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InteRNA Appoints Andrea van Elsas, Ph.D. to Scientific Advisory Board

InteRNA Technologies has appointed Andrea van Elsas, Ph.D., as a new member of the Company’s Scientific Advisory Board (SAB). Dr. van Elsas is an immuno-oncology expert with over 20 years of experience in advancing highly innovative oncology assets and currently serves as Chief Scientific Officer of Aduro Biotech. In his role on the SAB, Dr. van Elsas will support InteRNA’s pipeline development efforts and in particular the positioning and strategy for lead program INT-1B3 advancing into clinical development. Dr. van Elsas will succeed Allan Balmain, Ph.D., F.R.S., who has stepped down from his position on the board.

“Andrea has always worked at the heart of cancer therapy drug discovery efforts and his outstanding track record in identifying and developing innovative therapeutics will be a great benefit to us,” said Dr. Roel Schaapveld, CEO of InteRNA. “With his added oversight, we aim to further advance GLP toxicology studies and move towards the clinical evaluation of our promising lead candidate, INT-1B3, in the immuno-oncology field. We also would like to thank Allan for sharing his knowledge and providing significant contributions to our R&D programs over the years.”

“InteRNA has developed a uniquely positioned RNA therapy attacking cancer from multiple angles, with the potential of inducing durable immunity as a single agent and in combination therapy,” said Dr. van Elsas. “I am impressed by the team’s profound work on defining the mode-of-action and selecting an optimized delivery technology for INT-1B3 and am thrilled to contribute to the advancement of this novel therapeutic strategy.”

Prior to his position asCSO of Aduro Biotech,Dr. van Elsas was CSO of Aduro Biotech Europe from 2015 to 2017. He joined Aduro following the 2015 acquisition of BioNovion, a company he co-founded and served as CSO, that was focused on the development of innovative therapeutic antibodies in the field of immuno-oncology. In addition, Dr. van Elsas supports Gilde Healthcare as an Operational Partner in the evaluation of investment opportunities and has been acting as VP of Research for Gilde’s portfolio company, AM Pharma, since 2011. From 1999 to 2011, he held various positions of increasing responsibilities at Organon (acquired by Schering-Plough Corporation and later by Merck) in Oss, The Netherlands, and Cambridge, Massachusetts. As Organon’s Director of Tumor Immunology he oversaw the immuno-oncology portfolio and led the anti-PD1 program that later became known as pembrolizumab. As a post-doc he worked in the lab of Nobel Laureate Jim Allison at the University of California, Berkeley and is a co-inventor on the original anti-CTLA4 patents that formed the basis for the development of ipilimumab (YervoyTM), the first checkpoint inhibitor approved for the treatment of melanoma. Dr. van Elsas holds a Ph.D. in Immunology and Oncology from the University of Leiden.

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Carmen van Vilsteren is het nieuwe gezicht van de Topsector Life Sciences & Health

Carmen van Vilsteren is per 1 april 2019 het nieuwe boegbeeld van de Topsector Life Sciences & Health. Met deze benoeming tot voorzitter van het Topteam Life Sciences & Health door Staatssecretaris van Economische Zaken en Klimaat Mona Keijzer neemt Van Vilsteren het stokje over van waarnemend boegbeeld Hans Schikan. Haar ruime kennis en ervaring binnen de wetenschap en het bedrijfsleven, gecombineerd met een ondernemende geest, geven Van Vilsteren een uitstekend profiel om aan de slag te gaan als het gezicht van de Topsector.

Op het snijvlak van ondernemen en onderzoeken


Carmen van Vilsteren heeft haar sporen verdiend in de medische industrie, bij Philips en later als CEO en co-founder van o.a. Microsure. In haar huidige rol als directeur van het Strategic Area Health van de Technische Universiteit Eindhoven (TU/e) combineert zij haar kennis van het opzetten van innovatieprogramma’s en publiek-private samenwerkingen met het wetenschappelijk onderzoek. Daarnaast heeft Van Vilsteren een uitgebreid netwerk en bekleedt zij diverse bestuurlijke functies op nationale en regionale schaal (Brainport), waardoor zij kruisbestuiving tussen regio’s kan initiëren. Als voorzitter van het bestuur van EIT Health Benelux, doet ze dit ook op Europese schaal. De benoeming als boegbeeld is een waardevolle aanvulling op haar huidige functies. Van Vilsteren zal haar werkzaamheden bij de TU/e combineren met haar rol bij de Topsector.

