Pipeline

We turn science into medicine

We are inspired by the power of the human immune system to fight diseases. We use our expertise to seek new and transformative antibody technologies and have a proven track record of discovering and developing innovative medicines targeting cancer and other serious diseases.

We also have a pipeline of antibody therapeutics that includes investigational medicines in clinical development, and in-house and partnered pre-clinical programs.

products

Our groundbreaking accomplishments

  • 6

    Approved therapies incorporating Genmab innovation

  • 4

    Proprietary Genmab technologies

  • +20

    Products in clinical development incorporating Genmab innovation

Products in development

At Genmab, we are inspired by nature and understand how antibodies work. We are proud to invest in and advance a robust pipeline of differentiated antibody candidates that are at the forefront of the industry. This is accomplished by leveraging our own cutting-edge scientific capabilities, innovative scientific approach, translational medicine laboratory expertise and strategic partnerships.

Our deep scientific understanding of antibodies, including which patients will benefit most from them, helps define Genmab as a leading biotechnology company.

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

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Product Pipeline

Genmab proprietary products

  • Tisotumab Vedotin

    Partnership: Seagen Inc.

    Target: Tissue Factor

    Cervical cancer:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Solid tumors:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Tisotumab Vedotin is an antibody-drug conjugate (ADC) targeted to tissue factor (TF), a protein involved in tumor signaling and angiogenesis.1 It is composed of Genmab’s human monoclonal antibody (mAb) that binds to TF and Seagen’s ADC technology that utilizes a cleavable linker and the cytotoxic drug monomethyl auristatin E (MMAE).1 TF is a transmembrane protein that is the main physiological initiator of coagulation and is involved in angiogenesis, cell adhesion, motility, and cell survival.2,3 The presence of TF is associated with poor prognosis.1

    Clinical Trials

    Tisotumab Vedotin is being tested in clinical studies in a variety of solid tumors.4

    References

    1. Breij ECW, de Goeij BECG, Verploegen S, et al. An antibody-drug conjugate that targets tissue factor exhibits potent therapeutic activity against a broad range of solid tumors. Cancer Res. 2014;74(4):1214-1226.
    2. Chu AJ. Tissue factor, blood coagulation, and beyond: an overview. Int J Inflam. 2011;2011:36784. doi:10.4061/2011/367284.
    3. Ruf W. Tissue factor and cancer. Thromb Res. 2012;130:S84-S87.
    4. US National Institutes of Health. Tisotumab vedotin continued treatment in patients with solid tumors. https://clinicaltrials.gov/ct2/show/NCT03245736?term=tisotumab+vedotin&rank=1 Updated August 10, 2017. Accessed March 14, 2018.
  • Epcoritamab (DuoBody®-CD3xCD20)

    Partnership: AbbVie Inc.

    Target: CD3, CD20

    Relapsed/refractory diffuse large B-cell lymphoma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Relapsed/refractory follicular lymphoma (combo):

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    B-cell non-Hodgkin lymphoma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    B-cell non-Hodgkin lymphoma (combo):

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Indolent NHL, pediatric patients:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Relapsed/refractory chronic lymphocytic leukemia and Richter’s Syndrome:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Epcoritamab (DuoBody®-CD3xCD20) is a proprietary bispecific antibody created using Genmab’s DuoBody® technology, jointly owned by Genmab and AbbVie Inc. It targets CD20 on the B-cells, a clinically well-validated target that is expressed in a wide variety of B-cell malignancies.

    Clinical Trials

    Epcoritamab (DuoBody®-CD3xCD20) is currently under investigation in multiple ongoing clinical studies including a phase 3 study for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, Phase 1/2 clinical studies in B-cell non-Hodgkin lymphoma (B-NHL) including chronic lymphocytic leukemia (CLL) and in combination with standard of care therapies for B-NHL are ongoing.

    More info

  • DuoBody®-PD-L1x4-1BB (GEN1046)

    Partnership: BioNTech

    Target: PD-L1, 4-1BB

    Solid tumors:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Non-small cell lung cancer:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    DuoBody®-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody® technology. It is being co-developed by Genmab under an agreement in which the companies share all costs and future profits for the product on a 50:50 basis. DuoBody®-PD-L1x4-1BB is designed to elicit an anti-tumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation, using inert DuoBody IgG1 antibody format.

    Clinical Trials

    A Phase 1/2 clinical study of DuoBody®-PD-L1x4-1BB in solid tumors and a Phase 2 clinical study of DuoBody®-PD-L1x4-1BB as a single agent or in combination with another anti-cancer therapy in relapsed/refractory metastatic non-small cell lung cancer are ongoing.

    More info

  • DuoBody®-CD40x4-1BB (GEN1042)

    Partnership: BioNTech

    Target: CD40, 4-1BB

    Solid tumors:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    DuoBody®-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody® technology. It is being co-developed under an agreement in which the companies share all costs and future profits for the product on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody® format.

    Clinical Trials

    A Phase 1/2 clinical study of DuoBody®-CD40 x4-1BB in solid tumors is ongoing.

