Het is Staatssecretaris Blokhuis menens: om de dalende vaccinatiegraad een halt toe te roepen zet hij in op meer zichtbaarheid voor het belang van vaccins en een vergroot draagvlak en vaccinatiebereidheid onder de bevolking. In een brief aan de Tweede Kamer, “Verder met vaccineren”, licht hij zijn aanpak nader toe. De doortastendheid van Blokhuis weten we bij HollandBIO te waarderen. Sterker nog, die smaakt naar meer. Want niet alleen de teruglopende vaccinatiegraad baart ons zorgen, ook het vastgelopen systeem rond de beoordeling en inzet van nieuwe vaccins schreeuwt om daadkracht.
Al in 2007, 2013 en 2014 concludeerden de Gezondheidsraad en toenmalig minister Schippers dat Nederland op het vlak van vaccinatie gezondheidswinst laat liggen. Om het tij te keren deed de oud-minister een voorstel voor een vaccinatiezorgmodel. Totdat dat model realiteit is, blijft HollandBIO pleiten voor structurele maatregelen om gezondheidswinst waar mogelijk te verzilveren met vaccinatie – zowel binnen als buiten de vaccinatieprogramma’s. Een infectiepreventieakkoord, met afspraken over zowel de beoordeling, vergoeding en implementatie van nieuwe vaccins als de communicatie hierover, is volgens HollandBIO een essentiële eerste stap.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-11-20 17:01:332023-09-27 16:32:20Staatssecretaris Blokhuis in actie voor het belang van vaccineren← #nieuws
Vijf Nederlandse ziekenhuizen hebben de handen ineen geslagen om optimale zorg te leveren aan mensen die lijden aan Inflammatory Bowel Disease (IBD). IBDream, een persoonlijk online dossier, dat tevens dient als onderzoeksregister, wordt hiervoor ingezet. IBDream bedient nu 2.000 patiënten. De ambitie is om in 2020, door meer ziekenhuizen te laten aansluiten, maar liefst 5.000 patiënten te bereiken. Het farmaceutisch bedrijf Janssen ondersteunt de IBDream-ziekenhuizen bij het realiseren van deze ambitie. Consultancybedrijf Vintura heeft het projectmanagement verzorgd.
Met IBDream heeft de arts of verpleegkundige een goed overzicht van de behandeling en uitkomsten, per patiënt en voor de gehele patiëntenpopulatie. Het inzicht in het ziekteverloop helpt daarnaast ook patiënten om meer grip op hun aandoening te krijgen en stelt farmaceutische bedrijven, op basis van geanonimiseerde data, beter in staat om innovatieve therapieën in IBD te ontwikkelen en op een goede manier aan te bieden. Om deze redenen is IBDream in de afgelopen jaren gesponsord door meerdere farmaceutische bedrijven (AbbVie, Celgene, Takeda, Pfizer, Janssen, Dr Falk, MundiPharma, MSD) en ZonMW, een overheidsinstelling die gezondheidsonderzoek financiert.
In 2011 richtten Dr. Rachel West, Drs. Tessa Römkens en Drs. Jeroen Jansen de initiële IBD-database op in het Franciscus Gasthuis en Vlietland Rotterdam, het Jeroen Bosch Ziekenhuis en het Onze Lieve Vrouwe Gasthuis. Vervolgens sloten het Medisch Spectrum Twente en het Radboudumc aan, onder leiding van Dr. Maurice Russel en Dr. Frank Hoentjen, en werd de database verder uitgebouwd tot IBDream. De belangrijkste redenen om IBDream op te zetten waren enerzijds IBD-patiënten de best mogelijke zorg geven, op een manier die past bij het individu, anderzijds de zorg betaalbaar houden.
Als vervolgstap is het project IBDream 2.0 van start gegaan, een uitbreiding van IBDream zowel qua bereik als inhoud van dit register. Dr. Frank Hoentjen, MDL-arts Radboudumc Nijmegen en bestuurslid van IBDream, licht dit verder toe: “Het doel van dit project is om de gebruiksvriendelijkheid verder te verbeteren en alle mogelijkheden van IBDream te benutten. Concreet betekent dit onder andere dat IBDream tegen 2020 5.000 patiënten wil gaan bedienen door de samenwerking aan te gaan met nog eens vijf nieuwe ziekenhuizen.“
Het project IBDream 2.0 wordt financieel ondersteund door het farmaceutisch bedrijf Janssen. Daarnaast delen Janssen en Vintura gezamenlijk hun expertise en tools met het IBDream team in het kader van innovatie en zorgverbetering. Zij doen dit vanuit hun beider ambitie om bij te dragen aan waardegedreven zorg, als manier om de gezondheidszorg duurzaam betaalbaar en tegelijk innovatief te houden.
