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.