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Okairos Oct. 2005 PER.C6® Hepatitis C Phase I Rome, Italy, 23 April 2009 Okairos Presents Hepatitis C Vaccine Interim Phase I Results Showing Specific T Cell Responses Okairos, a biopharmaceutical company developing genetic vaccines for major chronic infectious diseases, today announced the first interim results from a Phase I clinical trial of its hepatitis C virus (HCV) vaccine candidate, showing very strong HCV-specific T cell responses against multiple antigenic targets. This is the first such report for a prophylactic vaccine against HCV. These results are being presented at the Annual Meeting of the European Association for the Study of Liver Diseases (EASL) in Copenhagen on 23-26 April 2009. The Phase I trial, which began in October 2008, is designed to assess the safety and immunogenicity of a novel Adenovirus-based vaccine candidate for the prophylaxis and immunotherapy of HCV infection. The candidate vaccine is composed of two non-cross-reacting replication-defective Adenovirus vectors with very low seroprevalence in humans, and encodes the non-structural (NS) proteins NS3-5 of HCV. The Phase I trial is a double-prime, heterologous boost, dose escalation study being performed at the University of Oxford, England on a total of 36 healthy volunteers aged 18-50. Subjects are primed with one of three doses of one Adenovirus vector and boosted 12 or 24 weeks later with the maximum safe dose of the other Adenovirus vector in a crossover design. The trial will be completed by the end of 2009. Prof. Paul Klenerman, Principal Investigator of the trial, said: “These initial clinical trial data are extremely encouraging and support the feasibility of developing a vaccine against HCV based on T cell induction, which appears to be a prerequisite for successful protection from the virus. We look forward to further important data from the trial following the booster phase.” Prof. Riccardo Cortese, CEO of Okairos, added, “These exciting interim results clearly demonstrate our vaccine’s ability to stimulate very strong T cell immune responses, at a level higher than in any previous human vaccine trial after one injection, and also much higher than the level seen in individuals who spontaneously clear the HCV infection. These data also provide further validation of our Adenovirus platform and rich vaccine pipeline.” Okairos is developing both a prophylactic and a therapeutic vaccine against the hepatitis C virus (HCV). The prophylactic vaccine is in a Phase I trial that will be completed by the end of 2009, and is scheduled to enter a Phase II trial in early 2010. The therapeutic vaccine will be tested on chronically infected patients in a Phase Ib trial to begin in June 2009.www.okairos.it/
gocrucellgo schreef:
Okairos Oct. 2005 PER.C6® Hepatitis C Phase I
...
Rome, Italy, 23 April 2009
Okairos Presents Hepatitis C Vaccine Interim Phase I Results Showing Specific T Cell Responses
The Phase I trial, which began in October 2008, ...
Wellicht 2 opeenvolgende phase I trials, beginnend in 2005 resp. 2008.
maxen schreef:
[quote=gocrucellgo]
Okairos Oct. 2005 PER.C6® Hepatitis C Phase I
...
Rome, Italy, 23 April 2009
Okairos Presents Hepatitis C Vaccine Interim Phase I Results Showing Specific T Cell Responses
The Phase I trial, which began in October 2008, ...
[/quote]
Wellicht 2 opeenvolgende phase I trials, beginnend in 2005 resp. 2008.
Ik dacht licentie 2005 en phase 1 2008.
Okairos is a clinical stage biopharmaceutical company spun off from Merck, Inc. in 2007 and developing genetic vaccines for major chronic infectious diseases, using novel proprietary technology. The company’s laboratories are located in Rome and Naples, Italy, and its corporate headquarters in Basel, Switzerland. It currently has 16 employees. Okairos’ technology platform is centered on the development of new, potent Adenovirus vectors, derived from strains isolated from chimpanzees and used to encode and deliver prophylactic and therapeutic antigens. These vectors have several major advantages and hold promise in generating effective immune responses where existing vectors have failed. Okairos’ Adenovirus vector platform is being used to generate a pipeline of vaccines against a range of infectious diseases for which there is currently no effective vaccine, as well as for cancer. Okairos is led by Riccardo Cortese, MD, PhD CEO and co-founder, who spent many years at Merck, Inc. coordinating the efforts that led to the development of several novel antiviral drugs and vaccines which are now at various stages of clinical development. Dr. Cortese was a founder and the fi rst director of the Gene Expression Program at the European Molecular Biology Laboratory EMBL) in Heidelberg and is a professor of Molecular Biology at the Medical School of the University of Naples. He has published in leading scientifi c journals including Nature, Science and Cell, on a range of topics in immunology, molecular medicine and drug discovery.www.okairos.it/OkairosFS0904.pdf Leiden, The Netherlands, October 10, 2005 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL) announced today that Merck & Co., Inc. (NYSE: MRK) has exercised its option to use Crucell's PER.C6® production technology to develop an adenovirus-based vaccine against hepatitis C (HCV). Crucell will receive a US$ 1 million (€ 0.8 million) exercise fee with the prospect of annual fees and milestone payments, plus royalties on net sales.investors.crucell.com/C/132631/PR/200...