“Janssen wil bijdragen aan een toekomst waarin zorg wordt bekostigd op basis van de werkelijke waarde voor de patiënt, ofwel een Nederlands zorglandschap gebaseerd op de principes van Value Based Healthcare” zegt Michel Van Agthoven, Director External Affairs Nederland bij Janssen-Cilag B.V. in Breda.
Facio Therapies announced today that it had successfully completed an equity financing round with proceeds of €8M (approximately A$12.5M; C$12M; US$9M). FSHD Spain and 30 other members of the FSHD community newly invested alongside existing investors, including Facio’s drug discovery partner, Evotec. Facio will use these funds to expand its recently announced in vivoproof of principle and to advance selected lead candidates towards clinical studies.
The key event in FSHD is the undue production of the DUX4 protein in skeletal muscle. DUX4 sets in motion a cascade of biochemical events that eventually result in the devastating effects of FSHD. In people without FSHD, the production of DUX4 in skeletal muscle is repressed by regulatory mechanisms. Facio’s single goal is to develop therapies that restore this repression as much as possible. Facio is the only one in the FSHD field with a fully automated, high-throughput screening platform based on quantifying the DUX4 protein in unadulterated (“primary”) FSHD-affected muscle cells. Recently, Facio delivered the first-ever proof of principle in FSHD using one of its lead candidates in a unique FSHD-relevant animal model (“in vivo”).
Three FSHD-affected families founded Facio in September 2014. Since then, Facio has raised over €16M in equity. About 77% of that amount has been invested by members of the FSHD community. Facio’s investor base now spans 14 countries around the world. FSHD Spain became the fifth FSHD foundation to invest in Facio, joining Amis FSH(France), FSHD Canada, FSHD Global Research (Australia), and the FSHD Stichting (Netherlands).
“The success of this financing round is not only that we reached our goal of raising €8 million,” said Facio’s Chairman, Kees van der Graaf. “The success is just as well that Facio’s message resonates with an ever-growing number of FSHD-affected families across the globe. We, people living with FSHD, don’t have to wait and hope for a breakthrough to happen. We’re breaking through to therapy ourselves. That is Facio’s message.”
Voor HollandBIO kan een dag bijna niet beter beginnen: het FD openslaan en lezen ‘hoe een Nederlands middel tegen kanker de wereld verovert’. Een prachtige reconstructie van Thieu Vaessen over de Nederlandse roots van Keytruda, of Pembrolizumab, een innovatief medicijn tegen kanker dat soms spectaculaire resultaten laat zien. En als je dan na een lange werkdag thuiskomt en Aduro Biotech’s Hans van Eenennaam samen met een dankzij ‘Pembro’ weer gezonde patiënt ziet schitteren in De Wereld Draait Door, kan de dag echt niet meer stuk. Koplopers uit de Nederlandse biotech volop in de schijnwerpers, zo zien we het graag! Lees terug, kijk terug, en wees trots op onze prachtige sector.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-11-15 21:21:012018-11-20 21:23:54HollandBIO Kijk- en Leestip: het verhaal van Keytruda← #nieuws
DCprime, a clinical stage biotechnology company focused on cancer immunotherapies, announces that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II. Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.
Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: “We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse.”
The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.
Dr Jeroen Rovers, Chief Medical Officer at DCprime added: “Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study.”
Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).
uniQure, a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, today announced initial clinical data in patients treated in the Company’s Phase IIb dose-confirmation study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant, for the treatment of patients with severe and moderately severe hemophilia B. These data show that therapeutic levels of Factor IX (FIX) activity have been achieved and sustained in all three patients at six weeks after a single administration of AMT-061.* AMT-061 has been granted Breakthrough Therapy Designation by the United States Food and Drug Administration (FDA) and access to the Priority Medicine (PRIME) regulatory initiative by the European Medicines Agency (EMA).
