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NEW IMI PROJECT “GNA NOW” KICKS OFF ITS BATTLE AGAINST ANTIMICROBIAL RESISTANCE

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Evotec and Lygature announced their cooperation in a new initiative for the development of novel antibacterial agents today: Gram-Negative Antibacterials NOW (“GNA NOW”). The new GNA NOW project, led by Evotec, managed by Lygature and funded by the Innovative Medicines Initiative (IMI), will work on the development of novel antibacterial agents to battle antimicrobial resistance in gram-negative bacteria. The multi-stakeholder consortium includes nine other partners from academia, industry and SMEs: Nosopharm, BIOASTER, Helmholtz Centre for Infection Research, North Bristol National Health Service Trust, University of Liverpool, Inserm, Erasmus Medical Center, Medical University of Vienna, and Fraunhofer IME.

Collectively, the GNA NOW members will progress three programmes in parallel with the goal of bringing one through completion of Phase I studies and one reaching Investigational New Drug (IND) stage and/or up to two programmes reaching clinical development candidate stage, by 2024.

GNA NOW is supported by the IMI, a joint initiative between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), of which Evotec is a member. The IMI, the world’s largest public-private partnership (PPP) in life sciences, will match Evotec’s in-kind contribution with a € 12 m grant over the next six years, to fund the activities of the consortium. This award will allow the eleven partners of this consortium to build European platforms of excellence around each step of the critical path for drug discovery and development. European experts will join forces to contribute to “mechanism of action elucidation”, “medicinal chemistry and design”, “in vitro profiling”, “pre-candidate efficacy studies”, “candidate PK/PD studies”, “safety and ADME”, “CMC”, as well as “clinical studies and modelling”.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are extremely glad to initiate GNA NOW with the backing of the European Commission and the EFPIA. Bacterial infections are a growing threat around the globe and are driving the need for innovative therapeutics with new mechanisms of action. GNA NOW gives us the opportunity to join forces with leading institutions of both the public and the private sector across Europe to develop new gram-negative antibacterial agents as quickly and as efficiently as possible.”

Dr Kristina Orrling, program manager at Lygature and GNA NOW project coordinator, commented: “By joining forces we can fend off a grim future where a simple urinary infection can be fatal. Together, we’ll strengthen the antibacterial arsenal.”

About antibiotic-resistant bacteria and GNA NOW Antibiotic-resistant bacteria were estimated to be responsible for 670,000 infections and 33,110 attributable deaths in the EU and the European Economic Area (EEA) in 2015. From a global perspective, antimicrobial resistance could kill up to ten million people every year by 2050, which could cost up to € 94 trillion ($ 100 tn). In February 2017, the WHO published a list of priority pathogens for the development of new antibiotics. Carbapenem-resistant gram-negative bacteria (Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter baumannii) were at the top of that list, with critical priority.

GNA NOW is an Evotec-led joint initiative of eleven partners, project managed by Lygature, with the goal of developing novel antibacterial agents and bringing one of the three simultaneously developed compounds through completion of Phase I studies plus one compound reaching Investigational New Drug (IND) stage and/or up to two compounds reaching clinical development candidate stage, by 2024.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853979. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Source: Lygature


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Enhanced Bone Regeneration Properties of Osteo-Pharma’s OsteoActivator coated collagen membranes

Osteo-Pharma, a Dutch Life Sciences company developing novel pharmaceuticals and medical devices to improve the local healing of bone fractures and defects, today has announced that it has successfully completed a large preclinical study in mini-pigs, which shows its OsteoActivator coated collagen membranes to effectively promote new bone formation. The data obtained indicated a 24% increase of new bone within 6 weeks in defects covered by an OsteoActivator membranes as compared to uncoated collagen membranes. Importantly, OsteoActivator membranes were shown to be well tolerated and there were no findings of inflammation.

“We are very encouraged by the results of this clinically relevant mini-pig study that was performed in collaboration with the group of Prof. John Jansen from the Radboud university medical center (Nijmegen, The Netherlands) and are a good basis to advance into clinical studies in 2020” said Jan Gossen, chief executive officer of Osteo-Pharma.

