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Scenic Biotech Awarded €3.1 million Innovation Credit

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Scenic Biotech, a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, today announced that it has been awarded a €3.1 million Innovation Credit from the Dutch Government. The funds will be used to advance the Company’s lead CD47/QPCTL immuno-oncology program through preclinical development towards human clinical studies.

The Innovation Credit is awarded by the Dutch government through its agency RVO of the Ministry of Economic Affairs and Climate Policy and is aimed at the development of promising and challenging innovations. It will support the preclinical development of novel QPCTL (Glutaminyl-peptide cyclotransferase-like) inhibitors, completing the two-year project with an IND filing.

Scenic’s CD47/QPCTL immuno-oncology program builds on seminal work by the Netherlands Cancer Institute (NKI) and Leiden University Medical Centre (LUMC). An enzyme present in cancer cells, QPTCL was first demonstrated as a promising target for immuno-oncology by using the Company’s proprietary high-resolution genetics platform called Cell-Seq. The results of this discovery were published in the journal Nature Medicine.

QPCTL was found to be a druggable modifier of the CD47 innate immune checkpoint, which is one of the major mechanisms by which cancer cells evade detection by the immune system. As a result of this activity, CD47 is also known as the ‘don’t eat me signal’. After being the first to discover and validate QPCTL as a promising target in immuno-oncology, NKI and LUMCs scientists also showed that small molecule inhibitors of QPCTL can prevent the expression of functional CD47 on cancer cells, thereby causing the cancer cells to be attacked by macrophages and destroyed.

Scenic has gone on to develop a series of chemical inhibitors with potent inhibition against QPCTL and has filed a patent application related to this chemical series.

Dr Sebastian Nijman, co-founder and CEO of Scenic Biotech said:
“We are delighted to be selected for this award from the Dutch Government, recognizing the potential of our program to develop a new cancer therapy. The funding will enable us to accelerate the optimization of our proprietary small molecule QPCTL inhibitors and then advance them towards filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). This is the first step in the drug review process before clinical trials can begin and will represent an exciting milestone for our Company.”

An Innovation Credit can include the technical development of a new product or process or the clinical development of a medicine or device and requires matching funding from Scenic. After the IND approval phase, Scenic will seek a Partner to support human clinical trials.

Source: Scenic (press release)

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Key stakeholders Massachusetts and the Netherlands meet again in virtual session

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Two weeks ago, key stakeholders from Massachusetts and the Netherlands came together in a digital session to discuss how the Life Sciences & Health ecosystems are responding to COVID-19, which lessons could be learned from the reaction to the pandemic, and how to stimulate closer international collaboration.

The same organisations also signed a MoU in 2019 to advance ongoing collaboration in life sciences and included Mark Sullivan (Massachusetts Office of International Trade and Investment, MOITI), Elizabeth Steele (MassBio), and Jennifer Griffin (Massachusetts Life Sciences Center) from Massachusetts and Focco Vijselaar (Ministry of Economic Affairs and Climate Policy), Clémence Ross-van Dorp (Ministry of Economic Affairs and Climate Policy), Annemiek Verkamman (HollandBIO) and Carmen van Vilsteren (Health~Holland) from the Netherlands. Akshay Vaishnaw (Alnylam Pharmaceuticals) and Freddy Nguyen (MIT COVID-19 Challenge) were invited as speakers to share their activities in light of COVID-19. The session was moderated by Hans Schikan (Top Sector Life Sciences & Health). 

Biotech companies have proven to be dynamic and are pivoting to focus their work on therapies and vaccines. Even more so, participants observe an increased level of cooperation between different companies, researchers and governments to find solutions. For instance, the extent with which data has been shared across the sector has largely increased. This doesn’t stop at the private sector, as public and semi-public organizations have informed each other across borders to support each other in handling the situation. Also when looking at formal procedures, agencies have shown great efficiency in shortening approval procedures to speed up the development of vaccines and therapies.