The Phase IIb study of AMT-061 is an open-label, single-dose, single-arm, multi-center trial being conducted in the United States. Three patients with severe hemophilia were enrolled in this study and received a single intravenous infusion of 2×1013 vc/kg. Patients are evaluated for the presence of pre-existing neutralizing antibodies to AAV5 but not excluded from the trial on that basis. The objective of the study is to evaluate the safety and tolerability of AMT-061 and confirm the dose based on FIX activity at six weeks after administration. Patients in the study will be followed for 52 weeks to assess FIX activity, bleeding rates and usage of FIX replacement therapy, and will be monitored for five years to evaluate the safety of AMT-061.
Data from the study show that all three patients experienced increasing and sustained FIX levels after a one-time administration of AMT-061. Six weeks after administration mean FIX activity for the three patients was 31% of normal, exceeding threshold FIX levels generally considered sufficient to significantly reduce the risk of bleeding events. FIX activity was measured using an activated partial thromboplastin time (aPTT) assay performed at a central laboratory. The first patient achieved FIX activity of 37% of normal at ten weeks after administration. FIX activity in the second patient was 23% of normal at eight weeks following administration and in the third patient was 30% of normal at six weeks after administration. The second and third patients had previously screen-failed another gene therapy study due to pre-existing neutralizing antibodies to a different AAV vector.
ttopstart and PNO will join forces in their ambition to become Europe’s leading consultancy in strategy and funding services in life sciences and health. Together, ttopstart-PNO will now have 50 life sciences professionals located in 6 European countries.
ttopstart was founded in 2009 as a university spin-off from the VU University in Amsterdam. Since then, the company has rapidly grown into one of the leading consultancy companies in the field of life sciences and health. The collaboration with PNO Group is the next step to accelerate further growth of the company.
Avansya venture to help food and beverage producers deliver the products and brands consumers love, with significantly reduced calories
As food and beverage producers look to significantly reduce calories in their offerings to consumers, they are in need of non-artificial, zero-calorie, great-tasting sweetener options. Today,Cargill and Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announced a new joint venture, Avansya, to rise to this challenge. Together, the companies will produce highly sought-after, sweet-tasting molecules, such as steviol glycosides Reb M and Reb D through fermentation, giving food and beverage manufacturers an even more scalable, sustainable and low cost-in-use solution than if these same molecules were extracted from the stevia leaf.
The new venture will combine both companies’ technologies for producing steviol glycoside products made through fermentation and will market its products under one brand name, EverSweet™.
The joint venture will be a 50-50 partnership between the two companies. The establishment of the joint venture is subject to regulatory approvals and other customary closing conditions but expected to be finalized in the first calendar quarter of 2019.
The partnership leverages the two companies’ highly complementary strengths for bringing to market fermentation-derived Reb M and Reb D steviol glycosides:
DSM brings its leading biotechnology know-how, providing R&D expertise, including strain development and fermentation process development capabilities, as well as customer relationships in specific market segments;
Cargill brings its unrivalled application expertise and global commercial footprint in the sweetener market, as well as large-scale fermentation capacity with access to co-located, raw material suppliers at its Blair, Nebraska (USA) site.
The joint venture will make use of a new fermentation facility being built at the site in Blair, which is expected to be completed and operating in summer 2019.
“We are delighted to announce this game-changing joint venture with Cargill,” said DSM Food Specialties President, Patrick Niels. “One of the most significant transformations in global food & beverage markets is the drive to reduce sugar in people’s diets. This partnership will allow us to bring sustainably produced sugar-reduction solutions based on steviol glycosides to market faster and more effectively at a scale to deliver global impact. Both DSM and Cargill are purpose-led companies. We want to positively impact our societies, enable our customers’ brands and businesses to be successful in their markets, and in doing so support our own further growth.”
“The demand for sugar-reduction solutions is urgent, global, and growing fast,” said Cargill Vice President Food Segment North America, Chris Simons. “While consumers are searching out foods and beverages that help meet their dietary needs or goals, whether for a diabetic diet or simply reducing calories and sugar intake, brand-owners know that great taste can’t be compromised. By partnering with DSM, we can further advance a commercialized Reb M & Reb D product line that offers what consumers desire.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-11-13 23:04:092018-11-13 23:06:45Cargill and Royal DSM to establish joint venture Avansya: to bring zero-calorie, cost-effective sweeteners to market faster← #nieuws
Last week, more than 4300 attendees from all over the world visited BIO-Europe in Copenhagen, the largest European partnering conference for biotech and biopharma. The conference welcomed a strong delegation of over 150 Dutch biotech entrepreneurs. The well-attended Health~Holland Pavilion served as the central information point for international visitors with questions regarding the Dutch business and innovation climate and the national life sciences & health sector. During the Hospitality Reception on Tuesday, the Health~Holland Pavilion was the epicentre of BIO-Europe. All in all, a very inspiring and successful edition!
