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BIO International Convention goes BIO digital

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This year, the BIO International Convention will transition to virtual event format: BIO Digital. HollandBIO members can access this largest virtual gathering of the global biotech industry at a discounted rate of $950. Read more

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First MIT Covid-19 Challenge; a great success

In the weekend of 3 till 5 April, 1500 selected participants took part in the MIT Covid-19 Challenge – Beat the Pandemic Hackathon. They were selected out of more than 4500 applications from over 100 countries. Dutch participants were also joining team sessions in 10 different tracks.

The teams, under guidance of mentors, presented their work at the end of the weekend to judge panels that picked 40 winning teams out of 208 teams. The organization is now analyzing which teams are able to further work on their solutions and what is needed to get these solutions into practice.   

You can read more about the challenge at Mobi Health News

Or watch the Beat the Pandemic Kickoff at YouTube

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Synthon Biopharmaceuticals relaunches as Byondis

Synthon Biopharmaceuticals B.V., a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless cancers and autoimmune diseases, today announced that it is relaunching as Byondis.

Byondis is creating safe and effective precision medicines based on its proprietary technologies, targeting intractable cancers and auto-immune diseases, which aim to improve the standard of care for patients.

The Company has a broad development pipeline, including advanced clinical programs, such as anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) for breast cancer. In the second half of 2020, Byondis is expecting results from its pivotal TULIP® Phase III trial comparing SYD985 to physician’s choice treatment in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Submission of a Biological License Application is scheduled before the end of 2020.

The Company anticipates entering the clinic with four additional programs in the course of 2020/2021. After progressing to clinical proof of concept, Byondis intends to enter into partnerships for late-stage development and commercialization.

Synthon Biopharmaceuticals was established in 2007 as part of Synthon B.V., and became a separate biopharmaceutical subsidiary in 2012, quickly building a promising pipeline of innovative R&D programs. In November last year, following the acquisition of Synthon International Holding B.V. by BC Partners, the founder, Dr Jacques Lemmens, decided to continue as an independent biopharmaceutical company, with its own management team and state-of-the-art facilities. This company relaunches today as Byondis.

“Our relaunch as Byondis is an exciting moment for the Company” said Dr Jacques Lemmens, Founder. “Building on our heritage, while preserving our company culture, we are further progressing in innovation, quality and scientific excellence.”

“Now is the time to step up as an independent biopharmaceutical company, with our exceptional people, unique technologies and a well-established development pipeline, including our lead ADC, [vic-]trastuzumab duocarmazine. I am very proud of how the Company has grown and evolved. The new name, Byondis, represents the next chapter and embodies our entrepreneurial spirit and ambition to create innovative precision medicines to outsmart cancers and auto-immune diseases.”

The Byondis management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. Dr Marco Timmers, CEO, and others in the senior team have collaborated for many years as part of Synthon. During this time, they have created a company driven by science and innovation, with unique technologies and significant validation deals. These include the out-licensing of a biosimilar version of the monoclonal antibody trastuzumab (marketed as KANJINTI™) in a global partnership agreement with Amgen in 2012.

“As Byondis, we can now showcase our strong business and scientific proposition”, added Dr Marco Timmers, CEO. “We have generated a portfolio of preclinical and clinical programs with the potential to deliver completely novel treatments for cancer and auto-immune diseases. We have unique technologies with differentiating potential, state-of-the-art facilities including our own GMP manufacturing, and broad licensing expertise that makes us an attractive partner for out-licensing. This is a really exciting time for Byondis and our team.”

Byondis operates from its headquarters in Nijmegen in the Netherlands, with over 350 highly qualified employees working in state-of-the art research and development and GMP manufacturing facilities. The Company has strong links to academic institutions, global medical communities and the international pharma industry.

Source: Byondis (press release)

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Galapagos and Ryvu announce research collaboration

Galapagos and Ryvu Therapeutics have announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation.

Ryvu specializes in the discovery and development of first-in-class small molecules and drug candidates in diseases with high unmet medical needs. The collaboration announced today is based on a novel drug target identified by Ryvu, which will contribute its technology platform and related intellectual property (IP). Ryvu and Galapagos will both provide resources to support the collaboration and make use of their expertise in high-throughput screening, biology, medicinal chemistry, and toxicology.

This is a joint research collaboration in which Ryvu is responsible for early drug discovery. Under the terms of the agreement, Galapagos will have an exclusive option to license IP developed by Ryvu and to continue to develop this during the collaboration. Pending achievement of pre-agreed criteria and utilizing its option, Galapagos will be responsible for all further development of the program.