A paradox can be observed regarding the supply of PPE and other vital medical equipment that companies have sourced internationally. The pandemic has shown the limits of international supply chains, therefore, will governments require that vital manufacturing be maintained within their geographical reach? On the other hand, participants in this virtual session agree that there will always be a need to collaborate internationally and make use of each other’s strengths. According to the Airbus model, if all strengths from different countries or ecosystems could be brought together, this will create a stronger value chain where collaboration between partners is needed and truly adds value.

When looking ahead, participants recognize that in a post-COVID world, we should be better prepared for a possible outbreak of a pandemic. That we need to be ready to think and act together, internationally, so we can organize the supply chain and share data and expertise when needed.

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EenVandaag: loods innovatieve start-ups door de coronacrisis

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EenVandaag stond afgelopen zondag stil bij de grote gevolgen van de coronacrisis op innovatieve start-ups, scale-ups en MKB. Remko van Leeuwen, CEO van Madam Therapeutics, vertelt in de uitzending over de financiële uitdagingen. De kleine bedrijven zijn de groeimotor van de Nederlandse economie. Ze hebben zwaar te lijden onder de coronacrisis, maar de steunmaatregelen sluiten veelal niet aan bij hun behoefte. Ook de Corona-Overbruggingslening (COL), die in eerste instantie een uitkomst leek, schiet tekort. Het budget is zwaar overvraagd, tijdslijnen worden overschreden en 43,5% van aanvragers kreeg al nul op het rekest.

Recent onderzoek van StartUp Genome laat zien dat 86% van de innovatieve start-ups, scale-ups en MKB binnen drie maanden in financiële problemen komt. Naast de COL, werd ook het Tijdelijke Overbruggingskrediet innovatieve Start en Scale ups (TOPSS) in het leven geroepen om deze belangrijke bedrijven door de crisis heen te slepen. Met een totaal budget van €300 miljoen, zijn de regelingen echter een  druppel op een gloeiende plaat. Al meer dan 1700 bedrijven hebben een aanvraag ingediend goed voor een bedrag van €760 miljoen. De nood is dus hoog. 25,8% van de aanvragen wacht nog op een oordeel en 43,5% werd reeds afgewezen.

De COL-aanvraag van Madam Therapeutics was één van die afgewezen voorstellen. In EenVandaag vertelt CEO Remko van Leeuwen over de situatie. Hij geeft aan dat het normaal al geen sinecure is om investeerders aan te trekken voor de ontwikkeling van nieuwe antibiotica, laat staan in tijden van crisis. En dat terwijl de zorgen rondom infecties en resistentie groter dan ooit zijn. De afwijzing vindt hij dan ook onterecht.

Ook Luciel Burm, voorzitter van de Dutch Startup Association (DSA) spreekt zijn zorg uit. Als er niet meer geld bijkomt, dreigt een kaalslag van de sector. Landen om ons heen treden veel doortastender op: Duitsland, Frankrijk en Engeland investeren momenteel miljarden in start-ups, en daarmee in de economie van morgen.

De regionale ontwikkelingsmaatschappijen (ROMs), die de COL aanvragen beoordelen en verstrekken, zien zelf ook dat de nood hoog is. Zo spreekt Marc Janssen, manager Brabant Ventures bij de BOM de hoop uit dat er uiteindelijk nog meer geld beschikbaar komt, vooral voor bedrijven in hun vroege fase. HollandBIO kan zich daar alleen maar bij aansluiten, net als bij de woorden van DSA’s Luciel Burm:  ‘Minister Wiebes heeft gezegd dat we ons uit de crisis moeten investeren. Ik nodig hem van harte uit dat te doen in start-ups.’.

En dat alles liever vandaag dan morgen.

Lees meer

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ISA Pharmaceuticals Strengthens Strategic Immuno-Oncology Collaboration with Regeneron

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ISA Pharmaceuticals, a private clinical-stage immunotherapy company, plans to initiate a potentially pivotal clinical trial for the combination of ISA101b and Libtayo® (cemiplimab) in oropharyngeal cancer, a type of head-and-neck cancer, under its strategic immuno-oncology collaboration with Regeneron. In addition, Regeneron will increase its equity stake in ISA Pharmaceuticals.

