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Key stakeholders from Massachusetts and the Netherlands discuss lessons learned from COVID-19

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On Monday the 8th of June, key stakeholders from Massachusetts and the Netherlands will come together in a virtual session to discuss about the developments in both life sciences ecosystems in the light of the COVID-19 pandemic outbreak, and how international collaboration, now and in the future, could contribute to solutions.

Due to the COVID-19 pandemic outbreak, now more than ever, the world is dependent on life sciences ecosystems to find a treatment or vaccine. However, the life sciences sector also faces challenges in these difficult times. The virtual session is a perfect moment for key stakeholders from both Massachusetts and the Netherlands to exchange views on how we can build resilience during this outbreak and afterwards. And to discuss and learn from the dynamics in both life sciences ecosystems and what role of international collaboration is and could be.  

This virtual session fits in the longstanding ties that there are between the life sciences ecosystems of Massachusetts and the Netherlands, and that culminated in the signing of a a Memorandum of Understanding (MoU) in the Summer of 2019. This MoU was signed between The Massachusetts Office of International Trade and Investment (MOITI) and the Dutch Ministry of Economic Affairs and Climate Policy (EZK). Other signatories of the MoU include the Henri A. Termeer Tribute Committee, MassBIO, Massachusetts Life Sciences Center, Health~Holland and HollandBIO.

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BIO Digital 2020 Europe session “Start Me Up”: How Can Europe’s Biotech Sector Combat the Coronavirus?

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Focco Vijselaar, Director General for Enterprise and Innovation at the Ministry of Economic Affairs and Climate Policy will represent the Netherlands during the BIO Digital 2020 in the session ‘Start Me Up: How Can Europe’s Biotech Sector Combat the Coronavirus?’. Together with representatives of EuropaBIO, Biobe, Alnylam Pharmaceuticals and McKinsey the role of the biotech sector in addressing global challenges like COVID-19 will be discussed.

What is the contribution of the European biotech companies to the COVID-19 response and what is needed to find treatments and vaccines? The panel will reflect on the current state and preparedness to respond to pandemic outbreaks. What are the lessons learned and which strategies and policies are needed to support the life sciences sector in moving forward.

Interested in this session? Check here to register for BIO Digital with $250 discount for HollandBIO members.

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Intravacc and EpiVax team up in development of COVID-19 emerging vaccine

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Intravacc, one of the world’s leading translational research and development vaccine institutes, with an extensive track record in developing viral and bacterial vaccines, and EpiVax, a biotechnology company based in Providence with expertise in developing vaccines and therapeutics, announce that they have entered into a collaboration agreement to further progress a novel vaccine against COVID-19, based on Intravacc’s proprietary Outer Membrane Vesicles (OMV) technology platform.

For this joint research project, Intravacc will combine its safe and immunogenic OMV delivery platform with synthetically produced COVID-19 epitopes (protein allergens), designed and optimized by EpiVax using advanced immunoinformatics tools, in order to generate a safe and highly effective T-cell response against SARS-CoV-2 and related coronaviruses. Pre-clinical studies will start immediately so as to select the best candidate peptides for the vaccine. Intravacc will utilize its in-house pilot-scale facility for the GMP production of the OMV-peptide vaccine, for clinical (phase I) studies expecting to start in Q4 2020.

Annie De Groot, MD, CEO and CSO of EpiVax, said:

“We are thrilled to enter into a partnership with Intravacc using their very novel ‘click-on’ OMV technology and the highly immunogenic and safe SARS-CoV-2 multi-epitope-bearing peptides designed using the iVAX toolkit at EpiVax. We believe that the combination of technologies  and the strength of our longstanding collaboration with Intravacc will lead to the development of an effective and safe vaccine that could rapidly benefit hundreds of millions of people around the globe.”

