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Mymetics Reports Successful Preclinical Study Results with COP-Virosomes as Second-Generation Allergy Immunotherapy

Mymetics Corporation, a pioneer and leader in the research and development of virosome-based vaccines and immunotherapies against life threatening and life disabling diseases, announced today that Stallergenes Greer, a worldwide leader in allergen immunotherapy (AIT) and Anergis, a leader in ultra-fast AIT research and development, reported the results of a joint research study evaluating the effects of the second generation Contiguous Overlapping Peptides (COP) allergen immunotherapy in a therapeutic model of birch allergy, with the aim of shortening the AIT administration schemes.

In 2018, Anergis and Mymetics reported that the COP-Virosomes were able to elicit a strong boost in TH1 antibody response without any IgE response, unlike the first generation of Anergis’ COPs associated with aluminum hydroxide.

In this new study conducted by Stallergenes Greer, COP-Virosomes, and COP and virosomes alone were compared to a placebo group in an in-house therapeutic model of birch pollen allergy. Recombinant Bet v 1 alone (the major allergen of birch pollen) and birch extract were also used as controls in this setting.

COP-virosomes were the only synthetic therapy able to fully reverse asthma symptoms as well as lung inflammation (i.e. significant reduction in eeosinophils in bronchial fluids). Pro-allergic immune responses also decreased with COP-virosome therapy with a significant decrease of the IL-4, a Th2 cytokine. The results of the study will soon be published.

“This new data confirms that COP-virosomes are likely to be more efficacious clinically than a recombinant allergen or than our first generation COP allergy vaccines which did not include the Mymetics’ virosomes. COP-virosomes may thus represent a breakthrough AIT treatment of the future,” said Vincent Charlon, CEO of Anergis.

“This thorough study by Stallergenes Greer is a second confirmation of the potential for the COP-virosomes allergy therapy and we now look forward to turn this into a business opportunity and developing a safe and ultra fast immunotherapy against birch pollen allergy with Anergis,” said Ronald Kempers, CEO of Mymetics.

Source: Mymetics (press release)

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Technologie: de innovatieve motor

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Steeds meer partijen werken aan technologie die de inzet en ontwikkeling van geneesmiddelen en vaccins kan verbeteren en versnellen. Met genoegen ziet HollandBIO dat de aandacht voor deze prachtige innovaties toeneemt. Zo kwam er afgelopen week mooi nieuws uit het UMC Utrecht, dat met een nieuwe bloedtest honderden zeldzame ziekten tegelijk aan kan tonen. Daarnaast bracht premier Rutte een bezoek aan TNO’s Accelerator Mass Spectrometer, een andere technologische innovatie, waarmee bedrijven geneesmiddelen sneller en veiliger kunnen ontwikkelen door middel van vroeg-stadium concentratie- en effectmetingen.

Wat ons betreft snijdt het mes voor dit soort innovatieve technologieën aan twee kanten. Het stelt ons in staat om patiënten beter van medicatie op maat te bedienen én het vergroot de kans dat een geneesmiddel met succes en optimale snelheid de eindstreep van het onderzoeks- en ontwikkelproces haalt. Investeren in deze innovaties is dan ook een ontzettende no-brainer.

Toch is de route van lab naar praktijk lang niet altijd een gelopen race. HollandBIO helpt daarom graag bruggen te slaan tussen de verschillende stakeholders die deze route kunnen effenen. Meer weten? Contact HollandBIO’s Marit of Britt.

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Key stakeholders from Massachusetts and the Netherlands discuss lessons learned from COVID-19

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On Monday the 8th of June, key stakeholders from Massachusetts and the Netherlands will come together in a virtual session to discuss about the developments in both life sciences ecosystems in the light of the COVID-19 pandemic outbreak, and how international collaboration, now and in the future, could contribute to solutions.

Due to the COVID-19 pandemic outbreak, now more than ever, the world is dependent on life sciences ecosystems to find a treatment or vaccine. However, the life sciences sector also faces challenges in these difficult times. The virtual session is a perfect moment for key stakeholders from both Massachusetts and the Netherlands to exchange views on how we can build resilience during this outbreak and afterwards. And to discuss and learn from the dynamics in both life sciences ecosystems and what role of international collaboration is and could be.  

