Euretos joined a world leading consortium of universities and companies to co-found the Phenomix Fieldlab at the Leiden Bio Science Park. One of the first cases of the Phenomix fieldlab is to unravel the molecular mechanisms of Covid-19 and, based on this, determine the best treatment options for specific types of patients.
In this metabolomics lab, internationally renowned scientists from the Leiden University and Erasmus Medical Centre, (together forming the Medical Delta) work closely together with companies and healthcare institutions in the region. In Phenomix, Euretos contributes its world leading capability in AI & data-driven analysis to understand the molecular and metabolomic processes underlying the observed phenotypes and disorders. “This is a good example of how scientists, doctors and the industry can work together. Metabolomics can deliver important benefits not only for the individual patient, but for healthcare as a whole” says Medical Delta professor Thomas Hankemeier (Leiden Academic Centre for Drug Research), one of the initiators of the field lab. “This also applies to other sectors and companies, for example in the food industry.”
One of the first use cases the Phenomix lab is focusing on is Covid-19. How is it that some COVID-19 patients become seriously ill and others do not? Why do serious infections occur only in some patients? Why do patients respond so differently to treatment?
Within the field lab, metabolic profiles of patients were created and organ-on-a-chip models based on Mimetas OrganoPlates demonstrated the molecular impact of the SARS-Cov-2 virus on COVID-19 symptoms, such as vascular leakage and thrombosis. From the Euretos platform, researchers evaluate potential explanatory mechanisms that link the metabolic profile to the observed symptoms. Step by step, this process creates an increasingly clearer picture linking specific patient profiles to various symptoms.
“In this cycle of data acquisition, analysis, rationalization and then further elaboration on key observations through further measurements and experimentation, the field lab clearly proves its added value,” says Arie Baak, co-founder of Euretos. The field lab accelerates and improves this process as physicians, technicians and scientists are collaborating continuously on understanding the observations. In addition, the field lab is at the forefront of using the latest technologies and process automation. This not only provides new insights, it also significantly speeds up the process from ‘sample to analysis’.
On the basis of the biological patient profiles, consisting of both genetic and metabolic characteristics, the project expects to better understand the underlying mechanisms explaining the difference in disease progression of COVID-19 patients. This will help to find better treatment for patients. Ultimately, the aim is that a physician will be able to determine on the basis of a blood sample what are the best treatment options for each individual patient. Certain medication can be crucial to slow down a runaway immune system for one patient, but what you don’t want is for the virus to run wild by unnecessarily suppressing the immune reaction for other patients. “Ultimately, our collaboration should help doctors quickly and effectively make these kinds of treatment choices.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-08-03 14:12:462020-08-03 14:12:47Euretos co-founds Metabolomics lab addressing Covid-19 as a first use case← #nieuws
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zenocutuzumab (Zeno) for the treatment of patients with pancreatic cancer.
Zeno is a first in class bispecific antibody that potently binds to the HER2 and HER3 receptors, to potently block the interaction of HER3 with its ligand, neuregulin 1 (NRG1). Zeno has demonstrated promising early clinical responses in patients with previously treated pancreatic cancer harboring NRG1 gene fusions, as presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2019. The NRG1 gene fusion is a rare, powerful driver of cancer cell growth found in pancreatic, lung and other types of solid tumors. Zeno is now being evaluated in a global phase 1/2 clinical trial called the eNRGy trial.
“Receiving Orphan Drug Designation for Zeno is another important milestone for our lead program, and it validates the significant unmet need in patients with pancreatic cancer,” said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. “We are pleased with the progress we are making in our ongoing global clinical trial, and believe that Zeno has the potential to play a significant role in shifting the treatment paradigm for NRG1 fusion cancers from conventional chemotherapy to a personalized medicine approach.”
The FDA grants Orphan Drug Designation to drugs that are intended to treat rare diseases that affect fewer than 200,000 people in the U.S. Orphan Drug Designation may provide Merus certain benefits, such as grant funding towards clinical trial costs, tax advantages and eligibility for seven-year market exclusivity.