Dr. Jan Groen, CEO of Intravacc, stated:

“A COVID-19 vaccine based on this approach is expected to be very safe and to reduce the morbidity and mortality rates associated with COVID-19. The vaccine is expected to lower the risk that individuals infected with SARS-CoV-2 will require hospitalization and/or intensive care. It also expected to induce long-term memory responses to prevent COVID-19 disease and infection from other beta-corona viruses. We expect that leveraging Intravacc’s unique vaccine development expertise, broad-based network and successful track record in global technology transfer to vaccine manufacturers will bring success”.

About Intravacc’s OMV platform technology

For the development of vaccines against pathogens, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) – spherical particles with intrinsic adjuvating properties. Using genetic engineering, the OMVs can be decorated with immunogenic peptides that combine T- cell epitopes that will drive effective adaptive immunity. Heterologous OMV vaccines are a suitable alternative approach to protect against pathogens that require a high level of containment, that are difficult to cultivate, or that contain viral and/or parasitic proteins. The antigens of choice are attached to the ‘empty’ OMV carrier resulting in a more effective immune response.

Intravacc also has developed genetic tools to increase the yield of OMVs, to reduce toxicity, and to achieve the desired antigenic composition. Intravacc’s OMV platform is fully scalable and allows for fast and efficient modification of antigen composition, either via genetic modification of the bacterial host or by associating antigens to stockpiled carrier OMVs.

Source: Intravacc (press release)

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Nieuw noodmaatregelenpakket geen oplossing voor biotech ondernemers

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Vorige week heeft het kabinet aangekondigd dat er een verlenging en uitbreiding komt van het bestaande noodpakket. Zo voorziet de overheid de Nederlandse economie van financiële steun. Het resultaat daaruit is een noodpakket 2.0. Helaas is de Corona-Overbruggingslening (COL) vooralsnog het enige instrument dat past bij start-ups, scale-ups en innovatief MKB.

In de eerste tranche is er €100 miljoen vrijgemaakt voor de COL en daar komt nu €150 miljoen bij. Dat klinkt als een flink bedrag, maar de praktijk laat zien dat de urgentie en nood hoog is bij dit soort bedrijven. Volgens Techleap is er namelijk in de eerste weken al voor meer dan €500 miljoen aangevraagd en de verwachting is dat dit alleen maar zal toenemen. Ook de Dutch Startup Association (DSA) laat weten dat de €250 miljoen niet genoeg zal zijn en uit haar zorgen in een brief aan staatssecretaris Keijzer en minister Wiebes. Hetzelfde geldt voor VNO-NCW en MKB-Nederland die zich afvragen of dit bedrag voldoende is voor deze groep belangrijke bedrijven.

HollandBIO sluit zich hier volledig bij aan en brengt nogmaals naar voren dat innovatieve start-ups, scale-ups en MKB  allesbepalend zijn voor het toekomstige innovatie- en verdienvermogen van Nederland en ons vermogen om maatschappelijke uitdagingen op gezondheid en duurzaamheid het hoofd bieden.

De eerder benoemde problemen voor de biotech sector op een rij

  • R&D programma’s stagneren
  • Lopende financieringsrondes vertragen
  • Het aantrekken van nieuwe financiering wordt nog moeilijker.
  • Tegelijkertijd blijven bedrijven kosten maken, zoals personeelskosten, huur van lab- en kantoorruimtes, en aflossing van leningen.
  • Aangezien veel kleine biotech bedrijven opereren met een korte financieringshorizon, is running out of cash binnen slechts enkele maanden een reëel scenario.

De eerder benoemde mogelijke oplossingen voor de biotech sector op een rij

  • Het openstellen van de NOW voor biotech bedrijven en andere bedrijven die vanwege hun businessmodel geen omzet maken, door het omzetcriterium voor deze bedrijven te laten vallen.
  • Te waarborgen dat de WBSO niet wegvalt, wanneer er door COVID-19 tijdelijk geen onderzoek wordt gedaan, alsmede het tijdelijk verhogen van de WBSO.
  • Uitstel, of liever kwijtschelding van terugbetaling rente over leningen en kredieten (Innovatiekrediet, provincie en BBMKB (Rabobank/RVO).
  • Aanbieden van brugfinanciering in de vorm van converteerbare leningen.
  • Versnelling toekenning aangevraagde subsidies en kredieten (bijv. Innovatiekrediet, H2020-SME)

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SeraNovo Enters into a second License Agreement with Carna Biosciences

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SeraNovo has signed a second License Agreement with Carna Biosciences, Inc., a company engaged in the drug development of kinase inhibitors. Under the agreement, the companies will expand their existing collaboration and jointly develop an oral formulation of a new active ingredient with an enhanced bioavailability.

