Clinerion’s Patient Network Explorer and iClusion’s Trial Eye platforms both connect clinical trial sponsors with networks of partner hospitals, giving trial managers the ability to include eligible patients for trials more quickly and efficiently than before. Treating physicians and patients benefit from increased treatment options and quicker access to new medical interventions.
Together, the partners’ joint mission is to increase patient participation in studies to its full potential by optimizing protocol design, enabling study sites to efficiently start up their trials locally and plan and meet realistic patient recruitment and therefore total timeline targets.
This new clinical trial optimization partnership also facilitates a total study site network activation for all trials, beyond the study sites already chosen to participate, by facilitating online referral and activation services.
iClusion makes clinical research accessible for physicians and their patients by connecting sponsors and their research protocols with research sites. Connecting all stakeholders and automating standardized local approval procedures in one networked platform accelerates total study timelines and makes innovative products available to more patients faster.
Clinerion makes real-world patient data accessible for analysis so that study protocols can be optimized with real patients in mind and real-world patient data can drive study feasibility and patient recruitment.
Both iClusion and Clinerion maintain cloud platforms which bring together participants from across the clinical study ecosystem, comprising sponsors, hospitals and clinicians, and treating physicians and patients. However, the partners offer complementary support and solutions throughout the product development process.
“Never in history has the R&D engine in pharmaceuticals been more productive, driving a pool of promising new agents,” says Edwin Klumper, CEO of iClusion. “The growing pipeline of targeted and personalized medicines puts tremendous pressure on more trials to be conducted in smaller, more well-defined patient populations. As a result, patient recruitment has become the bottleneck, nowadays, which is delaying progress and withholding many patients from the benefits of participation. I am pleased that Clinerion and iClusion are partnering to start tackling the identification and recruitment of the right patients into the right studies to bolster trial conduct and innovation.”
“Our collaboration re-emphasizes that patients are at the heart of clinical development and clinical trial conduct,” says Ian Rentsch, CEO of Clinerion. “Our combined services cover trials operations from protocol design through operational feasibility, site selection, local approvals, startup of study sites and patient recruitment. This partnership is therefore ideally positioned to optimize and advance protocols faster, reach more study sites and offer more patients the possibility to participate in research.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-03-03 16:36:582020-03-03 16:36:59Clinerion and iClusion partner to boost the identification and recruitment of more patients into clinical trials← #nieuws
iOnctura, a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, has dosed the first patient in a first-in-human dose escalation and expansion study evaluating the safety and preliminary efficacy of its lead programme IOA-244, which is being developed as a novel targeted therapy for solid tumours.
The phase I study will enrol approximately 60 patients with solid tumours that overexpress PI3Kδ and are burdened by immune cells of the suppressor phenotype that are sensitive to PI3Kδ inhibition. The dose escalation part of the study will evaluate the safety, tolerability and pharmacokinetic profile of IOA-244 and is being led by principal investigators Professor Evans from the Beatson West of Scotland Cancer Centre and University of Glasgow, and Professor Maio from the University Hospital of Siena. Results from the phase I study are expected in early 2021.
Michael Lahn, Chief Medical Officer of iOnctura, commented: “Our mission is to achieve true precision medicine that optimally treats patients according to the root causes of their disease. The start of this trial represents an important milestone for iOnctura to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications. This study will generate important insights into IOA-244, and its potential to provide meaningful and lasting clinical benefit for patients with cancer. We are very pleased to collaborate with Professor Evans and Professor Maio on this significant first-in-human dose escalation study. We look forward to continuing our evolution into a leading biopharmaceutical company with a diverse and sustainable pipeline in cancer and fibrosis.”
Professor Maio, Department of Medical Oncology, University Hospital of Siena, Italy said: “We are excited to participate in iOnctura’s first-in-human study. iOnctura’s innovative and differentiated approach has the potential to offer new, advanced treatment options to cancer patients and we are looking forward to evaluating this promising and unique target.”
Commenting on the study, recently appointed Clinical Advisory Board member, Dr. Jordi Rodón Ahnert, Clinical co-director, MD Anderson Cancer Center, added: “The design of the clinical trial is novel because it is going to investigate patients with expected high PI3Kδ expression and immune suppression both of which are underlying causes of treatment resistance in many solid tumours. iOnctura’s novel compound, IOA-244, could be critically important for the treatment of solid tumours that are burdened with an immune-suppressive tumour microenvironment.”