Pancreatic cancer is estimated to occur in approximately 57,000 patients annually in the United States, according to the NCI SEER database. Pancreatic ductal adenocarcinoma (PDAC), the most common subtype of pancreatic cancer, is one of the most aggressive solid tumor cancers and the fourth leading cause of cancer related deaths.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-08-03 14:09:272020-08-03 14:09:28Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer← #nieuws
In de afgelopen weken spreken zowel de Duitse landbouwminister Julia Klöckner als het Britse ministerie voor milieu en landbouw zich uit voor bredere toepassing van nieuwe veredelingstechnieken, zoals Crispr-Cas. Klöckner roept in een opinieartikel in Der Tagesspiegel op tot meer lef omdat deze technieken het veredelingsproces aanzienlijk bespoedigen, planten beter bestand maken tegen klimaatverandering, ziektes en plagen en ook nog kunnen leiden tot minder gebruik van gewasbeschermingsmiddelen en grondstoffen. Het Britse DEFRA-departement is op dit moment bezig met een raadpleging over post-Brexit wetgeving waarin de rol van moderne veredelingsmethoden ook terugkomt. Het ministerie is van mening dat toepassing hiervan bijdraagt aan het verduurzamen van de landbouw en voordelen voor telers.
HollandBIO is blij dat ministeries en bewindspersonen zich ook in andere delen van Europa publiekelijk hard maken voor de bijdrage die moderne veredeling kan leveren aan een duurzame en gezonde landbouw en voedselproductie. We zetten ons er voor in dat dit uiteindelijk leidt tot een breed draagvlak voor een grondige modernisering van de Europese wet- en regelgeving voor genetische modificatie, hopelijk vanaf april 2021.
Verder lezen? Klik dan hier voor een samenvatting het Duitse opiniestuk of hier voor de ontwikkelingen in het Verenigd Koninkrijk.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-07-31 13:36:082020-07-31 13:36:09Duitsland en Verenigd Koninkrijk willen meer ruimte voor moderne veredeling← #nieuws
Den Haag, 30 juli 2020 – Vandaag lanceert HollandBIO, de belangenvereniging voor de Nederlandse biotechnologiesector, haar Life Sciences Verkiezingsmanifest in aanloop naar de Tweede Kamerverkiezingen van 17 maart 2021. In het manifest geeft HollandBIO politici, beleidsmakers en ambtenaren een overzicht van waar onze sector voor staat, waaronder de hordes die we nog moeten nemen. Het belang om te kiezen voor een duurzame en gezonde toekomst is – zeker in het licht van de huidige coronacrisis – urgenter dan ooit. De Nederlandse life sciences sector is bij uitstek geschikt om bij te dragen aan het oplossen van maatschappelijke uitdagingen, mits we daar de juiste randvoorwaarden voor scheppen.
De Nederlandse life sciences sector maakt haar belofte waar. “Innovaties uit biotechnologie brengen ons baanbrekende geneesmiddelen en vaccins, gewassen die bijdragen aan een duurzamere landbouw, en biobased grondstoffen en materialen die de transitie naar een hernieuwbare economie mogelijk maken”, aldus HollandBIO-directeur Annemiek Verkamman. Biotechnologie kan een rol spelen bij 11 van de 17 Sustainable Development Goals van de Verenigde Naties en kan daarmee van doorslaggevend belang zijn voor het aangaan van maatschappelijke uitdagingen rond gezondheid en duurzaamheid en aan een innovatieve en welvarende samenleving – nu én in de toekomst.
‘The Bio Revolution’
De biotechnologische mogelijkheden groeien exponentieel. HollandBIO’s Annemiek Verkamman licht die ontwikkeling verder toe: “Het McKinsey Global Institute spreekt zelfs van een ware ‘Bio Revolution’. Met haar sterke, opkomende life sciences sector heeft Nederland een beloftevolle uitgangspositie om in te spelen op die revolutie”. Met het Life Sciences Verkiezingsmanifest doet HollandBIO beleidssuggesties om de kansen van de life sciences sector te verzilveren op verscheidene onderwerpen, namelijk:
Ondernemerschap in de life sciences
Verduurzaming van landbouw, veeteelt, visserij en chemie
Preventie en gezondheid
Life Sciences Verkiezingsmanifest 2021
Benieuwd naar het volledige manifest? Belangstellenden kunnen het hier downloaden.
AON-platform with focus on therapies nearing phase I trials for forms of Spinocerebellar Ataxia and Huntington Disease
Other early discovery stage RNA editing platform focuses on RETT syndrome
Funding led by LSP, co-led by Kurma Partners, supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures
Vico Therapeutics,a Leiden, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that it has raised $31 million (€27 million) in a Series A financing round. Vico will use this funding to further advance its late preclinical stage Antisense OligoNucleotides (AON) lead platform for the development of therapies for different forms of Spinocerebellar Ataxia (SCA) and Huntington Disease (HD) into first-in-human clinical trials in late 2021. Its early discovery RNA editing platform is directed towards RETT syndrome. The financing was led by Life Science Partners (LSP), co-led by Kurma Partners, and supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures and Idinvest Partners.
