Janssen said FDA cleared an IND for CAR T therapy JNJ-68284528 to treat multiple myeloma. Next half, the unit of Johnson & Johnson expects to start a U.S. and European Phase Ib/II study of Legend Biotech’s therapy targeting BCMA.
At last year’s American Society of Clinical Oncology (ASCO) meeting, Legend reported JNJ-68284528 led to a 100% objective response rate among 19 MM patients in the first phase of the Chinese Phase I/II LEGEND-2 study. No neurotoxicities, which can plague anti-CD19 CAR T therapies, were observed.
In December 2017, Janssen obtained a global license to the therapy from the Legend Biotech USA Inc. and Legend Biotech Ireland Ltd. subsidiaries of Genscript Biotech Corp. The partners are developing JNJ-68284528 jointly worldwide.
The therapy is Janssen’s first in the CAR T space. At the time of the deal, Janssen’s Global Therapeutic Area Head of Oncology Peter Lebowitz told BioCentury BCMA was the first target to meet the company’s safety and efficacy standards for the CAR T modality (see BioCentury, Jan. 5).
Janssen said the primary efficacy endpoint in the Phase II portion of its planned trial to treat relapsed or refractory MM will be overall response rate (ORR) as defined by the International Myeloma Working Group response criteria.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-30 17:42:112018-06-05 17:43:44Janssen taking Legend CAR T therapy to clinic← #nieuws
GlycoMScan has opened their company’s doors in the van Leeuwenhoek building’s basement. GlycoMScan offers services in mass spectrometry, from screening of small molecules to absolute quantification in complex biological matrices. “As the name suggests, I am specialized in analyses of glycosylation and the building blocks thereof, the nucleotide sugars and phosphorylated sugars from intracellular metabolism,” tells Monique van Scherpenzeel, GlycoMScan’s CEO. ”I chose Pivot Park because of the inspiring atmosphere of (start-up) companies in pharma and life sciences, the good quality laboratory facilities and the opportunity for me and my company to serve your R&D with my services in mass spectrometry.”
“The fact that GlycoMScan is already developing several collaborations with community members shows what a good addition this company is to the Pivot Park pharma R&D ecosystem,” tells Brigitte Drees, Pivot Park’s CEO. “Thanks to our extensive experience we’ve been able to support GlycoMScan in becoming operable in a short time.”
Glycomscan has three types of mass spectrometers in-house, offering short time-to-results. These are:
Sensitive high-end UHPLC-QqQ for intracellular quantification of (sugar) metabolites
High-throughput, large capacity MRM analyses for pharmacokinetics and quantification of small molecules in complex biological matrices
Open access HPLC-MS for small molecule analyses.
High-resolution or other types of mass spectrometry, e.g. QTOF or GC-MS are available upon request. Interested in learning more? Contact Monique van Scherpenzeel bye-mail.
GOLDEN rice, which has been genetically modified to prevent blindness in undernourished children, was judged safe to eat last week by the US Food and Drug Administration.
The rice contains extra genes that make a precursor to vitamin A, which is vital for preventing childhood blindness. A single helping can supply half the recommended daily intake of vitamin A, according to its developers at the International Rice Research Institute in the Philippines. The genes also give it its distinctive golden hue.
The nod by the FDA makes the US the fourth country to approve the rice this year, behind Canada, Australia and New Zealand. Having the rice cleared in these countries means there would be no regulatory issues if they imported food containing small quantities of the rice.
But its developer says the most important approvals are still awaited in the Philippines and Bangladesh, where the rice could have the greatest impact. Applications were lodged there last year.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-30 11:23:362018-06-05 11:26:37GM golden rice gets approval from food regulators in the US← #nieuws
Phase 1 study suggests that novel oral formulation improves bioavailability while remaining well tolerated.
Treeway, a biotech company developing therapies against amyotrophic lateral sclerosis (ALS), announced the completion of its Phase I trial of lead program TW001, an oral formulation of edaravone. The study compared the bioavailability of TW001 in its novel market formulation to Radicava, an FDA approved, intravenous formulation of edaravone, indicated for the treatment of ALS. The study indicates increased bioavailability of TW001 in a single-dose treatment whilst no safety concerns developed within the subject group, implying the potential of the novel formulation to improve treatment strategies for ALS patients. Based on these results, Treeway has initiated the upscaling program and preparations for a pivotal Phase 3 study. Edaravone is a neuroprotective agent that reduces oxidative stress, a key contributor to neuronal death in ALS.