In exchange for global development and commercialization rights, Ryvu will receive an upfront payment and will be eligible for further option, milestone, and royalty payments.

“We believe that the collaboration with Ryvu is an excellent fit, as both companies are driven by the search for novel drugs to address unmet medical needs,” says Dr. Piet Wigerinck, Chief Scientific Officer at Galapagos. “We look forward to collaborating with the Ryvu team to push this program forward.”

Pawel Przewiezlikowski, Ryvu Chief Executive Officer, added: “We are thrilled to start working with Galapagos, a real role model for the European biotechnology sector. Throughout joint discussions on the collaboration, our teams have developed a strong rapport and built the foundations for a very promising start for the new project on an exciting novel target.”

Source: Galapagos (press release)

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LiteVax receives EU Horizon 2020 grant

A consortium of public and private R&D organisations from EU, India, and US has been awarded a 10 m€ grant for development of improved influenza virus vaccines for the globe. Later this year, this grant will be matched by the government of India. LiteVax BV (Oss, The Netherlands) and the Translational Health Science Technology Institute (Delhi, India) have initiated the project and the University of Amsterdam will be the coordinator. The INDIGO project builds on LiteVax’s patented, versatile adjuvant technology developed to improve prophylactic and therapeutic vaccines.

The grant will support the development of a next generation of influenza vaccines aiming at higher effectivity, lower costs and better accessibility. The INDIGO project combines innovations in antigen design, antigen delivery and immune-stimulation and plans to perform phase I/IIa clinical trials in EU and India. In addition to LiteVax, the INDIGO consortium consists of one Danish partner, two Belgian partners, three French partners, two Dutch partners, one US partner, and six Indian partners. An important goal is the collaboration between R&D organizations in these countries with complementary skills and know-how. See https://cordis.europa.eu/project/id/874653 for more information.

Source: LiteVax (press release)

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Help biotech sector door coronacrisis

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De economische gevolgen van het coronavirus stellen biotech start-ups en scale-ups voor grote uitdagingen. HollandBIO maakt zich hard voor ondersteuning toegesneden op de specifieke behoeften van de biotech sector. Op 7 april presenteerde het kabinet aanvullende maatregelen om ondernemers te ondersteunen. HollandBIO is blij met deze eerste stap, maar blijft benadrukken dat verdergaande en meer duurzame ondersteuning nodig is voor de Nederlandse biotech sector. Niet alleen is de sector cruciaal voor het toekomstig verdienvermogen van Nederland, vandaag de dag blijkt de innovatiekracht van de sector op alle fronten harder nodig dan ooit.

Overbruggingskrediet

Het kabinet maakt 100 miljoen euro vrij voor overbruggingskredieten voor non-bancair gefinancierde bedrijven. Kredieten tot een maximum van 2 miljoen euro worden verstrekt door regionale ontwikkelingsorganisaties (ROM’s), Invest-NL krijgt een rol voor hogere bedragen. Ook werken het ministerie van Economische Zaken en Klimaat (EZK), de ROM’s, Invest-NL en Techleap aan een gezamenlijk programma gericht op het verstrekken van overbruggingskrediet in de vorm van (converteerbare) leningen aan innovatieve start- en scale-ups. HollandBIO bepleit de snelle, eenvoudige en brede beschikbaarheid van converteerbare kredieten om biotech bedrijven in acute financiële nood te helpen.

Uitstel betaling Innovatiekrediet

In haar brief aan de Tweede Kamer kondigt het kabinet uitstel van betaling voor Vroege Fase Financiering (VVF) en het Innovatiekrediet aan, van maximaal 6 maanden. HollandBIO vindt dit echter onvoldoende. Met deze maatregel wordt de rekening slechts uitgesteld, terwijl die door rente op rente wel fors oploopt. Een tijdelijke rentestop, tot twee jaar uitstel van afbetalingen en een generieke en retrospectieve renteaanpassing geeft ondernemers meer lucht in deze moeilijke tijd. Op verzoek van vele bedrijven in onze achterban, bespreekt HollandBIO verdere mogelijkheden met RVO en EZK. Hierbij vragen we ook aandacht voor soepele honorering van aanvragen voor nieuwe Innovatiekredieten.

WBSO

Biotech bedrijven profiteren zonder uitzondering van de WBSO regeling, waarmee R&D intensieve bedrijven korting krijgen op de loonheffing. HollandBIO bepleit dat bedrijven hun volledige WBSO korting behouden, ook wanneer corona-beperkingen onderzoek en ontwikkeling tijdelijk stilleggen. Liever nog wordt er tijdelijk volledig afgezien van loonheffing voor innovatieve bedrijven.