Vico’s lead asset is an investigational AON therapy targeting expanded (CAG) trinucleotide repeats that translate into abnormally long and toxic polyglutamine (polyQ) stretches in proteins that cause a series of neurodegenerative polyQ disorders like Spinocerebellar Ataxia type 1 (SCA1), type 3 (SCA3) and Huntington’s disease (HD).
It has been demonstrated to preferentially reduce the levels of mutant polyQ compared to wildtype proteins. This was confirmed in several established mouse models for SCA1, SCA3 and Huntington Disease, with a long-term and widespread distribution of the compound throughout the central nervous system. Based on these encouraging data combined with the broad applicability of the lead compound to multiple different brain disorders with high unmet medical need, Vico is advancing this program towards a first-in-human trial expected in late 2021.
Luc Dochez, Founder and Chairman of Vico Therapeutics, stated: “This Series A funding will allow us to advance our lead program into the clinic and continue to build our capabilities as a leader in the development of novel therapies for serious CNS disorders. We see tremendous potential to advance the field and apply the breadth of our antisense oligonucleotide (AON) expertise to address severe neurological disorders. We are looking forward to accelerating the development of our platform technologies around AON technology and RNA-modulation/editing to bring best-in-class therapies to patients. The Vico team built this company around a unique synergy between state-of-the-art molecular biology, AON chemistry laboratories and industry experience in successfully developing drugs based on AON technology.”
Martijn Kleijwegt, managing partner at LSP, lead investor and board member, added: “Vico is building a leading team and has a cutting-edge infrastructure to engineer best-in-class therapies for severe neurological conditions and accelerate their advancement into human clinical trials. A major strength of Vico’s approach is the broad applicability to different polyQ diseases and the selectivity for mutant proteins.”
Vico’s Board will consist of Martijn Keijwegt, Managing Partner of LSP, Felice Verduyn-van Weegen, Investment Manager LSP, Rémi Droller, Managing Partner Kurma Partners, Silvia Noiman, Pontifax, Luc Dochez, Managing Partner, Droia Genetic Disease, Amy Schulman, Managing Partner Polaris Partners and Anja Harmeier, Partner Pureos Bioventures and Josh Mandel-Brehm, co-founder.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00HollandBIOhttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svgHollandBIO2020-07-29 09:30:052020-07-29 09:30:06Biotech Vico Therapeutics raises $31 million (€27 million) in Series A financing round to advance therapies for rare central nervous system diseases← #nieuws
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.
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 18:36:282020-07-28 18:36:29Inzet van dwanglicenties voor geneesmiddelen – wordt er een probleem opgelost?← #nieuws
Een behandeling kan pas van waarde zijn voor een patiënt, wanneer deze de patiënt ook echt bereikt. En die toegankelijkheid van innovatieve oncologische behandelingen in Europa verschilt enorm per land. Afgelopen tijd inventariseerde een multi-stakeholder coalitie van meer dan 30 betrokkenen onder leiding van Vintura de kansen en uitdagingen op weg van markttoelating tot aan patiënt in Europa.
De focus lag op uitdagingen in het proces van vergoeding én de beschikbaarheid voor patiënten vanaf het moment dat vergoeding geregeld is. Nederland was één van de tien landen in de benchmarkanalyse waarin voor het eerst ook naar gebruik na vergoeding werd gekeken. Spoiler alert: Nederland kent relatief weinig vertraging wat betreft vergoeding (top 3), maar eindigt laatste als het gaat om toegankelijkheid voor de patiënt.
Er zijn 10 factoren geïdentificeerd die het proces van toegankelijkheid vertragen en 6 aandachtsgebieden om werk van te maken, zodat de beschikbaarheid voor patiënten verbetert. Samenwerking tussen alle betrokken partijen is één van de belangrijkste sleutels tot succes.
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 18:01:022020-07-28 18:01:03Leestip: Every day counts← #nieuws
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.
