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Invest-NL schept kaders voor start-up en scale-up investeringen

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Eindelijk was daar afgelopen vrijdag het wetsvoorstel met de machtiging voor de oprichting van Invest-NL. Een belangrijk moment, omdat hiermee de oprichting van deze nieuwe Nederlandse financierings- en ontwikkelingsinstelling een stap dichterbij is. Invest-NL gaat zich richten op bedrijven met een innovatief karakter. Kenmerkend daarbij zijn de hoge risico’s in de beginfase waardoor de markt nog niet kan instappen, maar waar wel een groot verdienpotentieel is. Dit biedt in de ogen van HollandBIO verschillende aanknopingspunten voor de life sciences sector als het gaat om een betere beschikbaarheid van kapitaal voor start-ups en scale-ups!

 

Invest-NL heeft een duidelijke missie: het financieren en realiseren van innovatie met maatschappelijke impact waar de markt nu niet in voorziet. Invest-NL krijgt een investeringstaak met een investeringsvermogen van € 2,5 miljard voor een periode van 5 jaar. Het wetsvoorstel beschrijft een aantal randvoorwaarden voor het investeringsbeleid, die onder andere ingaan op het beoogde economische en/of maatschappelijke rendement. Een van de genoemde thema’s binnen de investeringsdomeinen is gezondheid en zorg. Invest-NL kan startende en innovatieve MKB-ondernemingen of doorgroeiende MKB-bedrijven financieren die onvoldoende financiering in de markt kunnen aantrekken.

 

Markt laat het afweten

Dat is hard nodig. Hoewel de Nederlandse life sciences sector overloopt van de mogelijkheden, laat de markt het afweten. De huidige financiering in de vroege fase is ontoereikend en onnodig complex te verkrijgen. Daarnaast heeft de Nederlandse wetenschap een toonaangevende kennispositie, maar blijven we achter op de internationale ranglijsten met het aantal start-ups dat daaruit voortkomt. Daarbij komt de beruchte ‘Valley of Death’: de financieringskloof waarin life sciences scale-ups dreigen vast te lopen. De benodigde bedragen zijn in dit stadium doorgaans te groot voor publieke fondsen, en private financiers staan vanwege het nog hoge risicoprofiel en de lange tijdslijnen niet in de rij om te investeren. Het resultaat is dat de doorgroei van life sciences bedrijven stagneert, dat het bedrijf in financiële nood raakt, of dat het voor een appel en een ei opgekocht wordt door een internationale speler.

 

Tweetrapsraket

Dit marktfalen kunnen we aanpakken door de financieringsgaten voor zowel start-ups als scale-ups dichten met een elegante tweetrapsraket. Met een uitgekiende financieringsmix voor alle fases van ontwikkeling ligt een mooie toekomst in het verschiet. De life sciences sector kan dan blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van gezondheid en zorg. Bovendien krijgt daarmee valorisatie van academische kennis een impuls, wordt de Nederlandse life sciences sector competitiever op de internationale kapitaalmarkt en neemt de bijdrage van life sciences aan economische groei en werkgelegenheid toe. De oprichting van Invest-NL geeft mogelijkheden om werk te maken van deze mooie ambitie!

 

Meer informatie

Wil je meer weten over HollandBIO’s programma ‘Een ijzersterk innovatieklimaat’? Kijk op de programmapagina of neem contact op met Fabian.

 

Voor de volledige wettekst en aanverwante documenten, zie https://www.tweedekamer.nl/kamerstukken/wetsvoorstellen/detail?cfg=wetsvoorsteldetails&qry=wetsvoorstel%3A35123

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Valorisatielessen uit de medtech

Uit een interview dat Jochem Overbosch (Global Healthcare Practice Co-Chair bij Odgers Berndtson) hield met drie kopstukken uit de Nederlandse medtech zijn in de bredere zin lessen te trekken over valorisatie in de life sciences en hoe dat het beste lukt. Uit het gesprek met Dirkjan Masman (Directeur Valorisatie bij Radboudumc), Marijn Meuwese (Head Of Consulting BCEGI, Integrated Health Solutions bij Medtronic) en Clemens van Blitterswijk (Hoogleraar bij de Universiteit van Maastricht).

