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Giga-Gilead-boost voor Galapagos

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Gilead steekt maar liefst €4,5 miljard in de innovatiekracht van biotech parel Galapagos. De twee bedrijven maakten zondagavond een even unieke als omvangrijke deal bekend: een win-win samenwerking tussen de innovatiekracht van Galapagos en de wereldwijde infrastructuur, expertise en sterke kaspositie  van Gilead. De drug discovery en R&D programma’s van Galapagos krijgen dankzij de investering een enorme boost. Gilead bemachtigt op zijn beurt een exclusieve plek op de eerste rij om de moleculen van Galapagos door te ontwikkelen en te verkopen buiten Europa. Een fantastische klapper, die niet alleen een grote impact heeft op de twee bedrijven, maar ook op de Nederlandse biotech sector als geheel.

Galapagos ontvangt een upfront betaling van Gilead van €3,5 miljard. Daarnaast vergroot de Amerikaanse farmaceut zijn aandeel in het Nederlands-Belgische bedrijf met €1 miljard tot 22%. De looptijd van de samenwerking is tien jaar, wat Galapagos de tijd geeft om zijn droom te realiseren: uitgroeien tot een onafhankelijk Europees farmaceutisch concern. Met de deal op zak gaat Galapagos zijn R&D programma’s versnellen en uitbreiden.

HollandBIO’s Annemiek Verkamman ziet het goede nieuws als een bevestiging van de innovatiekracht en potentie van de life sciences-sector:

“Galapagos is een fantastisch rolmodel voor de vele kleinere biotech bedrijven in Nederland en daarbuiten. Het succes van Galapagos heeft een grote magneetwerking: op financiers, op talent en alle mogelijke toeleveranciers van biotech bedrijven. Daarmee is de samenwerking niet alleen goed nieuws voor Gilead en Galapagos, maar ook voor de groei en ontwikkeling van de hele Nederlandse life sciences sector.”

De lange weg van Galapagos tot een van de sterspelers van Europa laat eens te meer zien dat succes in de biotech een lange adem vergt: dit jaar viert het bedrijf zijn 20ste verjaardag. Het vinden van kapitaal is voor de groei van biotech bedrijven – naast de wetenschappelijke complexiteit – met stip de grootste uitdaging. Het financieringslandschap vertoont fikse gaten. Een uitgekiende financieringsmix voor biotech bedrijven in alle fases van ontwikkeling moet het huidige marktfalen aanpakken. Invest-Nl kan daar hopelijk aan bijdragen. De nationale investeringsinstelling in oprichting heeft alles in zich om de gaten te dichten en door te investeren in biotech start-ups en scale-ups een brug te slaan tussen de publieke regelingen en private investeerders. Zo kan Invest-NL dienen als vliegwiel voor innovatie. Het succes van Galapagos laat zien waar het investeren in innovatieve biotech start-ups en scale-ups toe kan leiden. Daar kan Nederland er nog wel een paar van gebruiken, toch?

Lees meer

De fantastische samenwerking tussen Galapagos en Gilead krijgt – terecht – volop aandacht in de media. Een greep uit de berichtgeving:

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Ncardia Expands iPSC Manufacturing and Phenotypic Drug Discovery Services

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

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

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

Source: Ncardia

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Budget Klinisch Innovatiekrediet met €10 miljoen verhoogd

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Goed nieuws over het Innovatiekrediet: het budget voor 2019 voor klinische ontwikkelingsprojecten is met €10 miljoen verhoogd naar €40 miljoen. Het budget voor technische ontwikkelingsprojecten voor 2019 blijft €30 miljoen. De aankondiging verscheen op 7 juli in de Staatscourant, met de toelichting dat
hiermee wordt tegemoetgekomen aan de gestegen vraag naar innovatiekrediet voor klinische projecten. HollandBIO luidde meermaals de noodklok over het te krappe budget van dit voor de groei en ontwikkeling van life sciences-bedrijven cruciale krediet. Jaar in, jaar uit is het budget van het krediet al vroeg in het jaar overvraagd. Dankzij de verhoging is er nu voor zowel technische als klinische ontwikkelingsprojecten nog voldoende budget beschikbaar. Wil je dit jaar een aanvraag indienen? Kijk op de website van RVO voor meer informatie.

