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Hoopvolle stappen richting coronavaccin

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Het is een goede week in de zoektocht naar een coronavaccin, met positief nieuws uit de klinische onderzoeken van AstraZeneca & Oxford, Pfizer & BioNTech en CanSino. Ook Johnson & Johnson zet de eerste stappen richting de kliniek, met een door Janssen in Leiden ontwikkeld vaccin. Bovendien krijgt dit vaccin nog een extra Nederlands tintje…

Janssen haalt trials naar Nederland

Johnson & Johnson heeft een mooie opsteker voor Nederland: na België en de VS staan ook wij op de rol voor trials! Een prachtige resultaat voor iedereen die zich de afgelopen tijd heeft ingezet om de vergunningaanvraag voor klinisch onderzoek met cel- en gentherapie in Nederland te versnellen en te verbeteren.

Nederlandse bijdrage tegen corona in de spotlight

De multinationals zijn niet de enigen die zich wagen in de strijd tegen het coronavirus. Op de besloten website van het Financieele Dagblad schuilt een mooie tweeluik over de bijdrage van Nederlandse partijen in de ontwikkeling van vaccins en geneesmiddelen. De vaccins komen aan bod in deel 1, waarbij de bijdragen van Intravacc, Halix, Mymetics, Janssen en Viroclinics toegelicht worden. In deel 2 ligt de focus op geneesmiddelen en staan ISA Pharmaceuticals, Protinhi Therapeutics en Pharming in de schijnwerpers.

Met zoveel inspanningen zowel binnen als buiten Nederland is de vraag niet of, maar wanneer biotech deze crisis weet te bezweren. We zien namelijk steeds vaker dat biotech de onmisbare schakel vormt voor oplossingen van vele maatschappelijke vraagstukken. De huidige situatie laat bovendien duidelijk zien dat we gebaat zijn bij een snelle en vooral ook betere route van lab naar praktijk. Daarom zijn we bij HollandBIO erg benieuwd welke lessen beklijven, zodat we de bijdrage van biotech aan onze samenleving duurzaam kunnen verbeteren!

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Door coronapandemie uitgestelde tentoonstelling over uitbraken van besmettelijke ziekten alsnog door Koning Willem-Alexander geopend

Koning Willem-Alexander heeft de tentoonstelling ‘Besmet!’ op donderdag 16 juli in Rijksmuseum Boerhaave in Leiden geopend. De opening zou al op 15 april plaatsvinden, maar werd geannuleerd vanwege de uitbraak van de coronapandemie. De tentoonstelling gaat over de uitbraken van besmettelijke ziekten en hoe die het leven kunnen ontwrichten. Ook sluit de tentoonstelling aan bij de recente uitbraak van het coronavirus en bij de maatschappelijke discussie over de vaccinatiegraad.

Wat ons betreft laat de tentoonstelling goed zien wat het onverminderd grote belang is van vaccinaties en bovenal tipt HollandBIO deze tentoonstelling als een leerzaam zomeruitje! Meer weten? Lees verder bij Rijksmuseum Boerhaave.

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Crop biotechnology continues to provide higher farmer income and significant environmental benefits

Farmers who planted genetically modified (GM) crops increased their incomes by almost $19 billion in 2018 and reduced carbon emissions by 23 billion kilograms or the equivalent of removing 15.3 million cars from the roads that year.  The higher income represents $4.42 in extra income for each extra dollar invested, according to a report released by PG Economics.

“GM crop technology continues to make an important contribution to reducing the environmental footprint of agriculture and securing global food supplies in a sustainable way.  It has also helped lift many small, resource-poor farmers and their families in developing countries out of poverty” said Graham Brookes, director of PG Economics, co-author of the report.  

Highlights in the peer reviewed report include:

Crop biotechnology has reduced agriculture’s environmental impact

  • Crop biotechnology has significantly reduced agriculture’s greenhouse gas emissions by helping farmers adopt more sustainable practices such as reduced tillage, which decreases the burning of fossil fuels and retains more carbon in the soil.  Had GM crops not been grown in 2018, for example, an additional 23 billion kilograms of carbon dioxide would have been emitted into the atmosphere, which is the equivalent of adding 15.3 million cars to the roads.
  • From 1996 to 2018, crop biotechnology reduced the application of crop protection products by 776 million kilograms, a global reduction of 8.6 percent.  This is equal to more than 1.6 times China’s total crop protection product use each year.  As a result, farmers who grow GM crops have reduced the environmental impact associated with their crop protection practices by 19 percent.