We are already looking forward to BIO-Europe Spring in Vienna, March 25 – 27, 2019. HollandBIO members are eligible to a €300 discount per person on the regular registration fee, more information will follow soon here.
At HollandBIO, we are proud to announce that FunGeneX has joined our community.
FunGeneX BV develops Fungal Gene Expression and production technologies. The company has succeeded in expressing Hen Ovalbumin in Fungi, which is an interesting product to be used in various vegan food applications such as meat analogues, pastry and bakery applications.
The production of proteins in fungi is something that has been done in industrial enzymes production for decades but the production of food proteins in fermenters is becoming more and more interesting in view of the challenge to feed 10 billion people in a sustainable way by 2050 on 1500 million hectares of arable land. This new way of producing food proteins from sugars is also called “Cellular Agriculture” and is far more efficient (>10x) than traditional agriculture using animals. Moreover, this allows to reduce greenhouse gas emissions, less manure production, less animal cruelty, less smell, no vulnerable situation with bird’s flu and reduces the non-human antibiotic use that boosts the antibiotic resistant bacteria (AMR).
FunGeneX BV also licenses the fungal technologies to third parties for non-strategic food, industrial, pharmaceutical and agricultural applications.
FunGeneX BV, founded in 2016, is 100% daughter company owned by BioscienZ a company founded in 2010, which started a research lab in Breda in 2014. The company is now having a Food pilot facility with up to 15 L scale fermenters to produce kg scale wet or dried products and a molecular biology lab and employs 12 people in total.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-11-13 22:48:502018-11-13 22:48:50HollandBIO welcomes FunGeneX as a new member
Staatssecretaris Blokhuis in actie voor het belang van vaccineren
Gezondheid op maat, Hollandbio, GezondheidHet is Staatssecretaris Blokhuis menens: om de dalende vaccinatiegraad een halt toe te roepen zet hij in op meer zichtbaarheid voor het belang van vaccins en een vergroot draagvlak en vaccinatiebereidheid onder de bevolking. In een brief aan de Tweede Kamer, “Verder met vaccineren”, licht hij zijn aanpak nader toe. De doortastendheid van Blokhuis weten we bij HollandBIO te waarderen. Sterker nog, die smaakt naar meer. Want niet alleen de teruglopende vaccinatiegraad baart ons zorgen, ook het vastgelopen systeem rond de beoordeling en inzet van nieuwe vaccins schreeuwt om daadkracht.
Al in 2007, 2013 en 2014 concludeerden de Gezondheidsraad en toenmalig minister Schippers dat Nederland op het vlak van vaccinatie gezondheidswinst laat liggen. Om het tij te keren deed de oud-minister een voorstel voor een vaccinatiezorgmodel. Totdat dat model realiteit is, blijft HollandBIO pleiten voor structurele maatregelen om gezondheidswinst waar mogelijk te verzilveren met vaccinatie – zowel binnen als buiten de vaccinatieprogramma’s. Een infectiepreventieakkoord, met afspraken over zowel de beoordeling, vergoeding en implementatie van nieuwe vaccins als de communicatie hierover, is volgens HollandBIO een essentiële eerste stap.
Meer informatie
IBDream wil 5.000 IBD-patiënten gaan bedienen in 2020
GezondheidVijf Nederlandse ziekenhuizen hebben de handen ineen geslagen om optimale zorg te leveren aan mensen die lijden aan Inflammatory Bowel Disease (IBD). IBDream, een persoonlijk online dossier, dat tevens dient als onderzoeksregister, wordt hiervoor ingezet. IBDream bedient nu 2.000 patiënten. De ambitie is om in 2020, door meer ziekenhuizen te laten aansluiten, maar liefst 5.000 patiënten te bereiken. Het farmaceutisch bedrijf Janssen ondersteunt de IBDream-ziekenhuizen bij het realiseren van deze ambitie. Consultancybedrijf Vintura heeft het projectmanagement verzorgd.