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SMS-oncology opens new office in Frankfurt, Germany

SMS-ONCOLOGY, a full-service clinical CRO solely dedicated to oncology, is pleased to announce the opening of a new office and the establishment or subsidiary company: SMS-oncology GmbH.

SMS-oncology, Europe’s leading oncology CRO, opened the doors of its new office in Frankfurt, Germany. SMS-oncology GmbH is ideally situated in one of the major oncology biotech hubs within Europe and in the vicinity of Frankfurt Airport. SMS-oncology operates in over 20 countries from its headquarters at Schiphol Airport in the Netherlands, and has established local presence in the Nordics, Spain and now Germany. The new office accommodates the growing team of oncology drug development specialists.

The new German entity SMS-oncology GmbH will be led by Managing Director Mr. Raymond Hoffmans, who has 15 years of experience in cancer research. After receiving his PhD from the University of Zurich (Switzerland), he joined the Dana Farber Cancer Institute in Boston (US) as a postdoctoral research fellow. In 2009, he returned to the Netherlands to join the Hubrecht Institute in Utrecht, before he moved to SMS oncology about 9 years ago. Since 2014, Raymond has been Chief Business Development Officer at SMS-oncology, a position he will combine with his new role of Managing Director of the GmbH.

Raymond: “We are very proud and pleased to announce the opening of our new office in Frankfurt. We experienced strong organic growth over the past years. The current opening of our GmbH office is the perfect next step in line with our business planning of international expansion.”

He continues: “The expansion will not only allow us to be closer to our clients and the medical sites we work with but will also allow us to provide more tailored solutions to the individual needs of our clients.”

Ms. Philine van den Tol, Chief Executive Officer of SMS oncology, said: “We are delighted to bring the company one step closer in achieving our ambitious goal of becoming the go-to oncology specialist CRO in the world. This is another step forward in our mission to excel in oncology trials for the benefit of our clients and cancer patients worldwide.”

SMS-oncology GmbH address:
De-Saint-Exupéry-Str. 10
60549 Frankfurt
Germany

Source: SMS-oncology

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Dutch Biotech Event 2019 celebrates the beauty of biotech

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The Dutch Biotech Event 2019 had it all: a great line-up, over 250 eager biotech professionals, a lovely venue and perfect weather.

During her opening speech, Annemiek Verkamman brought the festive news that HollandBIO welcomed its 200th member! Our growing member base strengthens us in our mission to maximize the contribution of biotech products to our society’s health and sustainability. And it shows that HollandBIO’s impact is bigger than ever. Of course, HollandBIO will continue what we do best: paving the way for biotech’s frontrunners by challenging the status quo.

A three decade journey in cell therapy – Arie Belldegrun

Arie Belldegrun, our first keynote speaker, took us on a dazzling, three-decade journey in cell therapy. Arie played an instrumental role in several of today’s frontrunners in biotech, such as Kite Pharma, bringing ground-breaking science from bench to bedside. And, as he is convinced that science drives innovation, Arie is always looking for the next revolution. Today, he serves as Executive Chairman & Co-Founder of Allogene Therapeutics. The company’s Allogenic CAR-T therapy may be the next big breakthrough, since more patients can be treated with engineered T-cells after a single manufacturing run. Although no one can predict the future, Arie firmly believes cell therapy holds great promise for cancer therapy. What is it that keeps him going after so many successes? It is the great fun along the way. No better way to conclude a fantastic story of a true biotech pioneer!

AmbAgon wins Venture Challenge Spring 2019

Chrétien Herben, Director at LifeSciences@Work, announced AmbAgon as the winner of the Venture Challenge Spring 2019 edition. The Venture Challenge is a 10-week programme to develop an initial idea – a breakthrough research result – into a solid business case. This edition’s winners AmbAgon aims to develop small-molecule therapeutics for breast cancer by augmenting the tumor-suppressing functions of the 14-3-3 protein. The prize includes a cheque worth €25.000.

Personal perspectives on a career in biotech – Tim Knotnerus

“It’s not about where you work, nor what you do, it’s who you work with.” And Tim Knotnerus, our second keynote speaker, worked with the best. After graduation, Tim joined Aescap, a VC fund established by Dinko Valerio. The experience to work with one of the pioneers of the Dutch biotech sector, sparked Tim’s ambition to pursue an entrepreneurial biotech career of his own. He continued his career at AM-Pharma. Together with CEO Erik van den Berg, he secured multiple funding rounds. An option to acquire deal with Pfizer was the cherry on the cake. The deal also paved the way for Tim’s next big leap in biotech: becoming CEO of AgomAb, a Belgium biotech start-up holding an exclusive license agreement from argenx. With € 21 million secured in a series A earlier this year, exciting times lie ahead for this ‘fourth-generation’ biotech star.