Utilising its proprietary Deep Eutectic Solvent (DES) formulation platform, SeraNovo is formulating one of Carna’s proprietary drugs to increase its oral bioavailability. The DES formulation platform is based on GRAS excipients that are used for oral administration and broadly used in the industry.

Niall Hodgins, Chief Executive Officer of SeraNovo commented: “After our initial licence announcement in October 2019, we are pleased to extend our relationship with Carna to include the formulation of another promising active ingredient. This expansion of our partnership with an industry leader is a great development towards wide spread adoption of our breakthrough formulation technology.”

Source: SeraNovo

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BioConnection hijst vriesdroger van 12 ton in steriele productiefaciliteit

Vorige week werd een nieuwe vriesdroger, met een gewicht van 12 ton en een waarde van enkele miljoenen, afgeleverd op de derde verdieping van het RY gebouw van BioConnection op het Pivot Park in Oss. In dit RY gebouw wordt een nieuwe productielijn voor het produceren van steriele geneesmiddelen gerealiseerd. BioConnection, opgericht in 2005, breidt daarmee haar productiecapaciteit uit naar 50 miljoen vials op jaarbasis, een significante contributie aan het wereldwijde tekort aan productiecapaciteit van steriele geneesmiddelen.

De vriesdroger maakt deel uit van een nieuwe ultramoderne productielijn voor de productie van steriele innovatieve geneesmiddelen in een EMA- en US-FDA-gecertificeerde faciliteit. De nieuwe productielijn moet in april 2021 gereed zijn. Dankzij deze uitbreiding kan BioConnection haar productiecapaciteit verhogen naar 50 miljoen vials per jaar. 

De waardevolle vriesdroger is gebouwd in Duitsland, door de firma Hof. De machine van 12 ton moest drie verdiepingen hoog worden opgetild om in de productieruimte te worden geplaatst. Een precieze operatie, want er was slechts een veiligheidsmarge van vijf centimeter tijdens het tillen. Het inhijsen van de vriesdroger begon omstreeks 11.00 uur. Ongeveer 3,5 uur later waren alle onderdelen veilig binnengebracht.

De uitbreiding van BioConnection draagt bij aan de positie van het Pivot Park als hotspot voor de pharmaceutische industrie en de werkgelegenheid. Momenteel heeft BioConnection nog 15 vacatures openstaan. 

Bron: Bioconnection

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Het oranjegevoel binnen de biotech

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De afgelopen weken blikt de media regelmatig trots naar Leiden, waar Janssen Vaccines alle zeilen bijzet om zo snel mogelijk een coronavaccin te ontwikkelen. Janssen kan snel handelen, mede dankzij de eerdere aanschaf van Crucell’s AdVac en PER.C6 technologie. Technologie met Nederlandse wortels, zo lichten Dinko Valerio, Lex van der Eb en Ronald Brus in het Parool toe. Hoewel het geen geheim is dat de Nederlandse life sciences wetenschap van wereldklasse is, kunnen we de kennis daaruit volgens hen nog beter verzilveren.

Ook HollandBIO is ervan overtuigd dat Nederland met de juiste aanpak internationaal kan aansluiten bij de kopgroep op vaccin- en geneesmiddelenontwikkeling. Wij zetten daarom vol in op een vruchtbare voedingsbodem voor het Nederlandse bedrijfsleven. Zo komen we tot een ijzersterk innovatieklimaat waarin tech transfer soepel verloopt, waar voldoende financiering is voor de doorgroei van start- en scale-ups en waar de successen van de sector met oranjegevoel gevierd mogen worden. Want wie kennis zaait, zal bedrijvigheid oogsten.

