Emergex Announces MHRA Approval of MIA (IMP) Manufacturing and Import Authorisation License

Abingdon, United Kingdom, 18 June 2024 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming vaccine candidates, today announced that Emergex has received its Manufacturing and Import Authorisation (MIA) Investigational Medicinal Product (IMP) license from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to advance its novel T cell-priming vaccine candidates into clinical production. This will provide cGMP grade vaccine Drug Substance to support Emergex’s clinical trial pipeline.

Emergex’s MIA (IMP) license and cGMP accreditation, issued on 16 April 2024 [MIA (IMP) 57419] follows a rigorous multi-phase regulatory audit inspection of its GMP Quality Systems, Facilities, and Manufacturing Areas, conducted in September 2023 and March 2024.

Laszlo Fekete, Quality Director at Emergex, commented: “We are thrilled to announce the GMP certification of our in-house facilities, a critical milestone that allows us to confidently proceed with production of our novel T cell-priming vaccine candidates into clinical use. The infectious disease solutions we are developing aim to address significant unmet medical needs, offering the potential to provide coverage for billions of individuals at risk for dengue and pandemic influenza, among other urgent global health challenges. The MIA (IMP) license grants us the privilege and responsibility to manufacture clinical-grade products to protect these huge at-risk populations.”

Laurens Rademacher, Chief Technology Officer at Emergex added: “For Emergex, this is a milestone we have been working towards since its formation in 2016. Over the years, we have been dedicated to building the necessary infrastructure and establishing key collaborations in high-impact countries around the world. This has included developing innovative technologies such as the Stericube, outsourcing manufacturing in order to most efficiently scale our production capabilities, and engaging in technology transfer strategies to enhance the global reach and impact of our vaccine candidates to where they are needed most. Notably, our strategic ties with entities in Brazil and Saudi Arabia have been crucial in advancing our joint goals with potential to expand access in diverse markets.”

The MHRA is an executive agency of the UK Department of Health and Social Care, which is responsible for ensuring that medicines and medical devices properly work and are acceptably safe. MHRA licensing is globally recognized for requiring the highest standards of safety, quality and effectiveness for any vaccine. The receival of the MIA (IMP) license makes Emergex the only dedicated gold nanoparticle T cell vaccine cGMP facility in the world.

Emergex’s innovative T cell-based vaccines are unique in that they are 100% synthetic in composition, shelf stable for over 3 months at ambient temperatures, and designed to provide long-term and mutation-agnostic coverage against existing and emerging strains of viruses of the same virus family. Designed for delivery via novel microneedle technology, their scalable design and ease of administration facilitates manufacture in bulk, which is particularly crucial during the emergence of pandemics. Furthermore, their design offers improved access to remote and under-resourced regions of the world.

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic T cell-priming vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Pandemic Influenza candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page Twitter (X) account

 

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

1 Trademark application submitted

Emergex Announces R&D Collaboration with DEKA Research & Development Corp. for Assessment of Emergex’s Immunotherapeutic Candidates with DEKA’s Intradermal Therapeutic Applicator

  • – Emergex has entered into an agreement with DEKA Research & Development (‘DEKA’) to assess the compatibility of Emergex’s T cell-priming set-point immunotherapeutic candidates with DEKA’s Intradermal Therapeutic Applicator. The collaboration builds on previous data showing satisfactory loading and stability of Emergex’s therapeutic candidates when incorporated with the Intradermal Therapeutic Applicator.
  • – The collaboration also covers completion of a preclinical study to compare the pharmacokinetics of [i] Emergex’s Dengue treatment candidate by syringe-based microneedle technology, which have been used in previous preclinical and clinical Emergex studies, with [ii] DEKA’s Intradermal Therapeutic Applicator.
  • – Pending preclinical study results, the agreement allows for the possibility of advancing the Intradermal Therapeutic Applicator as an administration device for Emergex’s pipeline of treatments for viral diseases.

Abingdon, United Kingdom, 16 January 2024 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of synthetic T cell-priming set-point immunotherapy-based treatment candidates, today announced that the Company has entered into an agreement with DEKA to assess the compatibility of Emergex’s immunotherapeutic candidates with the DEKA Intradermal Therapeutic Applicator.

The Intradermal Therapeutic Applicator incorporates hollow microneedle technology into a convenient self-administration device. This agreement builds on previous data showing satisfactory loading and stability of Emergex’s product candidates when incorporated into the Intradermal Therapeutic Applicator.

Laurens Rademacher, Chief Technology Officer at Emergex, added: “We are delighted to announce this important collaboration with DEKA. Intradermal/Epidermal delivery is critical to the mechanism of our T cell-priming product platform. The use of microneedles, which have been utilized in all our previous preclinical and clinical work, paired with the ease-of-use of the Intradermal Therapeutic Applicator is a perfect complement to our own technologies.”

