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Invest-NL als vliegwiel voor innovatie

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Op donderdag 31 mei organiseert de vaste Kamercommissie EZK een rondetafelgesprek over de nieuwe investeringsinstelling Invest-NL. Hierbij komen verschillende stakeholders aan het woord. HollandBIO’s Annemiek Verkamman zal namens de biotech sector pleiten voor een ijzersterk innovatieklimaat met een uitgekiende financieringsmix voor life sciences bedrijven. Op deze manier hebben bedrijven in alle fases van ontwikkeling toegang tot voldoende financiering. Daarmee kunnen zij werken aan innovatieve oplossingen voor de grote maatschappelijke uitdagingen waar wij voor staan.

 

Investeren in de life sciences sector loont. In Nederland zetten we wetenschappelijke excellentie, technologie en ondernemerschap succesvol om in maatschappelijke en economische waarde. De Nederlandse life sciences sector zit stevig in de lift. De afgelopen tien jaar verdubbelde de sector in omvang. En, zoals we voor ogen hebben in onze toekomstvisie Life Sciences 2030, stoot de sector van een Europese topvijfpositie door naar de absolute wereldtop. Dat betekent dat er werk aan de winkel is.

 

Valley of death

Voor een sterk innovatieklimaat zijn voldoende financieringsmogelijkheden in de verschillende fases van ontwikkeling onontbeerlijk. Dit voorkomt dat bedrijven na hun eerste stappen in de beruchte valley of death belanden: de financieringskloof die doorgroei van startups naar scale-ups in de weg staat. Hier moeten zowel publieke als private partijen op inspelen. Invest-NL kan volgens HollandBIO helpen de kloof te dichten.

 

Rol van Invest-NL

Invest-NL gaat zich richten op het financieren en realiseren van innovatie met maatschappelijke impact waar de markt nu niet in voorziet, zoals bij langlopende, risicovolle activiteiten het geval is. Om de investeringsinstelling tot een succes te maken voor bedrijven in de life sciences, is er volgens HollandBIO actie vereist. Zo moet er een mandaat en uitvoeringstaak komen gericht op het financieren van risicovolle ondernemingen die bijdragen aan maatschappelijke uitdagingen, aanvullend aan de markt. Daarnaast zijn er openbare, objectieve en meetbare toetsingscriteria voor investeringen nodig om voorspelbaarheid voor bedrijven te garanderen en vertraging of mislukking van aanvragen te voorkomen. Als laatste is een goede samenwerking met andere investeerders en initiatieven vereist.

 

Invest-NL geeft de overheid een instrument om bij te dragen aan de doorgroei van biotech bedrijven in verschillende fases van ontwikkeling. Zo kan het als vliegwiel dienen voor de sector en kunnen de bedrijven met nog meer slagkracht blijven werken aan innovatieve oplossingen voor onze maatschappelijke uitdagingen op het gebied van duurzaamheid, gezondheid en zorg.

 

Lees de volledige inbreng van HollandBIO voor het rondetafelgesprek hier.

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EuropaBIO: SPC waiver risks downgrading the EU as a hub for health innovation

As an association that has manufacturers of both originator and biosimilar medicines as members, EuropaBio strongly doubts that the promises of today’s Commission proposal outweigh the risks of losing investment in new medicines. “Today’s proposal can only weaken the attractiveness of the EU as a hub for biopharmaceutical innovation. The approach of taking incentives away from one part of the biopharmaceutical industry to give to another part of the same industry is the wrong way to serve patients and foster innovation in Europe. Instead, solutions for enabling the entire EU biopharma industry to meet the needs of EU patients should have been explored.”, commented John Brennan, Secretary General of EuropaBio, on the European Commission’s proposal for a waiver of the rights of holders of Supplementary Protection Certificates for innovative medicines.

Costly and highly uncertain investment decisions into R&D in health can only be taken in the presence of carefully balanced, reliable and enforceable incentives and safeguards against failure and long-term lack of profitability. “European developers of tomorrow’s cures are mainly small businesses. In today’s world, where these small biotech businesses depend on investor funding from outside Europe, this proposal sends the wrong signal and jeopardises progress and innovation in health – where are the safeguards to make sure that does not happen?”, added Mr. Brennan.