Start-Up
Stadium is a platform, organized at the BIO International Convention, that
provides early-stage emerging companies exposure to key investors, venture
philanthropy groups, strategic partners, and non-dilutive capitalists. During
Start-Up Stadium, 50 selected companies have the opportunity to share their
technology and value proposition to an audience of investors, analysts and
strategists from across the value chain providing companies feedback and
Q&A.
By
participating in Start-Up Stadium, companies benefit from the exposure to
investors, discounted registration fees, and complimentary access to BIO
One-on-One Partnering.
Which
companies can apply for Start-Up Stadium?
Companies
that have:
Raised less than $10M round since inception
Previous business pitch/competition experience (desired, not required)
Fewer than 20 full-time employees
No previous experience in BIO One-on-One Partnering at BIO events
The application deadline is 27th of March and you can apply here. You can find out more about the program of Start-Up Stadium and find the pitch presentation guide via the same application link!
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-03-03 13:15:562020-03-11 15:05:10Apply now for the BIO Start-Up Stadium← #nieuws
Nederland is straks twee nieuwe regionale
ontwikkelingsmaatschappijen (ROM’s) rijker. Staatssecretaris Mona Keijzer van
het ministerie van EZK maakte op 20 februari bekend dat er in Utrecht en
Flevoland ook ROM’s zullen worden opgezet. Hierdoor ontstaat een stelsel dat
heel Nederland dekt.
Net zoals bij de andere ROM’s zal naast provincies,
gemeentes en andere entiteiten, ook de Rijksoverheid een belang nemen in de
fondsen. Het startkapitaal voor Flevoland komt daarbij neer op €16 miljoen en
zal voor Utrecht €22 miljoen bedragen. Dit kapitaal zal worden aangewend voor
het uitvoeren van acquisitie, business development en ondernemersfinanciering in
de regio. Ondernemersfinanciering zal voornamelijk worden verstrekt als
risicodragend kapitaal aan startende en innovatieve MKB’ers.
Meer informatie en een uitgebreid overzicht van de structuur van de ROM’s vind je hier terug in de Kamerbrief ‘Oprichting ROM’s in Utrecht en Flevoland’.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-03-03 13:00:192020-03-03 13:00:19Twee nieuwe ROM’s in ontwikkeling← #nieuws
De
internationale Zeldzameziektendag viel dit jaar op de zeldzaamste dag van het
jaar: 29 februari. Op deze dag wordt er wereldwijd aandacht gevraagd voor de
uitdagingen voor zeldzame aandoeningen. HollandBIO zet een selectie van
interessante artikelen en ontwikkelingen rond deze dag voor je op een rij.
In Nederland organiseerde de VSOP de bijeenkomst ‘Zeldzaam – Samen Sterker’ ter inspiratie en kennisuitwisseling. De potentie van nieuwe behandelingen (zoals gentherapieën) en slimmer meten testen kwamen aan bod in de presentatie van Martina Cornel (hoogleraar community genetics & public health genomics, Amsterdam UMC).
Ook diverse media vroegen afgelopen weekend aandacht voor zeldzame aandoeningen. Zo was er de speciale commerciële bijlage bij Trouw waarin patiënten en zorgprofessionals hun ervaringen delen; een gesprek met Cees Smit (hemofilie patiënt) en Connie Stumpel (hoofd van de Polikliniek Klinische Genetica van het Maastricht UMC+) op NPOradio1 over Rare Disease Day; een hoopvol item in de Volkskrant en op het Youtube kanaal van Duchenne Parent Project over de opening van het Dutch Center for RNA Therapeutics voor de behandeling van zeer zeldzame ziekten en de publicatie van de campagne Zeldzame Ziekten van Mediaplanet als bijlage in De Telegraaf. In deze special komen artsen, patiënten en hun naasten aan het woord over verschillende zeldzame aandoeningen zoals galwegkanker, pulmonale arteriële hypertensie, neuroblastoom en bijnierschorsinsufficiëntie. Voor het voorwoord van deze special werd HollandBIO’s Annemiek geïnterviewd over de hordes op het pad van lab naar patiënt.
