• Combining Intravacc’s OMV-delivery platform with Covid-19 Spike proteins
• Preclinical studies to start shortly for candidate selection and inhouse pilot scale GMP production

Bilthoven, Netherlands and BASEL, Switzerland, 29 July, 2020 – Intravacc, a global leader in translational research and development of viral and bacterial  vaccines, and Celonic Group, a premium biopharmaceutical contract development and manufacturing organization (CDMO), specialized in development and production of Advanced Therapy Medicinal Products (ATMP) and mammalian cell lines expressed bio-therapeutics, today announced that they have signed a research agreement to further design, develop and produce a Covid-19 vaccine based on an immunogenic Spike (S) protein of SARS-CoV-2 combined with Intravacc’s prorietary Outer Membrane Vesicle (OMV) technology.

In the beginning of March this year Intravacc started working on the development of four candidate coronavirus vaccines based on three proprietary technologies: Vero cell, OMV and iBoost.

For this specific joint vaccine development, Intravacc combines its safe and immunogenic OMV delivery platform with S-proteins expressed by Celonic Group’s industry-leading CHOvolution^®  mammalian cell expression sytem, in order to generate a highly effective and balanced B and T cell response against SARS-CoV-2. Swiss based Celonic Group  will construct cell lines producing the  S-protein in high quantities and develop a GMP production process. Preclinical studies will start shortly to select the best candidate protein for the vaccine. The collaboration aims to accelerate development of Intravacc’s COVID-19 OMV protein  vaccine, which is expected to enter clinical testing in 2021.

Dr. Jan Groen, Intravacc’s Chief Executive Officer of Intravcc said:

“Several studies have shown that OMVs have the ability to enhance the immune response and can be relatively easy formulated with target specific peptides and proteins. This, combined with the fact they can be quickly scaled-up for manufacturing, makes it an ideal suited platform under the current circumstances where quantity and speed are critical”

Dr. Konstantin Matentzoglu, Chief Executive Officer of Celonic, adds:

“At Celonic, we are thrilled to join hands with Intravacc in the fight against this worldwide pandemic. The novel vaccine has the potential to prevent morbidity and mortality of COVID-19. Together, we have an opportunity to make a difference in the lives of patients at this time of great need.”

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About OMV platform technology

For the development of vaccines against pathogens, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) – spherical particles with intrinsic adjuvating properties. The OMVs can be decorated with immunogenic peptides and/or proteins that that will drive effective adaptive immunity. The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens. 

Intravacc also has developed genetic tools to increase the yield of OMVs, to reduce toxicity, and to achieve the desired antigenic composition. Intravacc’s OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by associating antigens to stockpiled carrier OMVs.

About Intravacc

The Netherlands-based Intravacc is one of the world’s leading institutes for translational vaccinology. As an established independent CDMO organization with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

To learn more, visit www.intravacc.nl

About Celonic

Celonic Group is a privately-owned CDMO based in Basel, Switzerland, with a state-of-the-art bio manufacturing facility in Heidelberg, Germany. Celonic provides comprehensive development and manufacturing services for bio therapeutics including cell line development, USP and DSP development, GMP and non-GMP manufacturing of biopharmaceutical drug substances and drug products, along with cell expression platforms and diagnostics. Celonic offers two cell expression platforms to clients, developers, and service providers – CHOvolution™, developed by Celonic and GEX®, developed by Glycotope GmbH and in-licensed by Celonic. With a new state-of-the-art GMP manufacturing facility for gene vectors and cell therapy, Celonic is soon expanding its existing ATMP development and GMP manufacturing capacity.

For more information, visit www.celonic.com

Contact info

Download Nederlandstalig persbericht (pdf)

• Need for alternatives to animal testing in quality control of vaccines
• Inactivation of vaccines can be traced without using laboratory animals
• Findings published in medical journal Scientific Reports

Bilthoven, The Netherlands, 23 July 2020 – Bilthoven, Netherlands based, Intravacc, a global leader in translational research and development of viral and bacterial vaccines, today announced the publication of a study in Scientific Reports on alternatives to the use of laboratory animals in vaccine quality control. The study was conducted together with Leiden Academic Center for Drug Research (LACDR) at Leiden University.

A great number of laboratory animals are still being used all over the world for the quality control of vaccines. This also applies for tetanus and diphtheria vaccines, both consisting of bacterial toxins inactivated by formaldehyde. This inactivation largely determines the quality of these vaccines. Researchers from Intravacc and LACDR have been searching for a test that reduces the use of laboratory animals.

To this end, a small but important step in the way vaccines work was reproduced in a test tube. Inactivated model vaccines were treated with an enzyme that plays an important role in the first steps of the immune response. The enzyme, cathepsin S (CS), breaks down vaccines and pathogens into fragments that are recognised by immune cells. The inactivation step with formaldehyde affects the rate of breakdown by CS. It was assumed that the breakdown of inactivated vaccines would be slowed down by CS, but the opposite was the case.

It became apparent that it is possible to accurately and sensitively measure vaccine inactivation by quantifying the formation of vaccine fragments during breakdown by CS. This is remarkable as formaldehyde chemically alters vaccines in dozens of places, resulting in a heterogeneous protein mixture that is difficult to analyse.

This means that it may be possible to replace animal testing in the future for vaccines using this inactivation, such as diphtheria and tetanus toxoids. As these vaccines are effective and inexpensive, they will not be easily replaced by ‘modern’ products. 

Dr Jan Groen, CEO of Intravacc, says:

"As a result of the Covid-19 pandemic, some 400 therapies and vaccines against this virus are currently being developed worldwide. This affects the number of laboratory animals used in studies. Intravacc considers limiting the need for animal testing to be particularly important and plays an important role in the development of alternatives for this vaccine-related research. This study shows the progress we are making on this front.”

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About animal testing alternatives

In routine vaccine production, animal testing is still regularly used to ensure the safety and efficacy of vaccines. Animal testing is inaccurate, expensive and raises ethical concerns. In 1959, Russell and Burch published their Principles of Humane Experimental Technique, which laid the foundation for the Reduction, Refinement and Replacement of animal experiments (the 3R Principle). This has led to more thoughtful and responsible use of laboratory animals worldwide for the release of medicines and vaccines. Non-animal methods have been accepted by regulators and intensive development, validation and harmonisation of 3R methods is still ongoing. The Dutch Ministry of Agriculture, Nature and Food Quality fosters 3R research in the Netherlands. 

About Intravacc

Intravacc, based in Bilthoven, the Netherlands, a global leader in translational research and the development of viral and bacterial vaccines. As an established independent R&D organization with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF) and biotech and pharmaceutical companies. Intravacc also has its own proprietary vaccine platform, and established state-of-the-art research and (GMP) production facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. For more information, see www.intravacc.nl

About the Leiden Academic Center for Drug Research

Developing new drugs is a complex process in which many parties work together. The researchers at the Leiden Academic Centre for Drug Research (LACDR) are committed to develop new and optimized drugs that are more effective and easier to manufacture. Their work covers the entire development and production of a drug, from molecule to pharmacy. The institute combines knowledge from various disciplines: chemistry, biology, computer science, physics and mathematics. To  get the right result the eventual drug, the researchers from Leiden share their fundamental knowledge with partners such as the Leiden University Medical Centre, companies at the Leiden Bio-Science Park, and numerous other Dutch and international institutes and companies.

