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BIO 2019 in Philadelphia – One to remember

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Last week, a stunning number of 17,300 attendees joined the BIO International Convention in Philadelphia. Branded with the theme “It Starts With One”, BIO highlighted the game changing impact of the small, daily efforts of BIO attendees. One of the exhibition floor’s highlights was the Health~Holland Pavilion, a not-to-miss orange landmark in a sea of country pavilions. Together with a delegation of 120 Dutch biotech entrepreneurs, we look back on a successful edition.

The orange Health~Holland Pavilion was once again the eye-catcher of the exhibition floor. Dressed up with tulips, stroopwafels and a Dutch bike, the pavilion was an orange living room. But most importantly, it was the central information point for international visitors with questions regarding the Dutch business and innovation climate and the national life sciences & health sector.

Biotech hotspot

In a 13 minutes pitch as part of the Global Innovation Hub, HollandBIO’s Annemiek Verkamman zoomed in on today’s Dutch masters of biotech. She explained why the Netherlands has Europe’s most attractive business climate for biopharmaceutical companies. With this year’s relocation of the EMA, the Netherlands has what it takes to evolve into a true global biotech hotspot.

Dutch Strengths

During the Hospitality Reception, the pavilion transformed in one of BIO’s best-visited happy hours. In a powerful and hilarious quiz-style speech, Hans Schikan introduced the one Dutch Strength after another to the eager crowd. His take-home message: the Netherlands is the place to be for life sciences companies. After the traditional raffle of the Loyens & Loeff bike, everyone grabbed the opportunity to meet new business partners. For all disappointed participants of the raffle: rest assured, there will be a new bike to win at BIO 2020 in San Diego.

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Xenikos receives IND clearance Phase 3 trial using T-Guard(R) for treating steroid-refractory acute GVHD

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The Dutch company Xenikos B.V., which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application to initiate a U.S.-based clinical Phase 3 registration trial in order to test the efficacy of T-Guard for treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation.

This single-arm, multi-center Phase 3 trial (BMT CTN 1802) is designed to evaluate the efficacy and safety of T-Guard in 47 patients who receive an allogeneic stem cell transplantation and subsequently develop SR-aGVHD. The primary endpoint of the study will be the complete response rate at day 28, and key secondary endpoints will include the duration of complete response and overall survival rate at six months.

“Receiving FDA approval to initiate our U.S. Phase 3 registration trial is a major milestone for us, as it is the next step in advancing T-Guard towards the market,” says Dr. Ypke van Oosterhout, Chief Executive Officer of Xenikos. “Importantly, T-Guard can be administered as a single one-week treatment and was previously shown to promote swift restoration of the immune system, potentially reducing the risk of future infection and relapse. Effective therapies for treating patients with SR-aGVHD are urgently needed, and we believe that T-Guard has the potential to be an important addition to the medical arsenal available for treating patients with this devastating and potentially fatal condition.”

The trial will be conducted in the U.S. by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), funded by the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI), which are co-funding the trial. Drawing on its vast network of leading transplant centers throughout the U.S., the BMT CTN is expected to be able to quickly recruit patients for the trial, thereby helping bring T-Guard to market as quickly as possible.

Dr. Gabrielle Meyers, Study Co-Chair, asserts, “The BMT CTN is the only U.S. clinical trial group focused on improving outcomes for transplant recipients. For many years few studies were conducted for steroid-refractory GVHD due to the difficulty in treating this challenging patient population. We are excited about the opportunity to work with Xenikos to bring novel therapies to benefit patients in greatest need.”

Study Co-Chair Dr. John Levine notes, “Steroid-refractory GVHD is the driver for non-relapse deaths after allogeneic HSCT. Poor immune reconstitution and the resulting infections are major contributors to the high mortality. T-Guard’s novel mechanism of action that preferentially targets activated T cells has shown rapid immune recovery and high response rates. This collaboration with the BMT CTN will hopefully develop the confirmatory evidence needed to move T- Guard towards FDA approval.”

T-Guard: Helping reset the body’s immune system

T-Guard is designed to safely and swiftly reset the body’s immune system in life-threatening T cell‒mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease. T-Guard consists of a unique combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on T cells and NK cells. Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with minimal treatment-related side effects. Importantly, T-Guard’s action is short-lived, thereby significantly reducing the patient’s vulnerability to opportunistic infections compared to currently available therapies. Xenikos successfully completed a Phase 1/2 study for the second line treatment of SR-aGVHD in patients following hematopoietic stem cell transplantation (HSCT). The results of this study showed that just one week of T-Guard treatment triggered a strong clinical response and doubled the 6-month overall survival rate. These results were published in the peer-reviewed journal Biology of Blood and Marrow Transplantation. In addition to receiving IND clearance in the U.S., T-Guard has also been granted Orphan Drug Designation status in both the E.U. and the U.S.