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MIT COVID-19 Challenge II

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Get ready for a new MIT COVID-19 Challenge! HollandBIO is again a proud supporter of this great initiative. This second hackathon is a follow-up to the first ‘Beat the Pandemic’ event and will focus on addressing new issues that have arisen now that we are several months further into the ongoing pandemic. We invite you again to join actors in Massachusetts to take action on the COVID-19 crisis.

You can join the MIT COVID-19 Challenge II from Friday May 29 till Sunday  May 31, 2020. This is a 48-hour virtual event and you can contribute as a participant, mentor, judge or partner organization. Teams will be formed on Friday May 29 and during the weekend there are sessions with mentors refining solutions. On Sunday May 31 the teams have to present their work for a panel of judges. After the weekend, the best ideas and teams will have the opportunity to co-develop and implement their solution with the support of the MIT COVID-19 Challenge partners.

  • The application deadline is Tuesday May 26.
  • For more information and to apply, please check out the website.
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Survey results: impact and response to the COVID-19 crisis in the European Life Sciences sector

This month ttopstart has interviewed 50 European life sciences companies on how they are impacted by and have responded to the COVID-19 crisis. In the report the results are discussed and translated into recommendations. Jasper Levink, director of ttopstart: “Whereas some life sciences companies seem to benefit from the pandemic, many are facing severe delays, funding issues, and are at risk of default. With this report we provide useful recommendations to these companies. They could benefit from quickly finding the right investors, partners, and making strategic switches to adopt to the corona-induced situation.”

Results: impact of COVID-19 on life sciences industry

  • Nearly two-thirds of the companies interviewed expect delays in the development of their lead product due to the COVID-19 crisis. The average expected delay is 6-months.
  • About half (51%) of the companies expect to require extra funding. Most of the firms in need for additional funding require an amount between €100.000-€400.000, and it is not rare for companies to require an amount of even more than €800.000. Interestingly, these data also imply that an equal amount of companies does not face a financial setback.
  • Our data shows that the impact of the exit value of companies is very mixed; A quarter of the companies expect their exit value to be influenced negatively whereas about an equal amount of them expects a positive effect, no effect, or find it hard to make a prediction. Of the firms older than 11-years 21% are at risk of default (compared to 42% of younger companies) and only 36% of them require extra funding due to the COVID-19 crisis (compared to 63% of younger companies). This may indicate that older firms have a higher chance of surviving this crisis.
  • A wide range of strategic moves in response to the crisis are being made. Amongst financial strategies, reduction in operational costs and postponing investments are the most common. Interestingly, nearly a third of the interviewees have responded to the pandemic by switching to infectious diseases or other COVID-19 related areas.
  • Many companies are forced to revise their R&D and funding strategies while facing future uncertainties. The long-term effects of postponing investments could be the most detrimental for biomedical innovation.
  • Nearly 60% of the companies applied for the governmental support measures offered. Interestingly, only a quarter of the respondents in need of extra funding attempted to raise this via EU grants.

For the full report visit: https://www.ttopstart.com/news/results-survey-covid19

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Lava Therapeutics and Janssen to develop Bi-specific Gamma-Delta T-cell Engager Therapeutics

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Lava Therapeutics has entered into a research and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to discover and develop novel bispecific antibodies to gamma-delta T cells for the treatment of cancer. The collaboration was facilitated by Johnson & Johnson Innovation.

“We are excited to enter into this collaboration with Janssen, a global innovator and leader in the development of new medicines,” said Stephen Hurly, chief executive officer of Lava Therapeutics. “We strongly believe in the strength of our bispecific gamma-delta T cell engager platform and are committed to creating highly potent, target-specific therapeutics with increased durability and safety over current T cell-based approaches.”

Under the terms of the agreement, Lava Therapeutics will perform discovery and product development activities, and is eligible to receive an undisclosed financial package consisting of an upfront payment and potential development and commercial milestones, and future tiered royalties.

Source: Lava Therapeutics (press release)