Onder andere het sterke onderzoeks- en wetenschapsklimaat in Nederland komen aan bod als factor die helpt in het verder aanjagen van valorisatie en innovatie, of dat nu academies, onderzoeksinstellingen of startups zijn. Daarnaast bespreken de geïnterviewden ook de verschuiving naar preventie in de zorg, en de rol daarin van data en diagnostica. Die verschuiving heeft ook gevolgen voor de manier waarop we in Nederland om moeten gaan met het vergoeden van zorg, want op preventie is ons systeem nog niet goed toegerust. Het gebeurt vaak dat de kosten en baten op verschillende vlakken liggen, waardoor ook de overheid hier een duidelijke rol in zou moeten aannemen om te werken aan oplossingen waarbij gezondheidswinst, betaalbaarheid en innovatie hand in hand gaan.

Het volledige, Engelse artikel vind je hier

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Kabinet maakt werk van ijzersterk innovatieklimaat

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Het Nederlandse ecosysteem voor start‑ups en scale-ups moet van sterkste van Europa doorstoten naar een wereldwijde top 5 positie. Dit blijkt uit een brief van Staatssecretaris Mona Keijzer die op de valreep van 2018 is gepubliceerd. Het kabinet streeft ernaar dat Nederland haar concurrerende en innovatieve positie verder versterkt. Een mooie ambitie die helemaal in lijn is met de toekomstvisie uit HollandBIO’s Life Sciences 2030. De Nederlandse life sciences sector heeft alles in zich om het Boston van Europa te worden. Cruciaal daarbij is dat er voldoende kapitaal beschikbaar is om te groeien. In de brief komen een aantal suggesties naar voren om het innovatieklimaat verder te versterken.

Startende en groeiende bedrijven leveren een belangrijke bijdrage aan de Nederlandse economie. Ze investeren veel in R&D en dragen bij aan werkgelegenheid. En daar blijft het niet bij. Start-ups en scale-ups uit de life sciences leveren keer op keer oplossingen op het gebied van maatschappelijke uitdagingen in de zorg. Denk aan de mogelijkheden die gentherapie biedt met een belangrijke rol voor uniQure of de opkomst van CAR-T met een prominente rol voor het Amsterdamse T-Cell Factory en later Kite Pharma. Maar willen ook in de toekomst de vruchten blijven plukken van innovatie, dan moet Nederland blijven investeren in de aanwas én doorgroei van Nederlandse life sciences bedrijven.

Overbrug de gaten in het financieringslandschap

De meest prangende uitdaging ligt in het overbruggen van de gaten in het financieringslandschap. Ten eerste is de huidige financiering in de vroege fase ontoereikend en onnodig complex te verkrijgen. Het is illustratief dat de Nederlandse wetenschappelijke kennispositie op diverse vakgebieden wereldwijd toonaangevend is, maar het aantal start-ups op de ranglijsten in vergelijking daarmee achterblijft. Ten tweede is daar de beruchte ‘Valley of Death’: de financieringskloof waarin life sciences scale-ups dreigen vast te lopen. In dit stadium zijn de benodigde bedragen doorgaans te groot voor publieke fondsen, en private financiers staan vanwege het nog hoge risicoprofiel en de lange tijdslijnen bepaald niet in de rij om te investeren. Het resultaat is dat de doorgroei van life sciences bedrijven stagneert, dat het bedrijf in financiële nood raakt, of dat het voor een appel en een ei opgekocht wordt door een internationale speler. Kortom, hoewel de Nederlandse life sciences sector blaakt van potentieel, laat de markt het afweten.

Een ijzersterk innovatieklimaat

Voor start-ups en scale-ups is het cruciaal dat er voldoende kapitaal beschikbaar is om te groeien. Op het gebied van risicokapitaal in die fases loopt Nederland nog ver achter. Ons land kent verschillende maatregelen om bedrijvigheid te stimuleren. Maar wil het kabinet werk maken van haar ambitie is er meer nodig. Staatssecretaris Keijzer stelt in haar brief dat Invest-NL vanaf 2019 een belangrijke rol kan spelen bij risicovolle investeringen voor bedrijven. HollandBIO ziet hierbij veel kansen om de gaten in het financieringslandschap voor biotech bedrijven te overbruggen en daarmee een vliegwiel te creëren voor innovatie. Door meer bedrijvigheid te stimuleren kan valorisatie van academische kennis een impuls krijgen, wordt de sector competitiever op de internationale kapitaalmarkt en neemt de bijdrage aan economische groei en werkgelegenheid toe. Laten we in 2019 werk maken van een ijzersterk innovatieklimaat, zodat de Nederlandse life sciences sector tot de absolute wereldtop gaat behoren!

Wil je meer weten over HollandBIO’s programma ‘Een ijzersterk innovatieklimaat’? Kijk op de programmapagina of neem contact op met Fabian.

De brief van Staatssecretaris Mona Keijzer lees je hier.