Contact details

Intravacc

Dr Jan Groen, CEO

Tel: +31 30 7920 454

Mirjam Hartman, Media relations

Tel: +31 6 115 969 94

Email: press.office@intravacc.nl        

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

Tel: +31 6 538 16 427

Email: lmelens@lifespring.nl

Download Nederlandstalig persbericht (pdf)

• iBoost technology well suited for developing cancer vaccines
• Joint development of Covid-19 vaccine using iBoost

Bilthoven, The Netherlands, 1 July 2020 – Bilthoven, The Netherlands based Intravacc, a worldwide leading translational research and development vaccine organization with an extensive track record in developing viral and bacterial vaccines, today announced the signing of a strategic partnership agreement with Dutch based CimCure, focusing on cancer immunotherapies for solid tumors, for in-licensing CimCure’s iBoost technology. This agreement offers Intravacc access to this technology in developing new vaccines and for providing services involving the in-licensed technique in mutually agreed countries. This technology also enables Intravacc to expand its translational expertise towards the development of cancer vaccines.

The iBoost (immune boost) technology was developed at Amsterdam UMC, lab-location VUMC, by Prof. Dr. Arjan Griffioen, professor of experimental oncology and CSO at CimCure. This technology overcomes limitations over current methods for inducing antibody responses against cancer specific antigens. iBoost is currently applied to elicit antibody responses against the tumor vasculature, a strategy that conquers the problem of drug resistance. This treatment strategy has a long-term efficacy and is extremely cost-effective. Proof-of-concept has been shown in several preclinical models.

By using the patented iBoost technology, Intravacc and CimCure are also involved in the joint development of a COVID-19 vaccine. CimCure/Amsterdam UMC received a 1.3 million euro grant from Health Holland, an investment organization of the Ministry of Economic Affairs. In the collaboration, CimCure will focus on the design and preclinical validation of three different types of COVID-19 vaccine concepts, while Intravacc will be responsible for the vaccine process development, the pilot production of the candidate vaccine under GMP conditions and for a phase I clinical trial.

Dr. Jan Groen CEO of Intravacc stated:

“We are excited to have signed an agreement with CimCure providing us access to the iBoost technology, which will have a game changing effect on the vaccine industry and the near future development of oncology vaccines. This agreement expands our platform offering towards potential clients and will further boost our developments within our oncology- and infectious disease vaccine portfolios"

Diederik Engbersen, CEO of CimCure said:

“We believe that this license agreement with Intravacc and the value of our platform outside oncology will contribute to future revenue growth of the Company.

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About Intravacc

Intravacc, based in Bilthoven, the Netherlands, is one of the world’s leading institutes for translational vaccinology. As an established independent R&D organization with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF) and biotech and pharmaceutical companies. Intravacc also has its own proprietary vaccine platform, and established state-of-the-art research and (GMP) production facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. For more information, see www.intravacc.nl

About Cim Cure

CimCure is a new generation company founded in 2015, as a spin-off of the VU University Medical Center. CimCure focuses on design and development of a novel class of active cancer vaccines targeting the tumor blood vessels that are common to most solid tumors. The company has discovered and patented multiple highly specific targets and a novel conjugate vaccine technology that can be employed to induce polyclonal antibody responses to targets specific to the tumor (vasculature). With this platform the company aims to combine the proven efficacy of tumor angiogenesis inhibition with the advantages that a vaccine may provide: long term efficacy, limited side-effects, out-patient application and limited cost of goods. For more information, see www.cimcure.com

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A new preclinical study published  in Scientific Reports showed promising  results in mice with Intravacc's experimental whooping cough vaccine. 

• Need for improved whooping cough vaccines
• Outer membrane vesicles from Bordetella pertussis bacteria are potent immunogens
• Intranasal immunization shows both excellent systemic and immune responses
• Needle free immunization possible
• Data published in medical journal Scientific Reports

Bilthoven, The Netherlands, 22 June 2020 - Intravacc, one of the leading translational research and development vaccine institutes with an extensive track record in developing viral and bacterial vaccines, today announced promising results of a preclinical study with its experimental whooping cough vaccine in mice. Published in Scientific Reports (2020) 10:7396, the study shows that intranasal immunization induced both excellent systemic and local immune responses, but also prevented colonization of the lung, trachea and nose.

Current vaccines against whooping cough have serious disadvantages. Inactivated whole cell vaccines are relatively reactogenic resulting in reduced use in vaccination programs. Subunit vaccines on the other hand, have limited efficacy. This results in outbreaks of whooping cough, even in vaccinated populations. There are indications that an effective whooping cough vaccine should prevent colonization of the upper respiratory tract. Asymptomatic carriage facilitates spreading of the bacteria and a vaccine that prevents this could contribute to herd protection.

Intravacc scientists used a vaccine consisting of outer membrane vesicles (Intravacc’s OMV vaccine delivery platform) to immunized mice via the subcutaneous or intranasal route. Whereas subcutaneous immunization resulted in robust systemic immune responses of high quality, it could not prevent colonization of the nasal cavity. Intranasal immunization did not only induce excellent systemic responses but also strong local immune responses. Most importantly, intranasal administration prevented colonization of the lung, trachea and nose. Further testing, preferably in humans is needed to confirm these findings.

Prof. Dr. Gideon Kersten, CSO of Intravacc, commented:

“Intravacc’s vaccine concept has several potential advantages. Because of its composition outer membrane vesicles reduce the risk of vaccination induced selection of strains not matching with the vaccine, it induces immunity at the port of entry and it is needle free, allowing easy administration and flexible incorporation in immunization programs.”

Whooping cough, or pertussis, is a highly contagious respiratory disease that is caused by the gram-negative bacterium Bordetella pertussis and transmitted through Flügges droplets. It is a strictly human pathogen and all age groups can be infected. However, infants are the main risk group. Diagnosis of pertussis is often difficult in the early stage with only a mild cough, and fever is uncommon. Later, the severity of the disease increases with pneumonia, vomiting and increased coughing that in infants can lead to death.

Dr. Jan Groen, CEO of Intravacc, said:

“This study, showing full protection against whooping cough after intranasal immunization with our OMV based pertussis vaccine, provides us with a lot of comfort towards the development of our Covid-19 intranasal vaccine based on OMV’s”

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About OMV technology

For vaccine development, Intravacc has designed a vaccine delivery platform based on outer membrane vesicles (OMVs) - spherical vesicles with strong immunogenic properties. These vesicles are naturally secreted by so-called gram-negative bacteria and contain proteins that play a role in the survival of bacteria in the body. Due to their immunogenic properties, they are also very suitable for use as a vaccine. OMVs can be rigged with immunogenic proteins and peptides from other pathogens. This can be done by allowing the OMV-producing bacteria to produce these proteins or by chemically linking them to OMVs. Heterologous OMV vaccines make manipulation with the pathogen from which the vaccine is produced unnecessary. This is a great advantage if there are strict isolation measures or if the pathogen is difficult to cultivate. Intravacc has also developed genetic tools to increase the yield of OMVs, reduce toxicity and achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable.