Source: Osteo-Pharma

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Johnson & Johnson Establishes International Consortium to End Tuberculosis

Multi-partner collaboration aims to advance the discovery and development of critically-needed innovative TB antibiotics

As part of the Company’s 10-year initiative to drive progress against tuberculosis (TB), Johnson & Johnson today announced that it has launched an international research consortium to discover and develop new TB antibiotics in collaboration with eight European academic and biotechnology partners. Co-funded by Europe’s Innovative Medicines Initiative (IMI) and Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), the initiative—called RESPIRI-TB—is the first in a series of new collaborations that Johnson & Johnson is undertaking to advance TB research and development.

TB is the world’s deadliest infectious disease, killing an estimated 1.6 million people in 2017 alone.[i] Current TB treatment regimens have suboptimal cure rates because they are lengthy, complex and difficult for patients to adhere to, and growing resistance to first-line treatments is compounding this challenge. Drug-resistant TB (DR-TB) is the single biggest contributor to the rising global health challenge of antimicrobial resistance (AMR).

“Over the past half century, just two new TB medicines have been developed. To achieve the ambitious global goal of ending TB, we urgently need many more innovative therapies,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “No single company or institution holds all the answers.  As we did in the case of HIV, we need to work together to advance the very best science as quickly as possible. We are proud to be a founding partner in the RESPIRI-TB consortium, and we look forward to working with our global partners to develop the necessary TB treatments of the future.”

The ultimate goal of the RESPIRI-TB collaboration is to help enable the development of a new, more efficient combination drug regimen to cure multidrug-resistant TB (MDR-TB), with a focus on shortening treatment duration and minimizing the likelihood of resistance. To this end, the partners will work to advance the discovery and early-stage development of new compounds from different drug classes that could be used – in combination with each other or with existing therapies, such as Janssen’s bedaquiline. Bedaquiline was the first novel TB medicine to be approved in more than 40 years and, today, is one of the last lines of defense against MDR-TB.

The new consortium includes nine research teams spanning five European countries with expertise in mycobacterial diseases and drug target investigation, as well as project management. In addition to Janssen, members include: Leiden University Medical Center and the University of Leiden (Netherlands, which will serve as the project coordinator); University of Antwerp, Belgium; Sorbonne University, France; Medical University of Vienna, Austria; University of Copenhagen, Denmark; Mitologics, France; and FFUND B.V., Netherlands.

In addition to RESPIRI-TB, the research consortium will also work to build a pipeline of drug candidates for the non-TB mycobacterial (NTM) species M. avium and M. abscessus through a second project, RESPIRI-NTM. Although NTM infections are less prevalent than TB, currently available treatments for NTM infections are suboptimal, underscoring the urgent need for new therapeutic options.

“Tuberculosis and related diseases represent a major threat to public health worldwide, and a collaborative approach is essential if we are to develop new, safe and effective treatments,” said Pierre Meulien, Executive Director, IMI. “I am delighted that the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners in RESPIRI-TB and RESPIRI-NTM have come together to form the type of strategic, multi-sector alliances we need to boost the world’s response to the threat of these serious infectious diseases.”

IMI is supporting the development of a number of multi-partner research consortia under its AMR Accelerator program that aim to speed TB drug development across the R&D spectrum – from discovery/early-stage development (i.e., RESPIRI-TB) to later-stage translational development – with the overarching goal of dramatically improving TB treatment regimens.

Together, these and other company-specific and collaborative R&D efforts will help drive critical and necessary TB innovation. This is in line with the current draft of the World Health Organization’s Global Strategy for TB Research and Innovation, which is currently undergoing review and is expected to be finalized for adoption by the World Health Assembly in May 2020.


