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HUB schittert in het FD

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Naar aanleiding van de recent aangekondigde samenwerking met Crown Bioscience, schittert het Hubrecht Organoid Technology (HUB) in het FD. Het Utrechtse onderzoeksinstituut en het internationale biotechbedrijf bundelen de krachten om ontwikkeling van HUBs organoïde technologie te versnellen. Het Hubrecht Laboratorium ontdekte een technologie om stamcellen van patiënten op te kweken tot mini-orgaantjes. “In feite hebben we een patiënt in een petrischaaltje”, aldus HUB directeur Rob Vries in het FD. De mini-orgaantjes, of organoids, kunnen een revolutie ontketenen in ontwikkeling van geneesmiddelen en in de inzet van geneesmiddelen in de kliniek. Een fantastische mogelijkheid om de route van lab naar patiënt te versnellen en te verbeteren.

De overeenkomst tussen Crown Bioscience en HUB geeft niet alleen de ontwikkeling en validatie van technologie een impuls, maar ook aan de Nederlandse life sciences sector: Crown Bioscience concentreert als onderdeel van de samenwerking zijn Europese activiteiten in Utrecht.

Het volledige FD artikel lees je hier. (login verplicht)

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Leading Dutch alliance in biochip development: Qurin Diagnostics and LioniX International acquire Surfix

As of April 15, 2019, Qurin Diagnostics and Lionix International have acquired Surfix. As a supplier of custom-made nanocoatings, the capabilities of Surfix are highly complementary to the products and services offered by Qurin and LioniX International. The companies are already working together closely on early cancer detection and have realized a sensitive biochip, bringing together their respective complementary technologies for this purpose. This acquisition strengthens their relationship and mutual commitment towards bringing this technology to the global biomedical market.

Molecular (“DNA”) diagnostics hold great promise for early diagnosis and personalized medicine and has clear clinical added value. Nevertheless, market penetration falls short of expectations, as the costs of current diagnostic platforms are too high. Currently available diagnostic platforms based on Polymerase Chain Reaction and Next Generation Sequencing are very expensive, time consuming, and require extensive infrastructure and highly skilled personnel. A breakthrough is needed for the desired mass implementation of molecular diagnostics to revolutionize medicine.

Qurin has the goal to realize a diagnostic test platform that will overcome these limitations for the early detection and monitoring of cancer, using urine as a liquid biopsy. This platform uses the biophotonic sensor technology developed by Lionix International and the nanocoatings of Surfix. With this acquisition, Qurin and LioniX International strengthen their technology position by adding Surfix’s biofunctionalization technology to their portfolio.

‘With Qurin and Lionix International, Surfix gets strong strategic partners to collaboratively achieve our goals and enable further growth and development of the company’, said Luc Scheres, CEO of Surfix. ‘This acquisition fits with our technical and commercial strategy, since it strengthens our focus and accelerates the development and commercialization of our nanocoating technologies.’

According to Qurin’s CEO Coenraad K. van Kalken, MD, PhD, Surfix’s advanced nanocoating technology, almost literally represent the necessary chemical “glue” between the globally recognized nanophysics technology of Lionix and oncological diagnostic expertise of Qurin. An effective and stimulating collaboration has been established with Dutch industrial and academic partners leading this international field, enjoying increasing recognition and support.

‘This acquisition further strengthens the position of LioniX International as a vertical integrated supplier in the bio-photonic sensing market, since the technology of Surfix also enables the offering of surface functionalization for biological applications in the modules we develop for our customers, the novel biochip is broadly applicable in Medical and other global fields requiring low-threshold sensitive biodiagnostics’, said Hans van den Vlekkert, CEO of LioniX International.

Source: Surfix

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Kiadis to acquire CytoSen Therapeutics

Kiadis Pharma has entered a definitive agreement to acquire US-based CytoSen Therapeutics, subject to Kiadis’ shareholder approval and customary closing conditions.

Privately held CytoSen has developed a proprietary natural killer (NK)-cell platform to enable NK-cell therapy with broad anti-cancer potential. It was founded on technology exclusively licensed from the University of Central Florida (UCF) and further developed at Nationwide Children’s Hospital (NCH). The company’s founders, including Dean Lee, Stefan Ciurea and Robert Igarashi, are leading physicians and scientists at NCH, MDACC and UCF, respectively. Following the transaction, Dr. Carl June, a pioneer in the development of CAR T-cell therapy and current scientific advisor to CytoSen, will join Kiadis’ Scientific Advisory Board.

