Interessante zomerlectuur in het Financieele Dagblad van octrooiadvocaat Wouter Pors (Bird & Bird) over de inzet van dwanglicenties voor geneesmiddelen. En wie zich in het onderwerp wil verdiepen: eerder verscheen van de hand van Pors op IE-Forum.nl al een uitgebreide juridische analyse over dwanglicenties voor geneesmiddelen, waarin hij uiteenzet dat het instrument niet zo eenvoudig ingezet kan worden zoals soms wordt voorgesteld.
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Companies to collaborate on mRNA vaccine and monoclonal antibody research programmes in infectious diseases
GSK to make equity investment of £130m (€150m) in CureVac, and an upfront payment of £104m (€120m)
GlaxoSmithKline plc (LSE/NYSE: GSK) and CureVac announced the signing of a strategic collaboration agreement for the research, development, manufacturing and commercialisation of up to five mRNA-based vaccines and monoclonal antibodies (mAbs) targeting infectious disease pathogens. The collaboration complements GSK’s existing mRNA capabilities with CureVac’s integrated mRNA platform.
mRNA (messenger RNA) technology is a rapidly progressing, cutting-edge platform for the development of new vaccines and medicines, potentially expanding the range of diseases which can be prevented or treated, while also promising to significantly speed up development and manufacturing. mRNA enables protein synthesis in the human body, carrying the genetic code required for cells to manufacture and express proteins. By using mRNA technology in vaccines and medicines, specific proteins, or antigens, can be produced by the body’s own cells, enabling the human immune system to prevent or fight disease.
CureVac’s leadership in mRNA technology, along with its mRNA manufacturing capability, complements GSK’s existing scientific leadership in vaccines, including GSK’s own self-amplifying mRNA (SAM) vaccine technology platform, and further builds on GSK’s growing capability in mAbs innovation, aligned to its R&D focus on the science of immunology. Advancing mRNA-based vaccine and treatment technologies is also expected to play a role in further improving response against future pandemics.
Roger Connor, President GSK Vaccines, said: “GSK’s self-amplifying mRNA (SAM) vaccine technology has shown us the potential of mRNA technology to advance the science of vaccine development, and CureVac’s experience complements our own expertise. Through the application of mRNA technology, including SAM, we hope to be able to develop and scale up advanced vaccines and therapies to treat and prevent infectious diseases quicker than ever before.”
Dr. Franz-Werner Haas, acting Chief Executive Officer of CureVac, added: “We are delighted to partner with GSK. With this collaboration, we are gaining a world-class partner whose expertise and global footprint will allow us to further develop and translate the value of our platform into potential products for the world.”
The companies will combine their mRNA expertise on development opportunities across a range of infectious disease pathogens, selected with the potential to best leverage the advantages of this platform technology, while addressing significant unmet medical need and economic burden. CureVac’s existing COVID-19 mRNA and rabies vaccines research programmes are not included in the collaboration announced today.
Under the terms of the deal, GSK will make an equity investment in CureVac of £130m (€150m), representing close to a 10% stake, an upfront cash payment of £104m (€120m) and a one-time reimbursable payment of £26m (€30m) for manufacturing capacity reservation, upon certification of CureVac’s commercial scale manufacturing facility currently under construction in Germany.
CureVac will be eligible to receive development and regulatory milestone payments of up to £277m (€320m), commercial milestone payments of up to £329m (€380m) and tiered royalties on product sales.
GSK will fund R&D activities at CureVac related to the development projects covered by the collaboration. CureVac will be responsible for the preclinical- and clinical-development through Phase 1 trials of these projects, after which GSK will be responsible for further development and commercialisation. CureVac will be responsible for the GMP manufacturing of the product candidates, including for commercialisation, and will retain commercialisation rights for selected countries for all product candidates.
Dutch scale-up PlantLab has raised a first external investment of 20 million from De Hoge Dennen Capital. The company has developed a globally patented technology for ‘vertical farming’, a hyper-efficient method for growing vegetables and fruits. It will use the injection of capital to open indoor production sites in various countries, including the Netherlands, US, and Bahamas.
Over the last 10 years, PlantLab has succeeded in developing an innovative and revolutionary technology for hyper-efficient urban farming, which is already being successfully applied in a commercial production site in Amsterdam. The new technology makes it possible to grow fresh, healthy, and delicious vegetables on a large scale very close to the consumer without using any chemical crop protection agents. On a surface area the size of only two football fields, it is now possible to produce enough crops to feed a city of 100,000 residents with 200 g of vegetables each on a daily basis.
