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MOR103 (PerC6 inside) PHASE I

1. flosz 19 januari 2010 09:27

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   MorphoSys Enrolls First Patient in Phase 1b/2a Clinical Trial for MOR103 Program in Rheumatoid Arthritis
   01/19/2010 at 07:00 AM
   Company Provides Guidance on R&D Investment in 2010
   
   MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it has enrolled the first patient in its Phase 1b/2a clinical trial of its lead drug MOR103. The Company's lead development program, MOR103, is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis (RA), where current treatment options are inadequate.
   
   "We are very pleased that our Phase 1b/2a study in patients with rheumatoid arthritis has now started according to plan," commented Dr. Arndt Schottelius, Chief Development Officer. "This is an important step for MorphoSys, since we will test an antibody from our growing proprietary pipeline for the first time in patients. We have thus made significant progress in bringing a potential future drug with a promising new mechanism of action closer to patients. The past year saw a major expansion of MorphoSys's development team and capabilities. Today's news also demonstrates that we have made major progress in building an excellent development organization capable of producing and advancing valuable drug candidates.
   
   "In total, the randomized, double-blind, placebo-controlled, dose-escalation trial is expected to enroll 135 patients and will be conducted in multiple centers in several European countries. Patients with active RA despite previous therapy with NSAIDs, corticosteroids, DMARDs and/or anti-TNF-alpha therapies will each receive four infusions of either the HuCAL-derived antibody MOR103 or placebo in three ascending dose cohorts. Enrollment is expected to be completed in the first half of 2011 with the final results expected in H1 2012.
   
   The primary endpoint of the trial is to determine the safety and tolerability of multiple doses of up to 1.5 mg/kg of MOR103 in patients with active RA. Secondary outcome measures will evaluate pharmacokinetics, immunogenicity, and the drug's potential to improve clinical signs and symptoms of RA as measured by reduction of synovitis and bone edema as well as by ACR/ EULAR28 response criteria and patient reported outcomes.
   
   Proprietary R&D Investment 2010
   The phase 1b/2a trial for MOR103 is expected to constitute a significant share of MorphoSys's anticipated proprietary R&D investment in 2010 of EUR 26 million to EUR 29 million. In addition to conducting the phase 1b/2a trial in RA and preparing for phase 2 testing of MOR103 in a second indication, MorphoSys will further accelerate and expand its proprietary development activities during the next 12 months. The Company plans to add up to four new proprietary programs including both fully owned and co-development opportunities. MorphoSys today reconfirmed its commitment to remaining profitable and expects the solid business performance and top-line growth of previous years to continue through 2010. More specific financial guidance for 2010 will be given at the Company's full year 2009 results presentation on February 25th, 2010.
   www.morphosys.com/en/news_investors/p...
   
2. [verwijderd] 20 januari 2010 09:56

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   Tja of dit nu zo'n superbericht voor Crucell is?
   
   MorphoSys and WACKER Expand Cooperation to Use WACKER's ESETEC® Technology for Production of Antigen Material
   
   01/20/2010 at 07:30 AM
   
   The patented ESETEC® secretion system from WACKER, which is based on E. coli, is a tried-and-tested technology for the cost-effective production of proteins including antibody fragments. The system comprises a specific E. coli strain developed and patented by WACKER which is able to secrete recombinant proteins in their native conformation into the culture medium during fermentation. This extra-cellular production makes it easier to purify the recombinant products, and the expensive process step of refolding is also dispensed with. This means the entire production is much more efficient and cost-effective. WACKER and MorphoSys entered into an initial feasibility study agreement for the use of the WACKER secretion technology for the production of antibodies in 2005. Due to significant success, this agreement was supplemented in 2008 with a formal license to use the WACKER technology.
   www.morphosys.com/en/news_investors/p...
   
   www.wacker.com/cms/en/products-market...
   With more than 20 years of experience in the field of microbial systems, Wacker Biotech GmbH is a skilled partner for the contract-manufacturing of therapeutic proteins. We understand our customers’ requirements and know that quality and speed determine a project’s success - regardless of whether you require the product for clinical testing purposes or for market supply.
   One of our core skills is the GMP-compliant development of stable, high-efficiency processes. Our outstanding technologies can significantly contribute to your projects’ success. The ESETEC® E. coli secretion technology enables highly efficient extracellular production of proteins using E. coli K12. The biomass produced by the DENSETEC® high-cell-density fermentation system surpasses typical industry standards. This is how we achieved product yields of over 10 g/l. Our technologies are ideal for challenging products such as antibody fragments, which we manufacture with outstanding quality and exceptional yields.
   In our production plants, we either work with these proprietary high-performance technologies, or we transfer your existing process to our facilities. Our production facility fully complies with GMP regulations and offers you an integrated approach. Our focused teams identify critical process parameters and our project managers work closely with you to ensure an continuous flow of communication and precise adherence to deadlines.
   