[i] World Health Organization. Global Health Observatory (GHO) data. Tuberculosis. Last accessed June 2019. Available at: https://www.who.int/gho/tb/en/

Source: J&J pressrelease

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TPI Bidbook: sneller en beter met proefdiervrije innovaties

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TPI is op zoek naar Nederlandse bedrijven die hun proefdiervrije innovaties willen publiceren in een bidbook: een mooie kans om je bedrijf in de kijker te spelen! TPI staat voor Transitie Proefdiervrije Innovatie. Deze transitie is gaande: wetenschap, gezondheidszorg, beoordeling van veiligheid en acceptatie van dierproeven veranderen. TPI staat ook voor de groep die deze ontwikkelingen wil versnellen: RIVM, NFU, VSNU, ZonMw, Samenwerkende Gezondheidsfondsen, Stichting Proefdiervrij en de ministeries van LNV, VWS, EZK, OCW en IenM. Het TPI-netwerk signaleert dat er behoefte is meer te zien van wat start en scale ups allemaal ontwikkelen zonder proefdiergebruik.

TPI nodigt leveranciers van proefdiervrije innovaties daarom uit om zich in het TPI bidbook te profileren. Het doel is om met zo’n bidbook overzichtelijk te laten zien wat en waarom Nederlandse start en scale ups proefdiervrij innoveren. Het bidbook wordt gepresenteerd tijdens de International pioneer2policymaker conference ‘Accelerating animalfree innovations’ van 27-29 november 2019.

Wil je dat TPI jouw bedrijfsprofiel in het bidbook opneemt? Laat het HollandBIO dan uiterlijk 23 juli weten via info@hollandbio.nl.  

Meer informatie:

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Drempels cel- en gentherapie in de media

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De beslissing van het Nederlandse bedrijf Orca Therapeutics om uit te wijken naar Canada onderstreept de urgentie om de nationale drempels rondom klinisch onderzoek naar cel- en gentherapie weg te nemen. Afgelopen week besteedden het Financieele Dagblad en BNR Nieuwsradio aandacht aan het probleem en de oproep van de Tweede Kamer aan het kabinet om met spoed knelpunten weg te nemen. Eerder deelden we al onze blijdschap over de politieke steun.

In de krant en op de radio vertelt Orca Therapeutics CEO Kees Groen dat het vergunningsverleningstraject voor klinisch onderzoek naar gentherapie tegen prostaatkanker in Canada slechts een maand duurde. Dit in schril contrast met het jaar dat Nederland gemiddeld uittrekt voor een dergelijk traject. Naast Kees geven ook VVD-Kamerlid Arne Weverling en HollandBIO’s Annemiek een toelichting op de problematiek en de hopelijk spoedige oplossing.

Het volledige FD-artikel lees je hier (inlog nodig).

De bijdrage op BNR van Kees Groen luister je hier terug, de bijdrage van Annemiek Verkamman hier.

Ons bericht van vorige week vind je hier.

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Ncardia Expands iPSC Manufacturing and Phenotypic Drug Discovery Services

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Ncardia expands its iPSC manufacturing site in Belgium, R&D and drug discovery center in the Netherlands, and commercial operations in the USA. The accelerated investment followed the retraction of the Cor.4U product line from the market and resulting insolvency of its former legal entity in Germany(operating under the name Ncardia AG / former Axiogenesis).

Ncardia shared today that all active investors participated in a capital increase, signaling confidence in its expanded offerings in iPSC drug screening services, contract cell manufacturing and iPSC-based cardiovascular and neurological cell models. Under the restructuring following the closing of Ncardia AG operations in Germany, all manufacturing services have been concentrated at its ISO 9001-certified contract and product manufacturing facility in Gosselies, Belgium and activities in drug discovery / safety services continue to operate from its Leiden, Netherlands headquarters.

“We continue our dedication to the advancement of iPSC technologies in the drug discovery space and are excited that with the support of our investors, we can continue providing quality iPSC-derived products and accelerate our capabilities in contract cell manufacturing and drug discovery assay development,” said Stefan Braam, CEO of Ncardia.

Source: Ncardia

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Subsidieoproep Create2Solve

Create2Solve is een oproep binnen het ZonMw programma Meer Kennis met Minder Dieren. Met Create2Solve ondersteunt ZonMw de ontwikkeling van impactvolle, proefdiervrije innovaties die moeten leiden tot verkoopbare methoden, modellen en/of diensten. Deze proefdiervrije innovaties verbeteren de gezondheid van de mens, de kwaliteit en relevantie van onderzoek en bedrijfsprocessen.