Euretos co-founds Metabolomics lab addressing Covid-19 as a first use case
GezondheidEuretos joined a world leading consortium of universities and companies to co-found the Phenomix Fieldlab at the Leiden Bio Science Park. One of the first cases of the Phenomix fieldlab is to unravel the molecular mechanisms of Covid-19 and, based on this, determine the best treatment options for specific types of patients.
In this metabolomics lab, internationally renowned scientists from the Leiden University and Erasmus Medical Centre, (together forming the Medical Delta) work closely together with companies and healthcare institutions in the region. In Phenomix, Euretos contributes its world leading capability in AI & data-driven analysis to understand the molecular and metabolomic processes underlying the observed phenotypes and disorders. “This is a good example of how scientists, doctors and the industry can work together. Metabolomics can deliver important benefits not only for the individual patient, but for healthcare as a whole” says Medical Delta professor Thomas Hankemeier (Leiden Academic Centre for Drug Research), one of the initiators of the field lab. “This also applies to other sectors and companies, for example in the food industry.”
One of the first use cases the Phenomix lab is focusing on is Covid-19. How is it that some COVID-19 patients become seriously ill and others do not? Why do serious infections occur only in some patients? Why do patients respond so differently to treatment?
Within the field lab, metabolic profiles of patients were created and organ-on-a-chip models based on Mimetas OrganoPlates demonstrated the molecular impact of the SARS-Cov-2 virus on COVID-19 symptoms, such as vascular leakage and thrombosis. From the Euretos platform, researchers evaluate potential explanatory mechanisms that link the metabolic profile to the observed symptoms. Step by step, this process creates an increasingly clearer picture linking specific patient profiles to various symptoms.
“In this cycle of data acquisition, analysis, rationalization and then further elaboration on key observations through further measurements and experimentation, the field lab clearly proves its added value,” says Arie Baak, co-founder of Euretos. The field lab accelerates and improves this process as physicians, technicians and scientists are collaborating continuously on understanding the observations. In addition, the field lab is at the forefront of using the latest technologies and process automation. This not only provides new insights, it also significantly speeds up the process from ‘sample to analysis’.
On the basis of the biological patient profiles, consisting of both genetic and metabolic characteristics, the project expects to better understand the underlying mechanisms explaining the difference in disease progression of COVID-19 patients. This will help to find better treatment for patients. Ultimately, the aim is that a physician will be able to determine on the basis of a blood sample what are the best treatment options for each individual patient. Certain medication can be crucial to slow down a runaway immune system for one patient, but what you don’t want is for the virus to run wild by unnecessarily suppressing the immune reaction for other patients. “Ultimately, our collaboration should help doctors quickly and effectively make these kinds of treatment choices.”
Source: Euretos (Press release)
Merus announces FDA Orphan Drug Designation of Zenocutuzumab for the Treatment of Pancreatic Cancer
GezondheidMerus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics™) for cancer, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Zenocutuzumab (Zeno) for the treatment of patients with pancreatic cancer.
Zeno is a first in class bispecific antibody that potently binds to the HER2 and HER3 receptors, to potently block the interaction of HER3 with its ligand, neuregulin 1 (NRG1). Zeno has demonstrated promising early clinical responses in patients with previously treated pancreatic cancer harboring NRG1 gene fusions, as presented at the AACR/NCI/EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2019. The NRG1 gene fusion is a rare, powerful driver of cancer cell growth found in pancreatic, lung and other types of solid tumors. Zeno is now being evaluated in a global phase 1/2 clinical trial called the eNRGy trial.
“Receiving Orphan Drug Designation for Zeno is another important milestone for our lead program, and it validates the significant unmet need in patients with pancreatic cancer,” said Bill Lundberg, M.D., President, Chief Executive Officer and Principal Financial Officer of Merus. “We are pleased with the progress we are making in our ongoing global clinical trial, and believe that Zeno has the potential to play a significant role in shifting the treatment paradigm for NRG1 fusion cancers from conventional chemotherapy to a personalized medicine approach.”
The FDA grants Orphan Drug Designation to drugs that are intended to treat rare diseases that affect fewer than 200,000 people in the U.S. Orphan Drug Designation may provide Merus certain benefits, such as grant funding towards clinical trial costs, tax advantages and eligibility for seven-year market exclusivity.
Pancreatic cancer is estimated to occur in approximately 57,000 patients annually in the United States, according to the NCI SEER database. Pancreatic ductal adenocarcinoma (PDAC), the most common subtype of pancreatic cancer, is one of the most aggressive solid tumor cancers and the fourth leading cause of cancer related deaths.