Met IBDream heeft de arts of verpleegkundige een goed overzicht van de behandeling en uitkomsten, per patiënt en voor de gehele patiëntenpopulatie. Het inzicht in het ziekteverloop helpt daarnaast ook patiënten om meer grip op hun aandoening te krijgen en stelt farmaceutische bedrijven, op basis van geanonimiseerde data, beter in staat om innovatieve therapieën in IBD te ontwikkelen en op een goede manier aan te bieden. Om deze redenen is IBDream in de afgelopen jaren gesponsord door meerdere farmaceutische bedrijven (AbbVie, Celgene, Takeda, Pfizer, Janssen, Dr Falk, MundiPharma, MSD) en ZonMW, een overheidsinstelling die gezondheidsonderzoek financiert.
In 2011 richtten Dr. Rachel West, Drs. Tessa Römkens en Drs. Jeroen Jansen de initiële IBD-database op in het Franciscus Gasthuis en Vlietland Rotterdam, het Jeroen Bosch Ziekenhuis en het Onze Lieve Vrouwe Gasthuis. Vervolgens sloten het Medisch Spectrum Twente en het Radboudumc aan, onder leiding van Dr. Maurice Russel en Dr. Frank Hoentjen, en werd de database verder uitgebouwd tot IBDream. De belangrijkste redenen om IBDream op te zetten waren enerzijds IBD-patiënten de best mogelijke zorg geven, op een manier die past bij het individu, anderzijds de zorg betaalbaar houden.
Als vervolgstap is het project IBDream 2.0 van start gegaan, een uitbreiding van IBDream zowel qua bereik als inhoud van dit register. Dr. Frank Hoentjen, MDL-arts Radboudumc Nijmegen en bestuurslid van IBDream, licht dit verder toe: “Het doel van dit project is om de gebruiksvriendelijkheid verder te verbeteren en alle mogelijkheden van IBDream te benutten. Concreet betekent dit onder andere dat IBDream tegen 2020 5.000 patiënten wil gaan bedienen door de samenwerking aan te gaan met nog eens vijf nieuwe ziekenhuizen.“
Het project IBDream 2.0 wordt financieel ondersteund door het farmaceutisch bedrijf Janssen. Daarnaast delen Janssen en Vintura gezamenlijk hun expertise en tools met het IBDream team in het kader van innovatie en zorgverbetering. Zij doen dit vanuit hun beider ambitie om bij te dragen aan waardegedreven zorg, als manier om de gezondheidszorg duurzaam betaalbaar en tegelijk innovatief te houden.
“Janssen wil bijdragen aan een toekomst waarin zorg wordt bekostigd op basis van de werkelijke waarde voor de patiënt, ofwel een Nederlands zorglandschap gebaseerd op de principes van Value Based Healthcare” zegt Michel Van Agthoven, Director External Affairs Nederland bij Janssen-Cilag B.V. in Breda.
Source: IBDream
Facio raises €8M in equity financing
InnovatieklimaatFacio Therapies announced today that it had successfully completed an equity financing round with proceeds of €8M (approximately A$12.5M; C$12M; US$9M). FSHD Spain and 30 other members of the FSHD community newly invested alongside existing investors, including Facio’s drug discovery partner, Evotec. Facio will use these funds to expand its recently announced in vivoproof of principle and to advance selected lead candidates towards clinical studies.
The key event in FSHD is the undue production of the DUX4 protein in skeletal muscle. DUX4 sets in motion a cascade of biochemical events that eventually result in the devastating effects of FSHD. In people without FSHD, the production of DUX4 in skeletal muscle is repressed by regulatory mechanisms. Facio’s single goal is to develop therapies that restore this repression as much as possible. Facio is the only one in the FSHD field with a fully automated, high-throughput screening platform based on quantifying the DUX4 protein in unadulterated (“primary”) FSHD-affected muscle cells. Recently, Facio delivered the first-ever proof of principle in FSHD using one of its lead candidates in a unique FSHD-relevant animal model (“in vivo”).
Three FSHD-affected families founded Facio in September 2014. Since then, Facio has raised over €16M in equity. About 77% of that amount has been invested by members of the FSHD community. Facio’s investor base now spans 14 countries around the world. FSHD Spain became the fifth FSHD foundation to invest in Facio, joining Amis FSH(France), FSHD Canada, FSHD Global Research (Australia), and the FSHD Stichting (Netherlands).