Lees meer

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BunyaVax provides technology to develop a human Rift Valley Fever vaccine in a $12.5 million project financed by CEPI

BunyaVax is technology provider in a consortium led by Wageningen Bioveterinary Research and financed by CEPI to develop a human vaccine against Rift Valley Fever. With support from the European Union’s (EU’s) Horizon 2020 programme, CEPI will provide up to US$12.5 million for vaccine manufacturing, preclinical research, and a phase 1 study to assess the safety, tolerability, and immunogenicity of a single-dose vaccine candidate (RVFV-4s) against Rift Valley fever virus for use in humans.

To produce this vaccine candidate, researchers at WBVR have altered the genome of the Rift Valley fever virus in a way that significantly weakens it. BunyaVax as a spin-off company from WBVR owns the underlying technology and further develops the vaccine towards application. The “attenuated” Rift Valley fever virus will now be used as a vaccine to generate a lasting immune response against the disease. This investment is part of CEPI’s third call for proposals, launched earlier this year with support from the EU’s Horizon 2020 research and innovation programme under grant agreement No. 857934.[1]

Rift Valley fever

Rift Valley fever vaccines have already been used successfully to protect livestock, but currently none have been licensed for use in humans.

Rift Valley fever virus mainly affects people living in pastoral communities in low-income and middle-income countries.[2] While the virus mostly infects humans through contact with the blood or organs of infected animals, there is a concern that it could also be transmitted from human-to-human by the Aedes aegypti mosquito, which could change its epidemiology considerably.[3] In view of the epidemic threat posed by this disease, the WHO has classified it as a priority pathogen in need of urgent R&D investment.[4]

Rift Valley fever kills about one in every hundred people infected. In people who develop the haemorrhagic form of the disease, the fatality rate is as high as 50%.[5],[6]

The virus was first identified in 1931 during an investigation into an outbreak among sheep on a farm in the Rift Valley of Kenya. Multiple outbreaks have since been reported across the African continent and on the Arabian Peninsula.

Between May and June, 2018, concurrent cases of Rift Valley fever were reported in farmers in South Africa and Kenya, nearly 5000 km apart.[7],[8] There is also an ongoing outbreak on the island of Mayotte, a French overseas territory in the Indian Ocean. As of May 13, 2019, 129 human and 109 animal cases of Rift Valley fever have been confirmed on the island.[9]

Prof. Jeroen Kortekaas, project lead and molecular virologist at WBVR, said:

“With this strategic collaboration, CEPI acknowledges the concept of One Health, by bringing together veterinary and public health experts to fight an emerging virus that affects both animals and humans.”

Jochem Bossenbroek, CEO of BunyaVax, said: “BunyaVax forwards a new generation of vaccines against infectious diseases, based on breakthrough platform technology originating from Wageningen Bioveterinary Research. We are excited to be working with CEPI to advance our lead vaccine against Rift Valley Fever and take key steps towards protecting societies at risk.”


[1] https://cepi.net/news_cepi/cepi-launches-call-for-proposals-to-develop-vaccines-against-rift-valley-fever- and-chikungunya-viruses/

[2] https://www.sciencedirect.com/science/article/pii/S2352771418300363

[3] https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0210122

[4] https://www.who.int/blueprint/priority-diseases/en/

[5] https://www.who.int/news-room/fact-sheets/detail/rift-valley-fever

[6] https://www.who.int/emergencies/diseases/rift-valley-fever/en/

[7] https://www.liebertpub.com/doi/pdf/10.1089/vbz.2018.2357

[8] https://www.who.int/csr/don/18-june-2018-rift-valley-fever-kenya/en/

[9] https://www.who.int/csr/don/13-may-2019-rift-valley-fever-mayotte-france/en/

Source: BunyaVax

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Tweede Kamer: vergunningverlening voor cel- en gentherapie moet sneller en beter