Crop biotechnology delivers an excellent return on investment for the farmers using the technology

  • In 2018, farmers in developing countries received $4.42 as extra income for each extra dollar invested in GM crop seeds, whereas farmers in developed countries received $3.24 as extra income for each extra dollar invested in GM crop seeds.
  • The net farm level economic benefit was just under $19 billion in 2018, equal to an average increase in income of $103/hectare.  From 1996 to 2018, the net global farm income benefit was $225 billion, equal to an average increase in income of $96.7/hectare.

Crop biotechnology has contributed to global food security and reduced pressure to use new land in agriculture

  • GM crop technology has improved yields through improved control of pests and weeds.  For example, insect resistant (IR) crop technology used in cotton and corn has, between 1996 to 2018, across all users of this technology, increased yields by an average of 16.5 percent for IR corn and 13.7 percent for IR cotton relative to conventional production systems.  Farmers who grow IR soybeans commercially in South America have seen an average 9.4 percent increase in yields since 2013.
  • Over 23 years of widespread use, crop biotechnology has been responsible for the additional global production of 278 million tonnes of soybeans, 498 million tonnes of corn, 32.6 million tonnes of cotton lint and 14 million tonnes of canola.
  • GM crops allow farmers to grow more without needing to use additional land. For example, if crop biotechnology had not been available to farmers in 2018, maintaining global production levels that year would have required the planting of an additional 12.3 million hectares (ha) of soybeans, 8.1 million ha of corn, 3.1 million ha of cotton and 0.7 million ha of canola.  This is equivalent to needing an additional 14 percent of the arable land in the United States, or roughly 38 percent of the arable land in Brazil or 16 percent of the cropping area in China.

Source: PG Economics

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Agraloop aims to boost farmer incomes while cutting your wardrobe’s carbon footprint

Consumers, food businesses, and policymakers are increasingly aware of the need to improve our food system’s impact on the environment. But what about the impact of the clothes we wear – another major product of agriculture?

Roughly 20% of industrial water pollution comes from garment manufacturing, according to the World Resources Institute, and the industry uses 1.3 trillion gallons of water each year to dye fabric alone. This is enough to fill 2 million Olympic-size swimming pools.

For one startup tackling the textile industry, the carbon footprint of your closet is just as important as the carbon footprint of your grocery list.

“[Ours] is a new and novel biorefinery process. All the energy and biochemistry required to run the mill has a beneficial impact, and all of it is generated from the plant waste,” Circular Systems CEO Isaac Nichelson tells AFN.

“There’s a big hole in the processing of natural fibers in that the fiber is great, but the processing creates a bunch of effluents with nowhere to go. They either build up caustic salts in landfills that leach into the water table, or go out the back of the factory into a river.”

Los Angeles-based Circular Systems has developed what it describes as a completely closed-loop system for textile production. Taking top prize at the 2018 H&M Global Change Award, the system is the brainchild of a few seasoned professionals from various supply chain points of textile production, which each boast more than 25 years experience in their respective fields, Nichelson says. 

Source: https://agfundernews.com/agraloop-aims-to-boost-farmer-incomes-while-cutting-your-wardrobes-carbon-footprint.html

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iOnctura Extends Series A to EUR 20.1M

iOnctura SA, a clinical stage biopharmaceutical company, developing a pipeline of next generation molecules targeting cancer and fibrosis announced that it has raised an additional EUR 5.1 million bringing the total Series A financing to EUR 20.1 million. New investor 3B Future Health Fund, previously known as Helsinn Investment Fund S.A., SICAR joins the existing blue chip investor syndicate of M Ventures, INKEF Capital, VI Partners, and Schroder Adveq, which all participated in the extension.

The funding will enable iOnctura to accelerate development of its next generation dual immune and tumour targeting therapies. Data emerging from early clinical evaluation of its lead molecule IOA-244, a highly selective PI3Kδ-inhibitor, in solid tumours is expected to enable progress into a Phase Ib trial earlier than anticipated and preclinical development of its second program, IOA-289, an ATX-inhibitor with dual utility in organ specific and cancer associated fibrosis will be expedited into human testing in early 2021. iOnctura has recently strengthened its team with the appointment of Dr. Joanna Horobin as Chair. Joanna is an accomplished drug developer and biotech leader with over 35 years of experience in the pharmaceutical and biotech sector in Europe and the US.

Catherine Pickering, Chief Executive Officer of iOnctura, said: “I am pleased to welcome 3B Future Health Fund to our strong investor syndicate. This oversubscribed Series A round provides further validation and support of our strategy as we progress our novel, highly selective, PI3Kδ inhibitor and our differentiated ATX inhibitor through clinical development.”