Weesgeneesmiddelen zijn de innovatieve kraamkamer van de life sciences sector. Baanbrekende nieuwe behandelingen bewijzen zich doorgaans als eerste in het zeldzame ziektedomein, voor ze breder toegepast worden. Dankzij onze toenemende kennis van de biologische processen die ten grondslag liggen aan ziekte, is de life sciences sector steeds beter in staat geneesmiddelen en therapieën te ontwikkelen die aansluiten op de individuele behandelbehoefte van de patiënt. Maar we zijn er nog lang niet. Wereldwijd zijn er nu ruim 100 weesgeneesmiddelen. Het aantal zeldzame zieken ligt tussen de 6000 en 8000. Willen we iedereen die ziek is van een effectieve behandeling voorzien, dan moet de ontwikkeling én inzet van (wees)geneesmiddelen sneller en beter, want op dit moment valt de stijging van de uitgaven aan weesgeneesmiddelen nog vies tegen.
HollandBIO
richt zich vol enthousiasme op het wegruimen van de obstakels die het succes
van deze innovatieve koplopers in de weg staan, zodat het wenkend perspectief
van personalized medicine en behandelingen voor veel meer zeldzame ziekten een
stap dichterbij komt.
Kanker
veroorzakende mutaties in het DNA kunnen het gevolg zijn van een alledaagse
darmbacterie die veel mensen bij zich dragen. Onderzoekers van het Hubrecht
Institute (KNAW) en het Prinses Máxima Centrum in Utrecht toonden dit aan. Zij
stelden in het laboratorium gekweekte menselijke minidarmen bloot aan een
variant van de bacterie Escherichia Coli en zagen dat deze bacterie een uniek
patroon van DNA veranderingen achterliet in de cellen. Dit exacte patroon
vonden de onderzoekers ook terug in het DNA van mensen met darmkanker, wat
impliceert dat de mutaties veroorzaakt zijn door de ‘slechte’ bacteriën. Het is
de eerste keer dat wetenschappers een direct verband leggen tussen onze
darmflora en DNA-afwijkingen die kanker kunnen veroorzaken. Deze ontdekking maakt
de weg vrij naar potentiële preventiemaatregels voor dikkedarmkanker door het
verwijderen van de schadelijke bacteriën. De onderzoekers publiceerden de
resultaten in het vakblad Nature op 27 februari.
A consortium
of Danish and Dutch research organisations led by AdaptVac ApS has been awarded
a EUROSTARS grant for the further development of the AV001 vaccine against
breast cancer. The combination of state-of-the art technologies revealed a
highly immunogenic vaccine against human epidermal growth factor receptor 2 (HER2)
expressed by cancer cells.
With the
support of EUROSTARS, we will be able to prove safety and immunogenicity in
different in vivo models,
finalize the production process and prepare for further clinical development.
The envisaged vaccine could be an effective tool in the treatment of patients
and in the delay of recurrence. The consortium consists of AdaptVac, ExpreSion
Biotechnologies, and University of Copenhagen (Denmark), and LiteVax BV and the
Biomedical Primate Research Centre (the Netherlands).
Breast cancer affects more than 1.3 million worldwide annually,
resulting in more than 450,000 deaths. Today, the most common treatment is
based on monoclonal antibodies against HER2. Such passive immunization has some
clear-cut limitations and therefore we developed a vaccine that activates patient’s
own immune system to destroy HER+ cancer cells. By combining technologies from
AdaptVac, xpreSion Biotechnologies and
LiteVax BV, the prototype vaccine generated strong immune responses in
different animal models. In this project, we will further prove safety and immunogenicity,
finalize the production processes and prepare for clinical development.
“We are particularly pleased by the strength of the consortium, bringing together expertise in vaccines, adjuvants, as well as canine and non-human primate vaccination to predict the performance in patients.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-02-25 14:26:382020-03-03 14:29:47EUROSTARS grant for vaccine against breast cancer← #nieuws
Het AD zoomt in op de zoektocht naar “gereedschap” tegen COVID-19, het coronavirus dat al weken stad, land en nieuws beheerst. De beste instrumenten? Vaccins! Dankzij nieuwe technieken, vooruitgang in het dna-onderzoek en betere internationale samenwerking is de ontwikkeling van vaccins de afgelopen decennia enorm versneld. Toch is het nog steeds een tijdrovende, risicovolle en kostbare exercitie om tot een passend vaccin te komen. Wat HollandBIO betreft slaat de conclusie van het AD de spijker op zijn kop: “De derde uitbraak van een coronavirus in twee decennia zet wel druk op de ketel. Er zal meer tijd en geld moeten worden gestopt in de ontwikkeling van vaccins”.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-02-25 12:50:132023-09-27 16:31:09De marathon naar een COVID-19 vaccin← #nieuws
Sanofi plans to create a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API), which are the essential molecules responsible for the beneficial effects used in the composition of any drug. The project consists of creating a standalone company which would combine Sanofi’s API commercial and development activities with six of its European API production sites : Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).