About Intravacc

Intravacc is one of the world’s leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

Intravacc also has its own proprietary vaccine platform, and established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

Contact info

Intravacc and Versatope will further develop a universal vaccine against influenza based on Intravacc’s OMV technology. Both parties will collaborate to further advance the candidate vaccine through clinical development.

• Influenza vaccines were overall only 29% effective during the 2018–2019 influenza season
• High medical costs drive the need for finding a more universal influenza vaccine
• Intravacc’s OMV technology platform well suited to support the development of new pandemic response vaccines

Bilthoven, The Netherlands, Lowell, Mass., USA,  June 8 2020 -  Intravacc, one of the leading translational research and development vaccine institutes with an extensive track record in developing viral and bacterial  vaccines and Versatope, a U.S. biotechnology company developing vaccines and therapeutics, today announced that they have signed a research service agreement to further develop a universal vaccine against influenza based on Intravacc’s innovative Outer Membrane Vesicles (OMV) technology. Both parties will collaborate to further advance the candidate vaccine through clinical development.

According to Centers for Disease Control and Prevention (CDC), influenza vaccines were overall 29% effective during the 2018–2019 influenza season due to the emergence of new, late season viral strains, resulting in 42.9 million illnesses, more than 16.5 million medical visits, 647,000 hospitalizations, and 61,200 deaths in the United States. Therefore, globally there is a high medical and cost saving need for finding a more universal influenza vaccine.

Intravacc’s unique expertise in OMV vaccine technology, which is proven to be safe in humans, will push the project forward to achieve this goal of finding the world’s first universal flu vaccine.

Dr Jan Groen, CEO of Intravacc, said:

“We are very happy to partner with Versatope and to be able to further expand the global reach of our OMV technology. This partnership is dedicated to finding in a much needed universal flu vaccine.”

Under the agreement, Intravacc will provide its services to Versatope in bringing their universal influenza vaccine candidate, VT-105, towards their first clinical trials.  Versatope’s approach combines diverse genetic variants of influenza strains on a single nano-sized OMV that may provide better cross-strain protection than influenza vaccines comprised of individual strains. 

Dr. Christopher Locher, CEO of Versatope, said:

“The alliance between Versatope and Intravacc will advance the VT-105 universal influenza vaccine candidate to the clinic in a rigorous and regulatory-compliant manner and help mitigate the risks associated with the chemistry, manufacturing and control process".

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About Intravacc’s OMV platform technology

For vaccine development, Intravacc has designed a vaccine delivery platform based on outer membrane vesicles (OMVs) - spherical vesicles with strong immunogenic properties. These vesicles are naturally secreted by so-called gram-negative bacteria and contain proteins that play a role in the survival of bacteria in the body. Due to their immunogenic properties, they are also very suitable for use as a vaccine.

OMVs can be rigged with immunogenic proteins and peptides from other pathogens. This can be done by allowing the OMV-producing bacteria to produce these proteins or by chemically linking them to OMVs.

Heterologous OMV vaccines make manipulation with the pathogen from which the vaccine is produced unnecessary. This is a great advantage if there are strict isolation measures or if the pathogen is difficult to cultivate.

Intravacc has also developed genetic tools to increase the yield of OMVs, reduce toxicity and achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable.

About Intravacc

The Bilthoven, the Netherlands, based Intravacc is one of the world’s leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

Intravacc also has its own proprietary vaccine platform, and established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

About Versatope Therapeutics:

Versatope Therapeutics, Inc., is a start-up biotechnology company located in Lowell, Mass. at the University of Massachusetts' M2D2 biotech incubator. This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No.  75N93019C00060.

Contact info

Intravacc

Dr. Jan Groen, CEO

T: +31 30 7920 454

Mirjam Hartman, Media relations

T: +31 6 115 969 94

E: press.office@intravacc.nl     

Versatope, Inc.

Dr Christopher Locher, CEO

T: +1 781-879-3119

E: Christopher.locher@versatope.com

LifeSpring Life Sciences Communication, Amsterdam

Leon Melens

T: +31 6 538 16427

E: lmelens@lifespring.nl

A newly established partnership will combine Intravacc's vaccine development technology, viral vector technology and animal technologies from Wageningen Bioveterinary Research  and the coronavirus expertise from Utrecht University. 

• Development through a newly established public private partnership
• Vaccine consists of a Newcastle disease virus (NDV) vector, expressing the immunogenic spike (S) protein of SARS-CoV-2
• Intravacc to develop a scalable vaccine production process, using its FDA-approved Vero cell platform, in preparation of GMP productions

Bilthoven, Lelystad and Utrecht, The Netherlands, 4 June 2020 -  Intravacc, one of the world’s leading translational research and development vaccine institutes, with an extensive track record in developing viral and bacterial vaccines, has announced more details on its development of an intranasal vaccine against COVID-19. The vaccine will be developed through a newly established public private partnership that combines the vaccine development technology from Intravacc, the viral vector technology and animal technologies from Wageningen Bioveterinary Research (WBVR) based in Lelystad, the Netherlands, and the coronavirus expertise from Dutch Utrecht University.

The aim of this partnership is to develop an intranasal vaccine to protect humans against COVID-19. The vaccine will consist of a Newcastle disease virus (NDV) vector that expresses the immunogenic spike (S) protein of SARS-CoV-2, which is an important target for neutralizing antibodies. NDV has been shown to be safe for intranasal/intratracheal delivery in mammals, including non-human primates.

The advantage of a nasal vaccination is that it induces both mucosal and systemic immunity, whereas an intramuscular vaccination primarily induces an antibody response. In addition, intranasal vaccination may also confer protection against infections at other mucosal sites, such as the lungs, intestines and genital tract. On top of this the nasal cavity is also  easily accessible.

Ludo Hellebrekers DVM, Director Wageningen Bioveterinary Research  (WBVR) stated:

”Intravacc, WBVR and Utrecht University create major synergy by combining distinct complimentary expertise and competencies. A promising collaboration!”

Intravacc will develop a scalable vaccine production process using its FDA-approved Vero cell platform, in preparation of GMP productions. The availability of a safe and efficacious vaccine against COVID-19 will have a large social and economic impact by reduction of severe disease and mortality, lifting bans on (inter)national travel and large gatherings, as well as by reducing the burden on the public healthcare system.

WBVR has developed a technique called ‘reverse genetics’, which allows the genetic modification of Newcastle disease virus (NDV). NDV can cause disease in birds but is harmless for mammalian species including humans. WBVR has used the reverse genetics technique to develop NDV as a vaccine vector against human and animal infectious diseases. This vector technology will now be used to generate a vaccine against COVID-19.

Dr Jan Groen, CEO of Intravacc, said:

“Intravacc’s strength is its ability of bridging the gap between academia and research centers towards pharma. Together with our partners WBVR and Utrecht University, we combine our expertise in developing an intranasal corona virus vaccine. Our safe Vero cell platform, widely used for the production of Polio vaccines, put us in the position to fast track the production of pilot lot of this NCD vector-based vaccine concept and to subsequently transfer this to large vaccine manufactures.”