“It is Treeway’s mission to identify novel treatment routes for ALS patients and we believe that this study indicates that an oral formulation of edavarone may offer patients a better quality-of-life through a simpler and more effective route of administration,” said Ronald van der Geest, Chief Development Officer of Treeway. “Given the nature of this program and based on the positive results we have seen in this comparative study, we can initiate a pivotal Phase 3 study and move rapidly toward bringing TW001 to patients.”
The randomized, cross-over comparative bioavailability trial tested a single oral dose of 140 mg TW001, compared to a 1-hour intravenous infusion of 60 mg edaravone in 18 healthy subjects. In this study, the bioavailability of the novel oral formulation exceeded the bioavailability of the intravenous infusion of Radicava. Within the subject group of the study the treatment was well-tolerated and no safety concerns arose during the conduct of the study. Furthermore, ongoing formulation studies also suggest that the formulation is stable.
Merit Cudkowicz, MD, Chief Neurology Service and Director of the ALS Clinic at the Massachusetts General Hospital, a key advisor to the company, commented:
“The results of this Phase I study are a promising sign for ALS patients, who are in high need of better and more patient-friendly treatments for their disease. I regard this study to be a key milestone for the development of TW001 in ALS and I look forward to supporting the company’s scientific and clinical progress.”
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-29 16:14:092018-05-29 16:14:41Treeway prepares phase 3 study for TW001 to treat ALS← #nieuws
Op donderdag 31 mei organiseert de vaste Kamercommissie EZK een rondetafelgesprek over de nieuwe investeringsinstelling Invest-NL. Hierbij komen verschillende stakeholders aan het woord. HollandBIO’s Annemiek Verkamman zal namens de biotech sector pleiten voor een ijzersterk innovatieklimaat met een uitgekiende financieringsmix voor life sciences bedrijven. Op deze manier hebben bedrijven in alle fases van ontwikkeling toegang tot voldoende financiering. Daarmee kunnen zij werken aan innovatieve oplossingen voor de grote maatschappelijke uitdagingen waar wij voor staan.
Investeren in de life sciences sector loont. In Nederland zetten we wetenschappelijke excellentie, technologie en ondernemerschap succesvol om in maatschappelijke en economische waarde. De Nederlandse life sciences sector zit stevig in de lift. De afgelopen tien jaar verdubbelde de sector in omvang. En, zoals we voor ogen hebben in onze toekomstvisie Life Sciences 2030, stoot de sector van een Europese topvijfpositie door naar de absolute wereldtop. Dat betekent dat er werk aan de winkel is.
Valley of death
Voor een sterk innovatieklimaat zijn voldoende financieringsmogelijkheden in de verschillende fases van ontwikkeling onontbeerlijk. Dit voorkomt dat bedrijven na hun eerste stappen in de beruchte valley of death belanden: de financieringskloof die doorgroei van startups naar scale-ups in de weg staat. Hier moeten zowel publieke als private partijen op inspelen. Invest-NL kan volgens HollandBIO helpen de kloof te dichten.
Rol van Invest-NL
Invest-NL gaat zich richten op het financieren en realiseren van innovatie met maatschappelijke impact waar de markt nu niet in voorziet, zoals bij langlopende, risicovolle activiteiten het geval is. Om de investeringsinstelling tot een succes te maken voor bedrijven in de life sciences, is er volgens HollandBIO actie vereist. Zo moet er een mandaat en uitvoeringstaak komen gericht op het financieren van risicovolle ondernemingen die bijdragen aan maatschappelijke uitdagingen, aanvullend aan de markt. Daarnaast zijn er openbare, objectieve en meetbare toetsingscriteria voor investeringen nodig om voorspelbaarheid voor bedrijven te garanderen en vertraging of mislukking van aanvragen te voorkomen. Als laatste is een goede samenwerking met andere investeerders en initiatieven vereist.