The transaction creates a leader in cell-based cancer immunotherapy. The combined company has a complementary development pipeline focused on improving outcomes for patients undergoing hematopoietic stem cell transplants (HSCT). Kiadis’ lead T-cell product ATIR101 is in EU registration and a global Phase 3 clinical trial;  CytoSen’s lead NK-cell product candidate, CSDT002-NK, building on promising clinical proof-of-concept studies in 25 patients carried out at MD Anderson Cancer Center, is expected to enter the clinic in the US in 2020. The unique combination of proprietary and synergistic NK-cell and T-cell therapy platforms has the potential to revolutionize HSCT and enables Kiadis to create a pipeline with novel cancer treatments.

Arthur Lahr, CEO of Kiadis commented: “Our vision is to leverage the strengths of the human immune system to help patients with life-threatening diseases. With the addition of CytoSen, we can create cell therapy treatments that combine the innate and adaptive arms of the immune system. The ATIR T-cell and CSDT002-NK-cell programs each have the potential to make transplants safer and more effective. In combination, they have the potential to revolutionize HSCT, making it suitable for an even wider group of patients. This transaction will transform Kiadis into a unique company with two synergistic proprietary cell-based immunotherapy platforms and the opportunity to create a pipeline of innovative treatments for cancer patients.”

Carl H. June, MD, Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, commented: “NK-cell therapy could significantly advance the field of immuno-oncology. Also, I believe the fields of NK-cells and T-cells are enormously synergistic and the combination could potentially help patients with devastating diseases. I am pleased to be joining the Scientific Advisory Board of Kiadis.”

Dean A. Lee, MD, PhD, co-founder of CytoSen and director of the Cellular Therapy and Cancer Immunology Program at Nationwide Children’s Hospital (NCH), commented: “CytoSen has the most advanced NK-cell technology to enable NK-cell therapy with broad anti-cancer potential. The strong experience, infrastructure, and competencies of Kiadis in cell therapy will accelerate our delivery of NK-cells to patients, and the new opportunities for exploring NK-cell and T-cell synergies will enable disruptive innovation in the cell therapy space. I am excited to collaborate with Kiadis to bring this innovation to patients.”  

NK-cells are one of the body’s first lines of immunological defense with an innate ability to rapidly and selectively destroy abnormal cells, such as cancer or virally-infected cells. Advancing research into the biology of NK-cells, as well as emerging early-stage clinical evidence, has increasingly shown that NK-cell immunotherapy has the potential to be at the forefront of cancer immunotherapy. CytoSen’s patented nanoparticle processing technology enables improved ex vivo expansion and activation of NK-cells supporting multiple high dose infusions with potent anti-cancer cytotoxicity.

CytoSen’s lead program, CSTD002-NK in HSCT, is built on proof-of-concept studies in 25 patients carried out at MDACC. First results of these studies demonstrated a relapse rate of 8% and progression-free survival (PFS) of 66% (published in Blood[1], with follow up data presented at the American Society of Hematology (ASH) annual meeting in 2018). The upcoming clinical study with CSDT002-NK, expected to start in 2020, has been designed with and will be supported by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The study will enroll high-risk acute myeloid leukemia (AML) patients undergoing a haploidentical HSCT at a consortium of leading US transplant centers in the BMT CTN network. Additionally, CytoSen’s NK-cell therapy will be investigated for other cancer treatments based on an 8-patient proof-of-concept study conducted at MDACC in refractory AML.

Source: Kiadis Pharma

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Dutch Biotech Event 2019 – registration now open

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HollandBIO’s Dutch Biotech Event will return to Maarssen on Friday June 28. Whether you’re working at a biotech startup, scale-up, runner-up or an established multinational, you do not want to miss out on this event. Be inspired by biotech’s bright innovation perspective, learn from leading biotech entrepreneurs, meet experts to boost your company’s performance, and upgrade your personal and professional skills during one of the hands-on workshops. We are proud to announce our first keynote speakers: Arie Belldegrun (Executive Chairman and Co-Founder of Allogene) and John Haurum (multi board member and former CEO of F-Star Biotechnology). Click here for all information about the Dutch Biotech Event.

Be sure to expect a great line-up of biotech entrepreneurs and interactive workshops. Of course, the program offers plenty of opportunity to catch up with your peers. The Dutch Biotech Event welcomes biotech companies of all sizes, from start-ups to multinationals. Click here to reserve your seat right now.

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Louise Fresco in Raad van Bestuur van Syngenta

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Na de jaarlijkse algemene vergadering van aandeelhouders op vrijdag 12 april werd aangekondigd dat Louise O. Fresco als onafhankelijk niet-uitvoerend bestuurder toetreedt tot de Raad van Bestuur, met ingang van april 12 2019 .