Duurzame innovatieve oplossingen

Naast een enorme passie voor hightech innovaties in de gezondheidszorg wordt Van Vilsteren gedreven door kansen voor de eindgebruiker, de patiënt. “Het bieden van duurzame, innovatieve oplossingen in de gezondheidszorg en daarmee een invloed hebben op het leven van mensen”, zegt Van Vilsteren, “dat is mijn drijfveer. Het Nederlandse onderzoek en bedrijfsleven hebben een toonaangevende rol op het gebied van innovaties in de gezondheidszorg. Om de impact op de kwaliteit van leven van mensen wereldwijd te vergroten, zet ik mij graag in om deze positie verder te versterken en internationaal uit te bouwen.”

Het stokje overnemen

Na het overlijden van voormalig boegbeeld Jan Raaijmakers in oktober 2017, heeft de  ervaren biotech ondernemer Hans Schikan de positie met verve bekleed. Schikan toonde zich in zijn rol als waarnemend boegbeeld een gedreven voorvechter van innovatie in de Life Sciences & Health (LSH) sector. De LSH sector heeft mede dankzij Schikan een aantal grote successen weten neer te zetten. Allereerst zijn er nationale samenwerkingsverbanden gevormd op o.a. regeneratieve geneesmiddelen (RegMed XB) en hart- en vaatonderzoek (Dutch CardioVascular Alliance). Maar ook de komst van het Europees Geneesmiddelen Agentschap (EMA) resulteerde reeds in diverse vestigingen van (bio)farmaceutische bedrijven in Nederland.   

Innovatiekracht van de topsectoren


De Topsector LSH is één van de negen topsectoren waar het Nederlandse bedrijfsleven en de kennisinstellingen internationaal bijdragen aan de concurrerende positie van Nederland op de wereldmarkt. Of het nu gaat om geneesmiddelen, medische technologie, diagnostiek, vaccinaties, digitale zorgoplossingen of de infrastructuur van de gezondheidszorg; de Nederlandse LSH sector biedt innovatieve oplossingen en is wereldwijd steeds toonaangevender. 

Bron: Health~Holland

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ProPharma Group Acquires Southwood Research

ProPharma Group, a portfolio company of Linden Capital Partners, announces the acquisition of Southwood Research. Based in Buckinghamshire, United Kingdom, Southwood Research is a leading provider of pre-approval regulatory science services to the pharmaceutical and biotech industries. “We are thrilled about our future as a part of ProPharma Group. The combination expands our global reach, as well as our ability to provide end-to-end services for our clients within regulatory affairs,” said Colin Wheeler, Southwood Research’s Managing Director.

This acquisition extends ProPharma Group’s highly specialized scientific regulatory affairs capabilities throughout the EU marketplace, while bolstering its regulatory affairs service portfolio from pre-clinical/pre-approval through post-approval. “Southwood Research’s proven experience is pivotal throughout the developmental phases of a product’s lifecycle and has made them an invaluable partner to their growing roster of pharmaceutical and biotech clients. We are excited to support the entire ProPharma Group organization as they expand their global presence and enhance their existing portfolio of services to better serve their customers,” said Michael Farah, Chairman of ProPharma and Partner at Linden Capital Partners.

ProPharma Group, a leading provider of compliance services, continues to expand its global presence, now with more than 1,100 employees across United States, Canada, Europe, Japan, and Australia. “The addition of Southwood Research’s deep scientific expertise emphasizes ProPharma Group’s commitment to providing industry leading regulatory support to our clients. ProPharma Group’s robust regulatory capabilities, bolstered by the recent additions of The Weinberg Group in the United States and now Southwood Research in the UK, represent a truly unique end-to-end global regulatory practice,” said Dawn Sherman, ProPharma Group’s CEO.

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Leestip: Verantwoord beleggen in farma

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Geen sector leent zich zo goed voor een verantwoorde belegging als onze eigen mooie life sciences & health sector. Dat vinden wij bij HollandBIO althans. Je maakt de ontwikkeling van de medicijnen van morgen mogelijk én realiseert een (hopelijk) mooi rendement voor de oude dag. Toch lijkt dat niet langer common sense onder verzekeraars en banken, al dan niet om het eigen imago op te poetsen. In een rake column in Medisch Contact gaat Henk Jan Out in op dit wonderlijke fenomeen. HollandBIO tipt: investeer in jezelf, lees dit artikel!

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ProQR Doses First Patient in Phase 1/2 STELLAR Trial of QR-421a for Usher Syndrome Type 2

ProQR Therapeutics, a company dedicated to changing lives through the creation of transformative RNA medicines for the treatment of severe genetic rare diseases, has dosed the first patient in the Phase 1/2 STELLAR clinical trial for QR-421a in patients with Usher syndrome type 2 or non-syndromic retinitis pigmentosa (RP). Interim data from the study are expected to be announced mid-2019.

