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Genmab Announces Data to be Presented at 2018 ASH

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  • Helge_LarsenPI-redaktørH Offline
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    Helge_LarsenPI-redaktør
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    Genmab A/S: Genmab Announces Data to be Presented at 2018 ASH Annual Meeting

    14:16
    Media Release

    • Thirty-five total abstracts on Genmab owned and partnered programs
      scheduled for presentation at ASH
    • Three abstracts related to Genmab owned programs: DuoBody-CD3xCD20 &
      DuoHexaBody-CD37
    • Daratumumab: 5 oral presentations; total of 30 accepted including ISS

    Copenhagen, Denmark; November 1, 2018 Genmab A/S (Nasdaq Copenhagen: GEN)
    announced today that 35 abstracts related to Genmab owned and partnered
    programs have been accepted for presentation at the 60th American Society
    of Hematology (ASH) Annual Meeting taking place December 1-4 in San Diego,
    California. Abstracts accepted for presentation include updates on multiple
    daratumumab and ofatumumab trials, as well as pre-clinical data from
    Genmabs DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs. All abstracts are
    available on the ASH website at www.hematology.org
    https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERsZg4aGjERm8OWk2fmt6BgmZmCq57AGm3kSYRhfVh1SpEI8Gn9vjHYI48TIdEgXW6fNBcyJn-1zGUACrka4LvvM=
    . Details regarding the key abstracts to be presented are included below.

    We are elated that out of the over eighty-five ongoing daratumumab
    clinical studies, a record thirty abstracts containing daratumumab data in
    multiple myeloma and other indications were accepted for presentation at
    this years ASH Annual Meeting. We are also thrilled that three abstracts
    related to pre-clinical data from wholly owned Genmab programs were
    accepted for inclusion at this prestigious event, including the first
    proprietary DuoBody program, DuoBody-CD3xCD20, and the first ever
    DuoHexaBody therapeutic program, DuoHexaBody-CD37, said Jan van de Winkel,
    Ph.D., Chief Executive Officer of Genmab.

    Late breaking abstracts are not yet available.

    Genmab Pre-Clinical Abstracts

    DuoBody-CD3xCD20 Shows Unique and Potent Preclinical Anti-Tumor Activity In
    Vitro and In Vivo, and is Being Evaluated Clinically in Patients with
    B-Cell Malignancies Poster presentation, Saturday, December 1

    DuoHexaBody-CD37 a Novel Bispecific Antibody with a Hexamerization
    enhancing Mutation Targeting CD37, Demonstrates Superior CDC in Preclinical
    B-Cell Malignancy Models Poster presentation, Monday, December 3

    Targeting CD37 in B-Cell Malignancies Using the Novel Therapeutic Ab
    DuoHexaBody-CD37 Results in Efficient Killing of Tumor B-Cells Ex Vivo via
    CDC, Even in Relapsed and/or Refractory Patient Samples Poster
    presentation, Monday, December 3

    Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

    Oral Presentations:
    Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from
    GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib,
    Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and
    Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible
    for High-Dose Therapy and Autologous Stem Cell Transplantation Oral
    presentation, Saturday, December 1

    LYRA A Phase 2 Study of Daratumumab Plus Cycolphosphamide, Bortezomib,
    and Dexamethasone in Newly Diagnosed and Relapsed Patients with Multiple
    Myeloma Oral presentation, Saturday, December 1

    One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus
    Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and
    Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple
    Myeloma: ALCYONE Oral presentation, Saturday, December 1

    Poster Presentations:
    Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus
    Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone
    in Relapsed or Refractory Multiple Myeloma Poster presentation, Saturday,
    December 1

    Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple
    Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter,
    Phase 1b Study (PAVO) Poster presentation, Saturday, December 1

    Pharmacokinetics of Subcutaneous Daratumumab in Patients with Relapsed or
    Refractory Multiple Myeloma: Primary Clinical Pharmacology Analysis of the
    Open-label, Multicenter, Phase 1b Study (PAVO) Poster presentation,
    Saturday, December 1

    Split First Dose Administration of Daratumumab for the Treatment of
    Patients with Multiple Myeloma: Clinical Pharmacology and Population
    Pharmacokinetic Analyses Poster presentation, Saturday, December 1

    Updated Results from the Phase 2 CENTAURUS Study of Daratumumab Monotherapy
    in Patients with Intermediate-risk or High-risk Smoldering Multiple Myeloma
    Poster presentation, Saturday, December 1

    Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural
    Killer/T-cell Lymphoma (NKTCL), Nasal Type: An Open-label, Single-arm,
    Multicenter Phase 2 Study Poster presentation, Saturday, December 1

    Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus
    Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of
    CASTOR Poster presentation, Sunday, December 2