Lessons in leadership – John Haurum

Biotech owes its success to innovation. But how to create and sustain an innovative corporate culture? John Haurum’s keynote focused on the strong leadership it takes to pull that off. John’s former roles as CSO of Symphogen and CEO of F-Star not only made him an expert in the field of therapeutic antibodies, but also gave him hands-on experience in corporate cultures. As board member of a growing number of biotech companies, his knowledge is of great value to a new biotech generation. Guided by a Harvard Business Review article, John shared his vision on building an innovative biotech culture, stressing the apparent paradoxes involved: tolerance for failure but  intolerance for incompetence, willingness to experiment combined with rigorous discipline and collaboration that involves individual accountability. All in all, John’s presentation provided plenty of food for thought for both established as well as up-and-coming biotech leaders.

Break-out session – Critical communication

As our beautiful biotech sector is under bigger scrutiny than ever before, simply being good is no longer good enough. The need to be good and tell it, to speak up, to explain what you do and why you do it, is bigger than ever before. But in a seemingly post-fact era, and a debate driven by emotion, that might be easier said than done. Hugo van Rooijen (Janssen Pharmaceuticals) and Guus Scheefhals (DegenRx) shared their communicative views, ideas and experiences. From fact-checking as pharmacovigilance for politicians, to setting the right frame for a constructive discussion, and managing expectations among patients and other stakeholders. The session delivered a number of best practices to move forward. HollandBIO hopes the attendees will also practice what these biotech frontrunners preached!

Break-out session – Cell land gene therapy in the spotlight

Kite Pharma is one of the frontrunners in cell therapy, with the approval of Yescarta for treatment of certain types of non-Hodgkin lymphoma. At the same time, gene therapy is also booming! Guided by Kite’s Markwin Velders, two pioneering companies shared their experiences in the gene therapy world. Rudolf van Olden (Avexis) highlighted the development of Avexis’ Zolgensma, which got just approved by the FDA to treat children with SMA. The results of the initial clinical trials were spectacular, resulting in an ultra-short time to market. Thanks to the rapidly built production site, patients in the US are already being treated. Tjarda Kasteel from bluebird bio shared the fascinating story of Zynteglo, a one-time gene therapy for patients with ß-Thalassemia. Based on the exceptional clinical outcomes, Zynteglo saw a ultra-fast approval by the EMA. Because both Zynteglo and Zolgensma are ‘one time’ treatments challenging the status quo, both companies introduced correspondingly novel payment strategies. The impressive results so far make it more than justified that cell and gene therapy are in the spotlight right now.

Break-out session – Think different

During the workshop Think Different, biotech entrepreneurs Wim de Laat (BioscienZ) and Jos Seegers (MyMicroZoo) gave us a sneak peek of tomorrow’s food and how insights in your microbiome can help you make better lifestyle choices. Wim aims to serve a Christmas dinner with egg ingredients produced by fermentation of a fungus, which converts sugar from sugar beet, cane or grain into ovalbumin. If you are curious about the effect of a (G)Meal, or any other lifestyle intervention, on your microbiome, the MyMicroZoo poo-it-yourself-test from Jos will provide you with answers based on the most advanced DNA sequencing techniques. HollandBIO is already looking forward to our next teambuilding activity!

Break-out session – How to fund a biotech

A no now, doesn’t mean a no later. That was one of the lesson’s learned by Synaffix’ CEO Peter van de Sande. To secure funding to commercialize antibody-drug conjugates and build a technology platform company, Peter had to knock on many doors. You definitely need to be persistent, Xenikos CEO Ypke van Oosterhout added. Ypke’s dedication did pay-off: Xenikos closed a €30 million series B financing round last year. Edward van Weezel agreed as well. As a managing partner of venture fund BGV, he sees hundreds of projects every year. The overall success rate for companies is very low, only a few get an investment. It is worrisome that the Netherlands is losing its strong start-up position to other countries around the globe. Especially in the United States, huge amounts of risk capital is invested in very young start-ups, paving the way for growth. To stay on track, the Netherlands should invest more in innovative start-ups. Government and private investors have to work together, to bridge the gaps in the funding landscape. Until then, you had better take into account the panelists’ lessons learned: stay flexible and creative along the way, and always keep looking for solutions.