“There are no effective treatments for most inherited retinal diseases, including Usher syndrome, and blindness often results,” said David G. Birch, Ph.D., Principal Investigator of STELLAR and ScientificDirector of the Retina Foundation of the Southwest in Dallas, Texas. “The STELLAR study is one of the first studies of its kind exploring the impact of ProQR’s RNA therapies on patients with Usher syndrome due to an Exon 13 mutation. The STELLAR trial will explore whether QR-421a (ProQR’s RNA therapy) can slow disease progression or even reverse it. Treatments such as this, that target the underlying cause of a disorder, have the potential to give new hope to patients and their families that life-changing therapies could be available in the near future.”

“Usher syndrome is a devastating disease, so we are pleased to advance QR-421a into the clinic with the goal to make a difference for these patients, similar to what we have observed with early but promising data for sepofarsen in patients with LCA10,” said Daniel A. de Boer, chief executive officer of ProQR. “We are committed to rapidly advancing our promising RNA therapies for inherited retinal diseases and we believe our platform of generating targeted RNA therapies with long retinal half-lives and the ability to reach both central and peripheral retina, we will be able to target many of these diseases in the coming years.”

Usher syndrome is the leading cause of combined deafness and blindness. Exon 13 mutations in the USH2A gene targeted by QR-421a cause vision loss in approximately 16,000 individuals in the Western world.

Source: ProQR

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Enpicom secures funding round to finalize igx platform development

Bioinformatics software engineering company ENPICOM has closed a series A investment round. BOM Brabant Ventures, Nextgen Ventures and Arches Capital have jointly invested 1.2 million euros to support the company’s repertoire sequencing data analysis platform. ENPICOM will use these proceeds to finalize development of its ImmunoGenomiX (IGX) platform and introduce it in the marketplace.

ENPICOM BV was founded in 2017 by Dr. Alvise Trevisan (CTO), Dr. Nicola Bonzanni (CSO) and Jos Lunenberg, MSc, MBA (CEO). Mid 2017 the company started the development of a unique platform to manage, store, analyze, visualize and interpret clone sequencing data from T and B cell receptor repertoires. ENPICOM is currently in the final stage of preparations for the global launch of the first full version of its ImmunoGenomiX (IGX) platform. This festive event will take place in Vienna at the 6th Immunotherapy of Cancer Conference (ITOC6) from April 11 to 13.

Dr. Bonzanni commented: “When studying immune system related diseases or developing drugs influencing this system, it is extremely important to be able to directly measure and closely monitor its status. Repertoire sequencing is a powerful way to analyze hundreds of thousands to millions of T or B cell receptors swiftly and in a cost-effective way.” “While there are different companies offering kits and service for this specific form of targeted sequencing, there is no commercial platform to manage the rapidly growing amounts of data generated in the lab in an intuitive, user-friendly way,” added Dr. Trevisan. He continued: “To get from data to powerful insights from this exciting technology, smart new analysis methods and rock-solid software were needed. We have built a team of experts, bringing together a wealth of knowledge and expertise in this field, to develop the IGX platform.”

“I am very pleased we have attracted this excellent syndicate of investors,” said CEO Lunenberg. “With the completion of this Series A financing, we are well funded to execute on our IGX development and market introduction programs.”

Quotes from the investors

Sjoerd van Gorp (BOM): “The ambitions of the ENPICOM team in the field of personalized immunotherapy fits perfectly with our investment goals. By providing innovative life sciences companies and healthcare providers with the tools to measure the status of the patients’ immune system we believe that ENPICOM can facilitate efficient drug development and ensure effective treatment for patients.”

Matthijs Blokhuis (NextGen Ventures): “The ambition of ENPICOM to personalize immunotherapy resonates extremely well with the objective of NextGen Ventures to provide meaningful results for patients and providers. An increased understanding of immune repertoire sequencing data significantly helps to improve outcomes in an efficient manner.”

Eric van der Maten (Arches Capital): “ENPICOM is a perfect example of what we look for in a portfolio company: a strong, highly skilled, motivated and dedicated team, that is showing the ability to combine innovative emerging technologies like data science, AI and medical science into an exhilarating and fast-growing Deep Tech company, eventually even with a real impact on society. We are very pleased to add ENPICOM to our investment portfolio”.