’This injection of capital will enable us to open up additional production sites and further perfect our technology’, explains Michiel Peters, CEO of PlantLab. ‘The increasing population of the planet and the climate crisis are posing new and enormous challenges to the production of food for the world’s population. We have no choice but to grow our food more sustainably and efficiently, and that demands innovative and revolutionary solutions.’
PlantLab’s production sites can be set up anywhere in the world, even on barren land or urban areas. Thanks to optimised temperature, moisture, and light control, the crops grow to their full potential, while water use is reduced by as much as 95%. Light is provided by specially developed LEDs that provide the specific wavelength needed by the plant for photosynthesis. ‘Our technology makes it possible to grow crops anywhere in the world very close to the consumer. The crops then no longer need to be transported over long distances. The result: less CO2 emissions, lower cost, and less food waste’, says Peters.
De Hoge Dennen is part of the investment company founded by the De Rijcke family, the former owners of Kruidvat. The company has made previous investments in the online supermarket Picnic, the salad producer De Menken Keuken, and the electric bicycle brand QWIC. CFO Jelle Roodbeen: ‘We are convinced that PlantLab’s technology will make a real difference on a global level. It will make healthy and delicious vegetables affordable and accessible to everyone, in an environmentally friendly and sustainable fashion’.
In addition to the injection of capital by De Hoge Dennen, CFO Frank Roerink and CEO Michiel Peters are joining the scale-up company to strengthen the management team, which also includes the founding partners Leon van Duijn, Marcel Kers and John van Gemert. PlantLab has its vertical farming R&D centre, the biggest of its kind anywhere in the world, in Den Bosch, and a commercial production site in Amsterdam. PlantLab already employs over 60 people.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-07-28 16:27:582020-07-28 16:27:59PlantLab raises €20 million in first external investment round← #nieuws
HollandBIO roept al jaren dat het vestigingsklimaat in Nederland fabelachtig is. De plannen om een research & development-campus voor onderzoek naar MS op te richten op het voormalige Land van Ooit in Drunen sluiten hier dan ook goed bij aan.
Jan Kelders, uitvinder van onder meer de prittstift, is de drijvende kracht achter de plannen om een onderzoekscampus naar neurologische aandoeningen op te zetten. Het onderzoek zal zich allereerst op MS en Alzheimer richten en wordt in de eerste plaats door hemzelf gefinancierd. Op de campus moet ook een diagnostisch centrum en zorgappartementen verrijzen.
De plannen laten zien dat Nederland een hotspot is voor biomedisch onderzoek, wat naadloos past bij andere succesverhalen in Zuid-Nederland zoals het Pivot Park in Oss en de Maastricht health campus. Om het sprookjeshuwelijk tussen biotech en Nederland nog lang niet te laten eindigen maken wij ons hard voor een IJzersterk innovatieklimaat. Daar lees je hier meer over.
iOnctura SA, a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis announced that it has raised an additional EUR 5.1 million bringing the total Series A financing to EUR 20.1 million. New investor 3B Future Health Fund, previously known as Helsinn Investment Fund S.A., SICAR joins the existing blue chip investor syndicate of M Ventures, INKEF Capital, VI Partners, and Schroder Adveq, which all participated in the extension.
The funding will enable iOnctura to accelerate development of its next generation dual immune and tumour targeting therapies. Data emerging from early clinical evaluation of its lead molecule IOA-244, a highly selective PI3Kδ-inhibitor, in solid tumours is expected to enable progress into a Phase Ib trial earlier than anticipated and preclinical development of its second program, IOA-289, an ATX-inhibitor with dual utility in organ specific and cancer associated fibrosis will be expedited into human testing in early 2021. iOnctura has recently strengthened its team with the appointment of Dr. Joanna Horobin as Chair. Joanna is an accomplished drug developer and biotech leader with over 35 years of experience in the pharmaceutical and biotech sector in Europe and the US.
Catherine Pickering, Chief Executive Officer of iOnctura, said: “I am pleased to welcome 3B Future Health Fund to our strong investor syndicate. This oversubscribed Series A round provides further validation and support of our strategy as we progress our novel, highly selective, PI3Kδ inhibitor and our differentiated ATX inhibitor through clinical development.”