HollandBIO roept biotech bedrijven op om ons te laten weten hoe zij ervoor staan en in hoeverre de huidige noodmaatregelen soelaas bieden. Aanspreekpunt is HollandBIO’s Wieteke. Ook voor andere vragen, uitdagingen of problemen waarbij HollandBIO’s inzet zou helpen: laat het ons weten!

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Blackstone and Alnylam Enter Into $2 Billion Collaboration

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Blackstone and Alnylam Pharmaceuticals have entered into a broad strategic collaboration under which Blackstone will provide up to $2 billion to support Alnylam’s advancement of innovative RNA interference (RNAi) medicines that have the potential to transform the lives of patients suffering from a range of debilitating diseases.

The deal is anchored by Blackstone’s purchase of 50 percent of the royalties owed to Alnylam on global sales of inclisiran, an investigational RNAi therapeutic for the treatment of hypercholesterolemia, currently under review by the U.S. Food and Drug Administration. Inclisiran is a twice-a-year, subcutaneously injected RNAi therapeutic that has been shown in a comprehensive Phase 3 program to reduce low-density lipoprotein (LDL) or “bad” cholesterol with an acceptable safety profile. If approved, this medicine is expected to help patients lower LDL cholesterol, a major risk factor for cardiovascular disease, the leading cause of mortality in the U.S. and globally.

The strategic financing collaboration, led by Blackstone Life Sciences and GSO Capital Partners (“GSO”), Blackstone’s credit platform, is expected to enable Alnylam’s achievement of a self-sustainable financial profile without need for future equity financing, accelerating the commercial potential of Alnylam’s rapidly advancing product portfolio. The investment by multiple Blackstone businesses will support the development and delivery of promising medicines to the patients who need them and is one of the largest ever private financings of a biotech company.

The transaction includes the inclisiran royalty monetization, corporate debt, purchase of Alnylam equity, and funding for certain R&D activities related to the clinical advancement of two Alnylam investigational RNAi therapeutic programs in cardiovascular disease.

Specifically, the transaction is comprised of the following components:

  1. $1 billion in committed payments, led by Blackstone Life Sciences, to acquire 50 percent of Alnylam’s royalties and commercial milestones for inclisiran;
  2. Up to $750 million in a first lien senior secured term loan led by GSO;
  3. Up to $150 million from Blackstone Life Sciences for development of Alnylam’s cardiometabolic programs vutrisiran and ALN-AGT (to be established based upon a non-binding letter of intent);
  4. $100 million purchase of Alnylam common stock.

“Alnylam is focused on building a top-tier biopharmaceutical company, advancing RNAi therapeutics as a whole new class of medicines with transformative potential for patients around the world. This exciting new relationship with Blackstone brings us much closer to that goal, securing our bridge towards a self-sustainable financial profile that we believe can now be achieved without any need for Alnylam to access the equity markets in the future,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. “A central component of this strategic relationship is a partial monetization of our royalty for inclisiran. If approved, we believe this therapy holds enormous promise as a potential game-changer in hypercholesterolemia management. We are pleased to retain half of the royalties we receive from Novartis, allowing Alnylam to benefit from inclisiran’s anticipated future success. We couldn’t be more pleased to enter into this highly innovative arrangement with Blackstone, which has shown a significant commitment to Alnylam’s future and alignment with our long-term vision.”

“Blackstone is uniquely positioned to provide customized, one-stop-shop financing solutions at scale while establishing development collaborations with the world’s leading biotech companies. Alnylam’s RNAi technology represents one of the most promising and rapidly advancing frontiers in biology and drug development today, and aligns perfectly with our investment strategy,” said Nicholas Galakatos, Ph.D., Global Head of Blackstone Life Sciences. “Our collaboration with Alnylam provides non-dilutive access to capital to advance important new medicines in development across several disease indications including heart disease, the leading cause of death in the U.S. and globally.”

“We’re thrilled to be able to partner with Blackstone Life Sciences to provide a customized solution for Alnylam, whose approved therapies provide important new options for patients,” said Dwight Scott, Global Head of GSO. “GSO’s capital will support Alnylam during a period of global growth as it continues to launch its medicines and pursue innovative RNAi approaches to bring new therapies to market and ultimately to patients around the globe.”