EuropaBio’s early analysis of the proposal finds that rather than promoting growth and jobs in the entire sector, an SPC waiver would simply shift value and jobs from the originator part of the biopharmaceutical industry to the biosimilar and generic part of the same EU health industry with the only result being a negative net impact on innovation for patients. The proposal also seems absent of robust safeguards in this regard. EuropaBio stands ready to contribute expertise and experience for alleviating the foreseeable damage to the finely balanced EU biopharma innovation ecosystem.

Source: EuropaBIO

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Hartwig Medical Foundation and ttopstart announce collaboration

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Hartwig Medical Foundation and ttopstart are pleased to announce collaboration to accelerate the implementation of clinical decision support systems for personalised cancer treatment in the Netherlands.

Hartwig Medical Foundation is developing innovative clinical decision support systems to enable personalised cancer treatment in the Netherlands. As a part of this, Hartwig Medical Foundation provides access to a unique databank of Whole Genome Sequencing and clinical data of thousands of patients. This will enable a substantial improvement in the quality of diagnosis and treatment of cancer patients, stimulate scientific research into methods of treatment and cancer therapies, and reduce the cost of care and over-treatment. Furthermore, Hartwig Medical Foundation has developed a unique patient report that provides clinicians with an actionable assessment of the genetic characteristics of the tumour to guide clinical decision-making for personalised cancer treatment.

Hartwig Medical Foundation is making important progress in advancing the implementation of DNA sequencing technology and clinical-decision making for personalised cancer care. To accelerate this process, Hartwig Medical Foundation and ttopstart co-design smarter strategies and develop new business models to support patient access to precision medicine in a timely and responsible manner and the introduction of actionable patient reporting for clinical decision-making in personalised cancer treatment. In addition, ttopstart will provide ongoing project management support for the different key partnerships of Hartwig Medical Foundation.

Source: ttopstart

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Lava Therapeutics Raises EUR 16 Million

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Gilde Healthcare and Versant Ventures have driven Lava Therapeutics to a €16 million ($18.8 million) financing. The round equips Lava to advance bispecific engagers of gamma-delta (γδ) T cells, a small subgroup of lymphocytes involved in natural and induced immunity to cancer.

Like other bispecific T-cell engagers, Lava’s drugs are designed to activate the lymphocytes while also acting on tumor cells. The drugs could, for example, block the EGFR-signaling pathway and activate T cells, triggering the production of pro-inflammatory cytokines and killing of tumor cells that express EGFR.

Lava’s platform is differentiated by its focus on Vγ9Vδ2 T cells. Researchers have plugged away on γδ T cells over the past 15 years without garnering the sort of results seen by peers focused on alpha-beta lymphocytes, such as CD4+ helper and CD8+ cytotoxic T cells. But interest has grown as studies have shown intratumoral γδ T-cell signatures correlate to positive prognoses and linked the cells to a range of antitumor activities.

“The cells exhibit potent cytotoxicity and interferon-γ secretion and HLA-unrestricted tumor cell killing and have antigen-presenting capabilities for αβ-T cells promoting the development of adaptive immune responses,” a spokesperson for Lava said.

Gilde and Versant have bought into the idea, as has Paul Parren, Ph.D. Parren, the former head of preclinical R&D at Genmab, has joined Lava as head of R&D. With MRL Ventures Fund also stepping up and joining with founding backers Lupus Ventures and Biox Biosciences to support Lava financially, the Dutch biotech is set up to move programs toward clinical trials.

In keeping with other preclinical biotechs, Lava is yet to say much about targets, indications or other specifics but the activities of the academic group that originated the platform provide some clues. Hans van der Vliet, M.D., Ph.D., Lava’s CSO and CMO, and his team at VU University Medical Center have published a series of papers on Vγ9Vδ2 T cells in recent years.

The papers analyzed the activity of the T cells and described the use of llama-generated single domain antibodies—the modality in which Ablynx is specialized—to activate them. The series culminated in a paper linking an anti-EGFR bispecific to decreased tumor burden and increased overall survival in mice.

That mice study administered the T-cell engagers in combination with Vγ9Vδ2 T cells. However, Lava thinks its candidates will work without an accompanying infusion of T cells.