With increasing medicine shortages that critically impact patient care, the new entity would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected to help in balancing the industry’s heavy reliance on API sourced from the Asian region3.
The new company would rank as the world’s second largest API company with approximately €1 billion in expected sales by 2022. It is expected to include 3,100 skilled employees and to be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.
Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said “Based on the expertise and experience built over decades within our industrial network, this new entity would help ensure a greater stability in supplying drugs to millions of patients in Europe and beyond. With this endeavor, this new entity would be agile as a standalone company, and able to unlock its growth potential, especially in capturing new third-party sales and all the opportunities of a market growing at a pace of 6 % per year4.”
By operating independently, the new entity plans to increase its sales to third parties and to expand its partnerships with other pharmaceutical companies in order to take advantage of new growth opportunities and have the ability to deftly adapt to customer needs. The new company would be uniquely positioned to benefit from its significant competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as leveraging an extensive commercial network covering more than 80 countries.
Sanofi is fully committed to the new company’s success and intends to establish a long-term customer relationship with the new API supplier and to hold a minority stake of approximately 30% in the new company. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities, and is committed to remaining an important customer.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-02-24 15:08:032020-02-25 15:14:57Sanofi to create new industry leading European company to provide active pharmaceutical ingredients← #nieuws
DSM, a global science-based company in Nutrition, Health and Sustainable Living, today announces that it has reached agreement to acquire Glycom, the world’s leading supplier of Human Milk Oligosaccharides (HMO) for an enterprise value of €765 million. This transaction represents an EV/EBITDA multiple of 20.6x based on the 2019 reported EBITDA, and around 15x based on the estimated 2021 EBITDA.
HMOs are a collection of carbohydrate structures found in human breast milk. They act as prebiotics in infants, which help to develop the desired microbial flora by serving as feed for the good bacteria in the intestine. HMOs are essential for both immune and cognitive development.
Glycom is a Danish company with more than 150 employees, founded in 2005, that pioneered the development and commercialization of HMOs for Early Life Nutrition applications. The company operates a state-of-the-art manufacturing plant in Esbjerg (Denmark) and is the only fully-integrated HMO provider in the world with its own product development, preclinical and clinical development, regulatory and large-scale production with an exciting innovation roadmap for next-generation HMOs. The company achieved €74 million of sales in 2019. These sales were pre-dominantly generated with Nestlé and Nestlé will continue to be an important customer in the future. The Nestlé contract is a mutually beneficial long-term contract with firmly committed volumes also covering the mid-term horizon.
DSM is a leading global solutions supplier to the Early Life Nutrition industry with its unique portfolio of, for example, nutritional lipids, vitamins and nutrient premixes. With the acquisition of Glycom, DSM adds HMOs to its portfolio, a novel high-growth ingredient for next generation Early Life Nutrition solutions.
This acquisition by DSM will be highly synergetic for both companies. DSM can accelerate the growth of Glycom by offering HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Early Life Nutrition customers. DSM can accelerate the HMO product development of Glycom by leveraging its strong R&D platform and clinical competencies to support Glycom’s development of next generation HMOs. DSM can furthermore introduce HMOs in other segments outside the Early Life Nutrition market, for instance for toddlers, children and adults, as well as in the medical nutrition and the pet food segments, creating additional growth potential.
Geraldine Matchett and Dimitri de Vreeze Co-CEOs of Royal DSM, commented: “We are looking forward to welcoming Glycom to DSM. Our companies have a great fit together, with a shared passion for purpose-led and science-based solutions in Nutrition & Health. This acquisition is an attractive and logical next step for DSM enabling us to provide our customers with innovative Early Life Nutrition solutions in our Human Nutrition business.”
Odd Hansen, CEO of Glycom, added: “We are excited to join DSM. This not only enables us to accelerate the growth of Glycom by adding our HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Infant Nutrition customers, it also creates leverage with DSM’s strong R&D platform and clinical competencies to support development of Glycom’s next generation HMO’s. DSM is a real great home for Glycom to reach its full potential”.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2020-02-21 12:52:402020-02-25 12:54:25DSM to acquire Glycom to accelerate growth in Early Life Nutrition
Clinerion and iClusion partner to boost the identification and recruitment of more patients into clinical trials
InnovatieklimaatClinerion’s Patient Network Explorer and iClusion’s Trial Eye platforms both connect clinical trial sponsors with networks of partner hospitals, giving trial managers the ability to include eligible patients for trials more quickly and efficiently than before. Treating physicians and patients benefit from increased treatment options and quicker access to new medical interventions.
