The agreement will involve a shared clinical development phase as well as allowing IBMP exclusive rights for the commercialization of the vaccine candidates in Brazil. In addition, clinical stage manufacturing of the vaccines will be conducted by Emergex; with a transition to commercial scale manufacturing being conducted in the region by IBMP.
Dengue is a mosquito-borne viral disease, which is widespread throughout the tropics.
The global incidence of dengue has grown dramatically with about half of the world's population now at risk. The number of dengue cases reported to WHO increased over 8 fold over the last two decades, from 505,430 cases in 2000, to over 2.4 million in 2010, and 5.2 million in 2019.
Dengue causes a wide spectrum of disease, ranging from mild to severe. Severe dengue affects most Asian and Latin American countries and has become a leading cause of hospitalization and death among children and adults in these regions.
However, the disease is now spreading to new areas including Europe: with local transmission reported for the first time in France and Croatia in 2010.
The agreement initially focuses on Emergex’s Dengue vaccine candidate, which is currently in Phase 1 clinical trials in Switzerland with top line results expected imminently. This represents one of Emergex’s most advanced candidates using its 100% synthetic T cell Adaptive Vaccine approach, with the Dengue vaccine showing potential to be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever.
Emergex also champions the potential of its vaccine candidates to be stable at ambient temperatures, reducing the burden and logistics of vaccine administration.
The only dengue vaccine currently on the market is Sanofi’s Dengvaxia, which is only approved for people with prior infection. Takeda, meanwhile, is in the process of applying for authorization in Europe for its TAK-003 vaccine.
Emergex and IBMP's collaboration also includes the shared development and commercialization of a COVID-19 vaccine, which is in Phase 1 trials with top line results due later this year.
The two bodies will also work together on pre-clinical testing and clinical testing of a Chikungunya vaccine candidate (which is being developed with support form a UK Aid grant). Further development of the Chikungunya vaccine candidate in Brazil would be jointly conducted by Emergex and IBMP with costs shared equally between both parties and with IBMP having the option for exclusive commercial rights for the Chikungunya vaccine in Brazil.
Abingdon-headquartered Emergex is pioneering the development of 100% synthetic T cell Adaptive Vaccines that harness the body’s natural T cell immune response to destroy pathogen-infected cells in order to provide protection against viral infectious diseases (amongst which are Dengue, Coronaviruses, and pandemic Influenza) as well as serious intracellular bacterial infectious diseases.
Emergex has a growing proprietary pipeline of CD8+ T cell Adaptive Vaccine and booster vaccine candidates that have the potential to deliver 'rapid, broad (mutation-agnostic) and long-lasting immunity to reduce serious illness associated with infectious disease'. It has several Phase I clinical trials underway, of which the most advanced are Dengue (which may also be disease-modifying for other members of the Flaviviridae virus family, such as Zika and Yellow Fever) and Coronaviruses. Other programs in development include vaccine candidates for universal (pandemic) Influenza, Chikungunya, and a booster vaccine for Yellow Fever.
Emergex’s T cell Adaptive Vaccines candidates combine two proprietary technologies, [i] an empirically determined library of pathogen-derived protein fragments expressed on the surface of pathogen-infected cells (forming the MHC Class I expression “ligandome” library), and [ii] a passivated gold nanoparticle carrier system designed to deliver the synthetic peptides to the skin-resident immune system (in combination with nociception) via microneedles in order to elicit a robust, adaptive CD8+ T cell response.