3. harrysnel 27 januari 2010 10:13

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   MorphoSys Licenses HuCAL PLATINUM® Antibody Library to Shionogi in Research Partnership
   
   01/27/2010 at 07:30 AM
   
   MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that Shionogi & Co., Ltd., Osaka, Japan, has elected to expand its current research license to cover the use of MorphoSys's HuCAL PLATINUM technology in drug discovery. In April 2009, MorphoSys and Shionogi entered into an agreement under which, for pre-agreed terms, Shionogi could gain access to HuCAL PLATINUM, the latest and most powerful MorphoSys antibody library, for a six-month beta test period. During this test period, Shionogi was able to compare HuCAL PLATINUM with its predecessor HuCAL GOLD®, and found the new library to be considerably better.
   
   "We have had the pleasure of using the MorphoSys HuCAL PLATINUM library for the last six months and were extremely impressed. HuCAL PLATINUM's capabilities go beyond any other antibody sourcing library we have used in the past, and we are very excited about being able to continue to use the PLATINUM library in the future," commented Dr. Yoshito Numata, Department Head, Drug Target Discovery, Discovery Research Laboratory.
   
   "Shionogi has been able to test-drive the latest version of our antibody library HuCAL PLATINUM extensively. Thus, their decision to upgrade speaks clearly to the quality and the success of our internal technology development work in recent years," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys.
   
   Under the terms of the agreement, Shionogi will now have the right to use HuCAL PLATINUM for research purposes at one of its sites. As a result of the expansion, MorphoSys will receive increased annual user fees from Shionogi. Further financial details were not disclosed.
   
   MorphoSys and Shionogi signed a three-year license agreement on the use of MorphoSys's HuCAL technology in September 2005. Under the terms of the agreement, MorphoSys granted Shionogi access to its HuCAL GOLD antibody library for research applications in Shionogi's drug discovery programs. The research alliance was extended for three additional years in September 2008. The HuCAL PLATINUM library was introduced in September 2008. PLATINUM contains several significant improvements over the previous version of the HuCAL library. The new library is based on the genetic information of approximately 45 billion different fully human antibodies.
   
   About MorphoSys:
   
   MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The Company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies. By successfully applying this and other proprietary technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human health-care. Through its alliances with some of the world's leading pharmaceutical companies, MorphoSys has created a pipeline of more than 60 drug candidates. The Company is expanding its drug pipeline by adding new partnered programs, and by building a portfolio of fully-owned therapeutic antibodies. For its proprietary portfolio, the Company is focused on the areas of oncology and inflammation. Its most advanced program MOR103, a first-in-class, fully human antibody against GM-CSF, is currently tested in a Phase Ib/IIa trial in rheumatoid arthritis patients. Via its business unit AbD Serotec, MorphoSys is expanding the reach of its technologies in the diagnostics and research markets. MorphoSys is headquartered in Munich, Germany and listed on the Frankfurt Stock Exchange under the symbol "MOR". For further information, visit www.morphosys.com/
   HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay® and RapMAT® are registered trademarks of MorphoSys AG.
   
   www.morphosys.com/en/news_investors/p...
4. [verwijderd] 9 februari 2010 15:52

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   AbD Serotec erweitert Vertriebsbüro in Düsseldorf zur Unterstützung des künftigen Wachstums
   
   09.02.2010 / 07.30 Uhr
   AbD Serotec steigert Vertriebsaktivitäten in Europa und Asien
   
   
   
   Die MorphoSys AG (Frankfurt: MOR; Prime Standard Segment, TecDAX) gab heute bekannt, dass ihre Sparte für Forschungs- und diagnostische Antikörper AbD Serotec ihr Vertriebsbüro in Düsseldorf ausbauen wird, um ihr Wachstum in Mittel- und Osteuropa sowie Asien voranzutreiben. Die heutige offizielle Eröffnungsfeier wurde vom Düsseldorfer Bürgermeister Friedrich G. Conzen vorgenommen. Dr. Simon Moroney, Vorstandsvorsitzender der MorphoSys AG sowie Dieter Feger, Leiter von AbD Serotec, waren ebenfalls anwesend. Die erweiterte Niederlassung in Düsseldorf wird die weltweiten Vertriebsaktivitäten von AbD Serotec außerhalb Amerikas koordinieren.
   
   "Während wir in unseren bestehenden Märkten weiterhin eine stabile Nachfrage erwarten, haben wir zusätzlich neue Bereiche mit Wachstumspotenzial identifiziert und planen nun, die Reichweite unseres Vertriebs zu vergrößern, um den Marktanteil in Osteuropa und Asien, aber auch in unserem hiesigen Kernmarkt Westeuropa zu erhöhen", kommentierte der Leiter von AbD Serotec Dieter Feger. "Ein zentraler Bestandteil der Wachstumsstrategie in diesen Märkten wird unser Vorhaben sein, dem Vertrieb ein eigenes Telemarketing-Team zur Seite zu stellen und unsere Direktmarketing-Aktivitäten zu verstärken."
   