    Evaluation of Sustained Minimal Residual Disease Negativity in Relapsed /
    Refractory Multiple Myeloma Patients Treated with Daratumumab in
    Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus
    Dexamethasone: Analysis of POLLUX and CASTOR Poster presentation, Sunday,
    December 2

    Efficacy of Daratumumab in Combination with Standard of Care Regimens in
    Lenalidomide-Exposed or Refractory Patients with Relapsed / Refractory
    Multiple Myeloma: Analysis of CASTOR, POLLUX and MMY1001 Studies Poster
    presentation, Sunday, December 2

    Ofatumumab Abstracts Sponsored by Novartis

    Oral Presentation:
    Results of the Primary Analysis of COMPLEMENT A+B: A Phase III Study of
    Ofatumumab in Combination with Bendamustine Versus Bendamustine Alone in
    Patients with Indolent Non-Hodgkins Lymphoma That is Unresponsive or
    Relapsed Following Rituximab or Rituximab-containing Regimen Oral
    presentation, Sunday, December 2

    Poster Presentation:
    Long-Term Evaluation of Efficacy and Safety of Ofatumumab Added to
    Fludarabine & Cyclophosphamide in Subjects with Relapsed Chronic
    Lymphocytic Leukemia: Final Analysis of COMPLEMENT 2 Trial Poster
    presentation, Sunday, December 2

    About Genmab
    Genmab is a publicly traded, international biotechnology company
    specializing in the creation and development of differentiated antibody
    therapeutics for the treatment of cancer. Founded in 1999, the company has
    two approved antibodies, DARZALEX (daratumumab) for the treatment of
    certain multiple myeloma indications, and Arzerra (ofatumumab) for the
    treatment of certain chronic lymphocytic leukemia indications. Daratumumab
    is in clinical development for additional multiple myeloma indications and
    other blood cancers. A subcutaneous formulation of ofatumumab is in
    development for relapsing multiple sclerosis. Genmab also has a broad
    clinical and pre-clinical product pipeline. Genmabs technology base
    consists of validated and proprietary next generation antibody technologies

    • the DuoBody platform for generation of bispecific antibodies, the
      HexaBody platform, which creates effector function enhanced antibodies and
      the HexElect platform, which combines two co-dependently acting HexaBody
      molecules to introduce selectivity while maximizing therapeutic potency.
      The company intends to leverage these technologies to create opportunities
      for full or co-ownership of future products. Genmab has alliances with top
      tier pharmaceutical and biotechnology companies. For more information
      visit www.genmab.com
      https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERhZXV-w9pnlcpf9jlCUpftrylSPDwQAdytaeOTEv-j2Ymcbf24Xp3vVMBphrZk7LKQ==
      .

    Contact:
    Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
    Communication
    T: +45 33 44 77 20; E: [email protected]

    This Media Release contains forward looking statements. The words
    believe, expect, anticipate, intend and plan and similar
    expressions identify forward looking statements. Actual results or
    performance may differ materially from any future results or performance
    expressed or implied by such statements. The important factors that could
    cause our actual results or performance to differ materially include, among
    others, risks associated with pre-clinical and clinical development of
    products, uncertainties related to the outcome and conduct of clinical
    trials including unforeseen safety issues, uncertainties related to product
    manufacturing, the lack of market acceptance of our products, our inability
    to manage growth, the competitive environment in relation to our business
    area and markets, our inability to attract and retain suitably qualified
    personnel, the unenforceability or lack of protection of our patents and
    proprietary rights, our relationships with affiliated entities, changes and
    developments in technology which may render our products obsolete, and
    other factors. For a further discussion of these risks, please refer to the
    risk management sections in Genmabs most recent financial reports, which
    are available on www.genmab.com
    https://www.globenewswire.com/Tracker?data=5AQ3sqwzso-akEfNYBsERjaHZREk_mM1i19NHQPJXRqDYLL9odaWgZBvP1A-WYCrg-pAye-E_MVZneWnJkI5jw==
    . Genmab does not undertake any obligation to update or revise forward
    looking statements in this Media Release nor to confirm such statements to
    reflect subsequent events or circumstances after the date made or in
    relation to actual results, unless required by law.

    Genmab A/S and/or its subsidiaries own the following trademarks: Genmab;
    the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab
    logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo;
    HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody;
    HexElect; and UniBody. Arzerra is a trademark of Novartis AG or its
    affiliates. DARZALEX is a trademark of Janssen Pharmaceutica NV.

    Media Releaseno. 10
    CVR no. 2102 3884
    LEI Code 529900MTJPDPE4MHJ122

    Genmab A/S
    Kalvebod Brygge 43
    1560 Copenhagen V
    Denmark

    Attachment

    • i10_181101_MR_ASH Abstracts
      https://prlibrary-eu.nasdaq.com/Resource/Download/c2a67b38-0f6b-48d8-9e23-462a62bd65cb
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