This virtual session fits in the longstanding ties that there are between the life sciences ecosystems of Massachusetts and the Netherlands, and that culminated in the signing of a a Memorandum of Understanding (MoU) in the Summer of 2019. This MoU was signed between The Massachusetts Office of International Trade and Investment (MOITI) and the Dutch Ministry of Economic Affairs and Climate Policy (EZK). Other signatories of the MoU include the Henri A. Termeer Tribute Committee, MassBIO, Massachusetts Life Sciences Center, Health~Holland and HollandBIO.

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BIO Digital 2020 Europe session “Start Me Up”: How Can Europe’s Biotech Sector Combat the Coronavirus?

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Focco Vijselaar, Director General for Enterprise and Innovation at the Ministry of Economic Affairs and Climate Policy will represent the Netherlands during the BIO Digital 2020 in the session ‘Start Me Up: How Can Europe’s Biotech Sector Combat the Coronavirus?’. Together with representatives of EuropaBIO, Biobe, Alnylam Pharmaceuticals and McKinsey the role of the biotech sector in addressing global challenges like COVID-19 will be discussed.

What is the contribution of the European biotech companies to the COVID-19 response and what is needed to find treatments and vaccines? The panel will reflect on the current state and preparedness to respond to pandemic outbreaks. What are the lessons learned and which strategies and policies are needed to support the life sciences sector in moving forward.

Interested in this session? Check here to register for BIO Digital with $250 discount for HollandBIO members.

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HollandBIO welcomes Pantarhei as a new member

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HollandBIO is proud to announce that Pantarhei has joined the HollandBIO community! Pantarhei Bioscience and Pantarhei Oncology are Dutch bio-pharmaceutical companies that develop unique new treatment concepts in the areas of Women’s Health and Reproductive Endocrine Oncology. Founded in 2001 by the former R&D executive of Organon Herjan Coelingh Bennink, it has since then filed more than 220 patents.

Our pipeline focuses on Phase I and II clinical research for safe, innovative and fair oncological treatments for cancers sensitive to endocrine treatment or immunotherapy, as well as reproductive hormone related treatments and applications in the area of Women’s Health.

In our approach we build upon the effective applications of existing proven biological ingredients. Based upon thorough scientific knowledge and divergent thinking and our clinical and scientific endocrine healthcare background, we discover new applications for endocrine cancer treatments with a special emphasis on breast cancer, prostate cancer, ovarian cancer and lung cancer. Our dual goal is not only to develop effective new treatments, but also to improve patients’ wellbeing.

The Pantarhei companies develop patent protected new drugs up to and including efficacy (proof-of-concept) and safety in the human (Phase II). We invent and create intellectual property (IP) for new treatment concepts, provide in-house project management and select the best in class partners in the world for the outsourcing of our research and development activities. After generating favourable human proof-of-concept data, projects are sold or licensed-out to a (pharmaceutical) partner for final development (phase III), regulatory approval and commercialisation. Over the years, Pantarhei has sold and licensed its unique treatment concepts to Serono (now Merck), Schering (now Bayer), HRA Pharma SA, Mithra Pharmaceuticals and Gedeon Richter.

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Tamara van Ark nieuwe minister voor Medische Zorg

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VVD’er Tamara van Ark is vanaf 9 juli de nieuwe minister van Medische Zorg en volgt daarmee Bruno Bruins en zijn tijdelijke vervanger Martin van Rijn op. Van Ark is op dit moment staatssecretaris van Sociale Zaken, maar stapt over naar het ministerie van VWS. Daar is zij goed mee bekend, aangezien ze jarenlang als Kamerlid de langdurige zorg en thuiszorg in haar portefeuille had namens de VVD.

Bron: Skipr

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Brits parlement wil toelating moderne veredelingsmethoden moderniseren

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Pas de huidige, belemmerende wetgeving voor moderne veredelingsmethoden aan zodat boeren, wetenschappers, bedrijven en consumenten hier na Brexit de vruchten van kunnen plukken. Dat is de oproep die een coalitie van Britse parlementariërs van verschillende partijen aan de Britse regering doet. 