Fueled by the fascinating biotech stories and new insights, it was time to network while enjoying a refreshing drink and tasty BBQ. A great day to celebrate what biotech is all about: building a better world by combining top-notch science, true entrepreneurship and a lot of fun.

Be sure to mark the last Friday of June next year in your agenda. See you next year!

Photos by © Nils van Houts – 2019

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Citryll Completes First Closing of a € 15M Series A to Develop its NETosis Inhibiting Antibody

Citryll announced today the first closing of a targeted € 15 million investment round, funded by ModiQuest B.V., BOM Brabant Ventures, BrightGene, and Curie Capital. The proceeds will be used to progress the pre-clinical and clinical development of Citryll’s tACPA antibodies, inhibitors of neutrophil extracellular traps (NETs) and their formation (NETosis). tACPA interferes with the formation, function and clearance of NETs, but downstream of the peptidylarginine deiminase (PAD) dependant citrullination pathway. It does so by binding to N-terminal citrullinated epitopes in histones that are essential for NET formation.

 “We believe that drugs that interfere with NETs and their production have the potential to create game changing new treatments to prevent or treat human diseases. tACPA targets autoimmune and other diseases such as lupus, vasculitis, pulmonary fibrosis, rheumatoid arthritis and organ damage due to sepsis. Citryll’s approach does not broadly target inflammation or acquired immunity, instead it extinguishes the source of autoantigens and (NET)-derived toxic molecules in the safest way currently possible”, says CEO Helmuth van Es.

“We welcome the investment by this investor syndicate from the Netherlands and China, which will allow the development of Citryll’s antibody therapeutic for patients with significant medical needs”, says ModiQuest CEO, co-inventor of tACPA, Jos Raats.

“We are excited to be able to invest in Citryll as the company is an excellent example of a first in class therapeutic innovation that can have a strong impact on patients’ lives. An increasing amount of scientific data shows that NET formation plays a crucial role across various disease types, therefore we look forward to support the further development of tACPA”, says BOM Brabant Ventures Investment Manager Sjoerd van Gorp, speaking for the investor syndicate.

Source: Citryll

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Kiadis updates status of marketing authorization application for ATIR101

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Kiadis, a clinical-stage biopharmaceutical company, today announced that it has received feedback from the European Medicines Agency (EMA) related to the
marketing authorization application (MAA) seeking approval of ATIR101 in hematopoietic stem cell transplant (HSCT). As previously announced, Kiadis submitted responses to the second Day 180 list of outstanding issues for ATIR101 to EMA in May 2019.

As part of the review process, EMA today informed Kiadis that it will convene a Scientific Advisory Group (SAG) in September, comprising of experts in hematology and HSCT to assist EMA in arriving at a determination.

“We appreciate the feedback from EMA and look forward to continuing our interaction with them during the review of our MAA for ATIR101,” said Arthur Lahr, CEO, of Kiadis Pharma. “With the SAG meeting now preceding the subsequent CAT and CHMP meetings as part of the EMA approval process, we are changing our guidance to potential EU conditional approval in 2020.”

While initial launch in the EU is delayed, Kiadis is on track to complete enrollment in the Phase 3 ATIR101 HSCT study in 2021 to support potential marketing approval in the US. Additionally, the company is also on track to start the Phase 1/2 studies of CSDT002 in HSCT and relapse and refractory acute myeloid leukemia in 2020. With a novel cell-based cancer immunotherapy platform consisting of both T-cell and NK-cell technologies, Kiadis has the opportunity to potentially revolutionize transplants and develop novel cancer cell therapies.

Source: Kiadis Pharma

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The winner of the Venture Challenge Spring 2019 is AmbAgon

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First-in-class drugs through targeted stabilisation of protein complexes

During the Dutch Biotech Event where biotech companies of all sizes, from start-ups to scale-ups, meet and get inspired, the LifeSciences@Work Venture Challenge was annouced. This year’s winner of the Spring edition became AmbAgon. The Eindhoven-based start-up develops small-molecule therapeutics for breast cancer by augmenting the tumor-suppressing functions of the 14-3-3 protein.