The agreement covers completion of a preclinical pharmacokinetic study to compare the delivery of Emergex’s DengueTcP1 product candidate by syringe-based microneedle technology versus the DEKA Intradermal Therapeutic Applicator. Pending completion, if promising data is obtained, the agreement allows for the possibility of advancing DEKA’s Intradermal Therapeutic Applicator as a device for administration of Emergex’s T cell-priming set-point immunotherapeutic product candidates in the pipeline.

Dean Kamen, Founder and President, of DEKA Research & Development, commented: “The partnership with Emergex is a meaningful step forward in patient therapeutic delivery. The combined technologies of our novel intradermal therapeutic delivery platform along with Emergex’s products can open a new route to intradermal drug administration in a patient friendly, easy-to-use, painless way. We are excited by the potential of our combined technologies in saving numerous lives.”

About DEKA Intradermal Therapeutic Applicator
DEKA’s technology leverages hollow microneedles that offer a unique design with flexible features for efficient therapeutic delivery, self-administration and minimal pain. With a simple push of the top button on the device, the petal design spreads outward, thereby stretching the skin and enabling a consistent insertion of the microneedles into the skin. The continued downward motion then activates the trigger that applies pressure to the reservoir to expel the therapeutic agent into the intradermal region. Numerous advantages of this device include self-administration, dose-sparing and less overall waste than conventional needles

About DEKA Research and Development
Based in Manchester, NH, DEKA Research & Development Corp. is a technology development organization. The company was founded in 1982 by Dean Kamen.

Find out more online at www.dekaresearch.com.
Visit our LinkedIn page for updates.

 

About Emergex

Emergex is a clinical-stage, privately held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for updates.

 

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

1 Trademark application submitted

Emergex Announces Authorisation from Philippines FDA to Initiate Phase I-II Clinical Trial of CoronaTcP™

  • – Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses.
  • – Emergex is progressing trial initiation plans, with an anticipated start date in Q2 2024.

ABINGDON, United Kingdom, 3 January 2024 – 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 that the Philippines Food & Drug Administration has authorised the initiation of a Phase I-II clinical trial of CoronaTcP™1, Emergex’s T cell-priming set-point product, designed to be broadly effective against disease caused by Betacoronaviruses, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2.

The naNO-COVID 2 trial (NCT05633446) is a randomized, double-blind, placebo-controlled Phase I-II trial in the Philippines, which will investigate the safety and immunogenicity of CoronaTcP. The study is expected to enrol 110 healthy volunteers (18–75 years of age), who will each receive either one or two doses of CoronaTcP or placebo. All participants will be followed up for six months.

This study follows completion of the naNO-COVID trial (NCT05113862), a Phase I clinical trial in Switzerland which demonstrated that CoronaTcP had a favourable safety profile and successfully induced virus-specific CD8+ memory subsets.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland. Coronaviruses are susceptible to high mutation rates, and cellular immunity is critical for long-lasting protection. We look forward to evaluating our T cell-based approach, which has the potential to improve any previous immune status. Emergex is rapidly moving forward with plans for the trial, and we expect to start enrolling volunteers in Q2 2024.”

The naNO-COVID 2 trial
The naNO-COVID 2 trial (NCT05633446) is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell-priming immune set-point candidate for coronavirus disease in healthy adults. The clinical study will enrol 110 participants, who will be randomized into the following groups: Group 1: one vaccination on Day 0 (n=55): 44 CoronaTcP + 11 placebo; Group 2: two vaccinations on Day 0 and Day 21 (n=55): 44 CoronaTcP + 11 placebo. Overall, 88 participants will receive CoronaTcP (7.5 nmol peptide per dose) and 22 will receive placebo (water for injection). Safety and immunogenicity of CoronaTcP (cellular and humoral immune responses) during the six-month post-vaccination period will be evaluated.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.emergexvaccines.com.

Visit our LinkedIn page or Twitter account for updates.

1 Trademark application submitted

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Successful Transfer of New Drug Application (NDA), Acknowledged by U.S. FDA, from Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch

  • – Earlier this year, Emergex submitted a notification to the FDA regarding the transfer of ownership of Zosano Pharma’s Microneedle Array Patch (MAP) epidermal drug delivery system to Emergex itself following its acquisition of the operating assets of Zosano, which has been acknowledged by the FDA with the update reflected in its records.
  • – Emergex requested a 12-month extension to the submitted NDA to work toward potential marketing authorization of Zosano’s microneedle-based drug delivery patch originally intended to deliver zolmitriptanTM for the treatment of migraines, which will also be repurposed for the delivery of Emergex’s T cell-priming candidates. The FDA has acknowledged the extension request.

Abingdon, Oxon, UK, 18 December 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of T cell-priming, immune set-point drug candidates, today announced that the Company has transferred ownership, as of May 2023, of the existing U.S. Food and Drug Administration (FDA) New Drug Application (NDA) of the investigational MAP originally intended for the epidermal delivery of zolmitriptan1 (also known as M207) for the treatment of migraine attacks in adults. This transfer from the former California-based Zosano Pharma Corporation (Fremont, CA) follows the acquisition of Zosano operating assets by Emergex. Additionally, Emergex has notified the FDA of its request for a 12-month extension of the NDA.