Alnylam, an existing tenant of Blackstone Real Estate company BioMed Realty, is also in discussions with BioMed to expand its footprint in Cambridge, MA.

Source: Alnylam

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‘Care & Industry together against CORONA’ platform

The ‘Care & Industry together against CORONA’ platform is an initiative of the Enterprise Europe Network, government of Flanders and Flanders’ care. The platform has been brought to life to bring together to set up European collaboration between industry, academia, government, knowledge institutes and others to act together against Covid-19.

The platform is supported by 62 partners and 185 participants are already joining (most of them are SME companies). Your company can also join the platform to share knowledge, find the right partners, offer or ask support, etc.

Visit the website here to find out how it works and to join the platform! 

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Kabinet breidt pakket coronamaatregelen voor ondernemers uit

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De economische gevolgen van het coronavirus stellen biotech start-ups en scale-ups voor grote uitdagingen. Door hun bedrijfsaard komen zij niet in aanmerking voor de NOW, terwijl personeelskosten een zware wissel trekken op biotech bedrijven. HollandBIO maakt zich hard voor ondersteuning op maat voor de biotech sector. Niet alleen is de sector cruciaal voor het verdienvermogen van Nederland, vandaag de dag blijkt de innovatiekracht van de sector harder nodig dan ooit.

Op 7 april heeft het kabinet aanvullende maatregelen aangekondigd om ondernemers te ondersteunen vanwege de economische gevolgen van het coronavirus:

  • Het kabinet maakt €100 miljoen vrij dat moet fungeren als overbruggingskredieten voor non-bancair gefinancierde bedrijven. Deze specifieke kredietmogelijkheden zijn voor startups en scale-ups en worden verstrekt via de Regionale Ontwikkelingsmaatschappijen (ROM’s).
  • Terugbetalingen van Vroege Fase Financiering (VFF) en Innovatiekrediet (IK) worden uitgesteld tot een maximum van 6 maanden.
  • De premie van de BMKB-regeling wordt verlaagd van 3,9% naar 2% en het garantiebudget wordt verhoogd van €765 miljoen naar €1,5 miljard. Daarnaast maakt het kabinet de BMKB middels een coronamodule ook beschikbaar voor non-bancaire financiers.
  • Het plafond van de Garantie Ondernemersfinanciering (GO) regeling wordt verhoogd naar €10 miljard om zowel MKB als grote ondernemingen te helpen. Het maximale garantiepercentage voor MKB is verhoogd naar 90%, en voor grootbedrijven naar 80%.

Naast deze aanvullende maatregelen werken verschillende partijen (de ROM’s, Invest-NL en Techleap.NL) aan een gezamenlijk programma gericht op het verstrekken van overbruggingskrediet in de vorm van (converteerbare) leningen aan innovatieve start- en scale-ups.

HollandBIO onderzoekt op dit moment in hoeverre deze additionele maatregelen van waarde zijn voor biotech ondernemingen en welke specifieke behoeften zij hebben. Houd onze website en nieuwsbrief in de gaten voor updates!

HollandBIO roept biotech bedrijven op om ons te laten weten in hoeverre de huidige maatregelen soelaas bieden. Aanspreekpunt is HollandBIO’s Wieteke. Ook voor andere vragen, uitdagingen of problemen waarbij HollandBIO’s inzet zou helpen: laat het ons weten!

Lees meer:

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AGILeBiotics B.V. appoints new CEO Victor Schut

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Victor Schut has been appointed as the new Chief Executive Officer (CEO) of AGILeBiotics and co-founder Dr. Andreas A. Bastian has now taken on the role of Chief Operating Officer (COO). Currently raising Series A investment, the appointments come in line with the company’s plans and development strategy.

Victor joined the AGILeBiotics team in June 2019 as Chief Business Officer (CBO) bringing the required experience and strengthening the team in preparation for the next phase of the company. Closing the current financing round will enable the company to bring its lead compound, Toframicin, to the clinic. Toframicin is the next-generation antibiotic for the treatment of multidrug-resistant infections.

“I am delighted that Victor accepted the new role at the company. Undoubtedly, this set up will increase our efficiency in executing our program”, says Dr. Andreas A. Bastian. “During the current pandemic caused by the SARS-CoV-2 (COVID-19) most patients have a secondary bacterial infection, such as pulmonary infections and sepsis” he adds, “this clearly confirms the need of antibiotics and the importance of investing in a well filled pipeline of new treatments. We have the right team in place to bring our ultra-broad-spectrum antibiotic candidate Toframicin into the clinic.”

Source: AGILeBiotics