Kern van het voorstel is om de huidige, op de Europese wetgeving gebaseerde, definitie van een genetisch gemodificeerd organisme (ggo) in de Britse wetgeving aan te passen naar de definitie van een ggo in het Cartagena Protocol. Op basis van de Cartagena-definitie zijn producten verkregen via moderne veredelingsmethoden waarbij geen nieuwe combinatie van genen is ontstaan, vrijgesteld van de ggo-wetgeving. Dat is veel meer in lijn met de wetgeving buiten Europa. Dit geeft Britse boeren en bedrijven naast een gelijk speelveld ook de kans om snel in te spelen op klimaatverandering en een duurzame productie van gezond voedsel. HollandBIO blijft  de ontwikkelingen in het Verenigd Koninkrijk dan ook op de voet volgen.

Bron: Farming UK

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Intravacc and EpiVax team up in development of COVID-19 emerging vaccine

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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.

Source: Intravacc (press release)

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EUPATI NL studenten vragen: kan het niet altijd sneller?

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Vanwege het coranavirus verschijnen er steeds meer berichten over versnelde of aangepaste goedkeuringsprocedures van nieuwe geneesmiddelen en vaccins. Bij EUPATI NL studenten, de patiëntvertegenwoordigers van de toekomst, leidde dit tot de vraag: zijn de bestaande procedures dan niet efficiënt? Ze vroegen het aan prof. dr. Ton de Boer (voorzitter van het CBG). Zijn antwoord lees je hier. Het goede nieuws: nieuwe inzichten zullen worden gebruikt om het beoordelingsproces te verbeteren of te versnellen, zonder in te boeten op zorgvuldigheid en kwaliteit.      

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GSK announces intention to produce 1 billion doses of pandemic vaccine adjuvant in 2021 to support multiple COVID-19 vaccine collaborations

GSK today confirmed its intention to manufacture 1 billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted COVID-19 vaccine candidates.

GSK believes that its pandemic adjuvant technology could make a significant contribution against COVID-19.  As demonstrated in the last flu pandemic, GSK’s pandemic adjuvant can reduce the amount of vaccine protein required per dose, which allows more vaccine doses to be produced, contributing to protecting more people. Additionally, an adjuvant can enhance the immune response and has been shown to create a stronger and longer-lasting immunity against infections.

GSK has prioritised its efforts towards making its pandemic adjuvant technology available to partners developing promising COVID-19 vaccine candidates that are suitable for use with an adjuvant. To date, the company has formed several collaborations, including with scientific partners in North America, Europe and China, to develop vaccines. Discussions with potential partners on further collaborations are ongoing.

Confirmation of the enhanced manufacturing capacity follows completion of a review conducted across the company’s global supply network. GSK will manufacture, fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, US, Canada and Europe.

Roger Connor, President, GSK Global Vaccines, said: “We believe that more than one vaccine will be needed to address this global pandemic and we are working with partners around the world to do so. We believe that our innovative pandemic adjuvant technology has the potential to help improve the efficacy and scale up of multiple COVID-19 vaccines. With this significant expansion in our manufacturing capacity, we can help deliver up to 1 billion doses of adjuvanted vaccines through 2021, helping protect many more people and support the global effort to fight COVID-19.”

Given the unprecedented need to develop COVID-19 vaccines, GSK has started manufacture of the adjuvant at risk. The company is in discussions with Governments and global institutions about funding for production and supply of the adjuvant.

GSK is committed to making its adjuvant available through mechanisms that offer fair access for people across the world. Making the adjuvant available to the world’s poorest countries will also be a key part of these efforts, including donations, by working with governments and the global institutions that prioritise access.

Overall GSK does not expect to profit from sales of its portfolio of collaborations for COVID-19 vaccines made during this pandemic phase, as profit generated will be invested in support of coronavirus related research and long-term pandemic preparedness, either through GSK’s internal investments, or with external partners.

Source: GSK (press release)