On October 12, 2022, Emergex announced its acquisition of Zosano assets, including intellectual property, license agreements, and manufacturing equipment, as well as Zosano’s proprietary MAP epidermal drug delivery system.

Emergex had previously performed proof-of-concept studies with Zosano MAP technology-based microneedle patches coated with Emergex T cell-priming immune set-point candidates, observing favourable results regarding ease-of-use and shelf-life characteristics. The acquisition provided Emergex with innovative technology, among other assets, and optimised manufacturing capabilities that can be deployed for, and integrated with, the development roadmap of Emergex’s T cell-priming candidates. In April 2023, Emergex notified the FDA of that acquisition, as a full NDA package which had previously been filed with the FDA by Zosano.

Emergex also notified the FDA of an extension of Zosano’s submission of epidermal migraine treatment patch NDA for potential marketing authorization. The extension will allow Emergex to continue manufacturing the epidermal delivery patch with its own pipeline of T cell-priming candidates.

Laurens Rademacher, Chief Technology Officer at Emergex, commented: “The successful transfer of the NDA marks an important milestone in our goal to lead a new generation of treatments for acute viral infections. We look forward to expanding upon the promise of this MAP technology and are confident that its combination with our T cell-priming candidates will further advance Emergex’s core mission to combat viral threats around the world. We now have a highly sophisticated vaccine platform paired with a pragmatic delivery tool, which we believe makes a recipe for success”


1 Zolmitriptan is an active drug used to treat acute migraine headaches in adults, currently available under various brand names, such as Zomig®, among others.

About Epidermal Delivery and MAP Technology

Microneedle array patch (MAP) technology facilitates the use of coated microneedles for epidermal delivery of Emergex immunotherapy candidates to treat acute viral diseases. The novel technology has previously been validated with Emergex products in proof-of-concept studies. The use of MAP technology is intended to overcome the limitations imposed on supply chain logistics by traditional vaccine approaches, which require colder temperatures during both shipping and manufacture and greatly limit global accessibility. The technology also takes advantage of the high levels of antigen-presenting cells present in the skin to induce a stronger immune response
while using smaller quantities of antigens. Collectively, the novel drug delivery strategy is intended to provide an effective delivery tool with limited reliance on costly and complex supply chain logistics.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Visit our LinkedIn page or Twitter account for updates.

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Emergex Signs Contract of £1,79M with the UK Department of Health and Social Care’s UK Vaccine Network (“UKVN”) to Advance Its Novel Synthetic T Cell-Priming Set-Point Candidate Against Chikungunya Virus

Abingdon, United Kingdom, 17 November 2023 – Emergex Vaccines Holding Limited (‘Emergex’), a clinical-stage biotechnology company addressing major global infectious diseases through the development of 100% synthetic T cell-priming immune set-point candidates, today announced that it has signed a contract with the UK Department of Health and Social Care for £1,798,109 to advance a CD8 T cell-based vaccine candidate against Chikungunya virus (CHIKV).

CHIKV is a mosquito-transmitted alphavirus that causes epidemics of illness characterized by debilitating arthralgia and arthritis that can endure for months to years following infection. In the last decade, CHIKV has become a reemerging mosquito-transmitted virus that has spread into Europe, Asia, the Pacific Region, and the Americas, with epidemics causing severe economic impact.

The milestone-based contract is designed such that Emergex will advance the development of a CD8 T cell-priming Chikungunya virus (CHIKV) vaccine candidate (PepGNP-ChikV) through preclinical studies, manufacture the vaccine candidate under Good Manufacturing Practice (cGMP) standards, and apply for MHRA regulatory submission for a Phase-1 clinical trial in the UK. The programme is intended to position Emergex for entry to the clinic by its completion, ready to begin a Phase-1 clinical trial.

Laurens Rademacher, Chief Technology Officer of Emergex commented, “We are greatly looking forward to continuing development of our novel T cell-priming solutions against leading and reemerging global health threats of epidemic potential. Through this meaningful contract, we are pleased that the UK government and its advisors recognize the potential of our innovative technology in contribution to global epidemic (and pandemic) preparedness. The focus of this opportunity on developing groundbreaking solutions targeted to entire families of viruses aligns well with Emergex’s core mission and capabilities. Our T cell-priming set-point candidates are designed to deliver robust and long-lasting protection against current and existing strains of RNA viruses, from Influenza to Chikungunya, and to ultimately increase vaccine accessibility in endemic regions.”

This news follows a previous announcement in February 2022, highlighting a contract awarded by UK government’s Department of Health and Social Care (‘DHSC’) in support of the development of Emergex’s Chikungunya vaccine candidate prototype stages of which included 1) identification of novel CHIKV peptide antigen epitopes (collectively constituting Emergex’s “ligandome”), 2) synthesis of a vaccine candidate, and 3) testing in in vitro efficacy models. Subsequently, Emergex achieved all milestones priming the CHIKV candidate for progression to the next stage of its preclinical development.