Source: Xenikos

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Catalyze and BioHealth Innovation announce transatlantic partnership

Catalyze and BioHealth Innovation have entered an agreement to actively bridge the Life Sciences communities in the US and the EU. This transatlantic partnership will increase opportunities for translating biohealth discoveries to market through grant writing services, expanded technology commercialization and international soft-landing support. The two parties have a wide range of resources and knowledge which combined will better aid in delivering high-impact, customer-specific solutions.

BioHealth Innovation, based in Maryland, USA, is renowned for its efforts to source and evaluate market-relevant biohealth intellectual properties, connecting the IP with non-dilutive and early stage funding sources, and assisting businesses with marketing, funding applications and other resources for business growth. Richard Bendis, Founder, President and CEO of BioHealth Innovation: “We are excited to augment our resources for early stage companies with those of the Catalyze team.”

Catalyze Founder and Director Theodoor Rutgers: “This new partnership with BioHealth Innovations creates added value on a global scale. We are happy to be expanding in the US, bridging R&D innovations across the Atlantic.” Catalyze is a market leader in obtaining non-dilutive funding for biomedical and healthcare innovations. The Amsterdam-based company has built a network of more than 2,000 partners around the world, raising over half a billion Euro in funding for clients. According to Catalyze Commercial Director Quirein te Roller: “This is a unique opportunity for us to leverage the strengths of both parties, enabling more innovations and better innovations, to make it to market faster, effectively changing the lives of millions around the world.”

Source: Catalyze

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Biotech Campus Delft opent de deuren voor innovatieve biotechnologie bedrijven

DSM heeft hiermee een belangrijke stap gezet in het openstellen van de Biotech Campus Delft. De Campus is een perfecte omgeving voor innovatieve biotechnologie bedrijven. Die huren hier niet alleen een laboratorium en kantoorruimte, maar krijgen ook toegang tot een breed pallet aan kennis, ervaring en opschalingsmogelijkheden.

De startup Meatable is bezig is om 100% écht vlees op de markt te brengen dat vanuit één cel kan worden geproduceerd, zonder dat daarvoor dieren geslacht hoeven te worden. Voor de startup is dit het perfecte moment om z’n intrek te nemen op de Campus. Krijn de Nood, CEO van Meatable: “De verhuizing naar de Biotech Campus Delft is ontzettend belangrijk voor ons. Hiermee krijgen we als startup toegang tot de expertise van DSM op het gebied van opschaling, product development en voedselregelgeving. Daarmee komt de realisatie van onze plannen weer een paar flinke stappen dichterbij.”

De Biotech Campus Delft is een initiatief van DSM om innovaties op het gebied van biotechnologie te versnellen. De open innovatiecampus, centraal gelegen in Nederland, verwelkomt startups, scale-ups, bedrijven en kennisinstellingen die actief zijn op het gebied van industriële biotechnologie en biedt hen expertise en faciliteiten om innovaties op te schalen, te laten groeien en te commercialiseren. Edith Schippers, President DSM Nederland: “We zijn verheugd Meatable te verwelkomen op de Biotech Campus Delft. Net als DSM houdt Meatable zich bezig met de vraag hoe we in de toekomst onze voedselproductie vorm moeten gaan geven met een groeiende wereldbevolking, klimaatverandering en gezondheidswensen van consumenten. Deze startup kan nu zijn voordeel halen uit de kennis en expertise die beschikbaar is op de Campus. Door samen te werken met kleine innovatieve biotech bedrijven zoals Meatable, komen we sneller tot innovatieve oplossingen die essentieel zijn voor de ontwikkeling naar een duurzame ‘bio-based’ toekomst.”

Bron: Biotech Campus Delft

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HollandBIO leestip: Feike Sijbesma over impact en verantwoordelijkheid

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Impact en verantwoordelijkheid zijn niet los van elkaar te zien, stelt Feike Sijbesma, de topman van DSM, in een interview met De Volkskrant. Want: ‘Je kunt jezelf of je bedrijf toch niet succesvol noemen in een wereld die faalt?’ Daarom kiest DSM voor biotech toepassingen die verschil maken, die bijdragen aan de uitdagingen waar de wereld voor staat, zoals klimaat, duurzame grondstoffen en voeding. De grootschalige maatschappelijke programma’s van DSM sluiten naadloos op die uitdagingen aan.  