Together, the partners’ joint mission is to increase patient participation in studies to its full potential by optimizing protocol design, enabling study sites to efficiently start up their trials locally and plan and meet realistic patient recruitment and therefore total timeline targets.
This new clinical trial optimization partnership also facilitates a total study site network activation for all trials, beyond the study sites already chosen to participate, by facilitating online referral and activation services.
iClusion makes clinical research accessible for physicians and their patients by connecting sponsors and their research protocols with research sites. Connecting all stakeholders and automating standardized local approval procedures in one networked platform accelerates total study timelines and makes innovative products available to more patients faster.
Clinerion makes real-world patient data accessible for analysis so that study protocols can be optimized with real patients in mind and real-world patient data can drive study feasibility and patient recruitment.
Both iClusion and Clinerion maintain cloud platforms which bring together participants from across the clinical study ecosystem, comprising sponsors, hospitals and clinicians, and treating physicians and patients. However, the partners offer complementary support and solutions throughout the product development process.
“Never in history has the R&D engine in pharmaceuticals been more productive, driving a pool of promising new agents,” says Edwin Klumper, CEO of iClusion. “The growing pipeline of targeted and personalized medicines puts tremendous pressure on more trials to be conducted in smaller, more well-defined patient populations. As a result, patient recruitment has become the bottleneck, nowadays, which is delaying progress and withholding many patients from the benefits of participation. I am pleased that Clinerion and iClusion are partnering to start tackling the identification and recruitment of the right patients into the right studies to bolster trial conduct and innovation.”
“Our collaboration re-emphasizes that patients are at the heart of clinical development and clinical trial conduct,” says Ian Rentsch, CEO of Clinerion. “Our combined services cover trials operations from protocol design through operational feasibility, site selection, local approvals, startup of study sites and patient recruitment. This partnership is therefore ideally positioned to optimize and advance protocols faster, reach more study sites and offer more patients the possibility to participate in research.”
Source: iClusion (press release)
iOnctura Announces First Patient Dosed
GezondheidiOnctura, a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis, has dosed the first patient in a first-in-human dose escalation and expansion study evaluating the safety and preliminary efficacy of its lead programme IOA-244, which is being developed as a novel targeted therapy for solid tumours.
The phase I study will enrol approximately 60 patients with solid tumours that overexpress PI3Kδ and are burdened by immune cells of the suppressor phenotype that are sensitive to PI3Kδ inhibition. The dose escalation part of the study will evaluate the safety, tolerability and pharmacokinetic profile of IOA-244 and is being led by principal investigators Professor Evans from the Beatson West of Scotland Cancer Centre and University of Glasgow, and Professor Maio from the University Hospital of Siena. Results from the phase I study are expected in early 2021.
Michael Lahn, Chief Medical Officer of iOnctura, commented: “Our mission is to achieve true precision medicine that optimally treats patients according to the root causes of their disease. The start of this trial represents an important milestone for iOnctura to clinically demonstrate that highly selective PI3Kδ inhibition not only drives an immune-mediated response but also a direct anti-tumoural effect in a stratified patient population across multiple solid tumour indications. This study will generate important insights into IOA-244, and its potential to provide meaningful and lasting clinical benefit for patients with cancer. We are very pleased to collaborate with Professor Evans and Professor Maio on this significant first-in-human dose escalation study. We look forward to continuing our evolution into a leading biopharmaceutical company with a diverse and sustainable pipeline in cancer and fibrosis.”
Professor Maio, Department of Medical Oncology, University Hospital of Siena, Italy said: “We are excited to participate in iOnctura’s first-in-human study. iOnctura’s innovative and differentiated approach has the potential to offer new, advanced treatment options to cancer patients and we are looking forward to evaluating this promising and unique target.”
Commenting on the study, recently appointed Clinical Advisory Board member, Dr. Jordi Rodón Ahnert, Clinical co-director, MD Anderson Cancer Center, added: “The design of the clinical trial is novel because it is going to investigate patients with expected high PI3Kδ expression and immune suppression both of which are underlying causes of treatment resistance in many solid tumours. iOnctura’s novel compound, IOA-244, could be critically important for the treatment of solid tumours that are burdened with an immune-suppressive tumour microenvironment.”