gocrucellgo schreef:
Ik dacht licentie 2005 en phase 1 2008.
Juist ja, ik zie het nu ook op de Crucell website. Ondanks dat het slechts phase I is, goede resultaten. Einde phase I in 2009, opstarten phase II op z'n vroegst in 2010.
De zoveelste bevestiging dat Crucell het helemaal gaat maken en lekker zelfstandig kan doorgroeien tot een Pharma reus. Eddy
AdCh3NSmut and Ad6NSmut The Latium Vaccine Pole Background, Technological Platforms, Research Projects PROPHILACTIC AND THERAPEUTIC HEPATITIS C VIRUS VACCINE PI: Alfredo Nicosia Institution: Okairós Address: Via dei Castelli Romani 22, 00040, Pomezia – Roma - ITALY Phone: +39-06-97246470 E-mail: nicosia@okairos.it Introduction An effective vaccine for hepatitis C virus (HCV) is undoubtedly an area of unmet clinical need. Currently there is no vaccine available for either the prevention (prophylactic vaccination) or the treatment (therapeutic vaccination) of HCV and the currently available therapy is frequently ineffective.www.sta.uniroma2.it/stabulario/serviz... GTAC 144: A Phase 1 study to assess the safety and immunogenicity of new Hepatitis C virus vaccine candidate AdCh3NSmut and Ad6NSmut. Hep.C Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford Conditional Approval Dec 07 Ad6 AdCh3 Gene: Multiple hepatitis antigens Cell Line: PER.C6www.dh.gov.uk/ab/GTAC/Publications/in...
Research Area: Immunology Technology Exchange: Gene therapy Keywords: Hepatitis C, genotype-3, T cells, vaccine and therapy 1. HCV infection consists of 6 major genotypes. HCV genotype-3 infection is now the dominant genotype in the UK. HCV genotype-3 infection is particularly responsive to current gold-standard therapies. The reasons for this are unknown but may relate to a favorable T cell response against this specific sub-type. Although there has been extensive research into HCV genotype-1 infection, little is known about HCV genotype-3. Currently we are evaluating T cell immunity to this strain in the context of acute disease, chronic disease and therapy. Furthermore identifying those T cell epitopes that are important in genotype-3 control will be essential for vaccine design, that aims to induce inter-genotype immunity. 2. A recent award from the MRC will fund a phase Ib study into the use of adenoviral vectors (in collaboration with Okairos*), encoding HCV proteins, as a therapeutic vaccine for HCV infection. This study will begin in 2009 with the aim of inducing T cell responses during gold-standard therapy for HCV. Ultimately the aim will be to enhance the sustained virological rates of current therapy.www.ndm.ox.ac.uk/researcher/ellie-barnes * ism Alfredo Nicosia ********************* hepatitis C (HCV) vaccine The hepatitis C virus (HCV) chronically affects 1 in 50 people worldwide, with 3-4 million new cases each year, including 30.000 in the U.S. HCV is the leading cause of chronic liver disease in the world and has been correlated with an increased risk of developing primary hepatocellular carcinoma. No vaccine is yet available. The current therapy is effective in only about half of the treated cases and carries the risk of severe side effects. Obstacles to the development of an effective prophylactic vaccine have included the ability of the virus to escape antibody immunosurveillance, as well as the lack of in-depth study of the immune response in HCV-infected individuals. Okairos’ scientists have shown that the magnitude of an early T cell response during acute HCV infection correlates with the outcome, with a strong T cell response found in those rare individuals who spontaneously clear the virus infection. The company’s candidate prophylactic and therapeutic vaccines are based on the 2000-amino-acid-long Non-Structural region of HCV. The Okairos vaccine protected chimpanzees from acute and chronic infection induced by a highly heterologous HCV virus. The vaccine is presently undergoing a Phase I dose escalation trial in healthy human volunteers for an assessment of its safety and immunogenicity. The results obtained so far with a single injection of chimp-derived Adenovirus vectors in humans showed an extremely strong T cell response, greater than any previously observed with a genetic vaccine. A Phase II trial of the prophylactic vaccine is scheduled for early 2010. The therapeutic vaccine will be tested on chronically infected patients in a Phase Ib trial to begin in June 2009 Okairos obtained €14 million in grants from the NIH, the EU and the Wellcome Trust for the development and early clinical trials of the HCV and malaria vaccines. The company obtained a further €7.2 million from major life science venture capital funds in a Series A fi nancing round completed in February 2007, with the participation of LSP, BioMedInvest and Novartis Venture Funds. The funds raised are being used to fi nance the completion of clinical Phase I and II trials for malaria and Phase I and Ib trials for HCV.