Riccardo Braglia, 3B Future Health Fund Chairman and Helsinn Group Vice Chairman and Chief Executive Officer, commented: “We look to invest in early-stage companies which are developing novel treatments in areas of high unmet patient need. We have been very impressed with the world class team at iOnctura and the potential of its next generation molecules targeting cancer and fibrosis.”

Source: iOnctura

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ProQR Announces $30 Million Strategic Convertible Debt Financing Agreement with Pontifax Ventures

ProQR Therapeutics N.V. (Nasdaq:PRQR), a company dedicated to changing lives through the creation of transformative RNA therapies for severe genetic rare diseases, announced that it has entered into a $30 million convertible debt financing agreement with Pontifax Medison Debt Financing, the healthcare-dedicated venture and debt fund of the Pontifax life science funds.

“The access to capital provided by this facility is designed to increase our financial flexibility as we continue to advance our pipeline and build toward commercialization,” said Smital Shah, ProQR’s Chief Business and Financial Officer. “If fully drawn down, this capital would extend ProQR’s cash runway into 2023, which is beyond a number of anticipated catalysts and value inflection points for our clinical stage programs. Additionally, this funding will accelerate the advancement of our translational platform and discovery programs.”

“Pontifax is pleased to enter into this strategic financing partnership with ProQR as it continues to advance its pipeline of RNA therapies for inherited retinal diseases,” said Momi Karako, partner at Pontifax. “ProQR has expertise in antisense oligonucleotides, a productive platform, and a deep pipeline of novel RNA therapies focused on inherited retinal diseases, which fits well with our portfolio of companies that target transformative, cutting-edge life sciences technologies.”

Under the agreement with Pontifax, ProQR will have access to up to $30 million in convertible debt financing in three tranches of $10 million each that will mature over a 54 month period and have an interest-only period of 24 months.

Pontifax may elect to convert the outstanding loan into ProQR ordinary shares at any time prior to repayment at a conversion price of $7.88 per share, which is a 50% premium to the Company’s average closing share price during the 7 days prior to closing. ProQR also has the ability to convert the loan into its ordinary shares, at the same conversion price, if the Company’s stock price reaches a pre-determined threshold.

In connection with the loan agreement, ProQR has agreed to issue to Pontifax warrants to purchase up to an aggregate of 190,424 shares of its common stock at an exercise price of $7.88 per share, which is a 50% premium to the average closing price during the 7 days prior to closing.

J. Wood Capital Advisors LLC and Perella Weinberg Partners LP acted as financial advisors and Goodwin Proctor LLP and Allen & Overy LLP acted as legal advisors to ProQR on this transaction.

Source: ProQR

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Whitepaper – Demonstrating the Value of Drugs for Rare Diseases

Demonstrating the Value of Drugs for Rare Diseases – 8 Common Challenges and How to Address Them Before They Arise

James Horscroft, Linda Murphy, Ann-Marie Chapman and Ron Akehurst, BresMed

No matter how robust in design, clinical trials can never fully address the uncertainty surrounding the comparative effectiveness and safety of a novel product in the real world. This is particularly pertinent in rare diseases for several reasons: small sample sizes and heterogeneous populations create challenges in demonstrating clinically significant benefits, randomized head-to-head comparisons are often unfeasible or unethical, and relationships between measurable trial endpoints and patient-relevant outcomes are under-studied and poorly understood. When preparing for health technology assessments and reimbursement discussions for a rare disease product, we believe that it is both feasible and advisable to anticipate and subsequently minimize the key uncertainties before starting the later phases of clinical programmes. While this is not a new proposition, our experience suggests that this rarely happens in practice, and there is therefore a need to reinforce the value of this simple recommendation.

In this White Paper, we outline eight key challenges that manufacturers face when demonstrating the value of rare disease products to decision-makers, and set out our framework for proactively overcoming these challenges. Using this framework, we believe that manufacturers can achieve earlier access to market, at a price that reflects product value.

Download the white paper here

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Nederlandse biotech industrie boekt succesvolle investeringen

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Mooi financieringsnieuws uit de Nederlandse biotech industrie. Vorige week hebben biotech bedrijven Mosa Meat en VarmX en investeerder Forbion nieuwe financiering opgehaald: respectievelijk €5 miljoen, €32 miljoen en €185 miljoen.

De investering geeft het Leidse VarmX de kans om proof-of-concept voor hun antistollingsmiddel te behalen en hun productietak op te schalen voor commerciële doeleinden. Mosa Meat richt zich op kweekvlees en gebruikt de investering om een pilot productiefaciliteit op te zetten en hun technologie op te schalen. Met hun financiering richt Forbion een nieuw fonds op: het growth opportunities fund. Dit fonds richt zich op investeringen in Europese biotech bedrijven die zich in een latere fase begeven.