Source: Merus (Press release)
Duitsland en Verenigd Koninkrijk willen meer ruimte voor moderne veredeling
Voedsel en materialenIn de afgelopen weken spreken zowel de Duitse landbouwminister Julia Klöckner als het Britse ministerie voor milieu en landbouw zich uit voor bredere toepassing van nieuwe veredelingstechnieken, zoals Crispr-Cas. Klöckner roept in een opinieartikel in Der Tagesspiegel op tot meer lef omdat deze technieken het veredelingsproces aanzienlijk bespoedigen, planten beter bestand maken tegen klimaatverandering, ziektes en plagen en ook nog kunnen leiden tot minder gebruik van gewasbeschermingsmiddelen en grondstoffen. Het Britse DEFRA-departement is op dit moment bezig met een raadpleging over post-Brexit wetgeving waarin de rol van moderne veredelingsmethoden ook terugkomt. Het ministerie is van mening dat toepassing hiervan bijdraagt aan het verduurzamen van de landbouw en voordelen voor telers.
HollandBIO is blij dat ministeries en bewindspersonen zich ook in andere delen van Europa publiekelijk hard maken voor de bijdrage die moderne veredeling kan leveren aan een duurzame en gezonde landbouw en voedselproductie. We zetten ons er voor in dat dit uiteindelijk leidt tot een breed draagvlak voor een grondige modernisering van de Europese wet- en regelgeving voor genetische modificatie, hopelijk vanaf april 2021.
Verder lezen? Klik dan hier voor een samenvatting het Duitse opiniestuk of hier voor de ontwikkelingen in het Verenigd Koninkrijk.
Life Sciences Verkiezingsmanifest: voor een gezonde, duurzame toekomst
Wereld mét toekomst, Gezondheid op maat, IJzersterk innovatieklimaat, Hollandbio, UitgelichtDen Haag, 30 juli 2020 – Vandaag lanceert HollandBIO, de belangenvereniging voor de Nederlandse biotechnologiesector, haar Life Sciences Verkiezingsmanifest in aanloop naar de Tweede Kamerverkiezingen van 17 maart 2021. In het manifest geeft HollandBIO politici, beleidsmakers en ambtenaren een overzicht van waar onze sector voor staat, waaronder de hordes die we nog moeten nemen. Het belang om te kiezen voor een duurzame en gezonde toekomst is – zeker in het licht van de huidige coronacrisis – urgenter dan ooit. De Nederlandse life sciences sector is bij uitstek geschikt om bij te dragen aan het oplossen van maatschappelijke uitdagingen, mits we daar de juiste randvoorwaarden voor scheppen.
De Nederlandse life sciences sector maakt haar belofte waar. “Innovaties uit biotechnologie brengen ons baanbrekende geneesmiddelen en vaccins, gewassen die bijdragen aan een duurzamere landbouw, en biobased grondstoffen en materialen die de transitie naar een hernieuwbare economie mogelijk maken”, aldus HollandBIO-directeur Annemiek Verkamman. Biotechnologie kan een rol spelen bij 11 van de 17 Sustainable Development Goals van de Verenigde Naties en kan daarmee van doorslaggevend belang zijn voor het aangaan van maatschappelijke uitdagingen rond gezondheid en duurzaamheid en aan een innovatieve en welvarende samenleving – nu én in de toekomst.
‘The Bio Revolution’
De biotechnologische mogelijkheden groeien exponentieel. HollandBIO’s Annemiek Verkamman licht die ontwikkeling verder toe: “Het McKinsey Global Institute spreekt zelfs van een ware ‘Bio Revolution’. Met haar sterke, opkomende life sciences sector heeft Nederland een beloftevolle uitgangspositie om in te spelen op die revolutie”. Met het Life Sciences Verkiezingsmanifest doet HollandBIO beleidssuggesties om de kansen van de life sciences sector te verzilveren op verscheidene onderwerpen, namelijk:
Life Sciences Verkiezingsmanifest 2021
Benieuwd naar het volledige manifest? Belangstellenden kunnen het hier downloaden.
