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Nieuwe investeringsinstelling Invest-NL eerste helft 2019 operationeel

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Tijdens een Algemeen Overleg afgelopen donderdag in de Tweede Kamer over Invest-NL maakte minister Wiebes van Economische Zaken en Klimaat bekend dat de voorbereidingen in volle gang zijn. Eind dit jaar moet het wetsvoorstel naar de Tweede Kamer. Zo kan de nieuwe financieringsinstelling in de eerste helft van 2019 een vliegende start maken. Wiebes noemde verder uitdrukkelijk maatschappelijke uitdagingen als klimaat, energie en zorg als aandachtsgebieden. Ook herhaalde hij dat Invest-NL zich gaat richten op het (mee-)financieren en realiseren van innovaties met maatschappelijke impact waar de markt nu niet in voorziet, zoals bij langlopende en risicovolle activiteiten het geval is.

HollandBIO benadrukt bij Invest-NL in oprichting en andere stakeholders het belang van extra investeringen in de life sciences sector. Voor een ijzersterk innovatieklimaat zijn voldoende financieringsmogelijkheden in de verschillende fases van ontwikkeling onontbeerlijk. Met Invest-NL krijgt de overheid een instrument om bij te dragen aan de doorgroei van biotech bedrijven waar de markt nu niet in voorziet. Zo kan het als vliegwiel dienen voor de sector en kunnen de bedrijven met extra slagkracht werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van duurzaamheid en gezondheid.

Programmabijeenkomst 20 september

Vanuit HollandBIO’s programma ‘Een ijzersterk innovatieklimaat’ zetten we alles op alles om van Invest-NL een succes te maken voor de life sciences. Tijdens de programmabijeenkomst op donderdag 20 september praten we alle leden bij over de meest recente ontwikkelingen. Dit is ook de uitgelezen kans om te laten weten wat je van onze huidige aanpak vindt. Praat en discussieer mee, kijk voor meer informatie op de event pagina.

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Health~Holland opens call for Organ-on-Chip showcases

Stimulating the early phase in Organ-on-Chip technology development

The Top Sector Life Sciences & Health and hDMT join forces on the research and development of organ-on-chip technology. This field of technology offers our society and healthcare system great opportunities to treat chronic diseases in a personalized way. In addition, the technology can lead to the reduction of animal experiments by development of alternative preclinical test models. To enhance the R&D and develop organ-on-chip showcases the Top Sector and hDMT established the new Health~Holland Organ-on-Chip Showcases (HHOOCS) programme.

 

New programme and call

Within this new HHOOCS programme, interdisciplinary consortia of companies, recognised knowledge institutions, patient organisations and/or health foundations are invited to apply for financial support to develop an Organ-on-Chip showcase that integrates human stem cell or organoid in vitro cultures and/or microfluidics technology. The financial support is part of the public-private partnership (PPP) allowance of the Top Sector. The programme aims at developing showcases for specific organ or tissue functionalities which qualify for further research funding. The deadline for submission is 14 January 2019.

 

Want to join?

Interested in the research programme and the requirements for application? Please visit Health~Holland’s funding page.

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Dutch Startup Nestegg Biotech Approved for Innovation Loan

Dutch Startup Nestegg Biotech has been approved for a subordinated loan from Rabobank through their “AIL” program. The loans total €150.000 and will be used to bring new “Lab Automation” products to markets serving Dutch and Flemish research institutes and universities this fiscal year. Nestegg Biotech BV was assisted in applying for the loans by the Manager of Public Funding at the Brightlands Innovation Factory, Hugo Nikkel. Brightlands continues to support the development of Nestegg Biotech’s goal of bringing “enhanced automation” to laboratories performing cutting-edge research across Europe.

The Rabobank Achtergestelde Innovatie Lening or “AIL” program is provided to help with the financing of innovations. It is intended for funding early stage developments in within themes including smart technology for renewables, vitality, and sustainable solutions within the healthcare sector such as medical tech or biopharmaceuticals. More information about the program can be found here.

Obruza is a novel automated system provided by Nestegg Biotech to allow researchers to automate experiments in the fields of regenerative medicine, cell culture, drug development, and diagnostics. Nestegg Biotech has facilities on the Brightlands Maastrich Health Campus, in the southern Dutch province of Limburg. Nestegg Biotech expects to achieve validation of the Obruza system this fall in tandem with their initial partner the MERLN Institute for Regenerative Medicine in Maastricht. Announcement of new customers and partners is expected before the end of the calendar year.