Ondanks de grote impact van de coronapandemie op de kapitaalmarkt, laten deze nieuwe investeringen zien dat het Nederlandse financieringslandschap veerkrachtig is en investeerders nog steeds nieuwe kansen zien om te investeren.

Omdat het aantrekken van financiering is één van de grootste uitdagingen voor biotech start-ups en scale-ups, heeft dit onderwerp HollandBIO’s volle aandacht. Twee weken geleden wijdden wij ons eerste @homewebinar aan precies dit onderwerp. Tijdens dit webinar ging Daniel de Boer, CEO van ProQR Therapeutics, in gesprek met ondernemers en investeerders over de invloed van COVID-19 op het biotech financieringslandschap. Een kijktip als je meer van dit onderwerp wil weten! Hieronder kijk je het Webinar terug.

Lees hier meer over de investeringen:

Kijk hier het Webinar ‘Biotech financing during the pandemic’ terug:

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Europa kan het Nederlandse farma-debat verder brengen

VNO-NCW heeft een belangrijke bijdrage geschreven voor de Europese farma-strategie. Door de coronacrisis biedt dit initiatief van de Europese Commissie namelijk nieuwe kansen om het farmadebat in Nederland naar een ‘next level’ te brengen: hoe zorgen we samen – met een florerende Europese farmasector – dat nieuwe medicijnen voor patiënten sneller en overal beschikbaar zijn én betaalbaar blijven. Daar ligt de echte uitdaging.

Benieuwd naar de hele inbreng van VNO-NCW? Lees meer: https://www.linkedin.com/pulse/europa-kan-het-nederlandse-farma-debat-verder-brengen-anthony-stigter/

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DSM debuts integrated portfolio of solutions for winning plant-based meat alternatives

Royal DSM unveils its complete portfolio of integrated solutions for creating stand-out plant-based meat alternatives. The range is designed to enhance taste, texture and nutritional value, while also managing sodium content in meat alternative applications such as burgers, sausages and nuggets. Featuring a selection of yeast extracts, process flavors, hydrocolloids and nutritional ingredients, DSM’s full portfolio provides food producers with the tools they need to get to this thriving market fast, and meet growing consumer demand for an authentic, enjoyable and nourishing meat alternative experience.

While the demand for meat continues to grow, the retail value of meat alternatives is expected to more than double this decade. However, as the trend gains traction, consumer expectations and preferences are becoming more sophisticated. It is no longer enough that a product is plant-based. Consumers are increasingly looking for an end-to-end experience that offers great taste, compelling texture and mouthfeel, as well as a rich nutritional profile. Meanwhile, they expect reduced levels of sodium in their foods – which is typically present in high quantities in meat alternative products. This presents a range of complex challenges for manufacturers in this space.

DSM’s plant-based meat alternative solutions include: high nucleotide yeast extracts, such as Maxarome® Select, which help to mask the ‘beany’ off-flavors typically associated with plant-based proteins and create a rich umami taste; Multirome®, which increases juiciness and creates a succulent, fatty mouthfeel and experience; the concentrated Maxavor®flavor range to provide the desired meaty taste direction; and GELLANEER™gellan gum, which enhances water binding capacity for improved juiciness, while also building an authentic meaty texture and bite. For great-tasting products that also offer an appealing nutritional profile, DSM’s Quali® vitaminsand Premix Solutionscan be added to fill the gaps in the nutritional profile of plant based products, while the Maxavor® RYE LSrange can deliver a meaty flavor with reduced sodium to manage salt content.

DSM’s combined ingredient capabilities in taste, texture and nutrition not only enable meat alter-native producers to optimize the cost-performance ratio of their recipes, but also amplify front-of-pack claims thanks to DSM’s deep-rooted expertise into nutrition science.

Gilbert Verschelling, Director Business Development & Innovation at DSM, comments “Delivering plant-based products that meet today’s evolving consumer demands is no easy task for food manufacturers. At DSM, we are uniquely positioned to help producers create truly enjoyable meat-alternative products that will tick all boxes for consumers. Our complete integrated portfolio of solutions for plant-based meat alternatives complements DSM’s wider plant-based offering, includ-ing its range of recently launched solutions for dairy alternatives.”

DSM aims to support the agri-food sector in delivering high-quality, nutritionally valuable protein products, supported by its in-depth application and technical experience, as well as its regulatory know-how and expertise across the nutrition, flavor, sensory and materials sciences.

Source: DSM