Fresco is momenteel voorzitter van de Raad van Bestuur van Wageningen University & Research in Nederland. Ze combineert een lange academische carrière als hoogleraar aan zowel universiteiten in Wageningen als Amsterdam met een uitgebreide betrokkenheid bij beleid en ontwikkeling in Afrika, Azië en Latijns-Amerika.

“We zijn zeer verheugd dat Louise lid is geworden van het Syngenta-bestuur”, aldus Frank Ning, voorzitter van Syngenta. “Haar ervaring en expertise in duurzame, gezonde voedselproductie, samen met haar vermogen om mensen te betrekken bij de voordelen van de wetenschap en landbouw worden zeer gewaardeerd. “

Deze benoeming komt slechts enkele dagen nadat Syngenta aangekondigde dat het innovatie gaat versnellen om de toenemende uitdagingen voor boeren over de hele wereld, waaronder de klimaatverandering, bodemerosie en biodiversiteitsverlies aan te pakken, en in te spelen op veranderende verwachtingen van consumenten en opvattingen over landbouwtechnologie. Syngenta heeft deze toezegging gedaan in reactie op luistersessies eind 2018. Hieruit kwam een duidelijke oproep voor innovatie en meer actie om deze uitdagingen aan te gaan.

“Deelnemen aan het bestuur geeft mij de kans om te werken aan het verduurzamen van de voedselproductie en het verminderen van de impact op het milieu op basis van de meest recente wetenschappelijke inzichten”, aldus Fresco. “Ik ben vooral geïnteresseerd in hoe de beste wetenschap kleine boeren kan helpen hun opbrengsten duurzaam te verhogen.”

Fresco bracht 10 jaar van haar carrière door als adjunct-directeur-generaal van de Voedsel- en Landbouworganisatie van de VN. Ze is lid van acht wetenschappelijke academies en heeft in de raden van bestuur van de Rabobank en Unilever gediend. Haar boek “Hamburgers in het paradijs, voedsel in tijden van schaarste en overvloed,” is in 13 talen vertaald. Ze publiceerde meerdere boeken en schrijft een tweewekelijkse column in NRC. Ze heeft ook een 6-delige documentaire over voedsel en ontwikkeling voor de Nederlandse publieke omroep gepresenteerd en in 2009 was ze spreker op de TED-conferentie in Palm Springs, California.

Bron: Syngenta

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VitroScan closes funding round

VitroScan, developing tests to predict treatment outcome for cancer patients, has closed a round of seed funding for €800.000. Lead investor Libertatis Ergo Holding B.V. (LEH) will be welcomed as new board member. Pieter Geelen, TomTom founder and philanthropist, and co-founder of VitroScan also provides a major part of the funds in this round. VitroScan will use the proceeds to deliver Proof of Concept for application of its unique technology for treatment response prediction for cancer patients.

Suboptimal therapy responses for patients, unnecessary side effects, and high failure rates of clinical trials with cancer drugs, cause a high burden on the health care system. This emphasises the need for better selection of treatment for the individual patient, and more efficient drug development.

VitroScan’s unique technology platform combines automated 3D cell culture with high content 3D imaging and analysis in a robust platform that provides scalability without compromising precision of drug response analysis. A clinical trial program has been initiated with leading cancer hospitals in The Netherlands to establish the value of the technology for drug response prediction in selected cancers.  

Quote LEH: “Leiden University is very excited to support VitroScan’s ambition to develop solutions and optimize treatment for cancer patients, to build on the strong technical foundation between VitroScan and Leiden University and to support entrepreneurship on the Leiden Bio Science Park.” Quote Willemijn Vader, Managing Director VitroScan: “We are excited to welcome LEH in the board of VitroScan. LEH’s expertise will facilitate collaborations with the University Medical Centers, like LUMC and the Leiden Bio Science Park Community, and will be valuable to execute our strategy and achieve our goals.” 

Source: VitroScan

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Synaffix Announces $125m License Agreement with Shanghai Miracogen

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Synaffix, a Dutch biotechnology company exclusively focused on continued advancement of its clinical-stage antibody-drug conjugate (ADC) technology for the development of best-in-class ADCs, announces that it has entered into a license agreement with Shanghai Miracogen Inc., a Chinese biotechnology company with a clinical-stage pipeline of ADCs.