Source: Brightlands

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White paper ‘Towards a constructive dialogue on pharmaceutical pricing’

There is still a lot of unmet medical need that requires the combined effort and support of all stakeholders to develop new breakthrough therapies. Developing and getting these innovative therapies to patients results in growing pressure to healthcare budgets. At the same time, these healthcare systems need to remain affordable and accessible to all patients. In the past decade, pharmaceutical companies have experimented with innovative pricing schemes to ensure affordability and accessibility.

Despite these efforts, we still find ourselves in a deadlock in the pricing debate. It is time that pharma and payers start working together to find real solutions and to ensure patients have access to the best possible therapies for a fair price for all stakeholders.

Vintura, in collaboration with Lieven Annemans, professor in health economics at UGent, developed a framework to help pharma and payers start a new dialogue and explore where they might find common ground.

The framework provides a step-by-step approach for pharmaceutical companies and payers:

  • Step 1: come to an agreement on what constitutes value
  • Step 2: come to an understanding of the pricing criteria
  • Step 3: agree on the price dynamic over time
  • Step 4: agree on risk sharing and the payment scheme

This framework will enable pharmaceutical companies and payers to start a structured dialogue and explore where they might find common ground. The ultimate goal is to secure innovation at a sustainable cost and a “fair” price for all stakeholders.

Download your copy of the white paper here.

Co-author Lieven Annemans, professor in health-economics, about this publication: “It is time that pharma and payers start working together on pharma pricing to find solutions that balance the needs of pharmaceutical companies, payers and society. I am proud to be co-author of the attached paper.”

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Enquête over nieuw journalistiek platform voor life sciences

We leven in de eeuw van life sciences: technologische ontwikkelingen maken oplossingen mogelijk die onze gezondheidszorg gigantisch gaan veranderen.  De ontwikkelingen buitelen over elkaar heen. Onderzoeksbureau Motivaction onderzoekt of er behoefte bestaat aan een onafhankelijk journalistiek medium dat zich speciaal richt op mensen die werken in of met biotech, medtech, farma en e-health. Doe hier mee aan het onderzoek

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Geneesmiddelen: van kiloknaller naar hofleverancier

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Op uitnodiging van het ministerie van VWS reageerde HollandBIO vorige week op de voorgenomen wijziging van de Wet Geneesmiddelenprijzen, de WGP. Het vervangen van referentieland Duitsland door Noorwegen realiseert jaarlijks een besparing van 239 miljoen euro, zo becijfert de Stichting Farmaceutische Kengetallen. De maatregel is het zoveelste lapmiddel om de zorgkosten te beheersen door minimalisatie van de geneesmiddelenuitgaven. Geneesmiddelen fungeren zo als kiloknallers van de zorg, in plaats van als hofleveranciers voor volksgezondheid. In onze reactie breken we een lans voor duurzame oplossingen waarbij gzondheidswinst, innovatie en betaalbaarheid hand in hand gaan. Je leest onze brief hier.

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Madam Therapeutics closes first financing round to develop novel antibiotics against drug resistant bacteria

Madam Therapeutics closed its first financing round of 1,1M EUR. The biotech company develops a novel class of antibiotics inspired by the defense mechanisms of the human body. The new funding will be used to continue and accelerate the clinical development of Madam Therapeutics’ lead candidate SAAP-148, by executing a first-in-men proof of concept study starting early next year and preparation of the following clinical phase II trial. The investment comes from a network of European business angels facilitated by Ekoy Investment Partners, De Investeerders Club and Investormatch.

Lead candidate: SAAP-148

When a small subset of bacteria survives antibiotic treatment e.g. by mutations, an infection can get out of control fast. As these resilient microbes thrive, they can group together on a surface—like a wound or a medical device—and encase themselves in a slimy protective layer known as a biofilm. Such biofilm infections “are the really nasty things for patients,” says immunologist Peter Nibbering at Leiden University Medical Center in the Netherlands with whom Madam Therapeutics closely collaborates.

 

Madam Therapeutics and a team of esteemed Dutch scientists from o.a. Leiden University Medical Center (LUMC) and Amsterdam Medical Center(AMC) have developed a new antibiotic with improved characteristics to fight a broad spectrum of infections. In a recent editorial comment on the new compound on the website of the scientific journal Science, Dr Kim Lewis, a microbiologist at Northeastern University in Boston says that the candidate adds “an important piece … to the puzzle of creating a perfect antibiotic”.