Dr Phil Packer, Innovation Lead, AMR and Vaccines, from UK Research and Innovation (UKRI) added: “Innovate UK are delivering a further (£40M) Programme for DHSC to develop vaccines against diseases that have outbreak potential. This exciting project, spearheaded by Emergex, will pave the way for development of a vaccine against Chikungunya Virus that will be ready for evaluation in human clinical trials. This brings us one step closer to providing a solution that, if successful, will have huge benefit for people in Low- and Middle- Income Countries where this disease is most prevalent.”

Using the Emergex T cell-priming platform, Emergex has successfully completed Phase I trials of Dengue and Betacoronavirus vaccine candidates (DengueTcPTM1 and CoronaTcP, respectively) under Swiss Medic, which were shown to be safe and capable of inducing desired T cell effector and memory responses. A Phase-2 trial for CoronaTcP and a Phase-1 trial for a Universal Influenza vaccine candidate are planned in H1 2024.

About Chikungunya

Chikungunya is an alphavirus (group of RNA viruses) and genus of the Togaviridae family of viruses. It is transmitted through the bite of an infected mosquito and can cause epidemics of infectious disease. The illness is characterized by fever, rash, debilitating joint stiffness (arthralgia) and arthritis, which can endure for months to years following infection. Endemic in most countries in Central and South America and the Caribbean with first local transmission identified over the past decade, CHIKV cases have been reported in Europe, Asia, the Pacific region, as well as the Americas. An increasing trend in CHIKV cases has been observed in the Americas in recent years; in this region collectively, a four-fold increase in CHIKV cases and deaths has been reported between 1 January and 4 March 2023, compared with the same time period in 2022.2 Epidemics of CHIKV can severely impact the economy. It was announced last week that the U.S. Food and Drug Administration (FDA) has approved under accelerated approval a single-dose, live-attenuated vaccine for individuals over 18 years of age at increased risk of exposure to chikungunya virus (CHIKV) for the prevention of disease based on anti-CHIKV neutralizing antibody titres, the clinical benefit of which is contingent upon verification in confirmatory studies.

About UK Vaccine Network (“UKVN”)

This research was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs). It was delivered by Innovate UK.

The Department for Health and Social Care (DHSC) is the UK Government department which is responsible for helping people to live more independent, healthier lives for longer. This investment is part of the UK Vaccine Network (UKVN). UKVN was established to provide funding to support the development of promising vaccines and vaccine technologies that will help combat infectious diseases that have epidemic potential in low and middle-income countries (LMICs). UKVN is an UK Aid investment, which means all projects funded must support research primarily and directly for the benefit of people in low- and middle-income countries (LMICs).

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Visit our LinkedIn page or Twitter account for updates.

1 Trademark application submitted
2 https://www.who.int/emergencies/disease-outbreak-news/item/2023-DON448

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

Emergex and Saudi Arabia’s Vaccine Industrial Company (VIC) have signed MoU to Advance First-of-its-Kind Infectious Disease Solutions

  • – Emergex and VIC plan to collaborate to further develop and commercialise Emergex’s proprietary T cell-based vaccine candidates as designated in Saudi Arabia and the agreed Territory (including GCC Member States, other Middle Eastern territories and specified regions).

    – The Collaboration Agreement ultimately shall grant VIC first rights to distribute potential licensed products and to fill and finish activities in Saudi Arabia and the Territory.

    – This Collaboration supports the Kingdom of Saudi Arabia’s Vision 2030 to boost the biopharma sector through increasing local and regional production as well as accessibility of healthcare solutions.

ABINGDON, United Kingdom, October 05, 2023 – Emergex Vaccines Holding Limited (‘Emergex’, or the ‘Company’) a clinical-stage biotechnology company on the forefront of combatting global infectious diseases, has announced that the Company has signed a Memorandum of Understanding with the Vaccine Industrial Company (VIC) for a Collaboration Agreement advancing Emergex’s novel T cell-priming immune set-point candidates against designated infectious diseases. This follows recent announcements of promising data reported from successful completion of Phase I clinical trials of candidates for Betacoronaviruses and Dengue Fever. Currently, Saudi Arabia has an entirely nascent market in infectious disease solutions and has established companies such as VIC to position itself and associated territories as a global biotech hub to facilitate serious initiatives to localize the biotechnology industry and harness novel technologies to address this. This agreement is a testament to Emergex’s promising technology as a vital contributor to game changing healthcare solutions around the world.

Under the terms, VIC intends to take an equity stake in Emergex, subject to government support of Phase II/III clinical trials of Emergex’s T cell-priming candidates for Dengue, Coronavirus, Influenza, Yellow Fever, including add-on products related to these indications. VIC shall have a Right of First Negotiation (“ROFN”) over new candidates proposed by Emergex for the Territory. The venture would grant VIC exclusive rights to marketing and distribution of potential licensed products, as well as fill and finish activities for potential licensed products within Saudi Arabia and the designated Territory, with Emergex’s assistance for any technology transfer.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented, “This partnership with VIC propels our candidates into territories where these diseases strike hardest, where treatments are desperately needed. With this Memorandum, marking our second government-affiliated collaboration, we are delighted that global organizations recognize Emergex’s promise. We remain dedicated to forging these alliances in order to extend the reach of our candidates worldwide.”