Invest-NL geeft de overheid een instrument om bij te dragen aan de doorgroei van biotech bedrijven in verschillende fases van ontwikkeling. Zo kan het als vliegwiel dienen voor de sector en kunnen de bedrijven met nog meer slagkracht blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van duurzaamheid, gezondheid en zorg.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-29 11:32:162018-05-29 14:37:57Invest-NL als vliegwiel voor innovatie← #nieuws
Vanaf 25 mei 2018 moeten alle bedrijven en organisaties voldoen aan de nieuwe privacy wetgeving: de Algemene Verordening Gegevensbescherming (AVG). Bestuurders zijn persoonlijk aansprakelijk. Heb je als organisatie je zaken niet op orde? Dan kan de Autoriteit Persoonsgegevens een forse boete opleggen. De stichting AVG verenigingen heeft voor het MKB een programma ontwikkeld waarmee je in 16 eenvoudige stappen aan de AVG kunt voldoen. Leden van HollandBIO krijgen 50% korting op het programma.
Wat biedt het AVG-programma?
Praktisch 16-stappenplan
Uitlegvideo en invulformulieren bij elke stap
Juridische model documenten en contracten
Opleidingsvideo medewerkers
Extra ondersteuning van AVG-experts
AVG-verklaring
het AVG-programma is een praktisch online stappenplan dat resulteert in een AVG-verklaring. Met deze AVG-verklaring kun je aantonen dat je bedrijf aan de inspanningsverplichtingen van de wet heeft voldaan.
Voldoen aan de wet blijft best wat werk, maar door de logische opbouw en praktische voorbeelden wordt de ingewikkelde wetgeving ontrafeld in 16 stappen. Aan de hand van duidelijke instructies pas je de ICT, de organisatie, de communicatie en alle juridische zaken als contracten aan de nieuwe eisen aan. Met het programma zie je geen onderdelen van de wettelijke verplichting over het hoofd. Inmiddels is het online AVG-programma al door tienduizenden organisaties gebruikt!
Ondersteuning beschikbaar
Het programma is zo opgezet, dat je er zelf mee aan de slag kunt gaan. In veel gevallen is extra hulp niet nodig. Mocht je meer ondersteuning willen, dan biedt de AVG-vereniging een juridische helpdesk, verduidelijkende webinars en invulworkshops om het programma in 3 uur grotendeels of geheel af te werken.
As an association that has manufacturers of both originator and biosimilar medicines as members, EuropaBio strongly doubts that the promises of today’s Commission proposal outweigh the risks of losing investment in new medicines. “Today’s proposal can only weaken the attractiveness of the EU as a hub for biopharmaceutical innovation. The approach of taking incentives away from one part of the biopharmaceutical industry to give to another part of the same industry is the wrong way to serve patients and foster innovation in Europe. Instead, solutions for enabling the entire EU biopharma industry to meet the needs of EU patients should have been explored.”, commented John Brennan, Secretary General of EuropaBio, on the European Commission’s proposal for a waiver of the rights of holders of Supplementary Protection Certificates for innovative medicines.
Costly and highly uncertain investment decisions into R&D in health can only be taken in the presence of carefully balanced, reliable and enforceable incentives and safeguards against failure and long-term lack of profitability. “European developers of tomorrow’s cures are mainly small businesses. In today’s world, where these small biotech businesses depend on investor funding from outside Europe, this proposal sends the wrong signal and jeopardises progress and innovation in health – where are the safeguards to make sure that does not happen?”, added Mr. Brennan.
EuropaBio’s early analysis of the proposal finds that rather than promoting growth and jobs in the entire sector, an SPC waiver would simply shift value and jobs from the originator part of the biopharmaceutical industry to the biosimilar and generic part of the same EU health industry with the only result being a negative net impact on innovation for patients. The proposal also seems absent of robust safeguards in this regard. EuropaBio stands ready to contribute expertise and experience for alleviating the foreseeable damage to the finely balanced EU biopharma innovation ecosystem.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-28 16:20:422018-05-29 16:23:56EuropaBIO: SPC waiver risks downgrading the EU as a hub for health innovation← #nieuws
Hartwig Medical Foundation and ttopstart are pleased to announce collaboration to accelerate the implementation of clinical decision support systems for personalised cancer treatment in the Netherlands.
Hartwig Medical Foundation is developing innovative clinical decision support systems to enable personalised cancer treatment in the Netherlands. As a part of this, Hartwig Medical Foundation provides access to a unique databank of Whole Genome Sequencing and clinical data of thousands of patients. This will enable a substantial improvement in the quality of diagnosis and treatment of cancer patients, stimulate scientific research into methods of treatment and cancer therapies, and reduce the cost of care and over-treatment. Furthermore, Hartwig Medical Foundation has developed a unique patient report that provides clinicians with an actionable assessment of the genetic characteristics of the tumour to guide clinical decision-making for personalised cancer treatment.