“The success of this financing round is not only that we reached our goal of raising €8 million,” said Facio’s Chairman, Kees van der Graaf. “The success is just as well that Facio’s message resonates with an ever-growing number of FSHD-affected families across the globe. We, people living with FSHD, don’t have to wait and hope for a breakthrough to happen. We’re breaking through to therapy ourselves. That is Facio’s message.”
Source: Facio
HollandBIO Kijk- en Leestip: het verhaal van Keytruda
Hollandbio, Gezondheid, InnovatieklimaatVoor HollandBIO kan een dag bijna niet beter beginnen: het FD openslaan en lezen ‘hoe een Nederlands middel tegen kanker de wereld verovert’. Een prachtige reconstructie van Thieu Vaessen over de Nederlandse roots van Keytruda, of Pembrolizumab, een innovatief medicijn tegen kanker dat soms spectaculaire resultaten laat zien. En als je dan na een lange werkdag thuiskomt en Aduro Biotech’s Hans van Eenennaam samen met een dankzij ‘Pembro’ weer gezonde patiënt ziet schitteren in De Wereld Draait Door, kan de dag echt niet meer stuk. Koplopers uit de Nederlandse biotech volop in de schijnwerpers, zo zien we het graag! Lees terug, kijk terug, en wees trots op onze prachtige sector.
DCprime: first patient dosed in phase 2 study
GezondheidDCprime, a clinical stage biotechnology company focused on cancer immunotherapies, announces that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II. Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.
Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: “We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse.”
The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.
Dr Jeroen Rovers, Chief Medical Officer at DCprime added: “Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study.”
Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).
Source: DCprime
uniQure Announces Initial Topline Data
GezondheiduniQure, a leading gene therapy company advancing transformative therapies for patients with severe unmet medical needs, today announced initial clinical data in patients treated in the Company’s Phase IIb dose-confirmation study of AMT-061, an investigational AAV5-based gene therapy containing a patent-protected FIX-Padua variant, for the treatment of patients with severe and moderately severe hemophilia B. These data show that therapeutic levels of Factor IX (FIX) activity have been achieved and sustained in all three patients at six weeks after a single administration of AMT-061.* AMT-061 has been granted Breakthrough Therapy Designation by the United States Food and Drug Administration (FDA) and access to the Priority Medicine (PRIME) regulatory initiative by the European Medicines Agency (EMA).
The Phase IIb study of AMT-061 is an open-label, single-dose, single-arm, multi-center trial being conducted in the United States. Three patients with severe hemophilia were enrolled in this study and received a single intravenous infusion of 2×1013 vc/kg. Patients are evaluated for the presence of pre-existing neutralizing antibodies to AAV5 but not excluded from the trial on that basis. The objective of the study is to evaluate the safety and tolerability of AMT-061 and confirm the dose based on FIX activity at six weeks after administration. Patients in the study will be followed for 52 weeks to assess FIX activity, bleeding rates and usage of FIX replacement therapy, and will be monitored for five years to evaluate the safety of AMT-061.
Data from the study show that all three patients experienced increasing and sustained FIX levels after a one-time administration of AMT-061. Six weeks after administration mean FIX activity for the three patients was 31% of normal, exceeding threshold FIX levels generally considered sufficient to significantly reduce the risk of bleeding events. FIX activity was measured using an activated partial thromboplastin time (aPTT) assay performed at a central laboratory. The first patient achieved FIX activity of 37% of normal at ten weeks after administration. FIX activity in the second patient was 23% of normal at eight weeks following administration and in the third patient was 30% of normal at six weeks after administration. The second and third patients had previously screen-failed another gene therapy study due to pre-existing neutralizing antibodies to a different AAV vector.
Source: Forbion (press release)
ttopstart joins PNO Group
Innovatieklimaatttopstart and PNO will join forces in their ambition to become Europe’s leading consultancy in strategy and funding services in life sciences and health. Together, ttopstart-PNO will now have 50 life sciences professionals located in 6 European countries.
ttopstart was founded in 2009 as a university spin-off from the VU University in Amsterdam. Since then, the company has rapidly grown into one of the leading consultancy companies in the field of life sciences and health. The collaboration with PNO Group is the next step to accelerate further growth of the company.