   Der finanzielle Ausblick von MorphoSys für 2009 sieht vor, dass AbD Serotec dank Wachstumsraten, die über dem Marktdurchschnitt liegen, ungefähr ein Viertel des gesamten Konzernumsatzes beitragen wird, bei einer Gewinnmarge von bis zu 6 %. Die MorphoSys AG geht davon aus, dass sich die finanzielle Leistung des Segments in 2010 noch weiter verbessern wird. Details zum finanziellen Ausblick für 2010 werden bei der Bilanzpressekonferenz am 25. Februar 2010 bekanntgegeben.
5. [verwijderd] 18 februari 2010 08:38

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   Galapagos and MorphoSys expand antibody alliance
   
   Mechelen, Belgium and Martinsried/Munich, Germany; 18 February 2010 – Galapagos NV (Euronext: GLPG) and MorphoSys AG (FSE: MOR) announce that they have expanded their antibody alliance in bone & joint diseases. Based on the solid progress made so far, the partners have agreed to add another antibody target to the alliance, thereby increasing the total number of programs to four.
   
   The alliance aims to discover and develop antibody therapeutics based on novel modes of action in bone & joint diseases, including rheumatoid arthritis, osteoporosis and osteoarthritis. As part of the initial agreement, three targets implicated in bone & joint diseases were selected for the collaboration. Antibodies with high specificity towards the first target have been generated and are now being tested in disease-specific in vitro and in vivo experiments. In parallel, Galapagos has applied its target discovery platform to identify additional targets for antibody development. Based on this, Galapagos and MorphoSys have now added a fourth antibody target to the alliance. The partners have prioritized the targets in order to maximize the value and IP position of the respective therapeutic antibody programs.
   
   “This collaboration provides Galapagos with a platform to develop antibody drugs for our proprietary targets,” said Onno van de Stolpe, Chief Executive Officer of Galapagos. “This, together with more than 40 R&D small molecule programs, solidifies our leading position in discovering innovative approaches to address diseases with unmet medical need.”
   
   “The expansion of our proprietary pipeline is a key value driver for our company. In 2010, we plan to add up to four new proprietary programs including both fully owned and co-development opportunities such as with Galapagos,” commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. “Our alliance with Galapagos gives us access to novel disease-related target molecules which could build the basis for first-in-class antibody therapies in the future.”
   
   About the antibody alliance in bone and joint diseases
   In November 2008, Galapagos and MorphoSys entered an alliance aimed at discovering and developing antibody therapies based on novel modes of action in bone & joint diseases. The partners are developing fully human antibodies, which are recognized as the next generation of therapeutic antibodies.
   
   Both companies contribute their core technologies and expertise to the alliance: Galapagos provides antibody targets implicated in bone & joint disease in addition to its target discovery platform to discover further targets for antibody development; MorphoSys contributes its HuCAL antibody technologies to generate fully human antibodies directed against these targets. The initial goal is to further validate the targets through disease-specific in vitro and in vivo testing of the antibodies. After successful validation, the partners will select antibody programs for pre-clinical and clinical development. Following clinical Proof of Concept, it is anticipated that the programs will be partnered for subsequent development, approval and marketing. Under the terms of the agreement, Galapagos and MorphoSys share the research and development costs as well as all future revenues equally.
   
   www.glpg.com/press/2010/7.htm
6. aossa 18 februari 2010 10:01

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   Opmerkelijke uitspraak mi. Wat denken de specialisten hierover?
   
   www.glpg.com/press/2010/7%27.pdf
   
   "De gemiddelde tijd die nodig is vanaf ontdekking tot preklinische ontwikkeling voor een antilichaam is minder dan drie jaar, aanmerkelijk korter dan het gemiddelde zes jaar voor kandidaat medicijnen uit chemische moleculen. Antilichamen hebben ook een grotere kans op succes in het ontwikkelingstraject naar geneesmiddel. "
   
   
7. maxen 18 februari 2010 11:11

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   quote:

   aossa schreef:

   www.glpg.com/press/2010/7%27.pdf
   
   "De gemiddelde tijd die nodig is vanaf ontdekking tot preklinische ontwikkeling voor een antilichaam is minder dan drie jaar, aanmerkelijk korter dan het gemiddelde zes jaar voor kandidaat medicijnen uit chemische moleculen. Antilichamen hebben ook een grotere kans op succes in het ontwikkelingstraject naar geneesmiddel. "
   

   Voorbeeld: FlumAbs van Crucell
   
   PLANNING: gaat in de kliniek eind 2010/begin 2011.
   1e aankondiging kwam in September 14 2007. Dus een (verwachte) dikke drie jaar tussen aankondiging en start phase I.
   Hoeveel tijd zat er tussen de ontdekking en de aankondiging in september 2007? Toch wel minstens een jaar, waarschijnlijk meer. Dat maakt totale tijd tussen ontdekking tot KLINISCHE ontwikkeling, inclusief PREklinische ontwikkeling, minstens 4 jaar, misschien 5 of 6.
   Best wel netjes, als het daadwerkelijk op de gecommuniceerde tijd de kliniek ingaat.
   
   www.crucell.com/Investors-Press_Releases
   Leiden, The Netherlands, September 14, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced that its researchers have discovered a monoclonal antibody that is active against H5N1 avian influenza. The studies will be presented at the 5th International Bird Flu Summit scheduled for September 27 and 28 in Las Vegas, Nevada.
   