About Intravacc’s Vero cell platform

Intravacc’s viral vaccine production process is based on a cGMP-grade, regulatory approved, Vero cell line. This platform is being used for routine large-scale commercial vaccine manufacturing by clients world-wide. In addition, virus seed lots and clinical batches have regularly been produced on the Vero cells, for example Poliovirus, Enterovirus (EV71), and Respiratory Syncytial Virus (RSV).

=== E N D S ===

About Intravacc

Bilthoven, the Netherlands, based Intravacc is one of the world’s leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

Intravacc also has three proprietary vaccine platforms and established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

For more information: www.intravacc.nl

About Wageningen Bioveterinary Research

Wageningen Bioveterinary Research contributes to the prevention, eradication and control of animal infectious diseases through research, diagnostics and consultancy. By doing so, we contribute to the health and wellbeing of animals and people. We conduct research on health and (infectious) diseases e.g. in preclinical and clinical studies, animal models, epidemiology and risk management. The results of this research and analyses have been utilized to support dossiers, submitted to regulatory authorities in Europe and the US.

Our expertise is continuously expanding by ongoing research projects for private and public stakeholders on topics such as antibiotic resistance, vaccine development, gut health and vector borne diseases. For this, we use our unique facilities in Lelystad that house livestock individually or in groups up to human Biosafety Level 3 and veterinary Biosafety Level 4.

About Utrecht University

Founded in 1636, Utrecht University is one of the largest research universities of Europe, with over thirty thousand students and a staff of more than six thousand. We invest in creating the leaders of the future through innovative education of the highest quality, as reflected by the University's consistently high position in international rankings. Dedicated to performing groundbreaking research aimed at resolving large global issues, our culture of cooperation is a breeding ground for innovation, new insights and social impact. www.uu.nl.

For almost 50 years the Faculty of Veterinary Medicine has been at the forefront of coronavirus research. It has built up expertise and know-how on the fundamentals of coronavirus biology, particularly on issues like cell entry and virus replication. For 40 years it was actively engaged in vaccine research, both for animals and humans, in collaborations with numerous pharmaceutical companies. Through its research activities the faculty aims to continue having a scientific and societal impact.

Contact info

Intravacc

Dr. Jan Groen, CEO

T: +31 30 7920 454

Mirjam Hartman, Media relations

T: +31 6 115 969 94

E: press.office@intravacc.nl

Wageningen Bioveterinary Research

Annet Blanken, Press Officer

T +31 320 238 678

E: annet.blanken@wur.nl

Intravacc and EpiVax announced their collaboration agreement to further progress a novel vaccine against COVID-19, based on Intravacc’s proprietary Outer Membrane Vesicles technology platform.

• Combines Intravacc’s unique OMV delivery platform with synthetically produced COVID-19 epitopes from EpiVax’ immunoinformatics toolbox
• Goal is to generate safe and effective adaptive immunity against SARS-CoV-2 and related coronaviruses
• Clinical studies anticipated to start in Q4 2020

Bilthoven, The Netherlands, Providence, R.I., USA, 2 June 2020 -  Intravacc, one of the world’s leading translational research and development vaccine institutes, with an extensive track record in developing viral and bacterial vaccines, and EpiVax, a biotechnology company based in Providence with expertise in developing vaccines and therapeutics, announce that they have entered into a collaboration agreement to further progress a novel vaccine against COVID-19, based on Intravacc’s proprietary Outer Membrane Vesicles (OMV) technology platform.

For this joint research project, Intravacc will combine its safe and immunogenic OMV delivery platform with synthetically produced COVID-19 epitopes (protein allergens), designed and optimized by EpiVax using advanced immunoinformatics tools, in order to generate a safe and highly effective T-cell response against SARS-CoV-2 and related coronaviruses. Pre-clinical studies will start immediately so as to select the best candidate peptides for the vaccine. Intravacc will utilize its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine, for clinical (phase I) studies expecting to start in Q4 2020.

Annie De Groot, MD, CEO and CSO of EpiVax, said:

“We are thrilled to enter into a partnership with Intravacc using their very novel ‘click-on’ OMV technology and the highly immunogenic and safe SARS-CoV-2 multi-epitope-bearing peptides designed using the iVAX toolkit at EpiVax. We believe that the combination of technologies  and the strength of our longstanding collaboration with Intravacc will lead to the development of an effective and safe vaccine that could rapidly benefit hundreds of millions of people around the globe.”

Dr. Jan Groen, CEO of Intravacc, stated:

“A COVID-19 vaccine based on this approach is expected to be very safe and to reduce the morbidity and mortality rates associated with COVID-19. The vaccine is expected to lower the risk that individuals infected with SARS-CoV-2 will require hospitalization and/or intensive care. It also expected to induce long-term memory responses to prevent COVID-19 disease and infection from other beta-corona viruses. We expect that leveraging Intravacc’s unique vaccine development expertise, broad-based network and successful track record in global technology transfer to vaccine manufacturers will bring success".

About Intravacc’s OMV platform technology

For the development of vaccines against pathogens, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) – spherical particles with intrinsic adjuvating properties. Using genetic engineering, the OMVs can be decorated with immunogenic peptides that combine T- cell epitopes that will drive effective adaptive immunity. Heterologous OMV vaccines are a suitable alternative approach to protect against pathogens that require a high level of containment, that are difficult to cultivate, or that contain viral and/or parasitic proteins. The antigens of choice are attached to the ‘empty’ OMV carrier resulting in a more effective immune response.

Intravacc also has developed genetic tools to increase the yield of OMVs, to reduce toxicity, and to achieve the desired antigenic composition. Intravacc’s OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by associating antigens to stockpiled carrier OMVs.

About Intravacc

The Netherlands-based Intravacc is one of the world’s leading institutes for translational vaccinology. As an established independent R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the globe, including oral polio vaccines, measles vaccines, and DPT, Hib and influenza vaccines. Intravacc offers a wide range of expertise to independently develop vaccines from lead concept to clinical phase I/II studies for partners worldwide such as academia, public health organizations (WHO, BMGF), and biotech and pharmaceutical companies.

Intravacc also has its own proprietary vaccine platform. Intravacc has established state-of-the-art research and production (GMP) facilities. Its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

About EpiVax:

EpiVax is a 22-year old privately-held biotechnology company located in Providence, RI, with a broad portfolio of projects including vaccines and immunotherapies for infectious diseases, autoimmunity and cancer. Scientists at EpiVax, led by co-founders Annie De Groot, MD and Bill Martin, have a strong history of developing and applying innovative approaches to improving vaccines and biologics, making the former more immunogenic and the latter less immunogenic using their advanced immunoinformatic tools. The ISPRI and iVAX toolkits for therapeutics and vaccines are used by a global roster of companies. Visit www.epivax.com for more information.

Contact info

Intravacc

Dr. Jan Groen, CEO

T: +31 30 7920 454

Mirjam Hartman, Media relations

T: +31 6 115 969 94

E: press.office@intravacc.nl     

EpiVax, Inc.