Riccardo Braglia, 3B Future Health Fund Chairman and Helsinn Group Vice Chairman and Chief Executive Officer, commented: “We look to invest in early-stage companies which are developing novel treatments in areas of high unmet patient need. We have been very impressed with the world class team at iOnctura and the potential of its next generation molecules targeting cancer and fibrosis.”
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ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA therapies for severe genetic rare diseases, announced that it has entered into a $30 million convertible debt financing agreement with Pontifax Medison Debt Financing, the healthcare-dedicated venture and debt fund of the Pontifax life science funds.
“The access to capital provided by this facility is designed to increase our financial flexibility as we continue to advance our pipeline and build toward commercialization,” said Smital Shah, ProQR’s Chief Business and Financial Officer. “If fully drawn down, this capital would extend ProQR’s cash runway into 2023, which is beyond a number of anticipated catalysts and value inflection points for our clinical stage programs. Additionally, this funding will accelerate the advancement of our translational platform and discovery programs.”
“Pontifax is pleased to enter into this strategic financing partnership with ProQR as it continues to advance its pipeline of RNA therapies for inherited retinal diseases,” said Momi Karako, partner at Pontifax. “ProQR has expertise in antisense oligonucleotides, a productive platform, and a deep pipeline of novel RNA therapies focused on inherited retinal diseases, which fits well with our portfolio of companies that target transformative, cutting-edge life sciences technologies.”
Under the agreement with Pontifax, ProQR will have access to up to $30 million in convertible debt financing in three tranches of $10 million each that will mature over a 54 month period and have an interest-only period of 24 months.
Pontifax may elect to convert the outstanding loan into ProQR ordinary shares at any time prior to repayment at a conversion price of $7.88 per share, which is a 50% premium to the Company’s average closing share price during the 7 days prior to closing. ProQR also has the ability to convert the loan into its ordinary shares, at the same conversion price, if the Company’s stock price reaches a pre-determined threshold.
In connection with the loan agreement, ProQR has agreed to issue to Pontifax warrants to purchase up to an aggregate of 190,424 shares of its common stock at an exercise price of $7.88 per share, which is a 50% premium to the average closing price during the 7 days prior to closing.
J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and Goodwin Proctor LLP and Allen & Overy LLP acted as legal advisors to ProQR on this transaction.
Mooi financieringsnieuws uit de Nederlandse biotech industrie. Vorige week hebben biotech bedrijven Mosa Meat en VarmX en investeerder Forbion nieuwe financiering opgehaald: respectievelijk €5 miljoen, €32 miljoen en €185 miljoen.
De investering geeft het Leidse VarmX de kans om proof-of-concept voor hun antistollingsmiddel te behalen en hun productietak op te schalen voor commerciële doeleinden. Mosa Meat richt zich op kweekvlees en gebruikt de investering om een pilot productiefaciliteit op te zetten en hun technologie op te schalen. Met hun financiering richt Forbion een nieuw fonds op: het growth opportunities fund. Dit fonds richt zich op investeringen in Europese biotech bedrijven die zich in een latere fase begeven.
Ondanks de grote impact van de coronapandemie op de kapitaalmarkt, laten deze nieuwe investeringen zien dat het Nederlandse financieringslandschap veerkrachtig is en investeerders nog steeds nieuwe kansen zien om te investeren.
Omdat het aantrekken van financiering is één van de grootste uitdagingen voor biotech start-ups en scale-ups, heeft dit onderwerp HollandBIO’s volle aandacht. Twee weken geleden wijdden wij ons eerste @homewebinar aan precies dit onderwerp. Tijdens dit webinar ging Daniel de Boer, CEO van ProQR Therapeutics, in gesprek met ondernemers en investeerders over de invloed van COVID-19 op het biotech financieringslandschap. Een kijktip als je meer van dit onderwerp wil weten! Hieronder kijk je het Webinar terug.
Last week, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund, a ground-breaking partnership that aims to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections –also called antimicrobial resistance, or AMR. The companies have raised so far nearly US$1 billion new funding to support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. Through the AMR Action Fund, pharmaceutical companies will join forces with philanthropies, development banks, and multilateral organizations to strengthen and accelerate antibiotic development.The Fund will focus on urgent public health needs. It will provide much needed financial resources, as well as important technical support to help biotech companies bring novel antibiotics to patients.