Hartwig Medical Foundation is making important progress in advancing the implementation of DNA sequencing technology and clinical-decision making for personalised cancer care. To accelerate this process, Hartwig Medical Foundation and ttopstart co-design smarter strategies and develop new business models to support patient access to precision medicine in a timely and responsible manner and the introduction of actionable patient reporting for clinical decision-making in personalised cancer treatment. In addition, ttopstart will provide ongoing project management support for the different key partnerships of Hartwig Medical Foundation.
https://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svg00hollandbiohttps://www.hollandbio.nl/wp-content/uploads/2023/08/HollandBIO_logo.svghollandbio2018-05-28 10:18:582018-06-04 10:25:33Hartwig Medical Foundation and ttopstart announce collaboration← #nieuws
Merus, a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutic, announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.
MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.
“The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform,” said Ton Logtenberg, Ph.D., Chief Executive Officer. “We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with off-target toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively.”
The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA-158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.
From health benefits to increased flavour and longer shelf-life, discover the new generation of GM foods designed with the consumer in mind.
Non-browning apples
Some people dislike eating fruit with flesh that has become discoloured. This never happens to Arctic apples. They went on sale in the US in November 2017.
Potatoes that don’t bruise
The Innate potato is less prone to bruising and consequent black spots. When fried, it also produces less acrylamide, a substance suspected of causing cancer, than conventional spuds do.
Wheat with “good” gluten
People with coeliac disease could soon have their cake and eat it. At least two groups worldwide are editing out the genes for the gluten proteins that damage the guts of people with this digestive disorder. One GM wheat is undergoing clinical trials in Spain.
Pink pineapples
They are pink because they accumulate lycopene, the pigment that makes tomatoes red, instead of converting it into yellow beta-carotene as normal pineapples do. The US gave the green light for this variety to be eaten in December 2016, but it is yet to go on sale. Lycopene is thought to have various health benefits. The pink pineapples are also said to be sweeter – and add a twist to a pina colada.
Omega-3 rapeseed (canola)
This seed from the rape plant is rich in the beneficial omega-3 oil DHA. The plan is to market it first as fish feed and then for human consumption. Last year, 1200 hectares were grown and harvested in the US.
Blood oranges are regarded as beneficial because they are rich in antioxidants called anthocyanins. Normal blood oranges only turn red if they experience cold nights while growing. The GM strain is full of anthocyanins regardless of the weather. The oranges are not yet on sale.
Bananas with a boost
The matoke cooking banana is a staple in Uganda. The GM variety contains provitamin A, a lack of which can lead to blindness. It is being field tested in Uganda and could be on sale in 2021.
Lower-saturated fat rapeseed oil
Conventional rapeseed oil contains 7 per cent saturated fats. A gene-edited variety will have half this amount.
Golden rice
Rice designed to reduce vitamin A deficiency has been under development for decades, but has yet to reach market. It received a big boost earlier this year when Australia, New Zealand and Canada declared it safe for humans, meaning there would be no regulatory issues if those countries imported food containing small quantities of the rice.
Janssen taking Legend CAR T therapy to clinic
GezondheidJanssen said FDA cleared an IND for CAR T therapy JNJ-68284528 to treat multiple myeloma. Next half, the unit of Johnson & Johnson expects to start a U.S. and European Phase Ib/II study of Legend Biotech’s therapy targeting BCMA.
At last year’s American Society of Clinical Oncology (ASCO) meeting, Legend reported JNJ-68284528 led to a 100% objective response rate among 19 MM patients in the first phase of the Chinese Phase I/II LEGEND-2 study. No neurotoxicities, which can plague anti-CD19 CAR T therapies, were observed.
In December 2017, Janssen obtained a global license to the therapy from the Legend Biotech USA Inc. and Legend Biotech Ireland Ltd. subsidiaries of Genscript Biotech Corp. The partners are developing JNJ-68284528 jointly worldwide.
The therapy is Janssen’s first in the CAR T space. At the time of the deal, Janssen’s Global Therapeutic Area Head of Oncology Peter Lebowitz told BioCentury BCMA was the first target to meet the company’s safety and efficacy standards for the CAR T modality (see BioCentury, Jan. 5).