Annie De Groot, MD, CEO/CSO

T: +1 401-272-2123

E: KNelson@epivax.com

Intravacc today announced the development of three COVID-19 vaccine concepts. These concepts are all based on Intravacc’s platform technologies, that have been proven safe in humans.

Bilthoven, The Netherlands – 08.00 CET, May 14, 2020 - Intravacc, one of the leading translational research and development vaccine institutes with an extensive track record in developing viral and bacterial vaccines, today announced the development of three COVID-19 vaccine concepts. These concepts are all based on Intravacc’s platform technologies, that have been proven safe in humans.

“This global COVID19 pandemic requires an international effort to understand the complexity of the disease and to develop innovative COVID-19 emergency and conventional vaccines”, said Dr. Jan Groen CEO of Intravacc. “We also need to establish partnerships with pharma for large scale manufacturing and global distribution of these vaccines”.

To develop safe and effective COVID-19 vaccines, Intravacc is focusing on emergency and conventional vaccines. Intravacc’s emergency vaccine is designed to activate T-cell responses. This emergency vaccine would reduce mortality and morbidity and as a result reduces the pressure on the public health system. For this vaccine Intravacc uses its outer membrane vesicle (OMV) technology.

For its conventional COVID-19 vaccine Intravacc will use OMV’s as a carrier for spike proteins of the virus to induce a protective antibody response. For the third concept Intravacc’s approved Vero cell platform will be used to develop an intranasal vector vaccine based on Newcastle disease virus, that can replicate in humans but does not cause disease.

The expected development timelines for these COVID-19 vaccines to enter into phase 1 range from 9 to 21 months.

About OMV platform technology

Gram-negative bacteria naturally release vesicles from their outer membrane. Outer membrane vesicles (OMVs) harbor bacterial proteins that play a role in establishing infection and survival of the bacterium within the human host. They are very suitable vaccine candidates. Genetic engineering techniques are being used to achieve the required antigenic composition, and to optimize immune modulating properties and safety. OMV’s are safe in humans and can be injected or administered needle free via the oral or intranasal route to achieve mucosal immunity. Intravacc’s OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by conjugating antigens to stockpiled carrier OMVs.

About the Vero cell platform

Intravacc’s viral vaccine production processes is based on a cGMP-grade, regulatory approved, Vero cell line. This platform is being used for routine large-scale commercial vaccine manufacturing by clients world-wide. In addition, virus seed lots and clinical batches have regularly been produced on the Vero cells, for example Poliovirus, Enterovirus (EV71), and Respiratory Syncytial Virus (RSV).

About Intravacc

Intravacc is one of the leading institutes for translational vaccinology. As an established R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology all over the world. Its track record includes technology transfer of oral polio, measles, DPT, Hib and influenza vaccines. The institute has state-of-the-art research and production (GMP) facilities; its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide.

NOTE TO EDITORS

For more information, contact press.office@intravacc.nl or check our website at www.intravacc.nl

Op woensdag 22 april 2020 om 15.00 uur presenteert Intravacc samen met KNCV het webinar: ‘De zoektocht naar een coronavaccin’ door  Gideon Kersten, Chief Scientific Officer bij Intravacc.

Woensdag 22 april: 15.00 – 15.30 uur Webinar: De zoektocht naar een coronavaccin Met Prof Dr. Gideon Kersten, Chief Scientific Officer bij Intravacc

Deelname via Zoom en YouTube, kies het platform dat bij jou past.

Op woensdag 22 april om 15.00 uur presenteert Intravacc samen met KNCV (Kninklijke Nederlandse Chemische Vereniging) het webinar: ‘De zoektocht naar een coronavaccin’. Prof. Dr. Gideon Kersten, Chief Scientific Officer bij Intravacc, schetst in een half uur wat er komt kijken bij die zoektocht waar wereldwijd ruim zestig bedrijven en onderzoeksinstituten in een race tegen de klok in verwikkeld zijn.

Intravacc werkt samen met bedrijven en universiteiten bij de ontwikkeling van vaccins tegen infectieziekten, waaronder COVID-19. Intravacc vormt daarbij de schakel tussen het eerste vaccinconcept en de grootschalige productie ervan.

Voor de eerste en de goedkoopste leverancier van een coronavaccin ligt voor lange tijd een gegarandeerde wereldmarkt open. Maar wat komt er allemaal kijken bij het ontwikkelen van zo’n vaccin? Prof. Dr. Gideon Kersten, Chief Scientific Officer bij Intravacc, vertelt in het webinar in ca. 30 minuten hoe het proces van vaccinontwikkeling eruit ziet. Het webinar is interactief, dus deelnemers kunnen na afloop van zijn verhaal meteen hun vragen aan hem stellen.

Vanwege grote belangstelling is deelnemen via Zoom momenteel niet meer mogelijk. Heb je je al via Zoom geregistreerd? Zorg dan dat je je woensdag op tijd aanmeldt.

Via de livestream op het KNCV YouTube-kanaal bieden wij dezelfde mogelijkheden als via Zoom. Volg het webinar en stel jouw vragen, zodra de uitzending start. Deze link wordt zichtbaar vanaf 14.50 uur op ons KNCV YouTube-kanaal. Deelnemen is gratis! De presentatie zal in het Nederlands gehouden worden.

Over de spreker Gideon Kersten is Chief Scientific Officer bij Intravacc en bijzonder hoogleraar Vaccinontwikkeling aan de Universiteit van Leiden.

Intravacc today announced the appointment of Dr. Jan Groen as its Chief Executive Officer, effective 1 May 2020.

Bilthoven, The Netherlands – 07.00 CET, April 3, 2020 -

Intravacc, one of the leading translational research and development vaccine institutes with an extensive track record developing viral and bacterial vaccines from discovery to lead concept to clinical phase I/II, today announced the appointment of Dr. Jan Groen as its Chief Executive Officer, effective 1 May 2020.

Dr Groen has many years of experience in Life Sciences and Biotech and holds a PhD degree in medical microbiology. Dr. Groen has held numerous executive management and board mandates in international profit and nonprofit companies and organizations. He built several successful commercial biotech companies in Europe and the US, and raised over $150 million for private and public companies.

Mr Nico Oudendijk, General Director of Intravacc said: “With Dr. Groen, we have found the right person to take Intravacc into the new phase of an independent vaccine research organization”.

Dr Groen stated: “I am delighted to join Intravacc, an institute with a tremendous track record in vaccinology. Developing and improving vaccines remains vitally important in the world today and with its unique one-stop facilities, Intravacc can be at the forefront of the (co)development of a coronavirus vaccine. I look forward to working together with the professional and highly committed staff to develop Intravacc into a successful organistation within the vaccine industry”.