“These cells are very potent and we believe that sufficient cells are available in tumors and in circulation to obtain an effective therapy,” the spokesperson said. “The administration of therapeutic bispecific antibodies is a much more widely applicable and cost-effective treatment as it avoids cumbersome and costly ex vivo expansion of these cells.”

Lava is now progressing several T-cell engagers toward human testing but is yet to commit publicly to a timeline for getting into the clinic. To support the activity, the biotech is looking to add five to seven new hires to its existing nine-person team. Lava is outsourcing the bulk of its operational activities.

Source: FierceBiotech

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Thuja Capital invests in Salvia BioElectronics

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Salvia BioElectronics secured € 1.3 million in seed funding to develop a minimally invasive bioelectronics solution for people suffering from chronic neurological disease.

The funding is provided by a syndicate led by Thuja Capital Healthcare Seed Fund II and the Brabant Development Agency (BOM), and includes the Netherlands Enterprise Agency (RVO.nl) and founders and employees of Salvia. Salvia intends to use the funds to develop its product concept in preparation for a larger Series-A round that will support the realization of the device and the clinical studies towards CE marking and commercial launch.
Hubert Martens, CEO of Salvia BioElectronics, noted: “The treatment of chronic neurological disease with drugs is associated with undesired side effects that may be intolerable for patients. By gently influencing nerve activity, bioelectronics trigger the body’s natural mechanisms with the promise of being inherently free of side effects, and potentially more efficacious as a treatment.”
Florian Ludwig, investment manager at Thuja Capital: “Thuja Capital invests in early stage medical products for cure, care, diagnosis or prevention, that have a true impact on patients. We expect the neuromodulation field to develop rapidly in the coming years and believe that Salvia’s differentiated product concept will provide physicians with a powerful and patient centric tool in the treatment and management of their patients. The reason for our early contribution is the good track record of Salvia’s team. We recognise that there is a large unmet need for patients suffering from chronic neurological disease, to which Salvia’s innovative concepts can provide a solution. We are therefore delighted to contribute to the early development of this med-tech company.”

Source: Thuja Capital

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Shriram and KeyGene Join Forces To Develop Improved Hybrid Rice

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Shriram Bioseed and KeyGene announce a multi-year strategic co-development research program for development of improved rice hybrids with higher yields, increased tolerance to abiotic stresses, and better grain quality for consumers in India and south east Asia. KeyGene’s innovation platforms will be exploited to boost these important traits in Bioseed’s elite rice germplasm. The program will lead to growth of hybrid rice markets in the region.

Under this partnership both companies will make joint investments. “The aim of this strategic investment is to generate value in rice by incorporating new traits that help vigorous growth of rice with customized preferences for consumers in different parts of India and in the South-East Asian rice market. The end goal is to benefit the rice farmers by providing them with seed of high performing hybrids”, says Arjen van Tunen, CEO of KeyGene.

“We are excited about our extended collaboration with KeyGene and the opportunity of using KeyGene’s proprietary technologies and innovation platforms to develop novel tools specifically for rice which will enable us to improve our products with increased precision and efficiency”, says Dr. Paresh Verma, Director Research at Shriram Bioseed.

Bron: Keygene

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Eerste kwartaalwinst voor Pharming

Pharming heeft voor het eerst een kwartaalwinst in de boeken gezet. Dat meldde het biotechnologiebedrijf donderdag in een handelsbericht over de eerste verslagperiode van het jaar. De opbrengsten van de onderneming dikten bovendien flink aan.

Pharming noteerde een nettowinst van 3,3 miljoen euro. Dat was een jaar eerder nog een verlies van 5,7 miljoen euro. Topman Sijmen de Vries sprak dan ook van een belangrijke mijlpaal. Pharming dankt het positieve resultaat naar eigen zeggen onder meer aan ,,sterke verkoopprestaties”. De operationele winst steeg met 110 procent tot 8,2 miljoen euro.

De totale omzet van Pharming steeg met 90 procent tot 29,5 miljoen euro. Pharming zag de productverkopen van zijn middel Ruconest in de Verenigde Staten flink bijdragen aan de opbrengsten, ondanks een flinke waardevermindering van de Amerikaanse dollar in dezelfde periode.