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De Tweede Kamer roept Minister Van Nieuwenhuizen van Infrastructuur en Waterstaat (IenW) op haast te maken om de vergunningverlening voor klinisch onderzoek met, en de toepassing van cel- en gentherapie sneller en beter te laten verlopen. Arne Weverling (VVD) diende hiertoe een motie in die op brede steun van de Kamer kon rekenen. Die verbetering is urgent en noodzakelijk, want de huidige procedure voor vergunningverlening is onnodig lang en veeleisend door een zware milieutoets. Doordat Nederland klinisch onderzoek met, en de toepassing van cel- en gentherapie standaard indeelt in de risicoklasse Introductie in het Milieu (IM), dreigt de winst van deze nieuwe generatie therapieën aan ons land voorbij te gaan. In reactie op de motie gaf de Minister aan het gevoel van urgentie met de Tweede Kamer te delen. HollandBIO is blij met de belofte van de minister om met gezwinde spoed werk te maken van een oplossing.

HollandBIO gaf eerder aan teleurgesteld te zijn in de terughoudende Kamerbrief van de minister om over te gaan tot aanpassing van de nationale wet- en regelgeving om de lichtere risicoklasse van Ingeperkt Gebruik (IG) als uitgangspunt te bewerkstelligen. De motie van Arne Weverling constateert echter dat de Minister van mening is dat de huidige regelgeving op het gebied van klinisch onderzoek naar gentherapie al mogelijkheden biedt voor aanvragen op basis van IG. Als dat zo is, is de door HollandBIO aangedragen aanpassing van Besluit ggo overbodig en is verbetering sneller een feit. Het is nu aan het ministerie om deze nu in de praktijk onbegaanbare route vrij te maken. De Kamer is in ieder geval duidelijk: de regering moet haast maken om alle mogelijke verbeteringen van beleid door te voeren en hiervoor met spoed extra capaciteit vrijmaken.

Aan het eind van de zomer vindt een overleg plaats tussen de betrokken ministeries en veldpartijen, onder wie HollandBIO, om de mogelijkheden voor het wegnemen van de huidige belemmeringen met elkaar te bespreken. IenW lijkt daarmee dus de daad bij het woord te voegen. Natuurlijk is HollandBIO pas tevreden als een oplossing daadwerkelijk gerealiseerd is. Want alleen dan kan Nederland op alle fronten profiteren van deze baanbrekende nieuwe therapieën.

Leestip!

Marc Kaptein, medisch directeur bij Pfizer Nederland en bestuurslid van HollandBIO, klom in de pen en schreef een uitstekende blog over de kansen om gen- en celtherapie te verzilveren. Je leest zijn blog hier!

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Now online: English information about CBG-ZIN Parallel Procedures Pilot

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As previously highlighted in our newsletter, the Dutch Medicines Evaluation Board (CBG-MEB) and the National Health Care Institute (Zorginstituut Nederland: ZIN) joined forces in a pilot to accelerate access to innovative medicines in the Netherlands. To inform your international colleagues and/or international affiliates about this opportunity, the information about the “CBG-ZIN Parallel Procedures pilot” is now available online.

Recently, HollandBIO and the Association of Innovative Medicines organized together with CBG-MEB and ZIN a well-attended information session about the pilot, during which Kevin Liebrand (project lead on behalf of CBG-MEB) and Pauline Pasman (project lead on behalf of ZIN) elaborated on the aim of the pilot and the prerequisites for participation. Companies were very enthusiastic about the pilot, based on the amount of questions that were asked during the session. Frequently asked questions will be combined and published online in the near future.

The pilot is a seamless fit with the HollandBIO program Faster & better from bench to bedside, where we work towards solutions that boost both health, innovation and affordability. This pilot is a first step towards a more flexible health ecosystem, where the Netherlands can achieve the full potential of tomorrow’s medicines. We are therefore very curious who will be the frontrunner of this faster & better opportunity.

More information:

The most important information about the pilot can be found here, including a link to the Interest Form – CBG-ZIN Parallel Procedures pilot. Explanation in English of the interest form can be found here. If you have any questions, you can also always contact Marit.