 

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Synaffix Announces License Agreement with Mersana Therapeutics

Synaffix has entered into a license agreement with Mersana Therapeutics,  a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet need. This agreement provides Mersana access to Synaffix’s industry-leading site-specific GlycoConnect™ ADC technology that has consistently demonstrated an ability to improve both the safety and the efficacy profiles of ADC product candidates. Synaffix is eligible to receive upfront and milestone payments on a per-target basis with a projected total deal value of $295 million, plus royalties.

Under the terms of the agreement, Mersana has been granted a non-exclusive license to incorporate GlycoConnect™ into one of its ADC development candidates, as well as an option to expand to additional programs. This agreement follows a research collaboration between the two companies that was centered around multiple product candidates.

“After evaluating several site-specific conjugation platforms, we have chosen Synaffix’s GlycoConnect™ technology for use in future ADC candidates,” said Anna Protopapas, President and Chief Executive Officer of Mersana. “We are excited about the potential of this technology as it is designed not to require additional antibody engineering or cell-line modifications, which would offer us the potential to create site-specific antibodies for use in our ADCs when required.”

“We are particularly excited to enter into this agreement with a leading company in the field of ADCs such as Mersana,” said Peter van de Sande, CEO of Synaffix, who added “This collaboration is another testimony of the additional value that GlycoConnect™ is able to provide to already cutting-edge ADC technologies, thereby enabling novel medicines that are uniquely positioned to address areas of unmet medical need.”

Per the agreement, Mersana is responsible for the research, development, manufacturing and commercialization of any resulting ADC product while Synaffix will supply components that are specifically related to its proprietary GlycoConnect™ technology.

Source: Synaffix press release

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Fibrocor and Galapagos sign partnership in fibrosis

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Fibrocor Therapeutics, a privately held Canadian company, and Galapagos announced a global partnership focused on a novel target for idiopathic pulmonary fibrosis (IPF) and other indications.

Fibrocor specializes in the development of tissue-specific therapeutics to treat the underlying cause of fibrotic diseases of the kidney and other organs. The collaboration announced today concerns a small molecule inhibitor program, currently in the lead optimization stage of development for the treatment of fibrotic diseases of the lung and other organs, the target of which is undisclosed. In exchange for global commercialization rights to Galapagos, Fibrocor will receive an upfront payment, and potentially is eligible for further milestone and royalty payments. Galapagos will be responsible for all further development of the program.

“This collaboration validates the fibrosis drug development expertise of Fibrocor,” says Mark A. Steedman, President and CEO of Fibrocor. “I take my hat off to Dr. Richard Gilbert and the scientific team, including Evotec GmbH, our CRO1 partner, for establishing a compelling data package that ultimately attracted Galapagos, a world-renowned biotech company with a key franchise in fibrosis. We feel this is the beginning of a great relationship and look forward to working with Galapagos to the benefit of fibrosis sufferers everywhere.”

“The collaboration with Fibrocor announced today is an excellent strategic fit for Galapagos, as we continue to expand our franchise in IPF, and more broadly, in fibrosis,” says Dr. Piet Wigerinck, Chief Scientific Officer at Galapagos. “We are enthusiastic about the drug discovery approach at Fibrocor, and look forward to collaborating with the team to address the large unmet medical need in fibrosis.”

Source: Galapagos

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ProQR Receives Fast Track Designation from FDA for QR-421a for Usher Syndrome Type 2

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ProQR has received a Fast Track designation from the Food and Drug Administration (FDA) for QR-421a. QR-421a is a first-in-class investigational RNA-based oligonucleotide designed to address the underlying cause of the vision loss associated with Usher syndrome type 2 and non-syndromic retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.

Fast Track designation is granted by FDA to drugs that are under development for serious conditions and have the potential to fulfill an unmet medical need. It was established with the intention to bring promising drugs to patients sooner by facilitating the development with more frequent FDA interactions and expediting the review process.

“We are very pleased with the Fast Track designation the FDA granted us for QR-421a. Patients with Usher syndrome, the leading cause of combined deafness and blindness, currently have no available therapies for their vision loss and this designation emphasizes the high unmet need in this disease,” said Daniel de Boer, Chief Executive Officer of ProQR. “We are also looking forward to begin enrollment in the Phase 1/2 STELLAR clinical trial in the coming months with preliminary data expected in mid-2019.”

Source: ProQR

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Bristol-Myers Squibb acquires Celgene

Bristol-Myers Squibb and Celgene have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately $74 billion.

Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination.

The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company’s strategic approach.

Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR (as described below). When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69 percent of the company, and Celgene shareholders are expected to own approximately 31 percent.

“Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases,” said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. “As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms.”

Dr. Caforio continued, “We are impressed by what Celgene has accomplished for patients, and we look forward to welcoming Celgene employees to Bristol-Myers Squibb. Our new company will continue the strong patient focus that is core to both companies’ missions, creating a shared organization with a goal of discovering, developing and delivering innovative medicines for patients with serious diseases. We are confident we will drive value for shareholders and create opportunities for employees.”

“For more than 30 years, Celgene’s commitment to leading innovation has allowed us to deliver life-changing treatments to patients in areas of high unmet need. Combining with Bristol-Myers Squibb, we are delivering immediate and substantial value to Celgene shareholders and providing them meaningful participation in the long-term growth opportunities created by the combined company,” said Mark Alles, Chairman and Chief Executive Officer of Celgene. “Our employees should be incredibly proud of what we have accomplished together and excited for the opportunities ahead of us as we join with Bristol-Myers Squibb, where we can further advance our mission for patients. We look forward to working with the Bristol-Myers Squibb team as we bring our two companies together.”

Approvals and Timing to Close

The transaction is subject to approval by Bristol-Myers Squibb and Celgene shareholders and the satisfaction of customary closing conditions and regulatory approvals. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.

Source: Celgene

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DegenRx secures funding for Alzheimer’s disease gene therapy

DegenRx, a biopharmaceutical company developing novel therapeutic solutions to treat neurodegenerative diseases, has secured financing for their antibody-based gene therapy program for the treatment of Alzheimer’s disease (AD).

Participating in this Series A financing are Swanbridge Capital and BOM Brabant Ventures, together with several private investors seasoned in the pharma and biotech industry. The company will be managed by Guus Scheefhals as Chief Executive Officer and Hans Preusting as Chief Development Officer. DegenRx aims to develop vector-based gene therapies for degenerative brain disorders, such as Alzheimer’s and Parkinson’s disease. Gene therapy aims to provide a potentially lifelong effect after a single administration. DegenRX will develop its proprietary, highly specific antibody, targeting and neutralizing toxic Alzheimer proteins in the brain that would thus slow down or ideally stop disease progression. The current funding will be used to demonstrate the feasibility of this approach in a pre-clinical model.

 Guus Scheefhals, CEO of DegenRx, commented: “We are very pleased that the investors are prepared to take on this early opportunity. Degenerative diseases are having an increasing impact on society and most still lack disease-modifying treatments. This investment enables us to show that our innovative approach can work. By making the active compound in the brain, we avoid the need to pass the blood-brain barrier which is typically a significant hurdle for most drugs and certainly for the larger ones, such as antibodies. We are very excited about the potential of our program and hope it will ultimately contribute to the urgently needed benefit for AD patients.”

Nicky Rijk-Vogels, fund manager at Swanbridge Capital: “In terms of phase and technology, DegenRx fits perfectly with the mission of Swanbridge Capital. Our goal is to ensure that young biotech companies can take the next step by providing them with the necessary venture capital and relevant support. We believe in the potential of gene therapy and are happy to contribute to the broader application that DegenRx has in mind for the treatment of degenerative brain diseases. ”

Mercedes Tuin, Investment Manager Life Sciences & MedTech at BOM Brabant Ventures: “BOM Brabant Ventures invests in Brabant companies that have the potential to become disruptive world players. DegenRx has that potential. With Guus Scheefhals and Hans Preusting as Chief Development Officer on board, we have every confidence that the DegenRx team will succeed in their mission.”

Source: DegenRx press release

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Xenikos will conduct Phase 3 trial to test T-Guard(R) in acute graft-versus-host disease

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Xenikos has partnered with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to conduct a U.S.-based Phase 3 registration trial to test the efficacy of T-Guard in treating steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following an allogeneic stem cell transplant. Funded by the National Heart, Lung, and Blood Institute and the National Cancer Institute, both part of the National Institues of Health, the BMT CTN includes leading transplant centers in the United States (U.S.) and will provide a total of USD 1.37 million in funding for the T-Guard trial.

“At Xenikos, we see BMT CTN’s access to major transplant centers in the U.S., as well as their established track record for successfully recruiting patients with acute GVHD, and vast knowledge and expertise in this field, as aiding in the development of innovative new immunotherapies for improving patient outcomes” said Dr. Ypke van Oosterhout, CEO of Xenikos. “We are therefore confident that our partnership with BMT CTN will help bring T-Guard to transplant patients as quickly as possible.”