Janssen said the primary efficacy endpoint in the Phase II portion of its planned trial to treat relapsed or refractory MM will be overall response rate (ORR) as defined by the International Myeloma Working Group response criteria.
Source: Biocentury
New at Pivot Park: GlycoMScan
InnovatieklimaatGlycoMScan has opened their company’s doors in the van Leeuwenhoek building’s basement. GlycoMScan offers services in mass spectrometry, from screening of small molecules to absolute quantification in complex biological matrices. “As the name suggests, I am specialized in analyses of glycosylation and the building blocks thereof, the nucleotide sugars and phosphorylated sugars from intracellular metabolism,” tells Monique van Scherpenzeel, GlycoMScan’s CEO. ”I chose Pivot Park because of the inspiring atmosphere of (start-up) companies in pharma and life sciences, the good quality laboratory facilities and the opportunity for me and my company to serve your R&D with my services in mass spectrometry.”
“The fact that GlycoMScan is already developing several collaborations with community members shows what a good addition this company is to the Pivot Park pharma R&D ecosystem,” tells Brigitte Drees, Pivot Park’s CEO. “Thanks to our extensive experience we’ve been able to support GlycoMScan in becoming operable in a short time.”
Glycomscan has three types of mass spectrometers in-house, offering short time-to-results. These are:
High-resolution or other types of mass spectrometry, e.g. QTOF or GC-MS are available upon request. Interested in learning more? Contact Monique van Scherpenzeel by e-mail.
Source: Pivot Park
GM golden rice gets approval from food regulators in the US
Voedsel en materialenGOLDEN rice, which has been genetically modified to prevent blindness in undernourished children, was judged safe to eat last week by the US Food and Drug Administration.
The rice contains extra genes that make a precursor to vitamin A, which is vital for preventing childhood blindness. A single helping can supply half the recommended daily intake of vitamin A, according to its developers at the International Rice Research Institute in the Philippines. The genes also give it its distinctive golden hue.
The nod by the FDA makes the US the fourth country to approve the rice this year, behind Canada, Australia and New Zealand. Having the rice cleared in these countries means there would be no regulatory issues if they imported food containing small quantities of the rice.
But its developer says the most important approvals are still awaited in the Philippines and Bangladesh, where the rice could have the greatest impact. Applications were lodged there last year.
Source: New Scientist
Treeway prepares phase 3 study for TW001 to treat ALS
GezondheidPhase 1 study suggests that novel oral formulation improves bioavailability while remaining well tolerated.
Treeway, a biotech company developing therapies against amyotrophic lateral sclerosis (ALS), announced the completion of its Phase I trial of lead program TW001, an oral formulation of edaravone. The study compared the bioavailability of TW001 in its novel market formulation to Radicava, an FDA approved, intravenous formulation of edaravone, indicated for the treatment of ALS. The study indicates increased bioavailability of TW001 in a single-dose treatment whilst no safety concerns developed within the subject group, implying the potential of the novel formulation to improve treatment strategies for ALS patients. Based on these results, Treeway has initiated the upscaling program and preparations for a pivotal Phase 3 study. Edaravone is a neuroprotective agent that reduces oxidative stress, a key contributor to neuronal death in ALS.
“It is Treeway’s mission to identify novel treatment routes for ALS patients and we believe that this study indicates that an oral formulation of edavarone may offer patients a better quality-of-life through a simpler and more effective route of administration,” said Ronald van der Geest, Chief Development Officer of Treeway. “Given the nature of this program and based on the positive results we have seen in this comparative study, we can initiate a pivotal Phase 3 study and move rapidly toward bringing TW001 to patients.”
The randomized, cross-over comparative bioavailability trial tested a single oral dose of 140 mg TW001, compared to a 1-hour intravenous infusion of 60 mg edaravone in 18 healthy subjects. In this study, the bioavailability of the novel oral formulation exceeded the bioavailability of the intravenous infusion of Radicava. Within the subject group of the study the treatment was well-tolerated and no safety concerns arose during the conduct of the study. Furthermore, ongoing formulation studies also suggest that the formulation is stable.
Merit Cudkowicz, MD, Chief Neurology Service and Director of the ALS Clinic at the Massachusetts General Hospital, a key advisor to the company, commented:
“The results of this Phase I study are a promising sign for ALS patients, who are in high need of better and more patient-friendly treatments for their disease. I regard this study to be a key milestone for the development of TW001 in ALS and I look forward to supporting the company’s scientific and clinical progress.”