The new oropharyngeal cancer trial is the third trial planned under the clinical collaboration between ISA Pharmaceuticals and Regeneron. ISA101b, an immunotherapy targeting human papillomavirus type 16 (HPV16), is currently in a Phase 2 clinical trial for first- and second-line HPV16-positive head-and-neck cancer in combination with Libtayo, a PD-1 inhibitor that is being jointly developed by Regeneron and Sanofi. A second Phase 2 trial investigating the same combination in cervical cancer is also planned. More than 60 percent of head-and-neck cancers and approximately 55 percent of cervical cancers are HPV16 induced.

Under the revised agreement, the clinical collaboration offers a potential shortened path to first approval in the HPV16-positive oncology indications being studied in the next few years. The agreement also streamlines ISA Pharmaceuticals’ access to license fees, milestone payments and royalties. Together with the recently secured 20 million Euro loan from the European Investment Bank, development of ISA101b is now fully funded through the data readout of ongoing and planned pivotal trials which will support regulatory filings.

“This agreement will accelerate the development and commercialization of our lead asset, ISA101b, to treat two important cancers with high unmet medical needs.” commented Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals.“We are extremely pleased to be working with Regeneron and for their continued support of both ISA Pharmaceuticals and our clinical studies in both indications.”

“Thanks to this updated clinical collaboration, we are able to rapidly diversify our research into a broader array of HPV16-induced cancers,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology, at Regeneron. “ISA101b offers a validated mechanism of action, and we look forward to working with ISA Pharmaceuticals to determine the synergistic potential of combining this novel immunotherapy with Libtayo to better address these difficult-to-treat cancers.”

Source: ISA Pharmaceuticals

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In Ovo awarded €2.5 million EU grant

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In Ovo, spinoff from Leiden University, will receive €2.5 million from the prestigious European Innovation Council (EIC) Accelerator Pilot grant to support its mission to stop the culling of male chicks around the world.

Every year, the poultry industry culls 6.5 billion chicks. These are male, don’t lay eggs and so they are useless in egg production. In Ovo develops a high-throughput screening machine, that gender types the egg instead of the chick. The machine will make it possible to only hatch the females and prevents the killing of billions of male chicks. The company works in collaboration with a number of large industry players and technology providers and is well on its way to solve this decades old problem. Germany and France are putting legislation in place to end the culling of day-old chicks by 2022 and the technology that In Ovo is working on will help make this a reality.

The EIC Accelerator

The EIC Accelerator (previously known as the SME Instrument) is part of the European Innovation Council (EIC) pilot that supports top-class innovators and entrepreneurs with funding opportunities and acceleration services. The EIC Accelerator supports high-risk, high-potential small and medium-sized companies to help them develop and launch new innovative products and services that could drive economic growth. 

“This subsidy enables us to speed up development, scale up the company, and will have massive positive impact on the poultry industry across the globe”, says Wouter Bruins, director at In Ovo. “We are grateful and very happy to receive such a prestigious grant and look forward to working with the council on accelerating our business. Together, we can improve both sustainability and animal welfare in food production on a very large scale.”

In Ovo is one of only 72 companies that are awarded the grant. During this round, the EIC received 3,976 applications from companies based in more than 20 European countries, making it the most competitive round of this funding instrument to date. The company was supported by Scale-up Ventures and the Netherlands Enterprise Agency (RVO).

The company

In Ovo is a spinoff from Leiden University, founded by Wil Stutterheim and Wouter Bruins. It aims to positively impact the lives of billions of chicks and thousands of farmers, through the development and launch of new technologies. In Ovo is previously supported by investments from Leiden University, Evonik Industries and VisVires New Protein.