Dr. Khaled Almosa, Founder and Chief Executive Officer of VIC added, “We welcome the opportunity to work with Emergex at a time when infectious disease prevention is a priority to the Saudi Arabian government and people. Emergex’s novel approach offers a safe, easy-to-administer and highly effective solution, alternative to mainstream methods, to protect against infectious diseases. Advancing such innovative technologies locally will greatly contribute to Saudi Arabia’s Vision 2030 to become a global biotech hub, making headway toward greater vaccine accessibility and reducing dependance on other countries for vital healthcare solutions.”

Joining hands with forward-thinking biotech organizations such as VIC marks an important milestone for Emergex. Such partnership fortifies critical health infrastructure within regions such as the Middle East and North Africa (MENA) that are historically difficult for biopharma to reach, playing a pivotal role in safeguarding the public’s health against the looming threat of infectious diseases.

About Vaccine Industrial Company (VIC)

Vaccine Industrial Company (VIC) is a Saudi Arabian company based in Riyadh and founded in January 2022 by Dr. Khaled Almosa, a health care management consultant. Dr. Khaled is the Founder, Vice Chairman and Managing Director of Saudi Biotechnology Manufacturing Company for Insulin and Biologics (2010-2020), Member of Supreme Committee for Research, Development and Innovation, Council of Economic & Development Affairs, Council of Ministers, Saudi Arabia. VIC is the first and only company aiming to set up a state-of-the-art vaccine manufacturing facility in Saudi Arabia.

About Emergex

Emergex is a clinical-stage, privately-held biotechnology company, headquartered in Abingdon, UK, with an operating subsidiary in Doylestown, Pennsylvania and a GMP manufacturing facility in Fremont, CA, USA. The Company is pioneering the development of 100% synthetic, T cell-priming immune set-point vaccine candidates designed to mimic 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 protect against some of the world’s most urgent health threats. The candidates are also specifically designed for administration using novel micro-needles via skin immunisation into the epidermal layer, intended to reduce the burden and logistics associated with conventional preventative measures. Emergex’s first indications pursued are against infectious diseases: [i] viral infectious diseases, amongst which are Betacoronaviruses, Dengue Fever and Universal Influenza (including pandemic influenza) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. Emergex has a growing proprietary pipeline of innovative candidates with potential to deliver rapid, broad (strain and variant agnostic) and long-lasting prevention to reduce serious illness associated with infectious diseases.

Find out more online at www.emergexvaccines.com. Visit our LinkedIn page or Twitter account for updates

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

 

Emergex Reports Promising Data from Completed Swiss Phase I Trial of CoronaTcP™, T Cell-Priming Immune Set-Point Candidate for Betacoronaviruses

– First-in-human intradermal administration of CoronaTcP™ was generally well-tolerated

– Evidence for generation of virus-specific effector and memory CD8+ T cells

– Data reinforce findings from trial of DengueTcP, Emergex’s product candidate for Dengue,
further supporting the company’s T cell-based approach to protection against RNA viruses

 

ABINGDON, United Kingdom, 19 July 2023 – 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 the successful completion of naNO-COVID, a Phase I clinical trial in Switzerland investigating the safety and reactogenicity of CoronaTcP[1]  in healthy volunteers. CoronaTcP is Emergex’s multi-target T cell-priming set-point product, designed to be broadly effective against disease caused by Betacoronaviruses, including SARS-CoV-1, as well as known and emerging variants of SARS-CoV-2, which pose significant epidemic or pandemic risk.

Assessment of primary outcome measures of the trial indicate that CoronaTcP showed a favourable safety profile, with no treatment-related serious adverse events observed. The majority (88%) of adverse events were mild, with the most common being injection-site pain. There was no systematic difference between groups that received high or low dose CoronaTcP, in terms of overall safety or reactogenicity.

In secondary immunogenicity analyses, the assessment of baseline levels of SARS-CoV-2-specific anti-nucleoprotein antibodies indicated most participants had experienced previous SARS-CoV-2 infection. A number of participants seroconverted during the trial (as a consequence of exposure to SARS-CoV-2) but had mild symptoms, confirming that CoronaTcP does not worsen an acute episode of COVID-19. Cellular analyses demonstrated that CoronaTcP (two doses administered at Day 0 and 21) was able to activate virus-specific CD8+ T cells, with a significant increase in frequencies of CoronaTcP-specific CD8+ CD137+ CD69+ cells following in vitro antigenic stimulation in both low and high dose CoronaTcP groups at Day 35 post-treatment. Significant changes were also observed for several virus-specific CD8+ memory subsets. Further studies with a larger number of participants are warranted for full assessment of T cell responses, including whether they are the consequence of a prime or a boost, and their correlation with protection.