Het interview geeft een inspirerende inkijk in hoe het vooraanstaande biotechbedrijf maatschappelijke impact en aandeelhoudersbelang integreert. Sijbesma: ‘Omdat ik ervan overtuigd ben dat het niet alleen goed is voor de wereld, maar ook voor de financiën van DSM.’ Een lichtend voorbeeld voor bedrijven, vindt HollandBIO, en daarmee een absolute must-read. Lees hier het hele interview

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Kiadis Pharma raises €28 million

Kiadis Pharma, a clinical-stage biopharmaceutical company, has raised gross proceeds of €28 million through a private placement of 3,7 million new shares to institutional investors via an accelerated bookbuilding process.

Following the Company’s announcement on 17 April 2019 of its intention to acquire US-based CytoSen Therapeutics in an all share deal, Kiadis Pharma intends to use the net proceeds of the Placing to:

  • Progress Kiadis’ ATIR101 development, including the furtherance of Phase III trials, preparing for potential commercialization in Europe, and expanding ATIR manufacturing capacity
  • Progress CytoSen’s pipeline products as well as general corporate purposes and other working capital needs

Source: Kiadis Pharma

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Oprichting Invest-NL stap dichterbij

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In de Tweede Kamer is op 21 mei de machtigingswet voor de oprichting Invest-NL met algemene stemmen aangenomen. Daarmee is de oprichting van de nieuwe investeringsinstelling een stap dichterbij. Het wetsvoorstel zal hierna in de Eerste Kamer aan de orde komen. Met een snelle behandeling kunnen bedrijven eerder profiteren van investeringen op gebieden waar Nederland voorop loopt in onderzoek en ontwikkeling zoals de life sciences. Daarmee houden we de aansluiting bij landen om ons heen die hun investeringen opschalen. Een uitgelezen kans voor Invest-NL om het teruglopende aantal investeringen in de sector een impuls te geven en zo een vliegwiel voor innovatie in de life sciences te vormen.

Focus op biotech

De focus van Invest-NL wordt breder dan alleen energie en klimaat. Zo pleitte VVD-Tweede Kamerlid Hayke Veldman voor een rol voor Invest-NL in het stimuleren van bedrijven in kansrijke gebieden als de biotechnologie. Hij benadrukte tijdens het plenaire debat vorige week de financieringskloof waarin biotech bedrijven dreigen vast te lopen. Tijdens het debat ging minister Wiebes van Economische Zaken en Klimaat in op de investeringsmogelijkheden van Invest-NL. Zo moet het voor kleinere bedragen en een grotere hoeveelheid mogelijk zijn om via fondsen te investeren, eventueel samen met andere partijen. Dit maakt een uitgekiende financieringsmix voor zowel start-ups als scale-ups mogelijk.

Rendement en risico

Minister Wiebes benadrukte tijdens het debat verder dat Invest-NL bij hoge risicoprofielen gaat kijken naar een rendementseis op portfolioniveau. Alleen dan kan een revolverend instrument ontstaan waarbij winstgevende projecten corrigeren voor mislukte initiatieven. Een scenario dat goed aansluit bij de life sciences, waar de risico’s hoog zijn maar de potentiele rendementen net zo. En juist door het hoge risicoprofiel en de vaak lange tijdslijnen staan private financiers in deze fase bepaald niet in de rij om te investeren. Invest-NL kan dit marktfalen aanpakken.

Oprichting Invest-NL

Eerder drong minister Wiebes al aan op een snelle politieke behandeling zodat Nederland de aansluiting houdt bij landen om ons heen die hun investeringen opschalen in bijvoorbeeld de life sciences. De Tweede Kamer heeft daar gehoor aan gegeven, waardoor het nu aan de Eerste Kamer is om het wetsvoorstel te behandelen. Zodra Invest-NL is opgericht, kan het een brug slaan tussen de publieke regelingen en private investeerders. Zo kan het als vliegwiel dienen voor innovatie en kunnen biotech bedrijven met nog meer slagkracht blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van gezondheid en zorg.

HollandBIO blijft de ontwikkelingen nauwlettend volgen. Mocht je vragen hebben, naam dan contact op met HollandBIO’s Fabian.

Het hele debat is terug te kijken via debat gemist van de Tweede Kamer: https://debatgemist.tweedekamer.nl/debatten/machtigingswet-oprichting-invest-nl

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Groei in omzet en winst voor Pharming over het eerste kwartaal van 2019

Het Leidse biotechbedrijf Pharming presenteerde vorige week mooie cijfers over het eerste kwartaal van 2019. De productomzet groeide ten opzichte van Q1 2018 met bijna 20% tot € 35,2 miljoen. Het aantal productverkopen in de VS steeg met 21% tot € 33,7 miljoen, vergelijkbaar met het niveau van het laatste kwartaal van 2018. Ook de nettowinst steeg met 23% tot € 6,7 miljoen. De operationele winst steeg met bijna 50%. Pharming CEO Sijmen de Vries zegt verheugd te zijn met de sterke resultaten. De omzet- en winstprestaties van Pharming bevestigen volgens hem het succes van de marktstrategie voor RUCONEST.