Source: In Ovo

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Inclusieve Vaccin Alliantie sluit deal met AstraZeneca

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De Inclusieve Vaccine Alliantie (IVA) heeft afspraken gemaakt met AstraZeneca over de levering van in totaal 300 tot 400 miljoen doses van het COVID-19-vaccin AZD1222 van de Oxford Universiteit. Als alles goed gaat, worden de eerste leveringen voor het einde van dit jaar verwacht. Binnen de IVA bundelen Duitsland, Frankrijk, Italië en Nederland de krachten in de onderhandeling met ontwikkelaars en producenten van potentiële coronavaccins. De deal met AstraZeneca zijn de eerste afspraken van de alliantie om te zorgen dat een potentieel coronavaccin voor Europa snel beschikbaar kan komen. 

De corona-pandemie stelt de wereld voor ongekende uitdagingen. Wereldwijd bundelen partijen de krachten om zo snel mogelijk effectieve vaccins en geneesmiddelen te ontwikkelen. Dat vergt meer dan investeren in onderzoek alleen. In een recente publicatie gaat de Organisatie voor Economische Samenwerking en Ontwikkeling (OESO) in op de vraag hoe beleid de eerlijke en universele toegang tot behandelingen en vaccins voor het coronavirus kan stimuleren. De OESO adviseert publieke partijen ook later in het proces te investeren, te helpen om het risico te dragen, pull mechanismen uit te werken, om productiecapaciteit uit te breiden parallel aan ontwikkeling en bovenal grootschalige internationale samenwerking. Met haar aanpak lijkt de IVA die aanbevelingen ter harte te nemen.

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MIT COVID-19 Challenge; sequel in the Netherlands

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On Friday the 12th of June, a couple of international teams that joined the MIT COVID-19 Challenge at the beginning of April had the opportunity to pitch their solutions against COVID-19 to a group of Dutch stakeholders from the Life Sciences & Health community to explore possibilities to implement their solution in the Netherlands.

HollandBIO is proud supporter of the MIT COVID-19 Challenge and together with Health~Holland, Innovation Attaché Network in the US and the team of the MIT COVID-19 Challenge organized this follow-up pitch session. After the pitches, the Dutch stakeholders offered support for collaboration and implementation possibilities.

Due to great interest a lot of Dutch partners joined the pitch session including NeLL, Takeda, Invest in Holland, Noaber Foundation, Taskforce Health Care, RVO, NL Venture Builders, InnovationQuarter, ZonMW and the Dutch Taskforce for Applied Research (SIA). Especially in times when the focus tends to be national, support of cross-border collaboration should be supported.

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DSM to add world-leading animal nutrition and health specialty businesses with acquisition of Erber Group

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Royal DSM, a global science-based company in Nutrition, Health and Sustainable Living, announces that it has reached agreement to acquire Erber Group for an enterprise value of €980m. The value of the transaction represents an EV/EBITDA multiple of about 14x the 2020 EBITDA (fiscal year ending September 2020). The transaction – which excludes two smaller units in the Erber Group – is expected to be earnings enhancing in the first year upon completion.

Erber Group’s specialty animal nutrition and health businesses, Biomin and Romer Labs, specialize primarily in mycotoxin risk management, gut health performance management, and food and feed safety diagnostic solutions, expanding DSM’s range of higher value-add specialty solutions. Romer Labs also complements DSM’s human nutrition and health offering to food industry customers. Sanphar and EFB, representing 7% of Erber Group’s total sales, are not included in this transaction.

The acquired businesses have combined sales of €330m and an Adjusted EBITDA margin above 20% for the twelve months to the end of March 2020, with a high single-digit organic sales growth rate over the past 5 years. The acquisition will be debt financed, with committed bridge financing in place. DSM continues to benefit from a strong balance sheet and remains committed to maintaining a strong investment grade credit profile.

With state-of-the-art research and manufacturing facilities and approximately 1,200 employees around the world, the acquisition of Erber Group is a unique strategic opportunity that provides revenue-enhancing synergies from the combined offering, global customer base, and complementary geographic strengths. Austrian-based Erber Group offers DSM the opportunity to enter the mycotoxin risk management market as the world leader and extends the company’s position as one of the top suppliers in the rapidly growing animal gut performance management market.