   Crucell researchers produced antibodies in PERC6® cells and tested their biophysical and immunological properties.
   
   "Using phage display technology a set of human monoclonal antibodies active against a broad range of distinct H5N1 strains was developed," said Crucell Chief Scientific Officer Dr. Jaap Goudsmit. "We will show the ability of these antibodies to prevent infection as well as to prevent and cure disease caused by H5N1 virus in mice."
8. harrysnel 23 februari 2010 11:43

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   AbD Serotec Significantly Improves Antibody Generation Process
   
   02/23/2010 at 07:30 AM
   
   Automation and HuCAL PLATINUM Support Increase in Success Rates to 98%
   
   MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that its research and diagnostic antibody unit AbD Serotec has demonstrated significant progress using the HuCAL-based technology platform to generate custom-made monoclonal antibodies for research and diagnostic use. Over the course of the last four years, AbD Serotec gradually improved success rates year-on-year starting at 80% in 2006 to reach 98% in 2009. This was mainly achieved through a high degree of automation in many aspects of the antibody generation process, by optimizing protocols and finally by the implementation of HuCAL PLATINUM, the latest and most powerful version of MorphoSys's antibody libraries.
   
   "Thanks to the very effective technology and process development efforts at AbD Serotec, we have managed to deliver antibodies in almost every customer project we initiated in 2009. The success rates achieved by AbD Serotec in 2009 are significantly higher than the average success rate usually seen in the industry with animal-based methods, of around 75%,'' commented Dieter Feger, Head of AbD Serotec. "The HuCAL technology is making ever-increasing inroads into the diagnostics market as its intrinsic advantages are recognized."
   
   About MorphoSys:
   
   MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The Company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies. By successfully applying this and other proprietary technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human health-care. Through its alliances with some of the world's leading pharmaceutical companies, MorphoSys has created a pipeline of more than 60 drug candidates. The Company is expanding its drug pipeline by adding new partnered programs, and by building a portfolio of fully-owned therapeutic antibodies. For its proprietary portfolio, the Company is focused on the areas of oncology and inflammation. Its most advanced program MOR103, a first-in-class, fully human antibody against GM-CSF, is currently tested in a Phase Ib/IIa trial in rheumatoid arthritis patients. Via its business unit AbD Serotec, MorphoSys is expanding the reach of its technologies in the diagnostics and research markets. MorphoSys is headquartered in Munich, Germany and listed on the Frankfurt Stock Exchange under the symbol "MOR". For further information, visit www.morphosys.com/
   
   HuCAL®, HuCAL GOLD®, HuCAL PLATINUM® and RapMAT® are registered trademarks of MorphoSys AG
   
   www.morphosys.com/en/news_investors/p...
9. flosz 5 april 2010 18:10

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   MOR103 is a fully human HuCAL antibody targeting GM-CSF
   �� Primary indication: rheumatoid arthritis
   �� MOR103 blocks binding of human GM-CSF to its receptor with sub-pM affinity
   �� Clinical material is produced using PER.C6® cell-line (Crucell/DSM)
   �� Phase 1 successfully completed: 63 healthy volunteers, double-blind,
   placebo-controlled, single ascending dose
   �� Promising pre-clinical data for second indication
   
   MOR103: The Opportunity
   Target
   GM-CSF is clearly implicated in RA
   �� Leukine mediated flares in RA
   Leukine-patients
   �� Elevated presence in synovium of arthritic joints
   �� Antibodies ameliorate signs & symptoms of RA in
   established animal models
   
   Market
   Market >$10bn
   Fewer than 25% of RA patients adequately treated
   �� 50% of TNF-responders stop responding within
   2 years
   
   IP
   Broad patent protection in the USA
   Exclusive license to granted US patent covering key
   uses of antibodies against GM-CSF
   �� Patent applications covering antibodies themselves
   �� Patent applications
   covering new indications
   Genuine blockbuster
   Potential
   
   MOR103 – Ph 1b/2a (MSC-1001) in
   Rheumatoid Arthritis – Clinical Trial Update
   Trial approved in Germany, Bulgaria, The Netherlands
   �� Study in 135 RA patients, randomized, double-blind, placebo-controlled, multiple ascending dose
   �� Geographic mix provides access to full spectrum from biologics-pretreated to biologics-naïve
   RA patients
   �� Primary outcome measures: Adverse event rate and safety profile
   �� Secondary outcome measures: DAS28, ACR core set measures and EULAR28 response criteria,
   cytokines, synovitis, bone edema, pharmacokinetics, immunogenicity and patient reported
   outcomes up to 16 weeks
   �� Stable regimen of concomitant RA therapy (including anti-TNFs)
   