Source: iOnctura
Apply now for the BIO Start-Up Stadium
InnovatieklimaatStart-Up Stadium is a platform, organized at the BIO International Convention, that provides early-stage emerging companies exposure to key investors, venture philanthropy groups, strategic partners, and non-dilutive capitalists. During Start-Up Stadium, 50 selected companies have the opportunity to share their technology and value proposition to an audience of investors, analysts and strategists from across the value chain providing companies feedback and Q&A.
By participating in Start-Up Stadium, companies benefit from the exposure to investors, discounted registration fees, and complimentary access to BIO One-on-One Partnering.
Which companies can apply for Start-Up Stadium?
Companies that have:
The application deadline is 27th of March and you can apply here. You can find out more about the program of Start-Up Stadium and find the pitch presentation guide via the same application link!
Twee nieuwe ROM’s in ontwikkeling
IJzersterk innovatieklimaat, InnovatieklimaatNederland is straks twee nieuwe regionale ontwikkelingsmaatschappijen (ROM’s) rijker. Staatssecretaris Mona Keijzer van het ministerie van EZK maakte op 20 februari bekend dat er in Utrecht en Flevoland ook ROM’s zullen worden opgezet. Hierdoor ontstaat een stelsel dat heel Nederland dekt.
Net zoals bij de andere ROM’s zal naast provincies, gemeentes en andere entiteiten, ook de Rijksoverheid een belang nemen in de fondsen. Het startkapitaal voor Flevoland komt daarbij neer op €16 miljoen en zal voor Utrecht €22 miljoen bedragen. Dit kapitaal zal worden aangewend voor het uitvoeren van acquisitie, business development en ondernemersfinanciering in de regio. Ondernemersfinanciering zal voornamelijk worden verstrekt als risicodragend kapitaal aan startende en innovatieve MKB’ers.
Meer informatie en een uitgebreid overzicht van de structuur van de ROM’s vind je hier terug in de Kamerbrief ‘Oprichting ROM’s in Utrecht en Flevoland’.
#zeldzameziektendag #rarediseaseday
Hollandbio, Gezondheid, UitgelichtDe internationale Zeldzameziektendag viel dit jaar op de zeldzaamste dag van het jaar: 29 februari. Op deze dag wordt er wereldwijd aandacht gevraagd voor de uitdagingen voor zeldzame aandoeningen. HollandBIO zet een selectie van interessante artikelen en ontwikkelingen rond deze dag voor je op een rij.
In Nederland organiseerde de VSOP de bijeenkomst ‘Zeldzaam – Samen Sterker’ ter inspiratie en kennisuitwisseling. De potentie van nieuwe behandelingen (zoals gentherapieën) en slimmer meten testen kwamen aan bod in de presentatie van Martina Cornel (hoogleraar community genetics & public health genomics, Amsterdam UMC).
Ook diverse media vroegen afgelopen weekend aandacht voor zeldzame aandoeningen. Zo was er de speciale commerciële bijlage bij Trouw waarin patiënten en zorgprofessionals hun ervaringen delen; een gesprek met Cees Smit (hemofilie patiënt) en Connie Stumpel (hoofd van de Polikliniek Klinische Genetica van het Maastricht UMC+) op NPOradio1 over Rare Disease Day; een hoopvol item in de Volkskrant en op het Youtube kanaal van Duchenne Parent Project over de opening van het Dutch Center for RNA Therapeutics voor de behandeling van zeer zeldzame ziekten en de publicatie van de campagne Zeldzame Ziekten van Mediaplanet als bijlage in De Telegraaf. In deze special komen artsen, patiënten en hun naasten aan het woord over verschillende zeldzame aandoeningen zoals galwegkanker, pulmonale arteriële hypertensie, neuroblastoom en bijnierschorsinsufficiëntie. Voor het voorwoord van deze special werd HollandBIO’s Annemiek geïnterviewd over de hordes op het pad van lab naar patiënt.