Source: BusinessWire
Invest-NL als vliegwiel voor innovatie
IJzersterk innovatieklimaat, Hollandbio, InnovatieklimaatOp donderdag 31 mei organiseert de vaste Kamercommissie EZK een rondetafelgesprek over de nieuwe investeringsinstelling Invest-NL. Hierbij komen verschillende stakeholders aan het woord. HollandBIO’s Annemiek Verkamman zal namens de biotech sector pleiten voor een ijzersterk innovatieklimaat met een uitgekiende financieringsmix voor life sciences bedrijven. Op deze manier hebben bedrijven in alle fases van ontwikkeling toegang tot voldoende financiering. Daarmee kunnen zij werken aan innovatieve oplossingen voor de grote maatschappelijke uitdagingen waar wij voor staan.
Investeren in de life sciences sector loont. In Nederland zetten we wetenschappelijke excellentie, technologie en ondernemerschap succesvol om in maatschappelijke en economische waarde. De Nederlandse life sciences sector zit stevig in de lift. De afgelopen tien jaar verdubbelde de sector in omvang. En, zoals we voor ogen hebben in onze toekomstvisie Life Sciences 2030, stoot de sector van een Europese topvijfpositie door naar de absolute wereldtop. Dat betekent dat er werk aan de winkel is.
Valley of death
Voor een sterk innovatieklimaat zijn voldoende financieringsmogelijkheden in de verschillende fases van ontwikkeling onontbeerlijk. Dit voorkomt dat bedrijven na hun eerste stappen in de beruchte valley of death belanden: de financieringskloof die doorgroei van startups naar scale-ups in de weg staat. Hier moeten zowel publieke als private partijen op inspelen. Invest-NL kan volgens HollandBIO helpen de kloof te dichten.
Rol van Invest-NL
Invest-NL gaat zich richten op het financieren en realiseren van innovatie met maatschappelijke impact waar de markt nu niet in voorziet, zoals bij langlopende, risicovolle activiteiten het geval is. Om de investeringsinstelling tot een succes te maken voor bedrijven in de life sciences, is er volgens HollandBIO actie vereist. Zo moet er een mandaat en uitvoeringstaak komen gericht op het financieren van risicovolle ondernemingen die bijdragen aan maatschappelijke uitdagingen, aanvullend aan de markt. Daarnaast zijn er openbare, objectieve en meetbare toetsingscriteria voor investeringen nodig om voorspelbaarheid voor bedrijven te garanderen en vertraging of mislukking van aanvragen te voorkomen. Als laatste is een goede samenwerking met andere investeerders en initiatieven vereist.
Invest-NL geeft de overheid een instrument om bij te dragen aan de doorgroei van biotech bedrijven in verschillende fases van ontwikkeling. Zo kan het als vliegwiel dienen voor de sector en kunnen de bedrijven met nog meer slagkracht blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van duurzaamheid, gezondheid en zorg.
Lees de volledige inbreng van HollandBIO voor het rondetafelgesprek hier.
AVG-programma
Hollandbio, UitgelichtVanaf 25 mei 2018 moeten alle bedrijven en organisaties voldoen aan de nieuwe privacy wetgeving: de Algemene Verordening Gegevensbescherming (AVG). Bestuurders zijn persoonlijk aansprakelijk. Heb je als organisatie je zaken niet op orde? Dan kan de Autoriteit Persoonsgegevens een forse boete opleggen. De stichting AVG verenigingen heeft voor het MKB een programma ontwikkeld waarmee je in 16 eenvoudige stappen aan de AVG kunt voldoen. Leden van HollandBIO krijgen 50% korting op het programma.
Wat biedt het AVG-programma?
het AVG-programma is een praktisch online stappenplan dat resulteert in een AVG-verklaring. Met deze AVG-verklaring kun je aantonen dat je bedrijf aan de inspanningsverplichtingen van de wet heeft voldaan.
Voldoen aan de wet blijft best wat werk, maar door de logische opbouw en praktische voorbeelden wordt de ingewikkelde wetgeving ontrafeld in 16 stappen. Aan de hand van duidelijke instructies pas je de ICT, de organisatie, de communicatie en alle juridische zaken als contracten aan de nieuwe eisen aan. Met het programma zie je geen onderdelen van de wettelijke verplichting over het hoofd. Inmiddels is het online AVG-programma al door tienduizenden organisaties gebruikt!