Procell92 Okairos has developed a proprietary packaging cell line called PROCELL92, with better capability to support Adenovirus vector growth. PROCELL92 allows the efficient production of Adenovirus vectors that cannot be propagated in standard human HEK 293 or fetal PER C6 cells, because they encode proteins that interfere with the host cell metabolism (i.e. proteins with transmembrane domains or proliferative activity). In addition, PROCELL92 does not lead to the formation of replication-competent Adenovirus during vector propagation. Therefore, PROCELL92 represents the ultimate cell substrate for the production of any Adenovirus-based vaccine vector. The figure below shows the high level of productivity by PROCELL92 of an Adenovirus vector, encoding three toxic HCV proteins, which does not grow in 293 or PER C6 cells. www.okairos.it/e/inners.php?m=00044
gocrucellgo schreef:
... which does not grow in 293 or PER C6 cells.
www.okairos.it/e/inners.php?m=00044 ?????
An Adenovirus vector, Ad6 in dit geval. Uit 2005 Merck HCV:jvi.asm.org/cgi/reprint/80/4/1688.pdf
Bij mij in de tuin groeit echt alles, noten, kiwi's, appels, druiven en kersen dus ik dacht laat ik het eens met limoenen proberen. Niks nada noppes. Maar of dit nu een reden is om mijn hele tuin maar te betegelen, ik betwijfel het.
Participants are needed to help develop a vaccine against Hepatitis C Hepatitis C is a major cause of liver disease, worldwide - currently there is no vaccine available. A clinical trial is takling place at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Headington. Are you aged 18 to 50 years old? In good health, and never had Hepatitis C? Then you may be elegible to take part in this study. This study is based on visits to the out-patients clinic at the Churchill Hospital in Headington, Oxford. Volunteers will be compensated for their travel, time and blood donation. If you would like to know more about taking part in our studies please contact: VaccineTrials@well.ox.ac.uk xor call on (01865) 857401 (Study Coordinator).www.jenner.ac.uk/Volunteers/Hepatitis...
Study of a Novel Therapeutic Vaccine for Hepatitis C Virus This study is currently recruiting participants. Verified by Okairos, April 2010 HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of chimpanzee and human origin respectively, bearing the same genetic information for HCV antigens (NS region). The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results. HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination. The trial includes: • Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold standard therapy for hepatitis C); • Arm B, in which vaccinated patients are not into therapy. Hepatitis C Biological: AdCh3NSmut; Ad6NSmut Phase I Estimated Enrollment: 24 Study Start Date: November 2009 Estimated Study Completion Date: May 2012 Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)www.clinicaltrials.gov/ct2/show/NCT01... ************* A Study of a New Candidate Vaccine Against Hepatitis C Virus (HCV) This study is currently recruiting participants. Verified by Okairos, February 2010 HCV001 is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV). The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of human and chimpanzee origin respectively, bearing the same genetic information for HCV antigens (NS region). The two recombinant vectors, called Ad6NSmut and AdCh3NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. Although Ad6NSmut and AdCh3NSmut have never been given to humans before this trial, promising results have been obtained in non-human studies. The HCV001 study is designed to explore different prime-boost regimes concerning dose, order and interval of administration of Ad6NSmut and AdCh3NSmut. Hepatitis C Biological: Ad6NSmut; AdCh3NSmut Biological: AdCh3NSmut; Ad6NSmut Phase I Estimated Enrollment: 50 Study Start Date: July 2007 Estimated Study Completion Date: December 2010 Estimated Primary Completion Date: June 2010 www.clinicaltrials.gov/ct2/show/NCT01...