Source: ENPICOM

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Calypso Biotech BV Secures 20 Million EUR

Calypso Biotech, an emerging leader in the development of therapeutic antibodies for autoimmune diseases, closed a €20M Series A financing co-led by Gilde Healthcare and Inkef Capital. They are joined by Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and the company’s founding investor M Ventures. Further, Calypso Biotech has become Resident Company at Johnson & Johnson Innovation JLABS at Beerse in Belgium (JLABS@BE). Arthur Franken from Gilde Healthcare will join Fiona MacLaughlin (Inkef Capital), Jeanne Bolger (JJDC) and Jasper Bos (M Ventures) on the Board of Directors.

The proceeds from this financing round will support the development of Calypso Biotech’s best-in class anti-Interleukin-15 (IL-15) antibody CALY-002 up to First-in-Patient studies in several autoimmune indications. IL-15 is an immune checkpoint cytokine that controls inflammation as well as multiple tissue-resident immune cells and recently attracted much attention in the immune-oncology space. Especially, IL-15 is being recognized as a key factor in the survival of tissue resident memory T cells, a population of immune cells involved in disease maintenance and recurrence.  Calypso Biotech scientists believe that targeting tissue resident memory T cells offers significant advantages over traditional cytokine interventional approaches and could provide for unprecedented disease-modifying effects.

Calypso Biotech has chosen to develop CALY-002 in Eosinophilic Esophagitis (EoE) as well as in other undisclosed auto-immune indications. EoE is a severe and debilitating immune-related chronic disease of the esophagus that is the second leading cause of dysphagia (difficulty in swallowing) in adults. EoE has emerged as a frequent and significant cause of upper gastrointestinal morbidity particularly associated with important quality of life impairment and significant financial healthcare burden. CALY-002 has secured Orphan Drug Designation status from the European Medicines and Food & Drug Administration agencies for EoE.

“We believe the unique immunological insight and understanding  for the role of IL15 in disease brought by founders Alain Vicari and Yolande Chvatchko is now ready for translation into a therapy for patients with EoE, for whom limited therapies are available today, as well as in several large auto-immune indications” said Fiona MacLaughlin, Inkef Capital.

Calypso Biotech is also announcing major strengthening of its team. Bernard Coulie, current president and CEO of Pliant Therapeutics, will be appointed as independent Chairman of the Board. Together with Alexandre LeBeaut, Executive Vice-President and CSO of Ipsen and current independent Director of Calypso Biotech, they will contribute to develop its strategic vision and corporate success. Prof. Bart Lambrecht, from the VIB-UGent Center for Inflammation Research (Belgium), a leading translational immunology expert, will join Calypso Biotech Scientific Advisory Board. Dr. Josephin-Beate Holz (ex Ablynx NV), Dr Greg Elson (ex Glenmark, Novimmune), Dr Susana Salgado (ex Novimmune), and Duc Tran (ex Prexton Therepeutics, Preglem, Pfizer) will join as medical, manufacturing, non-clinical development and strategic planning advisors, respectively.

“We appreciate the confidence placed in our team by a strong and well-balanced investor syndicate” said Alain Vicari, CEO and co-Founder of Calypso Biotech. “With the proceeds of the Series A and our newly recruited team of seasoned experts, we are now well positioned to advance CALY-002 towards value-creating near-term milestones”.

Source: Calypso Biotech

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Export Manufacturing Waiver for SPCs: a red flag for investment in EU healthcare biotech

Response of EuropaBio to the recent agreement by the EU co-legislators on the Supplementary Protection Certificate (SPC) Export Waiver.

As the Association representing the European biotechnology industry, EuropaBio is fully committed to the development of a legislative environment which facilitates the creation of EU jobs and growth as well as new solutions to healthcare challenges.  We therefore note, with utmost concern, the recent agreement by the EU co-legislators on the Supplementary Protection Certificate (SPC) Export Waiver, which was endorsed by the Member States’ Deputy Permanent Representatives today.

EuropaBio Secretary General, Joanna Dupont-Inglis, commented: “The revision of the EU IP framework, to introduce a SPC manufacturing waiver, is a regrettable example of well-meant but, ultimately, counterproductive policy making, with far-reaching negative impacts on EU competitiveness. It is the small healthcare biotech companies, which are at the cutting edge of creating innovative technologies addressing patient’s unmet needs, that will be hardest hit. These companies, seeking treatments for some of our most devastating and difficult to tackle diseases, take the highest financial risks and rely heavily on investors’ money, often without making any profits for years.  They are, therefore, critically dependant on a robust and predictable IP framework.”

EuropaBio supports the overall objective of improving the global competitiveness of EU generic/biosimilar sector, but feels strongly that the agreement on the SPC Export Manufacturing Waiver is at odds with this goal.