   MOR202: The Opportunity
   Target
   CD38; found on the surface of many immune cells
   �� Primary indication: Multiple myeloma
   �� Heavily over-expressed in 95% of multiple myeloma
   and some leukemia cell lines
   �� Antibody induces cell-killing
   Multiple myeloma: Targeting a
   �� 10% of hematological cancers
   �� 1% of all cancers
   major unmet
   medical need
   
   Market
   �� 2% of cancer deaths
   �� No curative therapies on the market
   �� Median survival 24-30 months, all patients
   eventually relapse
   Other
   Indications
   Leukemia being evaluated
   
   MOR202 – Development Plan
   �� Manufacturing of clinical grade material completed according to plan
   �� Clinical material is produced using PER.C6® cell-line (Crucell/DSM)
   �� Prepare for Ph 1/2 in multiple myeloma in 2011
   �� File CTA in Q4 2010
   �� Rationale for extended timeline of MOR202
   �� Sharpened competitive profile
   �� Longer chronic toxicity study to enable long-term clinical development
   �� Competitive advantage: Tox species available (cross-reactivity to non-human primate), robust
   development plan
   
   www.morphosys.com/sites/default/files...
   
10. flosz 27 april 2010 09:16

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    MorphoSys AG Reports Results for the First Quarter of 2010
    Highlights of the First Quarter of 2010
    • In January 2010, MorphoSys began enrollment of rheumatoid arthritis patients in a phase 1b/2a clinical trial of its lead drug MOR103. MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis.
    • MorphoSys's drug pipeline now comprises 72 therapeutic antibody programs in total, of which eight are currently in clinical development, 28 are in preclinical development and 36 are in the discovery phase. Seven of these are MorphoSys's proprietary programs, including the co-development program with Novartis, with MOR103 being the most advanced. The early-stage cancer program MOR203 was discontinued during the first quarter of 2010.
    • MorphoSys and Galapagos expanded their antibody alliance in bone and joint diseases. Based on the solid progress made so far, the partners have agreed to add another antibody target to the alliance, thereby increasing the total number of programs to four.
    • Shionogi expanded its current research license to cover the use of MorphoSys's HuCAL PLATINUM technology in drug discovery.
    • MorphoSys and Wacker Chemie expanded their existing cooperation in the use of Wacker's bacterial secretion technology ESETEC®. As a result, MorphoSys will now be able to use the Wacker technology for the production of antigen material in addition to the production of antibodies in both the early development phase of therapeutic projects as well as in the production of diagnostic and research antibodies.
    • MorphoSys's research and diagnostic antibody unit AbD Serotec has made significant progress using the HuCAL technology platform to generate custom-made monoclonal antibodies for research and diagnostic use. Over the course of the last four years, AbD Serotec's technical success rates have improved from 80% to 98%.
    • The Japanese Patent Office granted a new patent providing extended protection for the Company's core technology HuCAL. The new patent (JP 4436457) covers the production and design of an antibody library based on phage display.
    "In the first quarter, MorphoSys advanced its first proprietary antibody program into a phase 1b/2a trial in rheumatoid arthritis patients, a major milestone for our Company," commented Dave Lemus, Chief Financial Officer of MorphoSys AG. "Our strong earnings-generating business allows us to further expand our proprietary product development activities in 2010 while maintaining our solid financial profile."
    
    www.morphosys.com/pressrelease/morpho...
    
    1st INTERIM REPORT JANUARY – MARCH 2010
    The Company will invest
    € 26 million to € 29 million into this important future value driver in this year, while remaining profitable.
    In addition to conducting the phase 1b/2a trial in rheumatoid arthritis and preparing for phase 2
    testing of our lead compound MOR103 in a second indication, MorphoSys will further accelerate
    and expand its proprietary development activities during the next 12 months. We aim to file a clinical
    trial application for our cancer compound MOR202 in the final quarter of the year. The Company
    also plans to add up to four new proprietary programs including both fully owned and codevelopment
    opportunities. In that vein, MorphoSys has selected two new target molecules for yet
    to be started internal programs, namely MOR105 and MOR206.
    
    MOR103
    In January 2010, MorphoSys enrolled the first patient in its phase 1b/2a clinical trial of its lead
    drug MOR103. The Company's lead development program, MOR103, is a fully human HuCAL
    antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being
    developed in the area of inflammatory diseases such as rheumatoid arthritis (RA), where current
    treatment options are inadequate.
    In total, the randomized, double-blind, placebo-controlled, dose-escalation trial is expected to
    enroll 135 patients and will be conducted in multiple centers in several European countries.
    Patients with active RA despite previous therapy with NSAIDs, corticosteroids, DMARDs and/or
    anti-TNF-alpha therapies will each receive four infusions of either the HuCAL-derived antibody
    MOR103 or a placebo in three ascending dose cohorts. Enrollment is expected to be completed
    in the first half of 2011 with the final results expected in H1 2012.
    The primary endpoint of the trial is to determine the safety and tolerability of multiple doses of
    up to 1.5 mg/kg of MOR103 in patients with active RA. Secondary outcome measures will evaluate
    pharmacokinetics, immunogenicity, and the drug's potential to improve clinical signs and
    symptoms of RA as measured by reduction of synovitis and bone edema as well as by ACR/
    EULAR28 response criteria and patient-reported outcomes.
    