Ondersteuning beschikbaar
Het programma is zo opgezet, dat je er zelf mee aan de slag kunt gaan. In veel gevallen is extra hulp niet nodig. Mocht je meer ondersteuning willen, dan biedt de AVG-vereniging een juridische helpdesk, verduidelijkende webinars en invulworkshops om het programma in 3 uur grotendeels of geheel af te werken.
Kosten
Lid van HollandBIO? Vraag de kortingscode via bs@hollandbio.nl
0 medewerkers 250,- (met kortingscode 125,-)
1-10 medewerkers 500,- (met kortingscode 250,-)
11-50 medewerkers 1000,- (met kortingscode 500,-)
51-250 medewerkers 2000,- (met kortingscode 1.000,-)
meer dan 250 medewerkers 4000,- (met kortingscode 2.000,-)
De prijs is in euro’s, per jaar, exclusief 21% btw.
Ook meedoen?
Meld je hier aan voor het programma. Tienduizenden bedrijven en organisaties gingen je voor!
Meer informatie vind je op de site van de AVG verenigingen
EuropaBIO: SPC waiver risks downgrading the EU as a hub for health innovation
InnovatieklimaatAs an association that has manufacturers of both originator and biosimilar medicines as members, EuropaBio strongly doubts that the promises of today’s Commission proposal outweigh the risks of losing investment in new medicines. “Today’s proposal can only weaken the attractiveness of the EU as a hub for biopharmaceutical innovation. The approach of taking incentives away from one part of the biopharmaceutical industry to give to another part of the same industry is the wrong way to serve patients and foster innovation in Europe. Instead, solutions for enabling the entire EU biopharma industry to meet the needs of EU patients should have been explored.”, commented John Brennan, Secretary General of EuropaBio, on the European Commission’s proposal for a waiver of the rights of holders of Supplementary Protection Certificates for innovative medicines.
Costly and highly uncertain investment decisions into R&D in health can only be taken in the presence of carefully balanced, reliable and enforceable incentives and safeguards against failure and long-term lack of profitability. “European developers of tomorrow’s cures are mainly small businesses. In today’s world, where these small biotech businesses depend on investor funding from outside Europe, this proposal sends the wrong signal and jeopardises progress and innovation in health – where are the safeguards to make sure that does not happen?”, added Mr. Brennan.
EuropaBio’s early analysis of the proposal finds that rather than promoting growth and jobs in the entire sector, an SPC waiver would simply shift value and jobs from the originator part of the biopharmaceutical industry to the biosimilar and generic part of the same EU health industry with the only result being a negative net impact on innovation for patients. The proposal also seems absent of robust safeguards in this regard. EuropaBio stands ready to contribute expertise and experience for alleviating the foreseeable damage to the finely balanced EU biopharma innovation ecosystem.
Source: EuropaBIO
Hartwig Medical Foundation and ttopstart announce collaboration
Gezondheid, InnovatieklimaatHartwig Medical Foundation and ttopstart are pleased to announce collaboration to accelerate the implementation of clinical decision support systems for personalised cancer treatment in the Netherlands.
Hartwig Medical Foundation is developing innovative clinical decision support systems to enable personalised cancer treatment in the Netherlands. As a part of this, Hartwig Medical Foundation provides access to a unique databank of Whole Genome Sequencing and clinical data of thousands of patients. This will enable a substantial improvement in the quality of diagnosis and treatment of cancer patients, stimulate scientific research into methods of treatment and cancer therapies, and reduce the cost of care and over-treatment. Furthermore, Hartwig Medical Foundation has developed a unique patient report that provides clinicians with an actionable assessment of the genetic characteristics of the tumour to guide clinical decision-making for personalised cancer treatment.
Hartwig Medical Foundation is making important progress in advancing the implementation of DNA sequencing technology and clinical-decision making for personalised cancer care. To accelerate this process, Hartwig Medical Foundation and ttopstart co-design smarter strategies and develop new business models to support patient access to precision medicine in a timely and responsible manner and the introduction of actionable patient reporting for clinical decision-making in personalised cancer treatment. In addition, ttopstart will provide ongoing project management support for the different key partnerships of Hartwig Medical Foundation.