The AMR Action Fund, an initiative of the international body representing the R&D pharmaceutical industry (International Federation of Pharmaceutical Manufacturers & Associations, IFPMA), was announced at simultaneous virtual launch events in Berlin, Germany, and Washington, D.C., USA, with a third event in Tokyo, Japan taking place on July 10.
AMR is a looming global crisis that has the potential to dwarf COVID-19 in terms of deaths and economic costs. While tragically the death toll of COVID-19 continues to rise, each year 700,000 people are dying from AMR. In some of the most alarming scenarios, it is estimated that by 2050 AMR could claim as many as 10 million lives per year.
“Unlike COVID-19, AMR is a predictable and preventable crisis. We must act together to rebuild the pipeline and ensure that the most promising and innovative antibiotics make it from the lab to patients,”said Thomas Cueni,Director General of the IFPMA, one of the organizers of the new fund. He adds: “The AMR Action Fund is one of the largest and most ambitious collaborative initiatives ever undertaken by the pharmaceutical industry to respond to a global public health threat”.
The world urgently needs new antibiotics, but there are few in the pipeline because of a paradox: despite the huge societal costs of AMR, there is currently no viable market for new antibiotics. New antibiotics are used sparingly to preserve effectiveness, so in recent years, a number of antibiotic-focused biotechs have declared bankruptcy or exited this spacedueto the lack of commercial sustainability, resulting in the loss of valuable expertise and resources. The consequenceis a huge public healthneed for new antibiotics, but a lack of funding available for antibiotic R&D, particularly the later stages of clinical research. This creates a “valley of death” between discovery and patient access.
“With the AMR Action Fund, the pharmaceutical industry is investing nearly US$1 billion to sustain an antibiotic pipeline that is on the verge of collapse, a potentially devastating situation that could affect millions of people around the world,” said David Ricks, Chairman and CEO of Eli Lilly and Company and President of IFPMA. “The AMR Action Fund will support innovative antibiotic candidates through the most challenging later stages of drug development, ultimately providing governments time to make the necessary policy reforms to enable a sustainable antibiotic pipeline.”
While the AMR Action Fund is an important step in addressing the challengeof AMR, policymakers across the globe must enact market-based reforms, including reimbursement reform and new pull incentives, to revitalize the antibiotics market and drive sustainable investments in antibiotic R&D. Until then, the biopharmaceutical industry is taking action now to support the current pipeline of antibiotics.
With this investment from leading biopharmaceutical companies, the AMR Action Fund will be the largest collective venture ever created to address AMR. The AMR Action Fund will:
Invest in smaller biotech companies focused on developing innovative antibacterial treatments that address the highest priority public health needs, make a significant difference in clinical practice, and save lives.
Provide technical support to portfolio companies, giving them access to the deep expertise and resources of large biopharmaceutical companies, to strengthen antibiotic development, and support access and appropriate use of antibiotics.
Bring together a broad alliance of industry and non-industry stakeholders, including philanthropies, development banks, and multilateral organizations, and help encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline.
The AMR Action Fund expects to invest more than US$1 billion with the support of future partners into a portfolio of companies to address the funding gap for the financing of antibiotic development. The Fund is expected to be operational during the fourth quarter of 2020.
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Gisteren is het Medical Delta Fieldlab Phenomix op het Leiden Bio Science Park geopend. In dit fieldlab werken bedrijven, zorginstellingen en wetenschappers samen aan praktische toepassingen van ‘metabolomics’-onderzoek: onderzoek naar stofwisselingsproducten. Door stofwisselingsproducten als aminozuren, hormonen, glucose of adrenaline te meten, ontstaat een goed beeld van iemands actuele gezondheid. Met zulke zogeheten ‘metabole profielen’ kunnen artsen bijvoorbeeld eerder diagnoses stellen of een persoonlijk behandelplan maken.
Bij metabolomics bestuderen wetenschappers de unieke chemische vingerafdrukken die specifieke stofwisselingsprocessen in ons lichaam achterlaten. Dit soort kennis kan helpen om de zorg als geheel meer toe te spitsen op preventie of vroegtijdige behandeling. Ook voor de agri- en foodindustrie kan metabolomics een grote rol spelen. Het nieuwe fieldlab biedt wetenschappers een open innovatiesetting om projecten in de zorg en het bedrijfsleven aan te pakken.