UK Latest summary of GTAC-approved research GTAC=Gene Therapy Advisory Committee October 2009. A Phase 1 study to assess the safety and immunogenicity of new Hepatitis C virus vaccine candidate AdCh3NSmut and Ad6NSmut. EudraCT 2007-004259-12 Hepatitis C Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Old Road,Headington, Oxford OX3 7LJ, Welcome Trust Clinical Research Facility, University Hospital Birmingham NHS Trust Cell line: PER.C6 NO. OF PATIENTS: - of 36 A phase 1 study to assess the safety and immunogenicity of Ad6NSmut and AdCh3NSmut in patients with hepatitis C virus infection EurdraCT No: 2008-006127-32 Hep C Dr Eleanor Barnes University of Oxford Nuffield Dept of Medicine Peter Medwar Building for Pathogen Research South Parks Road Oxford Provisional Opinion 04/09 Human Adenovirus Type 6 serotype pluse Chimpanzee Adenovirus Type 3 serotype Cell line: PERC.6 Verder: Gene directed enzyme prodrug therapy for the treatment of head and neck cancer (Phase I intratumoral) Head and Neck Cancer Queen Elizabeth Hospital, Birmingham; RoyalMarsden Hospital, London Nitroreductase Cell line: PER-C6 NO. OF PATIENTS: 7 of 30 CLOSED Gene directed enzyme prodrug therapy for the treatment of liver cancer (Phase I intratumoral) Liver Cancer Queen Elizabeth Hospital, Birmingham Nitroreductase Cell line: PER-C6 NO. OF PATIENTS: 25 of 30 CLOSED The safety and effects of Ad5.1 mediated human FGF-4 gene transfer in patients with peripheral arterial occlusive disease (PAOD) Peripheral Arterial Occlusive Disease St George’s Hospital, London FGF-4 Cell line: PER-C6 NO. OF PATIENTS: 13 (2 UK) of 30 CLOSED Gene directed enzyme prodrug therapy for the treatment of prostate cancer (Phase I intratumoral) Prostate Cancer Queen Elizabeth Hospital, Birmingham; Freeman Hospital Newcastle; St James’s University Hospital, Leeds Nitro reductase Cell line: PER-C6 NO. OF PATIENTS: 39 of 44 CLOSED A Phase 1 clinical trial of a replication defective Ad5 vector expressing nitroreductase and GMCSF (AdNRGM) given via brachytherapy, followed by CB1954 in patients with locally relapsed, prostate cancer. EudraCT No: 2007-007041-13 Prostate cancer Queen Elizabeth Hospital at UHB NHS Foundation Trust Cell line: PERC.6 Zie ook no.97 op p. 24 tinyurl.com/247d67p
PHASE I TRIAL OF A HIGHLY IMMUNOGENIC T CELL VACCINE FOR HEPATITIS C VIRUS BASED ON NOVEL ADENOVIRAL VECTORS FROM RARE SEROTYPES A. Folgori1, E. Barnes2, S. Aston2,3, K. Smith2, A. Brown2, M. Ambrosio4, V. Ammendola4, M. Bartiromo4, S. Capone4, M. Naddeo4, A. Sparacino4, L. Siani4, C. Traboni4, S. Colloca4, A. Nicosia4, R. Cortese4, P. Klenerman2 1Immunology, Okairos srl, Naples, Italy, 2Oxford University, 3The Jenner Institute, Oxford, UK, 4Okairos srl, Naples, Italy Background and aims: Hepatitis C virus (HCV) infection currently lacks an effective vaccine for prophylaxis or immunotherapy. The correlates of protective immunity in HCV infection are not fully defined. However, the strength, breadth and duration of the HCV specific T cell immune response clearly play a critical role in determining disease outcome. We have previously shown that a vaccine inducing T cells specific for non-structural proteins of HCV (NS) protected chimpanzees from chronic infection after challenge with a heterologous HCV viral strain. Translating these findings into man is critical. We therefore designed a Phase I study to assess the induction of NS protein specific T cell immunity in healthy human donors. Methods: We generated an HCV vaccine composed of two non cross-reacting replication-defective Adenovirus vectors of low sero-prevalence: human Adenovirus 6 and a novel simian Adenovirus 3. Each vector encodes 1985 amino acids derived from the NS3-5 region of a genotype 1b strain. Healthy volunteers aged 18-50 are enrolled in a double prime, heterologous boost dose escalation study (from 5x108 