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Crucell en Okairos

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[verwijderd] 17 mei 2009 10:49

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/

maxen 17 mei 2009 11:16

quote:
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.

[verwijderd] 17 mei 2009 11:21

quote:
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.

flosz 17 mei 2009 11:24

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...

[verwijderd] 17 mei 2009 12:21

Knap gevonden GO!

maxen 17 mei 2009 13:46

quote:
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.

eddy59 17 mei 2009 14:07

De zoveelste bevestiging dat Crucell het helemaal gaat maken en lekker zelfstandig kan doorgroeien tot een Pharma reus.

Eddy

flosz 10 juni 2009 14:34

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.C6
www.dh.gov.uk/ab/GTAC/Publications/in...

flosz 14 oktober 2009 09:05

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.

[verwijderd] 4 november 2009 12:11

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

aossa 4 november 2009 12:25

quote:
gocrucellgo schreef:
... which does not grow in 293 or PER C6 cells.
www.okairos.it/e/inners.php?m=00044

?????

flosz 4 november 2009 12:35

An Adenovirus vector, Ad6 in dit geval.

Uit 2005
Merck HCV:
jvi.asm.org/cgi/reprint/80/4/1688.pdf

[verwijderd] 4 november 2009 12:38

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.

flosz 20 december 2009 20:16

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...

flosz 22 april 2010 14:43

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...

flosz 22 april 2010 14:49

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

flosz 22 april 2010 14:52

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 2011
www.vacsera.com/R_&_D.html

Novartis Venture Funds
Okairos AG
Riccardo Cortese, Basel, CH
www.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...

flosz 30 mei 2013 09:51

GSK strengthens vaccines business with acquisition of Okairos
www.gsk.com/media/press-releases/2013...

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