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; Plasmodium vivax malaria vaccine; PvR II; PvRII/Matrix-M; Tetanus vaccine - Bharat BiotechLatest Information Update: 08 Jun 2022
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
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Preclinical Malaria
- No development reported Human papillomavirus infections; Methicillin-resistant Staphylococcus aureus infections; Pertussis; Salmonella infections; Tetanus
Most Recent Events
- 21 May 2022 PvR II is still in preclinical phase for Malaria (Parenteral) in India
- 21 May 2022 University of Oxford plans a phase-II trial for Malaria (In volunteers)in Thailand (Parenteral) in September 2022 (NCT05380388)
- 04 Nov 2017 No recent reports of development identified for preclinical development in Malaria 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)
Table of Contents
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 | - | - | Preclinical | India | Parenteral / unspecified | Bharat Biotech | 19 Mar 2009 |
| 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 |
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 21 May 2022 | Trial Update | University of Oxford plans a phase-II trial for Malaria (In volunteers)in Thailand (Parenteral) in September 2022 (NCT05380388) (700352391) | 08 Jun 2022 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 21 May 2022 | Active Status Review | PvR II is still in preclinical phase for Malaria (Parenteral) in India Updated 08 Jun 2022 |
| 21 May 2022 | Trial Update | University of Oxford plans a phase-II trial for Malaria (In volunteers)in Thailand (Parenteral) in September 2022 (NCT05380388) Updated 08 Jun 2022 |
| 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
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Bharat Biotech and University of Maryland Accelerate Development of New Life Saving Conjugate Vaccine for Invasive Non-Typhoidal Salmonella (iNTS) .
Media Release -
Bharat Biotech Unveils ZIKAVAC(R) First Vaccine Candidate for Zika Virus.
Media Release
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