Mycotoxins occur as a result of natural fungus contaminants in animal feed and threaten the health of both animals and humans. In addition to increasing the risk of illness, mycotoxins also reduce the nutritional value of feed. Biomin’s patented and proprietary technology provides the most scientifically advanced mycotoxin protection available. Biomin is also a major producer of phytogenic and probiotic feed alternatives to antibiotics, which complements and strengthens DSM’s position in the rapidly growing global eubiotics market for improving animal gut health.

Romer Labs is at the forefront of diagnostic technology with innovative testing solutions for the analysis of mycotoxins in feed and food, food allergens and pathogens as well as veterinary drug residues, with accredited full-service labs in Austria, UK, USA and Singapore. DSM’s extensive global network of food and beverage customers as well as feed customers stand to benefit from Romer Labs’ expertise and the combined group’s data-based quality assurance offering.

The acquisition of Erber Group further strengthens DSM’s expertise and reputation as a leading provider of animal health and nutrition solutions for farm productivity and sustainability, with an emphasis on emissions reduction, feed consumption efficiency, and better use of water and land.

Source: DSM

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Upfield and Beyond Meat choose for the Netherlands

Plantbased leader Upfield announced plans to build a new state-of-the-art Food Science Centre and Beyond Meat will open a new co-manufacturing facility of its first production site outside the US. Both Upfield and Beyond Meat have chosen the Netherlands to realize their plans.

Both companies want to start with their activities in 2021. Upfield explains it has chosen for the Netherlands, because of the Wageningen ecosystem. Wageningen is considered as the Silicon Valley of the food industry and a world-class location for food innovation. Wageningen University is ranked as the world’s leading University in Agri-Food. Upfield will invest €50 million for their Food Science Center.

HollandBIO is working on an attractive business climate for all biotechnology related businesses, whether entrepreneurs work on innovation in plants, medicines, vaccines, cultured meat or biobased materials. By attracting these two big Agri-Food disruptors, the Netherlands demonstrates its potential role in helping to enable a transition to a more sustainable food system.

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Kite Receives EMA approval for CAR-T Cell therapy manufacturing facility in Europe

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Kite has received approval to implement a variation to the Yescarta Marketing Authorization from the European Medicine Agency (EMA) for end-to-end manufacturing. With this approval, Kite’s European manufacturing facility, designed and dedicated to the manufacture of individualized cell therapies, is now fully operational.

https://www.youtube.com/watch?v=IN8hLsgyZeM
Time-lapse video of the construction of Kite’s cell therapy manufacturing facility located outside of Amsterdam.

“Kite is focused foremost on the needs of patients living with cancer and we are proud to now manufacture cell therapy directly in Europe,” said Christi Shaw, Chief Executive Officer of Kite. “This facility will benefit both patients and healthcare professionals, allowing Yescarta to reach European treatment centers more quickly and reducing the time it takes to reach patients by almost a week.”

Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel. The new European facility sits next to one of Europe’s largest airports, Amsterdam Airport Schiphol. This central location, with its transport links to the region, will reduce the delivery time to and from treatment centers. The facility has the capacity to produce therapy for up to 4,000 patients per year.

“With the enhanced technology and processes at our new facility we are pleased to be leading the next chapter in the manufacture and delivery of CAR T therapy,” said Charles Calderaro, Kite’s Global Head of Technical Operations. “Our new European manufacturing facility is dedicated to cutting-edge cell engineering, enabling patients to receive their potentially life-saving treatment more quickly.”

“The prognosis for patients with refractory large B-cell lymphoma is poor, with a median survival of approximately six months with the prior standard of care,” said Marie José Kersten, MD, PhD, Amsterdam University Medical Centers, Amsterdam, the Netherlands. “Timely access to cell therapy is critical, and the ability to manufacture CAR T cell therapies in Europe is welcomed by the clinical community.”

Source: Kite (press release)

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