Overall findings from the first-in-human clinical trials of Emergex’s T cell-priming immune set-point candidates against Dengue and Betacoronavirus diseases (naNO-DENGUE and naNO-COVID, respectively) have demonstrated a favorable safety profile. Immunogenicity assessments provide an initial proof of concept that products developed from Emergex’s therapeutic platform can successfully induce virus-specific T cell responses. Such results favour the further development of the Dengue and Betacoronavirus candidates in larger clinical trials. Overall, Phase I trial data validate Emergex’s T cell-based approach to protection against RNA viruses and confirm the platform’s potential using this innovative technology, supporting investigation of other T cell-priming immune set-point candidates from the same platform.

Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, said: “The positive data from both clinical trials – naNO-DENGUE and naNO-COVID – represent an important landmark for Emergex. Demonstrating that our platform has an acceptable safety profile and successfully mobilises specific T cells that may elicit broad and long-term immune memory, validates our approach. By improving T cell-based immunity, we can enhance any previous immune status. We are delighted that this first assessment of a treatment against infectious diseases for clinical use, based solely on a T cell response, was successful.”

 

The naNO-COVID Trial

The naNO-COVID trial (NCT05113862) was a Phase I double-blind, randomized, base particle-controlled, single centre study designed to evaluate the safety and reactogenicity of two intradermal injections of an anti-Betacoronavirus candidate, CoronaTcP, at two different dosages. Conducted at the clinical investigation unit of the CHUV (Centre Hospitalier Universitaire Vaudois)-UNIL (University of Lausanne) in Switzerland, the study enrolled 26 healthy adult volunteers previously vaccinated against SARS-CoV-2. Participants were randomized to receive one of the following treatments: low-dose CoronaTcP (n=10), high-dose CoronaTcP (n=10), low-dose base nanoparticle comparator (n=3), or high-dose base nanoparticle comparator (n=3) (low and high-dose CoronaTcP being 2.5 nmol or 7.5 nmol total peptide, respectively, and the comparator being the construct base particle without peptides but with equivalent gold content). Each participant received an intradermal injection of the assigned treatment on Day 0 and on Day 21 using a microneedle device and was followed up for six months. naNO-COVID was the second stage of a two-stage clinical trial of Emergex’s T cell priming platform technology, initiated upon the favourable outcome of an interim analysis of safety data from the first stage, naNO-DENGUE.

 

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’s 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) candidates, as well as [ii] intra-cellular bacterial infectious disease, such as tularemia caused by Francisella tularensis. In the near future, other disease applications will follow.
Find out more online at www.emergexvaccines.com.

For further information, please contact:

Emergex Media Inquiries
Storme Moore-Thornicroft, Executive Director

Phone: +44 (0) 1235 527589

Email: smt@emergexvaccines.com

 

Rachelle Babb, Account Executive

Phone: +1 (929) 325-7559

Email: rachelle.babb@russopartnersllc.com

Visit our LinkedIn page or Twitter account for updates

[1] Trademark application submitted

Emergex Appoints Sir Michael Rake as Board Chairman

  • Highly experienced international Board Leader joins Emergex as the company grows and progresses clinical development of its pipeline of T cell-priming immune set-point candidates

Abingdon, Oxon, UK, 29 June 2023 – Emergex Vaccines Holding Limited (‘Emergex’), 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 the appointment of Sir Michael Rake as Chairman of the Board. Sir Michael takes on this role from Finian Tan, Ph.D., who becomes Emergex’s Deputy Chairman.

Sir Michael has had a long and distinguished career in international business as a Senior Executive and Board leader over several decades. He is currently the Chairman of Great Ormond Street Hospital, the international centre of excellence in child healthcare; a position which he has held since 2017. He is also the Chairman of Wireless Logic Ltd, Newday Ltd, and Majid Al Futaim Holdings llc in the UAE and a Vice President of the UK charity The Royal National Institute of Blind People (RNIB). He is a Senior Advisor to Elliott Advisors and is a Director of Trust Payments Ltd.

During his career, Sir Michael has held the role of Chairman at many international blue-chip companies in numerous industry sectors, including: BT Group Plc (2007-2017); Worldpay Group Plc (2015 – 2017); EasyJet plc (2010 – 2013); KPMG, UK Chair (1998-2007). becoming Global Chair (2002-2007); and Deputy Chairman at Barclays Bank plc (2008 – 2015). He has also served as a Director at S&P Global (2007-2018), the UK Financial Reporting Council (2008-2011) and was the Lead Director of Worldpay Inc. (now FIS).

Sir Michael has additionally held many advisory roles during his career, including Senior Advisor to Citibank, Senior Advisor to the International Affairs Think Tank Chatham House, a member of the Oxford University Global Board for Business Reputation, and a William Pitt Fellow at Pembroke College, Cambridge. Sir Michael was also the President of the Confederation of British Industry (CBI), a member of former UK Prime Minister David Cameron’s Business Advisory Council and Chairman of the UK International Chamber of Commerce. In addition, he was a member of Former UK Prime Minister Gordon Brown’s National Security Forum, the first Chairman of the Commission for Employment and Skills and the first Chairman of the Private Equity Oversight Group Guidelines Monitoring Committee.