“Our network often conducts large, multi-institutional clinical trials in order to test new treatments designed to improve outcomes associated with hematopoietic stem cell transplantation or HSCT,” said Dr. Mehdi Hamadani of the BMT CTN. “Acute GVHD is a life-threatening complication of HSCT and better treatments are needed for our patients. The preliminary data obtained with T-Guard is quite promising, and we believe that the Phase 3 trial is the next logical step.”

The U.S.-based Phase 3 trial will be a multi-center study involving patients who have received an allogeneic stem cell transplant for a myeloid or lymphoid malignancy and subsequently developed SR-aGVHD. Importantly, the Phase 3 trial design is based on input received from the U.S. Food and Drug Administration at the End-of-Phase 2 meeting. Xenikos plans to file an Investigational New Drug application in 2019.

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Enpicom sets a new standard for B cell receptor repertoire analysis

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The Dutch bioinformatics software engineering company ENPICOM announced that they have finalized development and released an expanded version of their ImmunoGenomiX (IGX) platform to support discovery and development of novel immunotherapies, patient stratification for, and treatment monitoring of immunotherapies. IGX now also accepts B cell receptor (BCR) in addition to T cell receptor (TCR) sequencing data. Head-to-head benchmarking studies versus world’s most popular tool, pRESTO, show superiority on several levels.

The improvements in high-throughput sequencing (HTS) technology provide unprecedented opportunities to explore the enormous diversity of the immune repertoire by deep sequencing T cell receptors and B cell receptors. However, an efficient, integrated, easy-to-use and accurate analytical tool required to process the huge amounts of immunosequencing data has so far been lacking.

With the IGX platform, ENPICOM is on a mission to provide the immunotherapy community with a best-in-class solution to analyze T cell and B cell receptor (TCR/BCR) immunosequencing data. The base module of the IGX platform to perform T cell receptor repertoire analysis, IGX Explore, was launched in August this year. The current functional expansion of IGX Explore adds support for the identification and quantification of B cell receptors (BCRs) from HTS data. Dr. Nicola Bonzanni, ENPICOM’s Chief Scientific Officer, commented: “As BCR analysis harbors additional complexities, such as immunoglobulin (Ig) (i.e. antibody) gene somatic hypermutations, the development of a state-of-the-art solution for Ig/BCR sequence analysis offered more extensive challenges for our bioinformatics and software engineering teams. It is with great pleasure that we announce the timely release of the next version of IGX Explore and that our benchmarking studies showed even better performance than expected.”

Dr. Bonzanni continues: “We benchmarked the performance of IGX Explore for BCRs using both synthetic and experimental datasets. IGX Explore shows superior performance for critical metrics such as correctly identified CDR3 sequences and V/J gene identification. Specifically, we compared IGX Explore with pRESTO (Vander Heiden, et al. 2014), the world’s most popular BCR sequencing analysis tool. On synthetic data, we show that IGX Explore achieves consistent and highly precise performance across all commonly used read lengths, and outperforms pRESTO at short reads lengths in particular, as visualized in the graphs below.

Furthermore, using an independently published experimental dataset (Meng W, et al. 2017), we showed that IGX Explore is able to recapitulate the reference immune repertoire composition with high accuracy. Finally, IGX Explore outperforms pRESTO with regards to speed and scalability”.

As announced before, the ImmunoGenomiX (IGX) platform will be modularly expanded to become a comprehensive end-to-end immunosequencing data analysis platform designed to analyze, monitor, and compare immune repertoires in the context of immunotherapy development and at all stages of treatment and disease over time. Starting from high-throughput sequencing data, it will deliver an easy-to-read report appropriate for the specific application, be it research, diagnosis, patient stratification, or treatment monitoring. The IGX platform will allow customers to select their own sample preparation protocols and the HTS technology of choice. It requires no programming skills as the interface is intuitive and flexible.

The complete base module, IGX Explore, is now available and can perform clonality analysis of both TCR and BCR repertoires starting from raw sequencing data, report back the number of individual TCR/BCR clones and interactively visualize them in a user-friendly way. With IGX Explore, immunotherapy companies can boost their target discovery, research and drug development processes. Tailored software extensions to answer specific research or clinical questions can be custom-built in collaboration with ENPICOM’s team of immunologists and bioinformaticians.

Using a recently published and independent benchmark, ENPICOM showed in August that IGX Explore offered superior accuracy on TCRs and the current benchmark studies complement this picture for BCRs. More information about these benchmark studies can be found at the company’s website and will be published in a white paper shortly.

Source: ENPICOM

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