Bron: iex

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EMA zoekt sprekers voor MKB-dag

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Op 29 oktober organiseert het Europees medicijnen agentschap (EMA) een dag speciaal voor start-ups, kleine en middelgrote bedrijven (MKB). Onderwerpen die de revue zullen passeren zijn de stimuleringsmaatregelen voor weesgeneesmiddelen en geneesmiddelen voor kinderen, mogelijkheden voor versnelde toelating en toelating onder voorwaarden, de nieuwe wetgeving op het gebied van medische hulpmiddelen en de gevolgen van de Brexit. EMA is op zoek naar sprekers die hun ervaring met een van deze onderwerpen willen delen of een sessie willen modereren. Heb je ervaring, interesse en werk je bij een SME?

Wees er dan snel bij en neem nog deze week contact op met Irma Vijn van HollandBIO (irma.vijn@hollandbio.nl)

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Kite leased a new facility in the Netherlands

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Kite has leased a new facility in the Netherlands to engineer cell therapies in Europe. The 117,000 square-foot site in Hoofddorp (SEGRO Park Amsterdam Airport) will enable Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe and will provide more than 300 new jobs when fully operational in 2020.

The facility will engineer and produce innovative cell therapies, including axicabtagene ciloleucel, a Chimeric Antigen Receptor T cell (CAR T) therapy that is currently under review by the European Medicines Agency and which is approved in the United States as Yescarta.

“We are pleased to be leading a new frontier of cancer innovation that is bringing hope for people living with cancer,” commented John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “This new European manufacturing facility will enable personalized cell therapies to be manufactured in closer geographic proximity to the patients who will receive them, potentially shortening the turnaround time for people who urgently need care.”

In addition to the Netherlands facility, Kite has recently purchased a new building in Santa Monica from Astellas Pharma Inc. that will be used for cell therapy research, development and the expansion of clinical manufacturing capabilities, and has leased a 26,000 square-foot facility in Gaithersburg, Maryland. The Maryland site will support the work of a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and tumor, offering the potential for more targeted antitumor activity.

“We are proud to be at the forefront of advancing cell therapy, which we believe has the potential to transform cancer treatment,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “The addition of these three new facilities and the expanded CRADA with our research collaborators at the NCI will help us bring cell therapies to more people with cancer around the world.”

Bron: gilead

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Xenikos Secures USD 30 Million in Series B Financing

Xenikos, a clinical-stage biopharmaceutical company currently developing a novel therapy for treating acute graft-versus-host disease (aGVHD), announced the receipt of USD 30 million from a Series B financing. Two new investors in the Company – Medicxi and RA Capital Management – participated in the financing round. The funds will be used to advance the development of Xenikos’ lead compound, T-Guard, including conducting clinical Phase 3 registration trials in the US and EU, arranging commercial-scale production, and submitting the relevant applications for market approval. In connection with this financing, Dr. Jon Edwards of Medicxi and Dr. Jake Simson of RA Capital will join Xenikos’ Board of Directors.

“We are extremely pleased to have the support of these top-tier investors not just in terms of financing but also for the expertise and insight they bring to Xenikos. We very much look forward to welcoming Dr. Edwards and Dr. Simson to our Board of Directors at this important stage of development for the Company,” said Dr. Ypke van Oosterhout, Chief Executive Officer of Xenikos. “This round of financing is a critical milestone in our Company’s history, helping us bring T-Guard to market for treating steroid-resistant aGVHD in both the US and the EU. Based on the encouraging results of Phase 1/2 testing, we are confident that T-Guard has the potential to help cure patients who develop this devastating and often fatal condition. We are fully committed to moving T-Guard into Phase 3 testing as soon as possible.”

“We are excited to back Xenikos and their mission of bringing a new treatment to patients suffering from aGVHD. This is a very challenging indication with few options available and we feel T-Guard has the potential to significantly improve outcomes,” said Dr. Jon Edwards, Principal at Medicxi. “The investment is a perfect fit for our growth fund which has the goal of supporting European companies developing innovative therapies. We look forward to working with the Xenikos team and supporting their efforts.”

“Transplantation medicine has been starved of innovation for decades. For the thousands of patients receiving an allograft each year, GVHD can dash the hopes of recovery and cure,” added Dr. Jake Simson, Principal at RA Capital. “We are excited to team with Xenikos to help realize their life-long mission of bringing T-Guard to the fight against aGVHD.”

Bron: Xenikos

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