About Intravacc

Intravacc is one of the leading institutes for translational vaccinology. As an established R&D organization with over 100 years’ experience in the development and optimization of vaccines and vaccine technologies. Intravacc has transferred its technology all over the world. Its track record includes technology transfer of oral polio, measles, DPT, Hib and influenza vaccines. The institute has state-of-the-art research and production (GMP) facilities; its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. For more information please visit www.intravacc.nl

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NOTE TO EDITORS

For more information, contact Mirjam Hartman, press officer: mirjam.hartman@intravacc.nl tel +31 6 11596994; www.intravacc.nl

Intravacc today announced the establishment of Intravacc B.V. This is an important step in the anticipated privatization of Intravacc and the sale of its activities to a private party.

In May 2018, the Dutch Ministry of Health, Welfare and Sport announced the start of the privatization process of the activities of Intravacc a leading organisation in the field of vaccines research & development. As the privatization is progressing, the buyer of Intravacc is expected to be announced in the second quarter of 2019.

Preparing for the privatization, Intravacc B.V., a private company with limited liability, was established today. Once the shares of Intravacc are sold to the selected buyer, Intravacc B.V. will become operational and all assets, staff, intellectual property and contracts & agreements will be transferred to the new entity. This ensures a smooth transition of the business and the knowledge base of Intravacc with no interruption in servicing current customers.

Intravacc and CDBIO today announced that they have signed a research and license agreement to further develop a vaccine against Meningococcal type B based on Intravacc’s proprietary Nonamen^® vaccine technology.

Both parties will collaborate to tailor the Nonamen^® concept for the Chinese market. Following the successful completion of this phase, CDBIO will receive a license to further develop and commercialize the vaccine.

Intravacc’s unique Nonamen^® technology offers a broad panel of PorA proteins inserted in so called Outer membrane vesicles (OMV) expected to induce protection against the Meningococcal B (MenB) disease. Furthermore, the Nonamen^® technology can be included in a Meningitis combination vaccine.

Under the agreement, both parties will collaborate to establish the development of an efficacious vaccine against prevalent Men B serotypes in China.

“We are very happy to partner with CDBIO and to be able to expand the global reach of our Nonamen technology. We trust this will help to prevent the occurrence of Men B in China considerably”, said Mr Nico Oudendijk, General Director of Intravacc.

Intravacc and BCHT have entered into a non-exclusive license agreement for the development of a Hib conjugate vaccine within the People’s Republic of China.

Intravacc and Changchun BCHT Biotechnology Co today announced that they have entered into a non-exclusive license agreement towards the development ofa Haemophilus influenzae Type B (Hib) Conjugate Vaccine within the People’s Republic of China. By combining their strengths, the two parties can together lower the incidence of this vaccine preventable disease in China.

Through this agreement, BCHT obtained Intravacc’s unique Hib conjugate technology to further develop, produce and sell the vaccine. The vaccine consists of a Hib polysaccharide (poly-ribosylribitol phosphate, PRP) coupled to tetanus toxoid that has shown to be effective in preventing the disease. The Intravacc Hib vaccine technology has already been used for the vaccination of 100s of millions of children.The license agreement between Intravacc and BCHT will now help to reduce the incidence of Hib in Chinese children.

Of the 6 types of H influenzae, type B is responsible for more than 90% of systemic infections. Hib can cause serious illness like acute lower respiratory tract infection and bacterial meningitis. In China, for children under age of 5 years old, the incidence of meningitis caused by Hib was reported in a survey about 10.7/100 000 annually; 9.7% of these cases were fatal, and 21.4% of survivors suffered from neurological or psychological problems. The agreement between Intravacc and BCHT will help to bring this number down considerably.

‘’It’s great to hear that the innovative work of our researchers at Intravacc will contribute to the prevention of Hib in China. We are proud to partner with BCHT to prevent this disease.” said Mr Nico Oudendijk, General Director of Intravacc.

Intravacc has entered into a strategic partnership with TherapyX for the co-development of the world’s first prophylactic vaccine to provide lasting, protective immunity against Neisseria gonorrhoeae.

Intravacc is pleased to announce that it has entered into a strategic partnership with TherapyX for the co-development of NGoXIM^TM, the world’s first prophylactic vaccine against infection with Neisseria gonorrhoeae. This new vaccine is intended to enhance specific adaptive immune responses that provide lasting, protective immunity against N. gonorrhoeae. NGoXIM^TM is a combination of a sustained-release formulation of interleukin 12 (GneX12^TM) and bacterial outer membrane vesicles (OMV) formulated for mucosal delivery.

No effective gonorrhea vaccine is currently available and the disease is known to be acquired repeatedly with apparently no development of protective immunity from previous infection. The American Centers for Disease Control and Prevention (CDC) has listed antibiotic-resistant N. gonorrhoeae as one of the top three pathogens presenting “an immediate public health threat that requires urgent and aggressive action.” A recent WHO technical consultation on vaccines against sexually transmitted infections (2017) called for renewed efforts to develop a vaccine against gonorrhea. This partnership effort is a direct response to that call.

Under the terms of the partnership agreement, TherapyX will focus efforts on IND-enabling efficacy and toxicology studies in primates while Intravacc will be responsible for the discovery and development of OMVs with improved immunogenic properties and reduced toxicity. Financial terms were not disclosed.

“We are thrilled to partner with Intravacc” said Dr. Dominick L. Auci, Vice President for Research and Development at TherapyX. “They bring over 100 years of expertise in vaccines including novel OMV technology to this important project. We couldn’t be working with a more experienced, innovative and dedicated team”.

“We are delighted to be working with TherapyX” said Mr. Nico Oudendijk, General Director of Intravacc. “The IL-12 technology they bring into the project is key to develop an efficacious vaccine against this disease.”

New Delhi/Bilthoven, 29th May 2018: Life Sciences and Healthcare is a vital area of collaboration for India and the Netherlands.  Growing market opportunities in India, combined with the Netherlands’ strengths in Healthcare, create excellent opportunities for Indo-Dutch partnerships that address shared societal challenges with smart solutions. One of the key healthcare challenges that are being turned into Indo-Dutch collaborative solutions is vaccine delivery.

Serum Institute of India and Intravacc (part of the Netherlands Ministry of Health, Welfare and Sports) will jointly develop a novel delivery system for vaccines: Bioneedles. The Bioneedle, a tiny biodegradable mini implant, is a unique approach with ground breaking potential to transform vaccination campaigns, especially in low and middle income countries. The parties will develop Bioneedles for vaccines against measles and rubella. The Memorandum of Understanding confirming their collaboration was signed in the presence of Mark Rutte, Prime Minister of the Netherlands, Sigrid Kaag, Dutch Minister for Foreign Trade and Development Cooperation, Bruno Bruins, Dutch Minister for Medical Care and Sports, Hans de Boer, CEO, Confederation of Netherlands Industry and Employers VNO-NCW, and H.E Alphonsus Stoelinga, Ambassador of the Netherlands to India, during the Netherlands Trade Mission to India last week. The signatories were Dr Suresh Jadhav, Executive Director, Serum Institute of India and Thijs Veerman, CEO, Intravacc.

“I am happy that this MoU was signed during The Netherlands Trade mission to India. The collaboration between SII and Intravacc is a good example of a cooperation in which companies from India and The Netherlands join forces to help improve health worldwide,” Bruno Bruins, Minister for Medical Care of The Netherlands was quoted as saying. 