Het hele persbericht lees je hier.

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Erasmus MC and LUMC to co-participate in GenomeScan

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Erasmus MC (Rotterdam, The Netherlands) announced today the acquisition of shares of the fast-growing genomics service provider GenomeScan BV based in Leiden (The Netherlands). Together with the Leiden University Medical Center (LUMC), another shareholder in GenomeScan, they are joining forces in the field of molecular diagnostics and research.

In the fast-growing field of molecular diagnostics, it is critical to introduce and develop cutting-edge diagnostic technologies. One of these technologies is Next Generation Sequencing (NGS) that rapidly analyzes DNA and/or RNA of patients on a large scale.

GenomeScan is an ISO-accredited genomic service provider specialized in Next Generation Sequencing applications. The participation of Erasmus MC and LUMC in GenomeScan allows both UMCs to perform fast and sustainable molecular diagnostics under GenomeScan’s ISO-accreditation for NGS. Moreover, the collaboration will  increase the capacity to innovate, use new technologies and develop new applications for R&D and diagnostics in an international scientific environment.

GenomeScan’s expertise not only lies in molecular diagnostic, but also in developing customizable NGS solutions for pharmaceutical and biotech companies, academic centers and hospitals, mainly within Europe. In addition, GenomeScan collaborates with leading scientific institutes in a number of national and international research projects.

David Voetelink, vice-chairman of the Executive Board: “The Erasmus MC wants to drive innovation in healthcare and technology is becoming an increasingly important factor that requires consequent investments. Through our collaboration with the LUMC we optimize the use of capital equipment. As a result, not only we have access to the most advanced technologies, but also we have a chance to ensure that the healthcare costs remain affordable.”

Pancras Hogendoorn, vice-chairman of the Executive Board of LUMC: “The collaboration with GenomeScan and Erasmus MC fits perfectly with our strategy to develop cutting-edge applications to accelerate and improve diagnosis of patients in state-of-the art clinical research facilities. With the accession of Erasmus MC, we take a big step towards achieving this goal.”

Kees van den Berg, CEO GenomeScan: “Our partnership with both UMCs, allows GenomeScan to strengthen its engagement in developing new tools to diagnose genetic disorders quicker, affordably and more effectively. By sharing knowledge and regrouping facilities, this partnership helps the company to rapidly invest in costly emerging technologies, in a thoroughly sustainable manner, under ISO-accreditation for healthcare providers or academic research and under G(C)LP for the pharmaceutical market.”

Source: GenomeScan

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Alveron pharma closes series A round to advance a cyclodextrin based procoagulant medicine into the clinic

Alveron Pharma, a newly incorporated company established by Okklo Life Sciences BV and Sanquinnovate (part of Sanquin), is pleased to announce the closing of a EUR 6.5M Series A financing round led by Thuja together with Waterman Ventures and Oost NL. This investment allows Alveron Pharma to select a lead compound, conduct non-clinical studies, and complete a first clinical study to demonstrate safety and obtain a first clinical readout.

Alveron Pharma will focus on a unique class of cyclodextrin-based drugs, that have the ability to promote blood coagulation without inducing it in the absence of bleeding. Alveron’s first target is to reverse the effects of anticoagulants. Anticoagulants (“blood thinners”) are widely prescribed to patients with increased thromboembolic risk. While effective in preventing thrombosis, these drugs also inhibit blood coagulation when this is needed urgently, e.g. in patients who suffer a major bleed or in case of emergency surgery. Anticoagulant related bleedings are not uncommon, and may be serious, and difficult to treat since no or only selective reversal agents are available. Alveron’s cyclodextrins are unique in the sense that they restore coagulation independent of the type of anticoagulant used. Sales of selective reversal agents have been estimated at around $2 billion per annum.

Ben Nichols, CEO of Alveron Pharma: “There is a clear unmet clinical need for a universal anti-coagulant reversal agent, and the early pre-clinical data for Alveron’s unique cyclodextrin compounds are compelling. Having recently taken a new class of coagulant into clinical trials, I am thrilled to be joining the founders of this business,  Stephan Peters (who conceived the original idea, CSO) and Alex Zwiers (COO), with their expertise on cyclodextrins, and coagulation expert at Sanquin, Joost Meijers  (Chairman of the Scientific Advisory Board). Alex was also involved in the development of the world’s first cyclodextrin-based medicine, Bridion®.”

“Multiple factors come together in this investment that are highly attractive”, says Michel Briejer of Thuja, who led this transaction. “A highly experienced and knowledgeable team, a promising set of drug leads, and a reputable partner in the field of blood, Sanquin. We are extremely pleased to be part of this venture and are confident that Alveron will create success for doctors and patients alike.”