Sir Michael qualified as a chartered accountant in the UK in 1972 and became a partner with Peat Marwick (KPMG) continental firm in Brussels in 1979, subsequently becoming Senior Partner of Peat Marwick (KPMG) Middle East in 1986, before becoming Chair of the UK firm in 1998,the European firm in 1999, and Global firm in 2002.

Sir Michael was knighted by the late HRH Queen Elizabeth II in 2007 for his extensive service. In 2011, he received the British American Business UK Transatlantic Business Award and in 2013, he received the Channing Award for corporate citizenship, was voted the FTSE 100 non-executive Director of the year and received the ICAEW outstanding achievement award. Most recently, in 2021, he was made a Grand Cordon of the Order of Rising Sun, by the Emperor of Japan, for services to UK/Japan relations.

Sir Michael Rake, the new Chairman at Emergex, commented: “I look forward to joining the Emergex Board as Chairman and sharing my experience and network to help grow the business at such a pivotal time in the company’s evolution. Following the COVID-19 pandemic and its far-reaching global impact, there remains a vital need for innovative and durable therapies to tackle the continuing threat of COVID-19 and other, emerging infectious diseases. Emergex’s proprietary technologies and expansive pipeline of T cell-priming immune set-point candidates are well-placed to offer a valuable solution, with potential to offer long-term protection against infectious health threats to diverse and global communities.”

Dr Finian Tan, the former Chairman and new Deputy Chairman at Emergex, added: “Sir Michael has had a long and distinguished career to-date and will bring his global expertise to the Board, as well as an impressive body of international business contacts. I look forward to working closely with him to maximise and steward the opportunities available for Emergex at this exciting time of continued growth and development.”

 

– Ends –

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    Rachelle Babb

    Phone: +1 (929) 325-7559

    Email: rachelle.babb@russopartnersllc.com

     

     

    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.

    Visit our LinkedIn page or Twitter account for updates.

    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/.

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, Oxon, UK, 20 June 2023 – 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 DengueTcPTM (trademark application submitted) and CoronaTcP TM (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.”

 

– Ends –

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    Rachelle Babb

    Phone: +1 (929) 325-7559

    Email: rachelle.babb@russopartnersllc.com

     

     

    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.

    Visit our LinkedIn page or Twitter account for updates.

    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/.

Emergex Announces Positive Phase I Trial Data for DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate

  • naNO-DENGUE trial results demonstrate that DengueTcP is well-tolerated with no treatment-related serious adverse events
  • Immunogenicity data shows peptide antigen-specific effector and memory CD8+ T cells were elicited
  • Clinical proof-of-concept demonstration for Emergex’s therapeutic platform, supporting further development

Abingdon, Oxon, UK, 6 June 2023 – Emergex Vaccines Holding Limited (‘Emergex’), 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 positive outcomes from its first-in-human clinical trial of DengueTcP (trademark application submitted), a candidate against Dengue virus, the causative agent for Dengue Fever.

The primary objective of the naNO-DENGUE trial was to evaluate the safety, tolerability and reactogenicity of two different doses (2.5 and 7.5 nmol total peptide) of DengueTcP administered by intradermal microneedle injection to healthy volunteers. Both dose levels of DengueTcP appeared to be safe and well tolerated. No treatment-related serious adverse events were reported, and the majority of adverse events were mild and transient. From a safety perspective, both doses were considered acceptable for use in further trials.

The assessment of immunogenicity produced the following findings:

  • Statistically significant increases of virus-specific effector (CD137+CD69+) CD8+ T cells and memory CD8+ T cells were observed post-immunisation.
  • Notably, the elevated T cells included CXCR3+ central memory and differentiated effector memory cells. These T cell subsets are of particular relevance given their roles in locating virus-infected cells in the skin and in providing protective immunity to Dengue infection.2,3
  • DengueTcP did not induce anti-DENV antibodies, a favourable outcome that reduces the risk of antibody-dependent enhancement (ADE) of the disease that has been observed by others in trials of traditional vaccines.
  • Taken together, preliminary results indicate that treatment with DengueTcP generates memory T cells in peripheral blood that have the capability to home to tissues infected by that incoming virus.

Overall, the clinical results provide proof-of-concept that Emergex’s therapeutic platform can successfully induce virus-specific CD8+ T cell responses. Data from the trial support further development of Emergex’s platform, which has the potential to provide cross-reactive immunity to a range of existing or emerging viral and intracellular pathogens.

Dr. Ramila Philip, Chief Scientific Officer, Immunotope Inc, commented: “Up to 400 million people around the world are infected with Dengue Fever each year. However, with no approved antiviral treatments and with current vaccine strategies being potentially associated with ADE related safety concerns, there is an unmet and urgent need for novel, effective solutions. It gives me an immense satisfaction to see the realization and clinical proof of our T cell based protection. Emergex’s T cell-priming immune set-point vaccine, which delivers synthetic peptide antigens based on naturally processed and presented epitope candidates, should provide broad and long-lasting immunity against all Dengue virus serotypes and potentially against other Flaviviridae strains; thus, protecting people from illness associated with these lethal tropical disease.”