 

Dr. Remko van Leeuwen, CEO of Madam Therapeutics, comments on this first financing round: “Most of the antibiotic drugs currently in the worldwide clinical pipeline are modifications of existing classes of antibiotics and are only short-term solutions. Antimicrobial resistance is a global health emergency. There is an urgent need for more research and development for antibiotic-resistant infections, otherwise people will die from very simple infections”. Remko van Leeuwen is thrilled to welcome the group of investors to Madam Therapeutics.  “The recent investment clearly represents a growing commitment and understanding from the investment community to the development of new antimicrobial agents and reflects the potential of our drug programs.”

 

Jaap Wieling, a spokesmen of the investor group says: “This funding will allow Madam Therapeutics to take important steps forward with its lead candidate SAAP-148. Where most traditional antibiotics have a slow acting mechanism of action, SAAP-148 kills the bacteria very fast by attacking them directly from the outside, puncturing the cell membrane and make it deflate. Now with the backing of this solid investor base, the seasoned team will be able to explore the full potential of its technology”.

 

Ron Byron, Partner at Ekoy invest that helped to successfully put together the investment group says: “From my experience in marketing of antibiotics, I am very much aware of growing need for new antibiotics. Unless antibacterial development is re-energised, there is a serious risk that a growing proportion of infections, especially in hospitals, will become effectively untreatable leading to many unnecessary casualties.”

Source: Madam Therapeutics

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Novo Nordisk acquires Ziylo for 800 million USD

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Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK.

The acquisition gives Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulins. Ziylo’s glucose binding molecules are synthetic molecules that were designed by Professor Anthony Davis at the University of Bristol. These stable, synthetic molecules exhibit an unprecedented selectivity to glucose in complex environments such as blood.

“We believe the glucose binding molecules discovered by the Ziylo team together with Novo Nordisk world-class insulin capabilities have the potential to lead to the development of glucose responsive insulins which we hope can remove the risk of hypoglycaemia and ensure optimal glucose control for people with diabetes,” said Marcus Schindler, senior vice president, Global Drug Discovery, Novo Nordisk.

Novo Nordisk acquires all shares in Ziylo for an upfront payment and earn-outs with contingent milestone payments. Total payments under the agreement could ultimately exceed 800 million dollars upon the achievement of certain development, regulatory and sales milestones by Novo Nordisk.

A key strategic area

The development of glucose responsive insulins is a key strategic area for Novo Nordisk in its effort to develop this next generation of insulin which would lead to a safer and more effective insulin therapy, it reports. A glucose responsive insulin would help eliminate the risk of hypoglycaemia, which is the main risk associated with insulin therapy and one of the main barriers for achieving optimal glucose control. Thus, a glucose responsive insulin could also lead to better metabolic control and thus overall reduce the burden of diabetes for people living with the disease.

Carbometrics

Prior to closing of the acquisition, certain research activities have been spun out of Ziylo to a new company, Carbometrics. Carbometrics has entered into a research collaboration with Novo Nordisk to assist with ongoing optimisation of glucose binding molecules for use in glucose responsive insulins. Carbometrics has licenced rights to develop non-therapeutic applications of glucose binding molecules, with a focus on developing continuous glucose monitoring applications.

Source: Nordic Life Science News

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Aduro Biotech Granted Composition of Matter Patent for Novel Human APRIL Binding Antibodies

Aduro Biotech announced that the United States Patent and Trademark Office has issued a new composition of matter patent related to altered APRIL-binding antibodies, further enhancing the company’s B-select intellectual property portfolio. Specifically, the granted claims cover BION-1301, Aduro’s first-in-class anti-APRIL antibody being evaluated in a Phase 1/2 dose escalation trial for the treatment of multiple myeloma.

APRIL

APRIL (A PRoliferation-Inducing Ligand) is a member of the tumor necrosis factor (TNF) superfamily and is primarily secreted by bone marrow and/or myeloid cells. APRIL is overproduced in patients with multiple myeloma and binds to BCMA (B cell maturation antigen) and TACI (Transmembrane Activator and CAML Interactor) to stimulate a wide variety of responses that promote multiple myeloma growth and survival and suppress the immune system so that the tumor cells are protected and sustained in the bone marrow.