Weesgeneesmiddelen zijn de innovatieve kraamkamer van de life sciences sector. Baanbrekende nieuwe behandelingen bewijzen zich doorgaans als eerste in het zeldzame ziektedomein, voor ze breder toegepast worden. Dankzij onze toenemende kennis van de biologische processen die ten grondslag liggen aan ziekte, is de life sciences sector steeds beter in staat geneesmiddelen en therapieën te ontwikkelen die aansluiten op de individuele behandelbehoefte van de patiënt. Maar we zijn er nog lang niet. Wereldwijd zijn er nu ruim 100 weesgeneesmiddelen. Het aantal zeldzame zieken ligt tussen de 6000 en 8000. Willen we iedereen die ziek is van een effectieve behandeling voorzien, dan moet de ontwikkeling én inzet van (wees)geneesmiddelen sneller en beter, want op dit moment valt de stijging van de uitgaven aan weesgeneesmiddelen nog vies tegen.
HollandBIO richt zich vol enthousiasme op het wegruimen van de obstakels die het succes van deze innovatieve koplopers in de weg staan, zodat het wenkend perspectief van personalized medicine en behandelingen voor veel meer zeldzame ziekten een stap dichterbij komt.
Een alledaagse darmbacterie produceert een carcinogeen
GezondheidKanker veroorzakende mutaties in het DNA kunnen het gevolg zijn van een alledaagse darmbacterie die veel mensen bij zich dragen. Onderzoekers van het Hubrecht Institute (KNAW) en het Prinses Máxima Centrum in Utrecht toonden dit aan. Zij stelden in het laboratorium gekweekte menselijke minidarmen bloot aan een variant van de bacterie Escherichia Coli en zagen dat deze bacterie een uniek patroon van DNA veranderingen achterliet in de cellen. Dit exacte patroon vonden de onderzoekers ook terug in het DNA van mensen met darmkanker, wat impliceert dat de mutaties veroorzaakt zijn door de ‘slechte’ bacteriën. Het is de eerste keer dat wetenschappers een direct verband leggen tussen onze darmflora en DNA-afwijkingen die kanker kunnen veroorzaken. Deze ontdekking maakt de weg vrij naar potentiële preventiemaatregels voor dikkedarmkanker door het verwijderen van de schadelijke bacteriën. De onderzoekers publiceerden de resultaten in het vakblad Nature op 27 februari.
Lees verder over dit onderzoek in het nieuwsbericht van het Hubrecht instituut.
Zie ook:
EUROSTARS grant for vaccine against breast cancer
InnovatieklimaatA consortium of Danish and Dutch research organisations led by AdaptVac ApS has been awarded a EUROSTARS grant for the further development of the AV001 vaccine against breast cancer. The combination of state-of-the art technologies revealed a highly immunogenic vaccine against human epidermal growth factor receptor 2 (HER2) expressed by cancer cells.
With the support of EUROSTARS, we will be able to prove safety and immunogenicity in different in vivo models, finalize the production process and prepare for further clinical development. The envisaged vaccine could be an effective tool in the treatment of patients and in the delay of recurrence. The consortium consists of AdaptVac, ExpreSion Biotechnologies, and University of Copenhagen (Denmark), and LiteVax BV and the Biomedical Primate Research Centre (the Netherlands).
Breast cancer affects more than 1.3 million worldwide annually, resulting in more than 450,000 deaths. Today, the most common treatment is based on monoclonal antibodies against HER2. Such passive immunization has some clear-cut limitations and therefore we developed a vaccine that activates patient’s own immune system to destroy HER+ cancer cells. By combining technologies from AdaptVac, xpreSion Biotechnologies and LiteVax BV, the prototype vaccine generated strong immune responses in different animal models. In this project, we will further prove safety and immunogenicity, finalize the production processes and prepare for clinical development.
“We are particularly pleased by the strength of the consortium, bringing together expertise in vaccines, adjuvants, as well as canine and non-human primate vaccination to predict the performance in patients.
Source: Litevax
De marathon naar een COVID-19 vaccin
Gezondheid op maat, Hollandbio, UitgelichtHet AD zoomt in op de zoektocht naar “gereedschap” tegen COVID-19, het coronavirus dat al weken stad, land en nieuws beheerst. De beste instrumenten? Vaccins! Dankzij nieuwe technieken, vooruitgang in het dna-onderzoek en betere internationale samenwerking is de ontwikkeling van vaccins de afgelopen decennia enorm versneld. Toch is het nog steeds een tijdrovende, risicovolle en kostbare exercitie om tot een passend vaccin te komen. Wat HollandBIO betreft slaat de conclusie van het AD de spijker op zijn kop: “De derde uitbraak van een coronavirus in twee decennia zet wel druk op de ketel. Er zal meer tijd en geld moeten worden gestopt in de ontwikkeling van vaccins”.
