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