In addition, allowing the stockpiling of SPC-protected products, beyond the original export intent, only serves to further undermine confidence in the stability of the EU IP framework at a time our industry is facing increasing global competition. It diminishes the value of investments already committed that had previously been directly incentivised by the SPC framework itself.

Concluding, Dupont-Inglis commented: “What’s needed now is a reinforced incentives framework in order to reassure the global investment community of the EU’s capacity and commitment towards delivering breakthrough care and cures to patients.”

Source: EuropaBIO

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HUB and Yamaha Motor Combine their Proprietary Technologies

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Hubrecht Organoid Technology (HUB) and Yamaha Motor have announced their collaboration to provide solutions that deepen our understanding in predictive diagnostic of patients.

HUB has announced an innovative collaboration with Yamaha Motor to support organoid research applications in drug development and personalized medicine. With this collaboration, HUB aims to develop new methods for Organoid research and precision medicine in a short timeframe with as little material as possible. Automatization of this process by CELL HANDLER*1 would greatly increase accuracy, efficiency and throughput. 

HUB Organoids

HUB exploits the pioneering work of Prof. Hans Clevers, who discovered methods to grow stem cell-derived human ‘mini-organs’ (HUB Organoids).  Organoid Technology enables the generation of in-vitro models of any epithelial disease from any patient. HUB Organoids mimic organ functionality and are considered to be a clinically relevant model for human diseases such as Cystic Fibrosis, oncology and toxicology. HUB Organoids perform as “Patients in the Lab” and allow a better understanding of tumor heterogeneity and drug response. HUB has established a “Living Biobank” that links patient-specific genetic and phenotypic information to pre-clinical drug discovery, compounds validation and clinical drug-responsiveness. As a drug development tool, HUB organoids can efficiently identify novel therapeutic targets, provide drug efficacy, safety and mechanistical data.

HUB offers licenses to its patented HUB Organoid Technology for drug-screening and access to Organoids in the HUB biobanks for pre-clinical drug discovery and validation.  In addition, HUB is performing clinical studies to validate the technologies used as a companion diagnostic.

Yamaha Motor’s CELL HANDLER

Beginning with its foundation in motorcycle business, Yamaha Motor has leveraged its core competencies of small-engine technology, vehicle body/hull technology, and control technology to span a diverse range of businesses such as the marine business (boats, outboard motors, etc.), power products business (snowmobiles, generators, etc.), industrial robots, electrical power assisted bicycles, and automobile engines. The Yamaha Motor Group includes 140 companies across 30 countries and regions worldwide, which work through product development, manufacturing, and sales, to realize the Corporate Mission of being a “Kando*2 Creating Company.”

Yamaha Motor has developed a cell picking and imaging system CELL HANDLER for scientific research. It adopts pick-and-place technology from industrial robots like ultra-fast and highly accurate surface mounters designed to mount electric components on printed circuit boards inside electronic devices, e.g., cellular phones and automobiles. CELL HANDLER saves time and efforts and enables cell quality control by simultaneously picking cells and capturing and processing images at a speed and accuracy that would be difficult to achieve when performed manually. As such, Yamaha aims to keep contributing to medical research and drug discovery fields.

*1For research use only. Not for use in diagnostic or therapeutic procedures.

*2Kando is a Japanese word for the simultaneous feelings of deep satisfaction and intense excitement that we experience when we encounter something of exceptional value.

Source: Hubrecht Organoid Technology (HUB)

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Sapreme Technologies in a 6.8 M€ EU Alliance to Develop an Oligonucleotide Delivery Platform Based on Its Proprietary Endosomal Escape Enhancers

Sapreme Technologies, a privately-held biotech company developing a technology platform to enable the cytosolic delivery of macromolecule therapeutics, has been awarded a 6.8 M€ grant together with a multidisciplinary consortium including 11 other academic and industrial parties. The grant was provided by the European Union (EU) through Horizon 2020 to develop a non-viral based gene therapy using Sapreme’s proprietary endosomal escape enhancers.

Ruben Postel, CSO of Sapreme Technologies, “We are pleased to see that the EU has recognized the great potential of the ENDOSCAPE project and the expert multi-disciplinary consortium developing a novel oligonucleotide delivery technology for treatment of cancer and haemophilia patients”

Ernst Geutjes, acting Managing Director, “The fact that the EU awarded the proposal with the maximum score demonstrates the potential of Sapreme’s proprietary endosomal escape enhancement technology as well as the exceptional quality of the proposal and the consortium spearheaded by Sapreme and Charité – Universitätsmedizin Berlin”

Source: Sapreme Technologies