• Agreement provides a framework for future clinical trials, manufacturing, sales and marketing, and distribution within the National Health Service of Brazil
  • Bio-Manguinhos, is a world leader in vaccine development and manufacturing and one of the productive units of Fiocruz, one of the world’s most respected public health research institutions

ABINGDON, UK I January 05, 2021 I Emergex Vaccines Holding Limited (‘Emergex’, or ‘the Company’), a company tackling major global infectious disease threats through the development of synthetic ‘set point’ vaccines which prime the T-Cell immune response, today announces that it has signed a collaboration and development agreement with the Institute of Technology on Immunobiologicals (Bio-Manguinhos) of the Oswaldo Cruz Foundation (Fiocruz) in Brazil to develop a COVID-19 vaccine using Emergex’s next generation synthetic T-Cell vaccine technology.

The agreement provides a framework under which both parties will work together to progress certain immunotherapeutic programmes, including a vaccine candidate for COVID-19, through a regulatory pathway for the Brazilian National Health Service. Emergex will also support the performance of studies, including clinical trials, and to manufacture, market, promote and distribute certain infectious diseases vaccines within the National Health Service of Brazil.

Emergex has already completed preclinical development work including toxicology and immunoproteomic research into the MHC Class I peptide expression library for cell surface expressed peptides on SARS-Cov-2 infected cells, which define the repertoire of an effective T-Cell immune response to the COVID-19 disease.

In August 2020, a previous research collaboration between Emergex and Bio-Manguinhos / Fiocruz resulted in the determination of the MHC CD8 T-Cell epitope expression library for Fiocruz’s commercial yellow fever vaccine.

Bio-Manguinhos / Fiocruz and Emergex will share initial set up and development costs. Further financial details have not been disclosed.

Storme Moore-Thornicroft, COO and co-founder of Emergex, commented: “Bio-Manguinhos Institute of the Oswald Cruz Foundation, is a world leader in the development and manufacturing of vaccines. This agreement, which will enable us to work alongside Bio-Manguinhos/Fiocruz to develop our COVID-19 vaccine candidate, is an important validation of the potential of our technology. Access to a COVID-19 vaccine which is both easy to manufacture and deploy is critical, particularly in a country as large as Brazil and where there have been more than 6 million cases of COVID-19 reported to date.”

Sotiris Missailidis, Deputy Director of Technological Development of Bio-Manguinhos/Fiocruz, commented: “Given the geographical scale and logistical difficulties that underlie distributing a vaccine across Brazil, Emergex’s expertise and technology could play a vital role in overcoming such challenges, including the potential to allow for mass rollout of a vaccine for COVID-19. Emergex vaccines are 100% synthetic, requiring no biology for manufacturing, making rapid scale-up and production possible. Furthermore, delivery through a microneedle system on a single patch, make them easy to administer, requiring less clinical intervention, and allowing for wider public adoption. We look forward to working with Emergex on this and other co-development projects to bring safe and affordable vaccines to the Brazilian public market.

About Emergex

Emergex, a biotechnology company headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA, is pioneering the development of synthetic ‘set point’ vaccines which prime the T-cell immune response to address some of the world’s most immediate health threats such as COVID-19, Dengue Fever, Zika, Ebola, pandemic flu and serious intra-cellular bacterial infections.

These set-point vaccines modify the initial immune status of recipients in a way that ‘primes’ their immune systems to recognise subsequent infectious agents much like a natural infection would do, preventing an acute or severe manifestation of the disease.

Emergex combines validated technologies together with the very latest scientific insights in immunology and virology to develop its vaccines, including the use of synthetic peptide codes determined on actual infected cells and using a proprietary gold nanoparticle carrier system for programming.

The Company has a growing pipeline of vaccine candidates. The most advanced development programme is a vaccine for Dengue Fever, which may also be disease modifying for other Flaviviruses such as the Zika and Yellow Fever viruses. Emergex also has programmes in development for a universal Influenza vaccine and a universal Filovirus vaccine (including viruses such as Ebola and Marburg) and discovery programmes for a Yellow Fever Booster vaccine and a Chikungunya vaccine.