    MOR202
    Extended toxicological studies are being conducted on MOR202 during 2010 in preparation for
    human clinical trials. The Company expects to file a clinical trial application (CTA) in the fourth
    quarter of 2010 and commence a phase 1/2 trial in early 2011.
    Early-stage pipeline
    Work with MOR205 and MOR104, two early-stage programs in cancer and inflammation, continues
    as planned. The early-stage cancer program MOR203 was discontinued. MorphoSys has
    selected two new target molecules in cancer and inflammation for yet to be started internal
    programs, namely MOR105 and MOR206.
    
    Target Discovery
    As part of the antibody alliance in bone and joint diseases with Galapagos NV another antibody
    target was added to the alliance, thereby increasing the total number of programs from three to
    four. The alliance aims to discover and develop antibody therapeutics based on novel modes of
    action in bone and joint diseases, including rheumatoid arthritis, osteoporosis and osteoarthritis.
    Antibodies with high specificity towards the first target have been generated and are now being
    tested in disease-specific in vitro and in vivo experiments. The partners have prioritized the
    targets in order to maximize the value and intellectual property position of the respective therapeutic
    antibody programs.
    www.morphosys.com/sites/default/files...
    
11. harrysnel 22 juni 2010 13:05

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    MorphoSys Announces Clinical Milestone.
    June 22, 2010 / 08:30
    
    First of up to Six Expected Clinical Phase 1 Milestones During 2010
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that it will receive a clinical milestone payment from Centocor Ortho Biotech Inc. (formerly known as: Centocor, Inc.) in connection with the initiation of a phase 1 clinical trial of a HuCAL-derived antibody in the therapeutic area of inflammatory and autoimmune diseases. The target against which the antibody is directed is undisclosed.
    
    As part of the Centocor Ortho Biotech Inc. collaboration in 2007, a HuCAL antibody became the first from MorphoSys to be developed in two different therapeutic areas - oncology and immunology and in 2009, a different HuCAL antibody advanced in the therapeutic area of inflammation into a phase 1 trial. Today's announcement marks the start of a fourth clinical trial that will be running HuCAL antibodies. Further pre-clinical programs are ongoing.
    
    "Our clinical pipeline is progressing very well, and we expect significant progress in this regard during the course of 2010 with up to six new partnered programs advancing into the clinic," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "We are delighted to see another antibody program advance into phase 1 clinical trials."
    
    MorphoSys projects that in 2010 between four and six partnered programs could enter clinical trials. Today's news represents the first HuCAL-derived antibody to achieve this stage during the course of the year. By the end of this year, up to 14 proprietary and partnered antibody programs are expected to be in clinical trials including at least four programs in phase 2 clinical trials.
    
    About MorphoSys:
    MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The Company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies. By successfully applying this and other proprietary technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human health-care. Through its alliances with some of the world's leading pharmaceutical companies, MorphoSys has created a pipeline of more than 60 drug candidates. The Company is expanding its drug pipeline by adding new partnered programs, and by building a portfolio of fully-owned therapeutic antibodies. For its proprietary portfolio, the Company is focused on the areas of oncology and inflammation. Its most advanced program MOR103, a first-in-class, fully human antibody against GM-CSF, is currently tested in a Phase Ib/IIa trial in rheumatoid arthritis patients. Via its business unit AbD Serotec, MorphoSys is expanding the reach of its technologies in the diagnostics and research markets. MorphoSys is headquartered in Munich, Germany and listed on the Frankfurt Stock Exchange under the symbol "MOR". For further information, visit www.morphosys.com/
    
    www.morphosys.com/pressrelease/morpho...
    
    Centocor Ortho Biotech is 100% dochter J&J
    
    
    
12. [verwijderd] 19 oktober 2010 10:25

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    Germany's MorphoSys And Novartis Expand Antibody Co-operation
    
    Last update: 10/19/2010 2:05:22 AM
    
    FRANKFURT (Dow Jones)
    
    --German biotechnology company MorphoSys AG (MOR.XE) said Tuesday it's expanding co-operation with Swiss pharmaceutical company Novartis AG (NVS), with an agreement on pre-developing a second therapeutic antibody program on inflammatory conditions.
    
    MAIN FACTS:
    
    -MorphoSys said Novartis will carry all project-related costs until the program reaches formal co-development status. -"For the second time within this co-operation, we have chosen the opportunity to jointly develop an antibody candidate against a very promising target involved in inflammatory conditions, one of our core development areas," Marlies Sproll, Chief Scientific Officer of MorphoSys said in a statement. -Novartis and MorphoSys signed a collaboration agreement in 2007 and announced their first pre-development project in September 2008.
    