Dr Athanasios Papadopoulos, Chief Medical Officer, Emergex, said: “These positive study data represent an important landmark for both Emergex and people around the world living with the risk of Dengue. These data demonstrate that our product platform has an acceptable safety profile and successfully mobilises viral-specific CD8+ T cells, which may elicit broad and long-term immune memory. The findings validate our approach and may change the way that people view immune responses post-treatment.

“Showing that we can increase the T cell-based immunity without affecting the antibodies means that we can improve any previous immune status of a person. This trial is the first time that a regulator has approved an assessment of a T cell-priming set-point candidate against infectious diseases for clinical use based solely on a T cell response; thus, we are delighted that the trial was successful.

The naNO-DENGUE Trial
naNO-DENGUE (ClinicalTrials.gov NCT04935801) was a Phase I randomized, double-blind, vehicle-controlled, dose-finding, safety study of a synthetic nanoparticle-based, T cell-priming peptide antigen immune set-point against Dengue virus in healthy adults. A total of 26 healthy individuals aged 18-45 years recruited at the Centre for Primary Care and Public Health, Lausanne, Switzerland, were randomly assigned to receive the T cell-priming immune set-point candidate Dengue TcP or a comparator (nanocluster without peptide antigens, vehicle-nanocluster). Follow-up of trial participants took place over a six-month period following first injection.

About DengueTcP
DengueTcP,
Emergex’s immune set-point product to treat dengue, is designed to elicit a specific CD8+ T cell immune response without affecting the humoral response. The drug product is composed of synthetic T cell-selective multivalent (serotypes 1 to 4) Dengue virus peptide antigens carried on ultrasmall carbohydrate-passivated nanoclusters.

Immunotope Inc. developed an immunoproteomics approach to identify the peptide antigens presented by major histocompatibility complex Class I (MHC-I) molecules on the surface of Dengue-infected cells, representing the real-world targets of the CD8+ T cell response to natural infection.4,5 Nine peptide antigens from this expression library were then selected for inclusion in the DengueTcP drug product, notably on their ability to elicit a cross-reactive immune response against all four different Dengue virus serotypes and also against other Flaviviruses.

These viral peptide antigens are anchored with specific carbohydrates to a nanocluster core. Use of a self-assembling, nanocluster-based delivery system is intended to protect the peptide antigens from proteolytic degradation, which improves their delivery to antigen presenting cells and enables induction of targeted cellular immunity. Owing to targeted delivery, nanodoses of peptide antigens are expected to be sufficient to induce a satisfactory immune response.

As a low dosage is required and as a way to mimic immune cell recruitment during a natural infection by a mosquito, DengueTcP is suited to be delivered by intradermal injection. A microneedle (or dermal patch in the future) will be used to better standardize the intradermal injection.

DengueTcP and nanoclusters have been shown to be safe in preclinical in vitro studies utilising human peripheral blood mononuclear cells and in vivo animal studies. The present trial assessed the safety of the first T cell-priming immune set-point candidate designed specifically to elicit a CD8+ T cell immune response for prevention of an acute and severe manifestation of a viral infection by Dengue and other Flaviviruses. Emergex is working with governments around the world to make DengueTcP accessible to high-risk populations as a valuable option in the fight against Dengue.

  • For further information, please contact:
  • Emergex Media Inquiries
    Storme Moore-Thornicroft, Executive Director

    Phone: +44 (0) 1235 527589

    Email: smt@emergexvaccines.com

     

    David Melamed

    Phone: +1 (212) 845-4225

    Email: david.melamed@russopartnersllc.com

     

     

    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 candidates that harness and direct the body’s natural T cell immune response to destroy and 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. First indications 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.

    Visit our LinkedIn page or Twitter account for updates.

     

    References

     

    1. Rivino L, Kumaran EA, Thein TL, et al. Virus-specific T lymphocytes home to the skin during natural dengue infection. Sci Transl Med. 2015;7(278).
    2. Graham N, Eisenhauer P, Diehl SA, et al. Rapid Induction and Maintenance of Virus-Specific CD8(+) TEMRA and CD4(+) TEM Cells Following Protective Vaccination Against Dengue Virus Challenge in Humans. Front Immunol. 2020;11:479.
    3. Hickman HD, Reynoso GV, Ngudiankama BF, et al. CXCR3 chemokine receptor enables local CD8(+) T cell migration for the destruction of virus-infected cells. Immunity. 2015;42(3):524-537.
    4. Comber JD, Karabudak A, Huang X, Piazza PA, Marques ET, Philip R. Dengue virus specific dual HLA binding T cell epitopes induce CD8+ T cell responses in seropositive individuals. Hum Vaccin Immunother. 2014;10(12):3531-3543.
    5. Testa JS, Shetty V, Sinnathamby G, et al. Conserved MHC class I-presented dengue virus epitopes identified by immunoproteomics analysis are targets for cross-serotype reactive T-cell response. J Infect Dis. 2012;205(4):647-655.