Emergex has partnered with the Institute of Molecular and Cell Biology (IMCB) of Singapore to develop a vaccine for the emerging threat of Hand, Foot and Mouth (HFM) disease. The Company also has a collaboration in place with Brazil-based Bio-Manguinhos/Fiocruz for the development of several vaccine candidates, including a potential vaccine for COVID-19.

Find out more online at www.emergexvaccines.com.

Background to Emergex Vaccine Approach:

Both naïve T-Cells and memory T-Cells are activated in an acute viral infection via trogocytosis (or cross-dressing). This is a process in which a donor antigen presenting cell (APC) has acquired MHC Class I peptide complexes from an infected cell by membrane capture. This critical pathway ensures that the immune system is only activated by viral peptides that are present in infected cells and the resulting T-Cell repertoire accurately reflects only those targets expressed on infected cells. The other mechanisms of APC processing, such as direct priming (requires APC to be infected by the virus) or cross-presentation (requires APC to process protein fragments of the virus after the virus has successfully replicated and is producing virions) can lead to off-target T-Cell responses and a delay in response. Trogocytosis is the main mechanism of alloantigen recognition in acute allograft rejection.  
Emergex vaccines incorporate only peptides shown to be physically presented on class I molecules (independent of length or predicted affinity) in infected cells (pMHC target expression library) which can lead to cross-dressing of APCs – in contrast to peptides predicted hypothetically by computer or predicted from T-Cell reactivity to peptide pools in convalescent blood – many of which will be off-target.

By the use of microneedle injection from a small patch, Emergex unique TAP-responsive peptide delivery system mimics the trogocytosis process by directly cross-dressing skin reactive dendritic cells which are actively transported by rapidly migrating dendritic cells to multiple lymphoid organs. In vivo murine experiments on Dengue, Zika, SARS-2 and influenza have shown that doses as low as several femtomoles can generate robust T-Cell immune response resulting in Cytotoxic T lymphocytes that kill viral infected cells.

About Bio-Manguinhos/Fiocruz

As part of the Brazilian Ministry of Health, for 44 years the Institute of Technology on Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz) has expanded access to health care for the population through the research, development and supply of products that prevent, diagnose and treat diseases. To establish itself as the largest public laboratory in Latin America, Bio-Manguinhos wrote parts of the History of Public Health in Brazil. It has played a decisive role in the eradication of poliomyelitis in the country and in the Americas; was instrumental in the control of measles and yellow fever, becoming one of the main producers of this vaccine in the world, having already exported to more than 70 countries.

Partnerships with public and private institutions through technology transfer agreements, Partnerships for Productive Development (PDPs) and autochthonous development projects contribute to the expansion of its portfolio, which has more than 40 products among vaccines, in vitro diagnostics (IVDs) and biopharmaceuticals. Each year, millions of units are provided to the Brazilian Ministry of Health programs.

Find out more online at https://www.bio.fiocruz.br/

About the Oswaldo Cruz Foundation (Fiocruz)

The Oswaldo Cruz Foundation (Fiocruz) was founded by Dr. Oswaldo Cruz, a noted physician and epidemiologist and is considered one of the world’s main public health research institutions. Fiocruz is a scientific research foundation focussed on biological sciences, located in Rio de Janeiro, Brazil and part of the Brazilian government’s Ministry of Health. It has one of Brazil’s largest public laboratories for vaccine production – the Immunobiological Technology Institute (Bio-Manguinhos). Bio-Manguinhos is the world’s largest manufacturer of the yellow fever vaccine, and the only Latin American laboratory certified by the World Health Organization (WHO) for this purpose.

Find out more online at https://portal.fiocruz.br/en.

SOURCE: Emergex Vaccines Holding