Source: ttopstart
Merus’ MCLA-158 Phase I clinical trial has started
GezondheidMerus, a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutic, announced that the first patient has been dosed in a Phase 1, first-in human clinical trial of MCLA-158 in patients with solid tumors with an initial focus on metastatic colorectal cancer. The trial will be conducted in Europe, where several Clinical Trial Applications (CTAs) have been approved to date. The Company also announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for MCLA-158, which was accepted by the FDA in April 2018. With this acceptance, Merus plans to open additional sites for this trial in the United States.
MCLA-158 is designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). MCLA-158 was identified from a large library of bispecific antibodies targeting molecules belonging to the Wnt and receptor tyrosine kinase signaling pathways as part of work performed by the suppresSTEM consortium, a project that was funded by the European Union. Functional evaluation of patient-derived colorectal tumors, including those harboring RAS and/or PI3K mutations, demonstrated that MCLA-158 was more effective at inhibiting tumor growth and promoting apoptosis than an approved targeted therapy comparator for metastatic colorectal cancer, cetuximab. In preclinical studies, Merus also observed that the growth inhibitory activity of MCLA-158 was greater for colon tumors compared to normal colon tissue, consistent with its good safety profile in non-human primates.
“The commencement of our Phase 1 clinical trial of MCLA-158 is an important milestone for the advancement of our pipeline of bispecific antibodies obtained from our Biclonics technology platform,” said Ton Logtenberg, Ph.D., Chief Executive Officer. “We believe MCLA-158 has the potential to address features that limit currently approved colorectal cancer-targeted therapies, including issues with off-target toxicity and inability to target tumor stem cells, and thus, potentially treat a broader population of patients more effectively.”
The Phase 1, open-label, multicenter clinical trial of MCLA-158 consists of two parts, a dose escalation and a dose expansion. The dose escalation part is intended to determine the appropriate dose of MCLA-158. The dose expansion part will evaluate the safety and tolerability of the defined dose of MCLA-158 in patients with solid tumors. The dose escalation and expansion parts of the trial will also examine the preliminary antitumor activity of single-agent MCLA-158.
Source: GlobeNewsWire
Pink pineapples and healthy fries
Voedsel en materialenFrom health benefits to increased flavour and longer shelf-life, discover the new generation of GM foods designed with the consumer in mind.
Non-browning apples
Some people dislike eating fruit with flesh that has become discoloured. This never happens to Arctic apples. They went on sale in the US in November 2017.
Potatoes that don’t bruise
The Innate potato is less prone to bruising and consequent black spots. When fried, it also produces less acrylamide, a substance suspected of causing cancer, than conventional spuds do.
Wheat with “good” gluten
People with coeliac disease could soon have their cake and eat it. At least two groups worldwide are editing out the genes for the gluten proteins that damage the guts of people with this digestive disorder. One GM wheat is undergoing clinical trials in Spain.
Pink pineapples
They are pink because they accumulate lycopene, the pigment that makes tomatoes red, instead of converting it into yellow beta-carotene as normal pineapples do. The US gave the green light for this variety to be eaten in December 2016, but it is yet to go on sale. Lycopene is thought to have various health benefits. The pink pineapples are also said to be sweeter – and add a twist to a pina colada.
Omega-3 rapeseed (canola)
This seed from the rape plant is rich in the beneficial omega-3 oil DHA. The plan is to market it first as fish feed and then for human consumption. Last year, 1200 hectares were grown and harvested in the US.
High-fibre white bread
Gene-edited wheat yields white flour with three times as much dietary fibre as standard white flour.
Bloodier oranges
Blood oranges are regarded as beneficial because they are rich in antioxidants called anthocyanins. Normal blood oranges only turn red if they experience cold nights while growing. The GM strain is full of anthocyanins regardless of the weather. The oranges are not yet on sale.
Bananas with a boost
The matoke cooking banana is a staple in Uganda. The GM variety contains provitamin A, a lack of which can lead to blindness. It is being field tested in Uganda and could be on sale in 2021.
Lower-saturated fat rapeseed oil
Conventional rapeseed oil contains 7 per cent saturated fats. A gene-edited variety will have half this amount.
Golden rice
Rice designed to reduce vitamin A deficiency has been under development for decades, but has yet to reach market. It received a big boost earlier this year when Australia, New Zealand and Canada declared it safe for humans, meaning there would be no regulatory issues if those countries imported food containing small quantities of the rice.
Source: New Scientist