Emergex and Brazil’s IBMP Announce Clinical Development Collaboration for T Cell-Priming Immune Set-Point Candidates

• Emergex and Brazil’s IBMP to co-fund Phase II and Phase III studies of Emergex’s Dengue Fever and Betacoronavirus T cell-priming immune set-point therapeutic candidates in Brazil, with potential to expand to additional indications
• IBMP has made an equity investment in Emergex, contributing to the funding of Phase II clinical trials

ABINGDON, United Kingdom, June 20, 2023 (GLOBE NEWSWIRE) — Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of fully synthetic T cell-priming immune set-point candidates, today announced a multi-level collaboration agreement with the Molecular Biology Institute of Paraná (IBMP) in Brazil.

IBMP is a commercial organization embedded within Fiocruz, the Brazilian national institution for research and production of biopharmaceuticals and vaccines, linked to the Ministry of Health. Fiocruz has a strong commercial track record in the healthcare space, with expertise in the development, manufacturing, regulatory approval, and commercialization of medicines and medical diagnostics in Brazil.

Emergex and IBMP have agreed to co-fund Phase II and Phase III studies in Brazil of Emergex’s T cell-priming set-point candidates for Dengue Fever and Betacoronavirus, known respectively as DengueTcP™ (trademark application submitted) and CoronaTcP™ (trademark application submitted). Both clinical trial product candidates have successfully completed Phase I+ clinical trials in Switzerland and are nearing submission and evaluation by ANVISA, the Brazilian health regulatory agency.

Per the terms of this agreement, Emergex will conduct clinical-stage manufacturing of the products with the planned transition to IBMP for commercial scale manufacturing in the region. IBMP will obtain exclusive marketing and commercialization rights of the two candidate products in Brazil and South America. A Joint Steering Committee with representatives from both Emergex and IBMP will oversee the collaboration and commercialization of the select immunotherapies.

The agreement also allows for future expansion into additional indications. This arrangement potentially encompasses shared development and commercialization of Emergex’s T cell-priming set-point candidates targeting Chikungunya, for which development is underway, Influenza A (including pandemic strains), for which Emergex has advanced to cGMP manufacturing and is ready to initiate Phase I clinical trials in the U.S., and Yellow Fever. At the end of 2022, Emergex announced the generation of a Chikungunya ligandome, which is expected to progress into Phase I human trials in 1Q24.

IBMP has also made an early equity investment into Emergex, which has potential for future expansion pending the completion of its ongoing due diligence process. Additionally, IBMP will fund Emergex’s share of the costs for Phase II trials in Brazil for Dengue, Betacoronavirus and Universal Influenza A in return for additional equity, subject to shareholder approval.

Professor Thomas Rademacher, Co-founder, and CEO at Emergex, commented: “Following the successful Phase I trials for our Dengue Fever and Coronavirus candidates in Switzerland we look forward to progressing into a Phase II trial in Brazil, where Dengue is endemic. We have been working closely with the team at IBMP for several years, so it is wonderful to formalize our relationships with this agreement.”

Pedro Ribeiro Barbosa, CEO at the Molecular Biology Institute of Paraná (IBMP) in Brazil, added: “My team and I look forward to initiating this important international collaboration and progressing the Emergex Dengue candidate into Phase II. Dengue presents a serious disease burden in Brazil with hundreds of thousands of cases across the country each year and hundreds of deaths, so there is urgent need for new therapies.”

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About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania, USA. The company is pioneering the development of 100% synthetic, T cell-priming immune set-point therapeutic candidates that harness and direct the body’s natural T cell immune response to destroy and to clear pathogen-infected cells, using cytopathic or non-cytopathic mechanisms, in order to provide protection against some of the world’s most urgent health threats. Emergex’ first indications being pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronavirus, Dengue Fever and Universal Influenza A, including pandemic influenza, as well as [ii] intra-cellular bacterial infectious disease, such as Francisella tularensis. In the near future, other disease applications will follow.
Find out more online at www.emergexvaccines.com.

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About IBMP
With a broad and modern manufacturing plant, the Molecular Biology Institute of Paraná (IBMP) works in applied research, technological development, innovation and industrial production of inputs and diagnosis kits for health. The institution integrates and contributes to the development of the Economic and Industrial Complex of Health (Complexo Econômico e Industrial da Saúde – CEIS) and comprehends the development of Science and Technology as the best access to health products, services, and fundamental for the economic dynamism in the country. Its activities are intended to supply the health network with safe and quality products.

Find out more online at https://www.ibmp.org.br/en-us/.