Het AD artikel lees je hier
Sanofi to create new industry leading European company to provide active pharmaceutical ingredients
Hollandbio, InnovatieklimaatSanofi plans to create a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API), which are the essential molecules responsible for the beneficial effects used in the composition of any drug. The project consists of creating a standalone company which would combine Sanofi’s API commercial and development activities with six of its European API production sites : Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).
With increasing medicine shortages that critically impact patient care, the new entity would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected to help in balancing the industry’s heavy reliance on API sourced from the Asian region3.
The new company would rank as the world’s second largest API company with approximately €1 billion in expected sales by 2022. It is expected to include 3,100 skilled employees and to be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.
Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said “Based on the expertise and experience built over decades within our industrial network, this new entity would help ensure a greater stability in supplying drugs to millions of patients in Europe and beyond. With this endeavor, this new entity would be agile as a standalone company, and able to unlock its growth potential, especially in capturing new third-party sales and all the opportunities of a market growing at a pace of 6 % per year4.”
By operating independently, the new entity plans to increase its sales to third parties and to expand its partnerships with other pharmaceutical companies in order to take advantage of new growth opportunities and have the ability to deftly adapt to customer needs. The new company would be uniquely positioned to benefit from its significant competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as leveraging an extensive commercial network covering more than 80 countries.
Sanofi is fully committed to the new company’s success and intends to establish a long-term customer relationship with the new API supplier and to hold a minority stake of approximately 30% in the new company. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities, and is committed to remaining an important customer.
Source: Sanofi (press release)
DSM to acquire Glycom to accelerate growth in Early Life Nutrition
Voedsel en materialen, InnovatieklimaatDSM, a global science-based company in Nutrition, Health and Sustainable Living, today announces that it has reached agreement to acquire Glycom, the world’s leading supplier of Human Milk Oligosaccharides (HMO) for an enterprise value of €765 million. This transaction represents an EV/EBITDA multiple of 20.6x based on the 2019 reported EBITDA, and around 15x based on the estimated 2021 EBITDA.
HMOs are a collection of carbohydrate structures found in human breast milk. They act as prebiotics in infants, which help to develop the desired microbial flora by serving as feed for the good bacteria in the intestine. HMOs are essential for both immune and cognitive development.
Glycom is a Danish company with more than 150 employees, founded in 2005, that pioneered the development and commercialization of HMOs for Early Life Nutrition applications. The company operates a state-of-the-art manufacturing plant in Esbjerg (Denmark) and is the only fully-integrated HMO provider in the world with its own product development, preclinical and clinical development, regulatory and large-scale production with an exciting innovation roadmap for next-generation HMOs. The company achieved €74 million of sales in 2019. These sales were pre-dominantly generated with Nestlé and Nestlé will continue to be an important customer in the future. The Nestlé contract is a mutually beneficial long-term contract with firmly committed volumes also covering the mid-term horizon.
DSM is a leading global solutions supplier to the Early Life Nutrition industry with its unique portfolio of, for example, nutritional lipids, vitamins and nutrient premixes. With the acquisition of Glycom, DSM adds HMOs to its portfolio, a novel high-growth ingredient for next generation Early Life Nutrition solutions.
This acquisition by DSM will be highly synergetic for both companies. DSM can accelerate the growth of Glycom by offering HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Early Life Nutrition customers. DSM can accelerate the HMO product development of Glycom by leveraging its strong R&D platform and clinical competencies to support Glycom’s development of next generation HMOs. DSM can furthermore introduce HMOs in other segments outside the Early Life Nutrition market, for instance for toddlers, children and adults, as well as in the medical nutrition and the pet food segments, creating additional growth potential.
Geraldine Matchett and Dimitri de Vreeze Co-CEOs of Royal DSM, commented: “We are looking forward to welcoming Glycom to DSM. Our companies have a great fit together, with a shared passion for purpose-led and science-based solutions in Nutrition & Health. This acquisition is an attractive and logical next step for DSM enabling us to provide our customers with innovative Early Life Nutrition solutions in our Human Nutrition business.”
Odd Hansen, CEO of Glycom, added: “We are excited to join DSM. This not only enables us to accelerate the growth of Glycom by adding our HMO products to DSM’s broad global customer base and integrate it in its full solutions offering for Infant Nutrition customers, it also creates leverage with DSM’s strong R&D platform and clinical competencies to support development of Glycom’s next generation HMO’s. DSM is a real great home for Glycom to reach its full potential”.
The transaction is expected to close in Q2 2020.
Source: DSM