Biotech Vico Therapeutics raises $31 million (€27 million) in Series A financing round to advance therapies for rare central nervous system diseases
InnovatieklimaatVico Therapeutics,a Leiden, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that it has raised $31 million (€27 million) in a Series A financing round. Vico will use this funding to further advance its late preclinical stage Antisense OligoNucleotides (AON) lead platform for the development of therapies for different forms of Spinocerebellar Ataxia (SCA) and Huntington Disease (HD) into first-in-human clinical trials in late 2021. Its early discovery RNA editing platform is directed towards RETT syndrome. The financing was led by Life Science Partners (LSP), co-led by Kurma Partners, and supported by Pontifax, Droia Genetic Disease, Polaris Partners and Pureos Bioventures and Idinvest Partners.
Vico’s lead asset is an investigational AON therapy targeting expanded (CAG) trinucleotide repeats that translate into abnormally long and toxic polyglutamine (polyQ) stretches in proteins that cause a series of neurodegenerative polyQ disorders like Spinocerebellar Ataxia type 1 (SCA1), type 3 (SCA3) and Huntington’s disease (HD).
It has been demonstrated to preferentially reduce the levels of mutant polyQ compared to wildtype proteins. This was confirmed in several established mouse models for SCA1, SCA3 and Huntington Disease, with a long-term and widespread distribution of the compound throughout the central nervous system. Based on these encouraging data combined with the broad applicability of the lead compound to multiple different brain disorders with high unmet medical need, Vico is advancing this program towards a first-in-human trial expected in late 2021.
Luc Dochez, Founder and Chairman of Vico Therapeutics, stated: “This Series A funding will allow us to advance our lead program into the clinic and continue to build our capabilities as a leader in the development of novel therapies for serious CNS disorders. We see tremendous potential to advance the field and apply the breadth of our antisense oligonucleotide (AON) expertise to address severe neurological disorders. We are looking forward to accelerating the development of our platform technologies around AON technology and RNA-modulation/editing to bring best-in-class therapies to patients. The Vico team built this company around a unique synergy between state-of-the-art molecular biology, AON chemistry laboratories and industry experience in successfully developing drugs based on AON technology.”
Martijn Kleijwegt, managing partner at LSP, lead investor and board member, added: “Vico is building a leading team and has a cutting-edge infrastructure to engineer best-in-class therapies for severe neurological conditions and accelerate their advancement into human clinical trials. A major strength of Vico’s approach is the broad applicability to different polyQ diseases and the selectivity for mutant proteins.”
Vico’s Board will consist of Martijn Keijwegt, Managing Partner of LSP, Felice Verduyn-van Weegen, Investment Manager LSP, Rémi Droller, Managing Partner Kurma Partners, Silvia Noiman, Pontifax, Luc Dochez, Managing Partner, Droia Genetic Disease, Amy Schulman, Managing Partner Polaris Partners and Anja Harmeier, Partner Pureos Bioventures and Josh Mandel-Brehm, co-founder.
Source: VICO Therapeutics
Inzet van dwanglicenties voor geneesmiddelen – wordt er een probleem opgelost?
InnovatieklimaatInteressante 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.
Leestip: Every day counts
GezondheidEen behandeling kan pas van waarde zijn voor een patiënt, wanneer deze de patiënt ook echt bereikt. En die toegankelijkheid van innovatieve oncologische behandelingen in Europa verschilt enorm per land. Afgelopen tijd inventariseerde een multi-stakeholder coalitie van meer dan 30 betrokkenen onder leiding van Vintura de kansen en uitdagingen op weg van markttoelating tot aan patiënt in Europa.
De focus lag op uitdagingen in het proces van vergoeding én de beschikbaarheid voor patiënten vanaf het moment dat vergoeding geregeld is. Nederland was één van de tien landen in de benchmarkanalyse waarin voor het eerst ook naar gebruik na vergoeding werd gekeken. Spoiler alert: Nederland kent relatief weinig vertraging wat betreft vergoeding (top 3), maar eindigt laatste als het gaat om toegankelijkheid voor de patiënt.
Er zijn 10 factoren geïdentificeerd die het proces van toegankelijkheid vertragen en 6 aandachtsgebieden om werk van te maken, zodat de beschikbaarheid voor patiënten verbetert. Samenwerking tussen alle betrokken partijen is één van de belangrijkste sleutels tot succes.
Het hele rapport lees je hier.
GSK and CureVac announce strategic mRNA technology collaboration
InnovatieklimaatGlaxoSmithKline 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.
Source: GSK
PlantLab raises €20 million in first external investment round
InnovatieklimaatDutch 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.
Source: Plantlab
Een sprookjesachtig vestigingsklimaat
IJzersterk innovatieklimaat, Innovatieklimaat, UitgelichtHollandBIO 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.