Under the terms of the agreement, Miracogen has been granted non-exclusive rights to Synaffix’s proprietary  GlycoConnect™ and HydraSpace™ ADC technologies for use in its next clinical candidate. Synaffix is eligible to receive upfront and potential milestone payments that total $125 million, plus royalties­­.

Miracogen will be responsible for the research, development, manufacturing and commercial-ization of the ADC product while Synaffix will be responsible for the manufacturing of components that are specifically related to its proprietary GlycoConnect™ and HydraSpace™ technologies.

This agreement follows a research collaboration between the two companies which was centered around a specific drug candidate that has now been selected for clinical development.

Mary Hu, Chairman and CEO of Miracogen, said:

“We are very pleased to have reached this license agreement with Synaffix. We believe that their GlycoConnect™ and HydraSpace™ technologies will further differentiate our pipeline of ADCs by delivering valuable expansion of the therapeutic index. Our efficient and collaborative relationship during the research phase has provided us with a highly competitive new asset for the Miracogen pipeline in just a five-month timeframe. We look forward to continuing our collaboration as we advance this candidate into the clinic and beyond to benefit cancer patients.”

Peter van de Sande, CEO of Synaffix, said:

“Working with Miracogen has been a rewarding experience. As we transition into the development phase together, this license agreement with Miracogen provides additional validation of our GlycoConnect™ and HydraSpace™ technologies.”

“There is a clear trend in China towards developing innovative products and as such, ADCs have emerged as a strong area of growth within the field of oncology. Our proprietary technologies can address the current unmet need for clinical candidates with an enhanced therapeutic index, thereby driving further growth of our activities in China and other markets.”

Source: Synaffix

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Call for Applications: EuropaBio’s Most Innovative European Biotech SME Awards 2019

EuropaBio, the European Association for Bioindustries, invites biotech start-ups and small and medium sized biotech companies (SMEs) across Europe to apply for the 10th edition of the Most Innovative European Biotech SME Award – a unique annual initiative recognising biotech innovation and its contribution to society. Depending on their field of activity, SMEs can apply in three categories: healthcare, agricultural or industrial biotech. Applications must be submitted online at biotechSMEawards.eu by COB Sunday 15 September 2019. Two companies will be shortlisted in each category by a Jury of biotech and SME experts, with the winners celebrated during a landmark event held in Brussels on the 6th November. Each winner will also receive €10,000 prize money and two years free EuropaBio membership (runners-up also receive the latter), in addition to European-level exposure and visibility as well as press coverage.

Recognising SME biotech innovation in Europe

The European Commission considers, small and medium-sized enterprises to be the backbone of Europe’s economy. They represent 90% of all businesses in the EU. Peter Heinrich, Chair of EuropaBio’s SME Platform highlights: ‘The majority of the most valuable innovation happens in SMEs, which then go on to form relationships with larger companies, paving the way for improved health, cleaner energy and better environment, for products and processes as well as a sustainable farming for Europe’s societies.’

Biotech exemplifies the way in which science and scientific breakthroughs can be applied to respond to some of society’s most difficult challenges. From new therapies that can address unmet medical needs, to industrial processes that use resources more efficiently, to drought-resistant crops that allow farmers to feed a growing population in unpredictable climatic conditions, biotechnology pays economic, societal and environmental dividends.

Tjerk de Ruiter, EuropaBio’s Chair and CEO, Corbion added ‘the diversity and quality of applications received in previous years demonstrate the entrepreneurial excellence of EU biotech SMEs. They are at the forefront of some critical innovation and are delivering solutions under challenging circumstances. Through these awards we recognise the vital breakthroughs they are making.’

The awards have become one of the highlights in the European biotech calendar, with over 250 SMEs competing since they were initiated. Their success stories can be read online at biotechSMEawards.eu.

The jury

The experts who are part of the jury are involved in biotech and understand the science, the funding realities and the regulatory and political frameworks in which European biotech SMEs operate. They appreciate the contribution that innovative SMEs will make to Europe’s future, and together, they will carefully analyse each application to select the final nominees. Past jury members included: Dame Anne Glover, Dr. Phillipe de Backer, MEP Dr. Paul Rübig, Prof. Dr. Andrew Porter, MEP Kay Swinburne, Jos Peeters and many more.

Criteria for entry

In order to be considered for the EuropaBio SME awards a company must qualify as an SME under the standard EU SME definition (e.g. primary location of operations within Europe, 250 or less employees, €50 Million or less annual turnover). EuropaBio will award companies and runners-up in 3 categories: healthcare, agricultural and industrial biotechnology. Thus, the candidate is eligible as a candidate if active in at least one of the three fields of biotechnology.