Currently, vaccines are mostly administered through intramuscular or subcutaneous injection by needle and syringe. The use of needles however may cause pain and fear in vaccinated people, and  requires trained personnel, which is not always readily available in low and middle income countries.  Moreover, needle waste can be hazardous due to reuse and needle-stick injuries and, as a result, transmission of infectious diseases like hepatitis or HIV. To overcome these issues, numerous alternative vaccine administration devices and methods are currently being developed.

One of the most promising technologies in alternative vaccine delivery is a Bioneedle-based delivery device. “Vaccines play a critical role in public health globally- and for Intravacc, India is a vital market for partnerships in vaccine development. This project could potentially mark a major step towards vastly improved access to vaccines especially in low and middle income countries. We are very happy to be involved in such an innovative project with our Indian partner,” Thijs Veerman, CEO, Intravacc says.

Bioneedles are composed of a starch-like polymer, a product that is naturally degraded by the human body. The Bioneedle is administered by an implantation under the skin with an applicator. The Bioneedle matrix will degrade after implantation, which enables the release of the freeze dried vaccine. This reduces hazardous needle waste and results in a quick and pain-free delivery of the vaccine; it may even abolish the need for trained professionals to perform vaccinations – a huge benefit in developing countries where trained medical personnel is scarce. In addition, vaccines in Bioneedles are both freeze and heat stable and can be stored, transported and distributed outside any cold chain. Preclinical concepts of Bioneedles have been established with numerous vaccines, including tetanus, polio, influenza and hepatitis B. In all cases, Bioneedles filled with vaccine were able to induce potent systemic humoral immune responses against the respective antigen. Serum Institute of India and Intravacc will jointly develop Bioneedles for vaccines against Measles and Rubella. Intravacc will optimize the formulation of the vaccine and preparation of the Bioneedles and freeze drying process; Serum Institute of India will supply the MR vaccine. Both parties will search for a partner, preferably from India, for developing a suitable applicator device to administer the Bioneedles.
 

“We are now the world's largest vaccine manufacturer by number of doses produced. It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute, saving millions of lives throughout the world,” says Dr Suresh Jadhav, Executive Director, Serum Institute of India. With this project we continue to build a sustainable, long-term partnership with Intravacc in our effort to manufacture affordable life-saving vaccines .”

All together this is a unique approach with ground breaking potential to transform vaccination campaigns, especially in the low and middle income countries.

The Dutch Ministry of Health, Welfare and Sport has announced the start of the privatization process of the activities of Intravacc. Collegium Advisors is to act as lead advisor and co-ordinator of the privatization process.

Bilthoven, May 8th, 2018 - The Dutch Ministry of Health, Welfare and Sport (Ministerie van Volkgezondheid, Welzijn en Sport or MoH) has announced the start of the privatization process of the activities of Intravacc.

Intravacc (Institute for Translational Vaccinology) has a wide range of relevant expertise in independently developing vaccines from lead concept to clinical phase I/II studies, and has its own product pipeline and patents. Moreover, it provides and contracts R&D services to a range of public and private customers. During the last several decades, Intravacc has positioned itself as a global leader in the development of vaccines aiding in the eradication of Polio and has engaged in the research and development of bacterial and viral vaccines against, amongst others, Respiratory Syncytial Virus (RSV), Shigella, Rotavirus, Hib and DTP.

Intravacc was originally formed to perform public tasks concerning research and development of new vaccines resulting from the ambitions and objectives set out by the Dutch State. The company’s aim is to develop safe, effective and affordable vaccine concepts in order to find sustainable solutions to improve public health worldwide. Intravacc is located in Bilthoven, the Netherlands, where it operates state-of-the-art R&D and Good Manufacturing Practice (GMP) facilities for conducting vaccine research.

As a result of the increasing commercial focus of the organization and its close collaboration with the (global) pharmaceutical industry and Global Health parties such as the World Health Organization and the Bill and Melinda Gates Foundation, MoH decided Intravacc would be better suited in a private setting. In June 2015, the Minster of MoH informed the Dutch House of Representatives on its intent to privatize Intravacc and, has now obtained all required political approval to commence the privatization process in order to secure a suitable prospective buyer.

Collegium Corporate Finance and Valuation Advisors has been appointed to act as lead advisor to the MoH during the privatization of Intravacc. Collegium will aim to inform potential prospective buyers about the timelines and structure of the privatization process. Any contact and all expressions of interest with regards to the privatization process should be expressed via Collegium (Intravacc@CollegiumAdvisors.com).

Contact details: Collegium Corporate Finance and Valuation Advisors,
Joachim Schulz, Managing Director, Tel: +31-10 203 7856.
Correspondence address: Westplein 11, 3016 BM Rotterdam, The Netherlands.

Provention Bio, Inc. announced today that it has selected Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101).

• Coxsackievirus B appears to be an important trigger for type 1 diabetes

• Acute Coxsackievirus B infection and its complications present a serious unmet need in pediatrics

• L2D Services providing product development, regulatory and project management support

Lebanon, NJ, May 7, 2018 – Provention Bio, Inc. (Provention), a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced today that it has selected Netherlands-based Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101). France-based L2D Services SARL/Leads- To-Development (L2D) is providing expert development, regulatory and project management support to ensure rapid progress of PRV-101 into clinical development.

CVB, an enterovirus, has been identified as a possible common trigger for type 1 diabetes (T1D) onset. Vaccination of at-risk populations against CVB infection may lead to the prevention or delay in onset of T1D. The CVB vaccine was developed initially by Vactech Ltd. of Finland and licensed to Provention in April, 2017. Provention is planning to initiate first in-human clinical trials in 2020.

Enteroviruses are responsible for an estimated 30 million infections annually in the US. CVB contributes significantly to enteroviral healthcare costs, since it can result in hospitalization and severe morbidity. Usually asymptomatic or presenting as cold-like symptoms, fever, rash, hand-foot-mouth disease, and/or mild gastrointestinal distress, CVB infections can occasionally cause more serious and sometimes lifethreatening illnesses including pericarditis, myocarditis, meningitis and pancreatitis.

Provention, in partnership with Intravacc, Vactech and L2D is now developing its CVB vaccine for large scale manufacture of clinical trial material in accordance with current Good Manufacturing Practices (cGMP). Intravacc was chosen as Provention’s manufacturing partner based on its expertise and excellent track in enterovirus vaccine development, including IPV, sIPV, EV-71, and CV-A16, as well as Intravacc’s state-of-the-art vaccine cGMP production facilities. PRV-101 will be developed using Intravacc’s proven and well-established platform technology, including certain proprietary cell lines and production processes.

Ashleigh Palmer, co-founder and CEO of Provention Bio, stated, “Selecting Intravacc for PRV-101’s cGMP production is an important next step in our plan to initiate a potentially transformative clinical program to develop a vaccine to prevent acute coxsackievirus B infection and, ultimately, prevent or delay the onset of as much as half of the world’s cases of T1D. We welcome this opportunity to work alongside Intravacc, Vactech and L2D to advance our PRV-101 program to the clinic.”