Zowel de wetenschappers van Universiteit Leiden en het Erasmus MC die in Medical Delta verband samenwerken aan metabolomicsonderzoek, als de bedrijven en zorginstellingen uit de regio staan internationaal hoog aangeschreven. Hierdoor heeft het fieldlab de potentie een internationale ‘hotspot’ te worden voor de toepassing van metabolomics. De ambitie is dat het fieldlab de vestiging van bedrijven uit de farma-, agri en foodindustrie verder aanjaagt en daarmee de realisatie van een metabolomics ecosysteem accelereert.
Meer preventie en behandelingen op maat dankzij metabolomics Door stofwisselingsproducten als aminozuren, glucose of adrenaline te meten, kunnen artsen een voor elke patiënt een metabool profiel opstellen. Met metabolomics kunnen zij vervolgens bepalen welke bijwerkingen een medicijn zal hebben bij een bepaald profiel. Daarnaast helpen individuele gezondheidsprofielen om tijdig preventieve maatregelen te treffen, bijvoorbeeld door het eetpatroon aan te passen als een ziekte zich lijkt te ontwikkelen.
Momenteel onderzoeken wetenschappers van het LUMC, Erasmus MC en UMC Utrecht aan de hand van metabole profielen bijvoorbeeld hoe het kan dat coronapatiënten verschillend reageren op het virus en op ontstekingsremmers. De wetenschappers hopen hun bevindingen snel te kunnen delen, waarna de industrie en zorginstellingen de zorg beter kunnen afstemmen op het profiel van de patiënt.
“Dit is een goed voorbeeld van hoe wetenschappers, artsen en de industrie kunnen samenwerken. Niet alleen voor de individuele patiënt, maar voor de zorg als geheel kan metabolomics belangrijke voordelen opleveren,” zegt Medical Delta hoogleraar prof. dr. Thomas Hankemeier (Universiteit Leiden, Erasmus MC), een van de initiatiefnemers van het fieldlab. “Dat geldt ook voor andere sectoren en bedrijven, bijvoorbeeld in de foodindustrie. Mijn uiteindelijke doel is dat iedere Nederlander een metabool profiel kan krijgen wanneer hij of zij dat nodig heeft.”
Kansen door samenwerking De wetenschappers die samenwerken in het fieldlab komen uit verschillende disciplines. Het fieldlab bouwt daarmee voort op het wetenschappelijke programma ‘METABOLDELTA’ van Medical Delta.
“Het fieldlab geeft een extra stimulans om wetenschappelijke bevindingen te vertalen naar de markt, de zorg en de maatschappij waardoor het directe impact krijgt op patiënten en de zorg als geheel,” zegt Gertine van der Vliet, managing director en bestuurslid van Medical Delta.
In het fieldlab participeren de Universiteit Leiden en Erasmus MC met diverse bedrijven uit de biotech en farmaceutische industrie. Het is gevestigd op het Leiden Bio Science Park en wordt met EFRO-subsidie opgezet. Onder andere InnovationQuarter en Medical Delta zijn betrokken bij de opzet en uitbouw van het fieldlab.
Sleuteltechnologieën is een verzamelterm voor technologieën van de ‘toekomst’. Ze zetten een ideeën over wat mogelijk werd geacht overboord en hebben het potentieel om tot baanbrekende innovaties te leiden. Zo zal kunstmatige intelligentie de manier waarop we werken veranderen en behandelen we door nanomedicijnen patiënten op nieuwe manieren. De call ‘Sleuteltechnologieën’ stimuleert:
de ontwikkeling van wetenschappelijk excellente kennis en hieruit voor het bedrijfsleven en de maatschappij relevante nieuwe technologie via een multidisciplinaire aanpak;
het opbouwen van intensieve en duurzame samenwerkingsrelaties binnen consortia tussen kennisinstellingen, bedrijven en maatschappelijke organisaties;
het creëren van meer focus en massa (coherentie) in het onderzoek op voor Nederland relevante thematische gebieden en sleuteltechnologieën om sterke internationaal onderscheidende posities in het Nederlandse bedrijfsleven en de kennisinfrastructuur te creëren; en
het bevorderen van het valoriseren van de ontwikkelde kennis door (eind)gebruikers.
Opening call for proposals: juli 2020 Beoogde deadline vooraanmelding: niet eerder dan januari 2021 Bijdrage NWO: 11 miljoen euro Projectgrootte (inclusief cofinanciering): 750.000 euro – 2,5 miljoen euro