Deadline for applications

SMEs interested to enter the competition are invited to apply by 15th September 2019 on the awards website biotechSMEawards.eu.

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Europese top binnen handbereik voor biomedische start-ups

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Dat er verschillen zijn tussen het start-up landschap in Europa en de VS zal voor niemand een geheim zijn. Maar nooit eerder zijn de onderlinge verschillen tussen de Europese landen onderzocht. Een artikel in het april nummer van Nature Biotechnology illustreert de factoren die het succes van biomedische start-ups bepalen. Wat blijkt: lang niet alle landen zijn gelijkwaardig en Nederland schuurt op de verschillende factoren tegen Europese top aan. Het artikel geeft een aantal concrete aanknopingspunten om het innovatieklimaat verder te versterken en laat zien dat een plaats bij de Europese top haalbaar is.

Met het aantal biomedische start-up financieringsrondes als uitgangspunt, werd over een periode van vijf jaar gekeken naar de wetenschappelijke kwaliteit, biomedische patenten, aanwezigheid venture capital bedrijven en human capital. Met een vierde plaats voor wetenschappelijke output scoort Nederland ruim voldoende en ook voor het aantal VC-bedrijven doen we het met een derde plaats goed. Opvallend zijn de wat teleurstellende zesde plek als het gaat om biomedische patentaanvragen en de zesde plek op de Entrepreneurship Index. Overall staat Nederland in de middenmoot als het gaat om nieuwe biomedische start-ups.

Succesvol start-up ecosysteem

Uit de conclusies blijkt dat alle onderzochte factoren van significante invloed zijn op het aantal financieringsrondes. Wetenschappelijke output is daarbij doorslaggevend. Opvallend is dat Nederland ondanks de goede wetenschappelijke output achterblijft met het aantal start-ups deals. Gezien de huidige hoeveelheid start-ups, blijft ook het aantal VC in ons land achter. Willen we in Nederland een succesvol ecosysteem voor start-ups creëren, dan moeten we hier werk van maken.

Wat moet er beter?

Nederland weet biomedische kennis onvoldoende te verzilveren en om te zetten naar bedrijvigheid. De onderzoekers onderstrepen in het artikel het belang van een robuuste wetenschappelijke basis. Ze benadrukken dat beleidsmakers biomedisch onderzoek hoog op de agenda moeten blijven zetten. Maar voor een bloeiend start-up ecosysteem is er meer nodig, zoals toegang tot voldoende financiering. In Nederland kunnen initiatieven als Invest-NL het verschil maken. Door een brug te slaan tussen academische kennis en toegang tot financiering, kan Invest-NL mogelijk als vliegwiel dienen voor biomedische innovatie. Investeerders kunnen dan niet meer om Nederland heen, waarmee we het innovatieklimaat versterken en de Europese top binnen handbereik is. Het hele artikel lees je hier

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Update Modernisering Biotechnologiebeleid naar de Tweede Kamer

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Afgelopen week stuurde Staatssecretaris Van Veldhoven een update van de Modernisering van het Biotechnologiebeleid naar de Tweede Kamer. Naast een algemene update geeft de brief ook inzicht in de vervolgstappen om tot een modern biotechnologiebeleid te komen.

De Staatssecretaris geeft aan dat ze toe wil naar een beleid dat ruimte biedt aan de kansen van de biotechnologie voor een gezonde en duurzame samenleving. Uiteraard zonder daarbij de veiligheid uit het oog te verliezen. In 2018 zijn in samenwerking met stakeholders de bouwstenen voor een modern biotech beleid aangeleverd. De komende twee jaar wil de staatssecretaris deze samen met het veld verder concretiseren. Daarbij is er zowel aandacht voor korte termijn doelen, zoals optimalisatie van de uitvoeringspraktijk van de vergunningverlening in Nederland, als voor de langere termijn gericht op aanpassing van het Europees biotechnologiebeleid.

Daarnaast blijft Nederland zich in Brussel inzetten om de moderne veredelingsmethoden binnen handbereik van de Europese Agri-Food sector te krijgen. Modernisering van het huidige biotechnologiebeleid kan HollandBIO niet snel genoeg gaan. Als we in Nederland de vruchten willen plukken van de baanbrekende ontwikkelingen in de biotechnologie, zoals van cel- en gentherapie en plantenveredeling, is aanpassing van het nationale en Europese biotechnologiebeleid essentieel. HollandBIO is dan ook blij met het commitment van de Staatssecretaris en werkt graag mee om de mooie woorden in daden om te zetten.