According to the jury, led by Carine van den Brink, AmbAgon has a strong team that, with their unique combination of expertise, has discovered a new approach towards developing drugs for metastatic breast cancer. A ground breaking method that change the future of cancer patients and their therapy accurance.  

AmbAgon has developed small molecule screening technologies focused on discovering molecules that stabilize the direct interaction of oncogenic transcription factors with so-called 14-3-3 proteins, thereby inhibiting their pathological activities. This approach, to augment the endogenous tumor-suppressing functions of 14-3-3 within different breast cancer types with small molecule drugs, provides for a radically new entry. A method that has been long sought for by the pharmaceutical industry and which is urgently needed in the clinic. 

Luc Brunsveld, AmbAgon: “The Venture Challenge has been a fantastic learning experience for us. It brought us into contact with the Dutch biotech community. Winning this challenge is the absolute icing on the cake.”

The Venture Challenge Spring 2019 started in April this year and ended today at the Dutch Biotech Event, where AmbAgon takes home the €25.000 prize money to invest in their growth. The other highly-motivated participating teams were:  MissionMS, MULTISCREENING, Praxa Sense, and UFO Biosciences. Participating in the Venture Challenge leads to a clear venture plan, as well as to investor-ready pitches. The  LifeSciences@Work Accelerator  is powered by  Health~Holland, Top Sector Life Sciences & Health. 

Contact Luc Brunsveld for more information about AmbAgon.

Venture Challenge Fall 2019:
Call open! – Deadline: 5 September 2019

Our specialised coaching focuses on developing your initial idea into a solid business during a series of boot camps and 1-on-1 coaching and mentoring sessions. Startup teams learn to identify key risks, analyse customer value propositions, develop a validation strategy, learn to build a venture plan and, ultimately, get connected to Life Sciences experts, investors and seasoned entrepreneurs. 

Source: Health~Holland

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Trend analysis: bright future ahead for Dutch biotech

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Today, the leading global business development database Biotechgate presents its 2019 trend report for the Dutch life sciences market. The annual trend report shows that the Netherlands is on track to become a world leading life sciences cluster in 2030.

The total number of biotech companies is growing steadily to 470 in 2019. Oncology remains the most prominent therapeutic area, followed by neurology and infectious diseases. With many ground-breaking companies and world-class universities, the Netherlands is the perfect location for biopharmaceutical innovation in Europe.

Over the years, the Netherlands evolved into a fertile breeding ground for research and development. The number of products in our clinical pipeline slightly increased compared to 2018. At the moment there are 41 phase I, 49 phase II and 13 phase III studies in development. On top of that, almost 100 products are investigated in a preclinical setting. These numbers promise a bright future ahead.

HollandBIO’s managing director Annemiek Verkamman is happy to see the analysis confirms the leading position of the Dutch life sciences sector. “With top-notch scientists, outstanding research and education and great entrepreneurial spirit, we established our leading position in Europe. Add to that the recent relocation of the EMA, and it becomes clear that the Netherlands has what it takes to become one of the world’s top biotech clusters by 2030!”

Click here to go to the Dutch Life Sciences Trend Analysis 2019.

Biotechgate is a global business development database containing nearly 55,000 high-quality company profiles including company descriptions, contact information, product pipeline information, financing rounds and more. Biotechgate is owned and operated by Venture Valuation AG, a Zurich-based company specializing in independent assessment and valuation of technology-driven companies in high-growth industries.Whether you are looking to partner with a Dutch company or looking for a specific service, you’ll find the most complete overview of the Dutch life sciences sector at www.dutchbiotech.com.

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Eurostars project is awarded to VitroScan

A total grant sum of EUR €3.47 million, of which total subsidy ~ €1.82 million has been awarded to a multidisciplinary project, named ‘3D SELECT’. The European consortium consist of six collaborating partners: VitroScan (lead), Anapath, FHNW, Uppsala University, Oncodia, and Robovision. The project uniquely combines expertise in 3D culturing, pathology, genomics, proteomics and AI to accelerate the development of the 3D SELECT platform to analyse drug response on small tumour biopsies from individual patients and identify most efficacious treatment.

Eurostars is a joint programme between EUREKA and the European Commission, co-funded from the national budgets of 36 Eurostars Participating States and Partner Countries and by the European Union through Horizon 2020.

Click here to learn more about VitroScan.

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