Intravacc’s CEO Thijs Veerman, MSc, commented, “We are very excited to be involved in this project. Intravacc is uniquely positioned to develop cGMP clinical material for this vaccine and ensure its specifications, quality and patient-readiness. We have the necessary knowledge, expertise and experience to advance Provention’s PRV-101 program to the next stage and beyond.”

About Type 1 Diabetes and Coxsackievirus B Infection

T1D is a life-impacting chronic disease caused by immune destruction of the insulinproducing cells in the pancreas. Today, there is no cure. The only means for managing this devastating disease is life-long blood glucose monitoring and insulin replacement by way of injection, infusion or, potentially, pancreatic cell transplantation. Global longitudinal studies of more than 200,000 children screened, and more than 17,000 followed, over two decades in Finland by Vactech’s scientific founders and collaborators have identified CVB infection as a likely trigger for T1D onset. From this research, it was discovered that the diabetes process often starts after CVB infection. Insulin-producing cells in the pancreas express specialized receptors used for cellular infection by CVB. As a result, an exacerbated immune reaction against the virus may be involved in triggering the autoimmunity targeting the pancreas and gut, which appears to precede the onset of T1D and associated celiac disease. Importantly, the CVB-related risk of T1D autoimmunity was significantly reduced in children whose mothers previously had a CVB infection, thereby suggesting a transfer of protective CVB antibodies to their offspring via placenta and breast milk. This observation suggests the potential benefit of CVB vaccination for children.

About Intravacc

Intravacc, based in Bilthoven, the Netherlands, is an established R&D organisation with more than 100 years’ experience in the optimisation of vaccines, vaccine processes and vaccine technologies. Intravacc has state-of-the-art production facilities and its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. For more information on Intravacc, please visit www.intravacc.nl.

About Provention Bio, Inc.

Provention Bio, Inc. is a clinical-stage biopharmaceutical company leveraging a transformational drug development strategy that is focused on the prevention or interception of immune-mediated disease. Our diverse portfolio was assembled with product candidates that have undergone clinical testing but may have been underdeveloped or deprioritized assets at other companies. Provention’s mission is to in-license, transform and develop clinical-stage, or nearly clinical-stage, therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune and inflammatory diseases including: type 1 diabetes (T1D), Crohn’s disease, ulcerative colitis, lupus, and certain life-threating viral diseases. For more information on Provention Bio, please visit www.proventionbio.com.

About Vactech Ltd.

Vactech develops and licenses vaccines and novel technologies for vaccines and diagnostics with a pipeline of early stage product candidates focused on Type 1 Diabetes, Celiac Disease, Asthma & Allergy and diagnostics. Vactech is a privately owned company having a track record of collaboration with both industrial and academic partners. Vactech has engaged in strategic partnership with Provention Bio, Inc. especially in the field of preventive Type 1 Diabetes vaccine and related applications. Please see the company's website at www.vactech.fi for additional information.

About L2D

L2D is a Paris-based company that provides drug development and regulatory affairs support, with a particular emphasis on preclinical development and clinical trial applications. L2D can provide support in the generation and execution of preclinical development plans and has expertise in all aspects of production (CMC), toxicology and safety pharmacology. L2D also has expertise in early stage regulatory affairs including product classification, formal scientific advice with the FDA, EMA or national competent authorities, orphan drug designation requests and writing both EU and US clinical trial applications/INDs. For more information on L2D, please visit www.leadstodevelopment.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Provention’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA approvals or clearances and noncompliance with FDA regulations; uncertainties of patent protection and litigation; limited research and development efforts and dependence upon third parties; substantial

Hørsholm, Denmark / Bilthoven, the Netherlands, December 11, 2017 – Today, ExpreS2ion Biotechnologies ApS (“ExpreS2ion”) and Intravacc (the Institute for Translational Vaccinology), announce the signing of a collaboration agreement. This agreement strengthens ExpreS2ion’s ability to service customers and partners across the full value chain of vaccine development and expands the commercial opportunities for both organisations. Under the agreement, Intravacc will serve as a preferred GMP (Good Manufacturing Practice) partner for ExpreS2ion. The agreement contains no financial exchange between ExpreS2ion and Intravacc. However, it expands the commercial opportunities in the vaccine field for both organisations.

Memorandum of Understanding
ExpreS2ion, a fully owned subsidiary of ExpreS2ion Biotech Holding AB, and Intravacc, an experienced vaccine R&D institute, have signed a Memorandum of Understanding (MoU). The MoU enables ExpreS2ion to service customers and collaboration partners across the full value chain of development of vaccines, from discovery up till GMP production and clinical trials. Under the agreement, Intravacc will serve as a preferred GMP partner for ExpreS2ion. Serving as a reference for expanded customer outreach, the MoU contains no financial exchange between ExpreS2ion and Intravacc. However, it expands the commercial opportunities in the vaccine field for both organisations.

ExpreS2ion CEO Dr. Steen Klysner comments
“We are very satisfied to expand ExpreS2ion’s capabilities into the manufacturing of vaccines through the establishment of a preferred partnership with Intravacc. This strategic alliance increases ExpreS2ion’s service offerings and continues our repositioning into a one-stop solution provider for vaccine developing SMEs and Pharma companies.”

Intravacc CEO Thijs Veerman Msc comments
“We are proud to serve as a preferred GMP partner for ExpreS2ion and its clientele. Intravacc offers one-stop solutions for GMP production and clinical development and has a strong track record in the technology transfer of vaccine products and knowhow to our partners. Our experience with the development and successful technology transfer of vaccines such as Haemophilus influenzae b and Sabin inactivated Polio vaccine to vaccine manufacturers has paved the way for a fast and product oriented route to market.”

About Intravacc
Intravacc, based in Bilthoven, the Netherlands, is an established R&D organisation with more than 100 years’ experience in optimisation of vaccines, vaccine processes and vaccine technologies. Intravacc has state-of-the-art production facilities and its aim is to substantially reduce development risks and costs of new vaccines in order to contribute to global health and equity in access to vaccines worldwide. More information at www.intravacc.nl.

For further information about Intravacc, please contact:
Thijs Veerman Msc, CEO
Telephone: +31 30 7920445
E-mail: thijs.veerman@intravacc.nl

Certified Adviser
Sedermera Fondkommission is appointed as Certified Adviser for ExpreS2ion.

For further information about ExpreS2ion Biotech Holding AB, please contact:
Dr. Steen Klysner, CEO
Telephone: +45 2062 9908
E-mail: sk@expres2ionbio.com

This press release contains information that ExpreS2ion is obligated to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on December 11, 2017.

ExpreS2ion Biotechnologies ApS is a fully owned Danish subsidiary of ExpreS2ion Biotech Holding AB with company register number 559033-3729. ExpreS2ion’s unique proprietary platform technology, ExpreS2, is designed to enable accelerated, cost effective development and robust production of complex proteins for new vaccines and diagnostics. Since founded in 2010, more than 250 proteins involved in e.g. malaria and Zika were produced in collaborations with research institutions and companies with a superior efficiency and success rate. ExpreS2ion also develops competitive virus-like-particle based vaccines through its joint venture AdaptVac, which was founded in 2017.