    
    -Frankfurt Bureau, Dow Jones Newswires; 49-69-29725-500
    (END) Dow Jones Newswires
    October 19, 2010 02:05 ET (06:05 GMT)
13. flosz 15 november 2010 18:43

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    MorphoSys Presents New Antibody Technology arYla
    November 15, 2010 / 7:30 am, CET
    arYla Opens up New Ways to Optimize Therapeutic and Diagnostic Antibodies
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today the launch of a novel antibody optimization platform called arYla. The Company plans to use arYla to accelerate antibody optimization, with the goal of generating superior therapeutic and diagnostic candidates faster and more cost-effectively than is currently possible. arYla will be used to optimize a range of properties critical to the successful development of a therapeutic or diagnostic antibody. The arYla technology results from the combined technology platforms of MorphoSys and recently acquired Sloning BioTechnology.
    "We see many therapeutic and diagnostic antibody programs in our industry in which shortcomings in the antibody hinder the development of a successful product," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "arYla gives us a unique and proprietary means of optimizing antibody properties, which we expect to lead to better products - both therapeutics and diagnostics - faster than is possible today. We intend to apply the technology in our own programs and within existing as well as new partnerships, and are already seeing considerable interest in the pharmaceutical industry."
    With the arYla technology, MorphoSys combines more than 15 years of experience in design and selection of therapeutic antibodies with the unique library synthesis capabilities acquired with Sloning in October 2010. arYla brings significant advantages to antibody optimization especially in terms of speed and flexibility. The new technology enables individualized antibody libraries to be made with unprecedented speed and precision. arYla will be used to make diverse, customized sub-libraries based on an existing lead compound, incorporating many millions of pre-defined variations at precisely determined sites within the antibody structure. In this way, antibodies optimized for a multitude of properties, including affinity, specificity, humanness, solubility, stability, production yield and others, can rapidly be identified.
    www.morphosys.com/aryla
    
14. flosz 18 november 2010 19:15

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    MorphoSys invites you to an update on the Company’s
    pipeline and recent technology developments
    www.morphosys.com/sites/default/files...
    
    Agenda
    Introduction Dr. Simon Moroney, CEO of MorphoSys AG
    Technology Update Dr. Marlies Sproll, CSO of MorphoSys AG
    Update Partnered Pipeline Dr. Marlies Sproll, CSO of MorphoSys AG
    Proprietary Development Dr. Arndt Schottelius, CDO of MorphoSys AG
    GM-CSF
    A central mediator in inflammation Prof. John Hamilton, University of Melbourne
    MOR103 Dr. Arndt Schottelius, CDO of MorphoSys AG
    MOR208 New York: Dr. John Desjarlais, Vice President, Research, Xencor, Inc.
    London: Dr. Lisa Rojkjaer, Head of Clinical Development, MorphoSys AG
    MOR202 Dr. Lisa Rojkjaer, Head of Clinical Development, MorphoSys AG
    Closing Remarks Dr. Simon Moroney, CEO of MorphoSys AG
    
15. flosz 25 november 2010 18:36

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    Multiple Sclerosis Announced as Second Indication for MOR103
    
    New Announcements at Today's R&D Day include:
    • Disclosure of multiple sclerosis as the second indication for the Company's lead development program MOR103, a fully human HuCAL antibody targeting GM-CSF. The decision is based on a compelling scientific rationale and promising pre-clinical data. MorphoSys expects to start a phase 1b trial in multiple sclerosis with MOR103 in H2 2011.
    • Preclinical data for MOR103 in both rheumatoid arthritis (RA) and multiple sclerosis and an update on imaging/biomarkers used in the ongoing phase 1b/2a study in RA.
    • Preclinical data for MOR202, a HuCAL antibody targeting CD38 to treat multiple myeloma. A clinical trial application (CTA) to initiate a phase 1/2a trial with MOR202 in patients with relapsed/refractory myeloma has been filed in Europe and the Company expects to dose the first patient in H1 2011.
    • An update on MOR208, an Fc-enhanced anti-CD19 antibody to treat B-cell malignancies. The program was in-licensed from Xencor in June 2010 and is currently in a phase 1 clinical trial in relapsed or refractory CLL/SLL in the US with patient enrollment expected imminently.
    • An update on the Company's partnered pipeline, comprising now five partnered projects in phase 2 clinical trials. Roche has started a phase 2 clinical trial with Gantenerumab, a HuCAL antibody against amyloid-beta to treat Alzheimer's disease.
    • The latest technology developments, such as the recently announced optimization platform arYla(TM), as well as additional modules for more efficient selection and screening of antibody libraries.
    