Read more
Cargill and Royal DSM to establish joint venture Avansya: to bring zero-calorie, cost-effective sweeteners to market faster
Voedsel en materialen, InnovatieklimaatAvansya venture to help food and beverage producers deliver the products and brands consumers love, with significantly reduced calories
As food and beverage producers look to significantly reduce calories in their offerings to consumers, they are in need of non-artificial, zero-calorie, great-tasting sweetener options. Today,Cargill and Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announced a new joint venture, Avansya, to rise to this challenge. Together, the companies will produce highly sought-after, sweet-tasting molecules, such as steviol glycosides Reb M and Reb D through fermentation, giving food and beverage manufacturers an even more scalable, sustainable and low cost-in-use solution than if these same molecules were extracted from the stevia leaf.
The new venture will combine both companies’ technologies for producing steviol glycoside products made through fermentation and will market its products under one brand name, EverSweet™.
The joint venture will be a 50-50 partnership between the two companies. The establishment of the joint venture is subject to regulatory approvals and other customary closing conditions but expected to be finalized in the first calendar quarter of 2019.
The partnership leverages the two companies’ highly complementary strengths for bringing to market fermentation-derived Reb M and Reb D steviol glycosides:
The joint venture will make use of a new fermentation facility being built at the site in Blair, which is expected to be completed and operating in summer 2019.
“We are delighted to announce this game-changing joint venture with Cargill,” said DSM Food Specialties President, Patrick Niels. “One of the most significant transformations in global food & beverage markets is the drive to reduce sugar in people’s diets. This partnership will allow us to bring sustainably produced sugar-reduction solutions based on steviol glycosides to market faster and more effectively at a scale to deliver global impact. Both DSM and Cargill are purpose-led companies. We want to positively impact our societies, enable our customers’ brands and businesses to be successful in their markets, and in doing so support our own further growth.”
“The demand for sugar-reduction solutions is urgent, global, and growing fast,” said Cargill Vice President Food Segment North America, Chris Simons. “While consumers are searching out foods and beverages that help meet their dietary needs or goals, whether for a diabetic diet or simply reducing calories and sugar intake, brand-owners know that great taste can’t be compromised. By partnering with DSM, we can further advance a commercialized Reb M & Reb D product line that offers what consumers desire.”
Source: DSM
Fruitful BIO-Europe for Dutch Biotech Community
HollandbioLast week, more than 4300 attendees from all over the world visited BIO-Europe in Copenhagen, the largest European partnering conference for biotech and biopharma. The conference welcomed a strong delegation of over 150 Dutch biotech entrepreneurs. The well-attended Health~Holland Pavilion served as the central information point for international visitors with questions regarding the Dutch business and innovation climate and the national life sciences & health sector. During the Hospitality Reception on Tuesday, the Health~Holland Pavilion was the epicentre of BIO-Europe. All in all, a very inspiring and successful edition!
We are already looking forward to BIO-Europe Spring in Vienna, March 25 – 27, 2019. HollandBIO members are eligible to a €300 discount per person on the regular registration fee, more information will follow soon here.
HollandBIO welcomes FunGeneX as a new member
HollandbioAt HollandBIO, we are proud to announce that FunGeneX has joined our community.
FunGeneX BV develops Fungal Gene Expression and production technologies. The company has succeeded in expressing Hen Ovalbumin in Fungi, which is an interesting product to be used in various vegan food applications such as meat analogues, pastry and bakery applications.
The production of proteins in fungi is something that has been done in industrial enzymes production for decades but the production of food proteins in fermenters is becoming more and more interesting in view of the challenge to feed 10 billion people in a sustainable way by 2050 on 1500 million hectares of arable land. This new way of producing food proteins from sugars is also called “Cellular Agriculture” and is far more efficient (>10x) than traditional agriculture using animals. Moreover, this allows to reduce greenhouse gas emissions, less manure production, less animal cruelty, less smell, no vulnerable situation with bird’s flu and reduces the non-human antibiotic use that boosts the antibiotic resistant bacteria (AMR).
FunGeneX BV also licenses the fungal technologies to third parties for non-strategic food, industrial, pharmaceutical and agricultural applications.
FunGeneX BV, founded in 2016, is 100% daughter company owned by BioscienZ a company founded in 2010, which started a research lab in Breda in 2014. The company is now having a Food pilot facility with up to 15 L scale fermenters to produce kg scale wet or dried products and a molecular biology lab and employs 12 people in total.
For more information visit www.bioscienz.nl