BION-1301

Aduro is currently evaluating BION-1301, its most advanced proprietary B-select monoclonal antibody, as a novel therapy for multiple myeloma. Despite new treatments recently approved in multiple myeloma, this disease remains incurable as patients relapse, or become resistant to, currently-available therapies. In preclinical studies, Aduro has established that A PRoliferation-Inducing Ligand (APRIL) plays a crucial part in the protective bone marrow tumor microenvironment. In these studies, APRIL, through the B cell maturation antigen (BCMA), was shown to be critically involved in the survival, proliferation and chemoresistance of multiple myeloma, and upregulates mechanisms of immunoresistance, including PD-L1 upregulation. BION-1301, a humanized antibody that blocks APRIL from binding to its receptors, has been shown in preclinical studies to halt tumor growth and overcome drug resistance. In addition, BION-1301 also demonstrated the ability to inhibit immune suppressive effects of regulatory T cells via TACI but not BCMA in multiple myeloma blood and bone marrow. BION-1301 is currently being evaluated in a Phase 1/2 clinical study.

“Blocking APRIL represents a unique approach to treating patients with multiple myeloma and we believe BION-1301 has potential to treat a myriad of oncology indications as well as other autoimmune and inflammatory diseases,” commented Stephen Isaacs, chairman and chief executive officer of Aduro Biotech. “Ensuring a robust intellectual property position around BION-1301 is inherent to advancing the program and the claims granted in this particular patent exemplify the novel science behind this exciting program.”

U.S. patent 9,969,808 adds to previously issued U.S. and international counterpart patents and patent applications that form Aduro’s APRIL patent portfolio. Claims were granted on the basis that BION-1301 enables full blockade of APRIL binding to both its receptors BCMA and TACI. Preclinical studies have demonstrated that blocking APRIL with BION-1301 not only inhibited proliferation and survival of multiple myeloma cells but also alleviated drug resistance and immune suppression, leading to enhanced myeloma cell killing.1 Further preclinical research by Aduro and its collaborators indicate that blocking APRIL further enhances anti-BMCA cytotoxic cell killing and that prevention of APRIL binding to TACI may also be a potentially important mechanism for BION-1301 to inhibit the function of regulatory T cells.2

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WntResearch and SMS-oncology signed an agreement for the implementation of the phase II study with Foxy-5

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SMS-oncology has been selected as the contract research organization (CRO) to conduct the phase II study with Foxy-5 in patients with colon cancer.

WntResearch designed a clinical phase II trial with Foxy-5 as neoadjuvant therapy in colon cancer patients without evidence of metastases present. Their lead program Foxy-5, a small peptide that mimics the effects of Wnt-5a, is intended to compensate for the lack of protein Wnt-5a in the tumor tissue noted in patients with colon cancer, in order to reduce the risk of metastasis.

The trial will be conducted as a randomized, multicenter, controlled, open-label, two-arm trial to evaluate safety, tolerability and preliminary efficacy of Foxy-5. In addition, exploratory objectives include assessment of circulating tumor DNA (ctDNA) in subject plasma, as a surrogate for disease recurrences.

Based on the recently completed feasibility study, with a positive outcome and great interest shown by contacted research clinics, WntResearch has decided to perform the phase II study at a number of clinics in Spain and the Netherlands. The study aims to include up to 180 patients who are expected to be at high risk of recurrence in colon cancer.

SMS-oncology has been engaged for the implementation of the study owing to the expertise on conducting clinical oncology studies as well as a solid experience in carrying out studies in these two countries. Currently pre-study visits are performed and the CTA (Clinical Trial Authorization) applications will be submitted to the relevant authorities during the summer. Assuming necessary approvals, patient recruitment is expected to be initiated during the fourth quarter of 2018.

Peter Morsing, CEO at WntResearch, says: “I am very happy with the selection of SMS-oncology as our CRO. From the early beginning of contact between our companies, their in-depth oncology expertise and hands-on experience in the field was found to be of added value. The work is moving forward rapidly, and we are excited in taking these next steps with SMS-oncology as our partner.”

“The phase II study with Foxy-5 is very interesting as it has the potential to prevent and alleviate cancer invasiveness and metastasis, correlating with the poor prognosis of colon cancer patients. SMS-oncology is specialized in early phase I/ II trials and is pleased WntResearch has chosen us to implement this important clinical study”, Philine van den Tol, CEO of SMS-oncology, says.