    "MorphoSys has established a significant proprietary product portfolio and its clinical programs MOR103, MOR202 and MOR208 are on track to generate lucrative out-licensing opportunities in the years ahead," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys. "Our decision to develop MOR103 in a second indication beyond rheumatoid arthritis, namely multiple sclerosis, is based on a compelling scientific rationale and promising pre-clinical data and we are intrigued by its prospects. I'm excited about the progress we've made in Proprietary Development since I joined MorphoSys two years ago."
    The commercial opportunity for therapeutic antibodies is enormous. As we learn more about this class of drugs we are identifying ways of making antibodies that will be superior to currently available drugs, and our strategy is to command and apply a range of technologies to deliver these new therapies." commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys. "MorphoSys has now established a suite of technologies to enable generation of the best possible therapeutic antibodies and continues to set industry standards with its new arYla(TM) antibody optimization technology."
    www.morphosys.com/sites/default/files...
    
    Presentation with sound
    tinyurl.com/2vlf9h4
    
16. [verwijderd] 25 november 2010 21:01

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    Heel mooi en dank voor het plaatsen.
    Dit onderbelichte bedrijf blijf ik volgen.
    Het gaat gestaag beter en er bestaat kans op versnelling van de ontwikkeling.
    
    Interessante partners als takeda.
    
    Takeda is overigens ook een potentiele koper van Crucell.
    
    
17. harrysnel 10 december 2010 10:22

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    MorphoSys Signs Long-Term Alliance with Pfizer on Sloning Technology Platform.December 10, 2010 / 7:04 am, CET
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today the signing of a non-exclusive license and technology transfer agreement between its subsidiary Sloning BioTechnology GmbH and Pfizer. The agreement covers the installation, training and use of Sloning's technology platform Slonomics® for fabrication of highly-diverse gene and protein libraries at Pfizer's subsidiary Rinat Neuroscience Corp. in South San Francisco. The MorphoSys subsidiary will receive an upfront payment in 2010, and stands to receive annual license fees over the patent lifetime of the Slonomics technology platform. Further financial details of the agreement were not disclosed.
    
    "This significant alliance around the Slonomics technology, only weeks after we closed the acquisition of Sloning, clearly illustrates the potential value of the platform," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "This alliance with Pfizer creates immediate value for our shareholders and is just the beginning of what we expect to be a considerable return-on-investment from the combined technology platforms of MorphoSys and Sloning in the years ahead."
    
    "Rinat started using Sloning's services in 2009, and we were impressed by the diversity and quality of the libraries delivered," said Jaume Pons, PhD, Chief Scientific Officer at Pfizer's Rinat subsidiary. "We therefore decided to use this innovative technology platform further for our research and development activities."
    
    Sloning's state-of-the-art Slonomics technology enables the precise construction of protein libraries comprising defined mixtures of amino acids at pre-determined positions with unprecedented speed. The technology provides a new and flexible approach to generating optimized proteins. MorphoSys acquired Sloning BioTechnology in October 2010.
    
    www.morphosys.com/pressrelease/morpho...
    
    
18. harrysnel 10 december 2010 10:23

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    MorphoSys Increases Revenue and Operating Profit Guidance for 2010.December 10, 2010 / 7:05 am, CET
    
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today increased its financial guidance for 2010 mainly as a result of the achievement of revenues from additional commercial activities, resulting from the acquisition of Sloning BioTechnology GmbH in October 2010. MorphoSys now expects full-year revenues between EUR 91 million and EUR 94 million (from previously EUR 89 million to EUR 90 million). Correspondingly, the operating profit guidance is also increased, and expected to range between EUR 13 million and EUR 16 million (from previously EUR 7 million to EUR 9 million).
    
    www.morphosys.com/pressrelease/morpho...
19. harrysnel 12 januari 2011 12:45

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    MorphoSys Announces Clinical Milestone from Strategic Alliance
    
    www.morphosys.com/pressrelease/morpho...
20. flosz 8 februari 2011 09:15

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    February 07, 2011 / 7:30 am, CET
    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) announced today that the US Patent and Trademark Office (USPTO) has granted a patent covering the Company's most advanced proprietary compound MOR103. The new patent (US 7,867,495) covers MorphoSys's HuCAL antibody against GM-CSF as well as pharmaceutical compositions comprising the same, and has a scheduled expiry date in 2026, not including any potential extensions.
    This newly issued patent complements a US patent granted in 2008 covering medical uses of antibodies against GM-CSF, to which MorphoSys has exclusive access under a license agreement with the University of Melbourne. Together, the two patent families provide strong intellectual property protection for the MOR103 program.
    "The protection of our intellectual property is a central part of MorphoSys's business model," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "We will continue to strengthen still further our intellectual property position in antibody-based products and services, particularly in our most important markets Europe, the USA and Asia."
    Human GM-CSF (Granulocyte macrophage-colony stimulating factor), the target molecule of MorphoSys's lead program MOR103, is implicated in a number of inflammatory and other conditions including rheumatoid arthritis (RA) and multiple sclerosis (MS). The HuCAL-derived, fully human antibody is currently being tested in a clinical Phase 1b/2a trial in RA patients. Additionally, MorphoSys plans to start a Phase 1b safety study of MOR103 in multiple sclerosis patients in 2011.
    www.morphosys.com/