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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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Groen licht medicijn Kiadis nabij

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Topman Arthur Lahr van Kiadis Pharma heeft er vertrouwen in dat zijn medicijn Atir101 volgend jaar op de Europese markt wordt toegelaten.

Acute leukemie en andere vormen van bloedkanker worden veelal met chemotherapie behandeld. Dit werkt echter niet voor alle patiënten. Voor hen kan een allogene stamceltransplantatie uitkomst bieden. Hoewel alleen ons land al ruim tweehonderdduizend donors telt, is het niet eenvoudig om een goede match te vinden. Ook tussen familieleden zoals ouder en kind is gewoonlijk hooguit sprake van een halve match. Juist bij hen zorgt het gebruik van Atir101 ervoor dat een transplantatie veel effectiever en veiliger kan plaatsvinden, zo wijzen de door Kiadis uitgevoerde patiëntenstudies uit.

Het wachten is nu op toestemming van de EMA en Lahr acht de kans groot dat deze er in het vierde kwartaal daadwerkelijk komt. „In dit stadium is de kans gemiddeld genomen 80%. En wij denken hier nog wat boven te zitten, gezien de aard van de vragen die de EMA ons heeft gestuurd.”

Terwijl kleine biotechnologiebedrijven de marketing en verkoop van hun medicijn veelal uitbesteden aan een geneesmiddelenfabrikant, zet Kiadis zelf een commerciële infrastructuur op. „De transplantaties vinden vrij geconcentreerd plaats, voor wat betreft de vijf grootste EU-landen in 70 klinieken. Met enkele daarvan werken we nu al samen. De productie gebeurt op dit moment in Duitsland maar in de toekomst zal dit ook worden gedaan op onze locatie vlakbij het AMC in Amsterdam”, meldt Lahr.

Concurrentie ondervindt Kiadis vooral van het Amerikaanse Baltimore-protocol, waarbij chemotherapie na de transplantatie van een voor de helft gematchte familiedonor plaatsvindt. „Afgaande op de literatuur en onze fase 2-studie lijkt de overlevingskans vergelijkbaar, maar bij ons product lijkt het risico kleiner dat de ziekte weer terugkomt. Er is ook minder risico dat het immuunsysteem van de donor de patiënt aanvalt”, stelt Lahr.

Terwijl de topman erop vertrouwt dat Kiadis in het derde kwartaal van 2019 met de verkoop van Atir101 in Europa kan beginnen, laat de marktintroductie in de VS langer op zich wachten, aangezien voor de VS nog een zogenaamde fase 3-studie nodig is. „Ik geef geen prognose over de timing. Wel is het zo dat van de 50.000 patiënten in beide continenten die jaarlijks baat zouden kunnen hebben bij ons product, de meerderheid in Europa woont. De VS hebben we ook niet per se nodig om winstgevend te kunnen worden.”

Bron: Telegraaf

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Uniek Bio-economie Project haalt 21 miljoen in fondsen op

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Negen Europese bedrijven hebben hun krachten gebundeld in het SWEETWOODS topproject, dat voor het eerst productie op een industriëel niveau gaat uitvoeren van op hout gebaseerde biomaterialen. Deze materialen kunnen gebruikt worden om plastic in verschillende dagelijkse applicaties te vervangen. Het project kreeg onlangs een beduidende hoeveelheid fondsen van de Europese Unie.

“Wij produceren met hout wat eerst met olie werd gemaakt”
SWEETWOODS is een gezamenlijk proefproject van 43 miljoen euro waarvoor onlangs 21 miljoen euro is uitgetrokken in het kader van het financiële instrument “Biogebaseerde Industriëen” van het Horizon 2020-programma van de EU.

“Het verkrijgen van de fondsen is een gigantische overwinning voor alle betrokken partijen in het project. Specialisten van de EU en de bio-industriëen hebben het project bestempeld als het beste project in de financiëringsronde en gaf het hoge cijfers,” beschrijft Peep Pitk, de Onderzoek & Ontwikkelingsmanager van het Estse Graanul Invest Group.

Bron: Novum

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Intravacc and Provention Bio collaborate on Coxsackievirus B Vaccine

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Provention, a clinical stage biopharmaceutical company dedicated to sourcing, developing and commercializing novel therapeutics aimed at intercepting and preventing immune-mediated diseases, announced that it has selected Netherlands-based Intravacc to lead product development and manufacturing of clinical trial material for Provention’s Coxsackievirus B (CVB) vaccine (PRV-101).

France-based L2D Services SARL/Leads-To-Development (L2D) is providing expert development, regulatory and project management support to ensure rapid progress of PRV-101 into clinical development. CVB, an enterovirus, has been identified as a possible common trigger for type 1 diabetes (T1D) onset. Vaccination of at-risk populations against CVB infection may lead to the prevention or delay in onset of T1D. The CVB vaccine was developed initially by Vactech Ltd. of Finland and licensed to Provention in April, 2017.

Provention is planning to initiate first in-human clinical trials in 2020. Enteroviruses are responsible for an estimated 30 million infections annually in the US. CVB contributes significantly to enteroviral healthcare costs, since it can result in hospitalization and severe morbidity. Usually asymptomatic or presenting as cold-like symptoms, fever, rash, hand-foot-mouth disease, and/or mild gastrointestinal distress, CVB infections can occasionally cause more serious and sometimes lifethreatening illnesses including pericarditis, myocarditis, meningitis and pancreatitis.

Provention, in partnership with Intravacc, Vactech and L2D is now developing its CVB vaccine for large scale manufacture of clinical trial material in accordance with current Good Manufacturing Practices (cGMP). Intravacc was chosen as Provention’s manufacturing partner based on its expertise and excellent track in enterovirus vaccine development, including IPV, sIPV, EV-71, and CV-A16, as well as Intravacc’s state-of-the-art vaccine cGMP production facilities. PRV-101 will be developed using Intravacc’s proven and well-established platform technology, including certain proprietary cell lines and production processes.

Ashleigh Palmer, co-founder and CEO of Provention Bio, stated, “Selecting Intravacc for PRV-101’s cGMP production is an important next step in our plan to initiate a potentially transformative clinical program to develop a vaccine to prevent acute coxsackievirus B infection and, ultimately, prevent or delay the onset of as much as half of the world’s cases of T1D. We welcome this opportunity to work alongside Intravacc, Vactech and L2D to advance our PRV-101 program to the clinic.”

Intravacc’s CEO Thijs Veerman, MSc, commented, “We are very excited to be involved in this project. Intravacc is uniquely positioned to develop cGMP clinical material for this vaccine and ensure its specifications, quality and patient-readiness. We have the necessary knowledge, expertise and experience to advance Provention’s PRV-101 program to the next stage and beyond.”

Bron: PRNewswire

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