to 2.5x1010 viral particles). Volunteers are primed with two doses of one Adeno vector and boosted 12 or 24 weeks later with the maximum safe dose of the other Adeno vector in a crossover design. Immunogenicity is measured by ex-vivo IFNg ELIspot and proliferation assays. Results: Both vaccine vectors induced HCV specific T cell responses at the lowest doses administered. Frequency and potency of the responses increased at the medium dose, reaching up to 3,000 spots per million peripheral blood mononuclear cells. Responses were generally multi-specific and in some cases targeted all of the six pools of peptides covering the whole NS region. In addition, proliferative responses to different NS proteins were readily detected. To date, all tested doses were very well tolerated. Conclusions: We have generated a novel T cell vaccine based on adenovirus vectors from rare serotype expressing HCV NS proteins that is safe in man, highly immunogenic even at sub-maximal doses, and which readily induces responses against multiple antigenic targets. Okairos &Novartis:tinyurl.com/258s7ew With this project two vaccine companies in Europe, OKAIROS (a Biotech company created as a spin-off from Merck Inc.) and Novartis Vaccines & Diagnostics (ex-Chiron), join their efforts with several European groups and our institution VACSERA from Egypt to develop efficacious preventative and therapeutic Hepatitis C virus (HCV) vaccines. LSHB-2006-037435 New preventive and therapeutic Hepatitis C vaccines: from pre-clinical to phase I 1 February 2007 To 31 February 2011www.vacsera.com/R_&_D.html Novartis Venture Funds Okairos AG Riccardo Cortese, Basel, CHwww.okairos.it (This site is temporarily unavailable. We will come back as soon as possible). Okairos is a Swiss based vaccine company, with a subsidiary in Italy, developing vaccines for mutating viruses. Its innovative viral adenovirus T cell platform allows to develop novel vaccines for the prevention and treatment of major life-threatening infections, including malaria and hepatitis C. Company has entered clinical stage.www.venturefund.novartis.com/index.ph... WHO, Hepatitis C Virus. Virally vectored vaccines: Replicative defective adenoviral vectors that are genetically engineered to encode the non-structural proteins (NS3-NS5B) of a genotype-1b HCV strain have been developed by Okairos (Rome, Italy), and are currently in phase I clinical trials (Oxford, UK). This follows earlier studies in chimpanzees using a heterologous prime boost regimen of adenoviral/DNA (electroporated plasmid) vectors encoding the HCV NS proteins. This strategy induced broad CD8+ and CD4+ HCV specific T cell responses in 4/5 animals that were protected from heterologous viral challenge [29] . Since anti-adenoviral antibodies can limit the efficacy of these vectors, a number of adenoviral vectors derived from rare human adenoviral serotypes and also from chimpanzee adenovirus, to which humans have been rarely exposed, have been developed. A Phase I study of healthy volunteers, using a double prime/heterologous boost with two different adenoviral vectors has recently been shown to be highly immunogenic. A therapeutic vaccine approach using the same vectors in combination with interferon and ribavirin is currently underway in Oxford, UK.www.who.int/vaccine_research/diseases...
GSK strengthens vaccines business with acquisition of Okairoswww.gsk.com/media/press-releases/2013...
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SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)
Indices
AEX
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EUR/USD
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FTSE 100
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Germany40^
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15.611,76
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