    More info

  • DuoHexaBody®-CD37 (GEN3009)

    Partnership: AbbVie Inc.

    Target: CD37

    Hematological malignancies:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    DuoHexaBody®-CD37 (GEN3009) is a bispecific IgG1 antibody created with Genmab’s proprietary DuoHexaBody® technology platform, jointly owned by Genmab and AbbVie Inc. The DuoHexaBody® platform combines the dual targeting of our DuoBody® technology with the enhanced potency of our HexaBody® technology, creating bispecific antibodies with target-mediated enhanced hexamerization. In preclinical settings, DuoHexaBody®-CD37 has been shown to induce potent in vivo and in vitro anti-tumor activity.

    AbbVie has decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the notice period, Genmab will become solely responsible for the further development of DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product.

    Clinical Trials

    A Phase 1 clinical study of DuoHexaBody®-CD37 in hematological malignancies is ongoing.

    More info

  • GEN3014 (HexaBody®-CD38)

    Partnership: 

    Target: CD38

    Hematological malignancies:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    GEN3014 (HexaBody®-CD38) is a novel human CD38 monoclonal antibody incorporating Genmab’s HexaBody® technology. In June 2019, Genmab entered into an exclusive worldwide license and option agreement with Janssen Biotech Inc. to develop and commercialize HexaBody®-CD38. In preclinical models of hematological malignancies, HexaBody®-CD38 demonstrated enhanced complement-dependent cytotoxicity and potent anti-tumor activity1.

    Clinical Trials

    A phase 1 clinical study of HexaBody®-CD38 in hematological malignancies is ongoing.

    References

    1. H. Hiemstra I. et al. Superior anti-tumor activity of HexaBody®-CD38 in preclinical models of multiple myeloma, b cell lymphoma and acute myeloid leukemia. EHA Library. 06/12/20; 294801; EP884

    More info

  • DuoBody®-CD3xB7H4 (GEN1047)

    Partnership: 

    Target: CD3, B7H4

    Solid Tumors:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    DuoBody®-CD3xB7H4 (GEN1047) is a proprietary bispecific antibody created using Genmab’s DuoBody® technology. B7H4 is an immune checkpoint protein expressed on malignant cells in various solid cancers including breast, ovarian and lung cancer. In preclinical studies, DuoBody-CD3xB7H4 was shown to induce T-cell mediated cytotoxicity of B7H4-positive tumor cells.

    Clinical Trials

    A phase 1 clinical study of DuoBody®-CD3xB7H4 in solid tumors is ongoing.

    More info

Products created by Genmab*

  • Daratumumab

    Partnership: Janssen Biotech, Inc.

    Target: CD38

    Multiple myeloma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    AL Amyloidosis:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Non-MM blood cancers:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.1 Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab.

    Daratumumab (marketed as DARZALEX® for intravenous administration and as DARZALEX FASPRO® in the United States and as DARZALEX SC in Europe for subcutaneous administration (daratumumab and hyaluronidase-fihj)) is approved in certain territories for the treatment of adult patients with certain multiple myeloma indications. DARZALEX FASPRO is also approved in the United States for the treatment of adult patients with AL amyloidosis.

    Indication and Safety

    Daratumumab, marketed as DARZALEX®, is the first human CD38 monoclonal antibody to reach the market and the first monoclonal antibody (mAb) to receive the U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

    In the U.S., side effects may be reported to the FDA at 1-800-FDA-1088. Patients in the U.S., E.U. and Japan can also contact the local Janssen Drug Safety Team about reporting side effects.

    Clinical Studies

    A comprehensive clinical development program for daratumumab is ongoing by Janssen.

    Reference

    1. De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. J Immunol. 2011;186:1840-1848.

  • Ofatumumab

    Partnership: Novartis Pharma AG.

    Target: CD20

    Relapsing Multiple Sclerosis:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops.

    Indication and Safety

    Ofatumumab is approved in the U.S. and Europe as Kesimpta® for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. It is the first B-cell therapy that can be self-administered at home by patients using a Sensoready® autoinjector pen.

  • Teprotumumab

    Partnership: Horizon, under a license from Roche

    Target: IGF-1R

    Thyroid eye disease:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Diffuse Cutaneous Systemic Sclerosis:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Teprotumumab is a fully human antibody created by Genmab under a collaboration with Roche.

    Indication and Safety

    The U.S. FDA approved teprotumumab-trbw as TEPEZZA® for the treatment of thyroid eye disease (TED).

    To report an Adverse Event or Side Effect, Horizon requests patients contact 1-866-479-6742 {Option 1} or visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Partner-owned products incorporating Genmab’s innovation, Phase 2 and later

  • Amivantamab

    Partnership: Janssen Biotech, Inc.

    Target: EGFR, cMet

    Non-small-cell lung cancer:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Advanced or metastatic gastric or esophageal cancer:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Amivantamab is a fully human bispecific antibody that targets EGFR and Met, two validated cancer targets. In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody® technology platform. The two antibody libraries used to produce amivantamab were both generated by Genmab. The antibody pair used to create Amivantamab was selected in collaboration between Genmab and Janssen. Subsequent development work was carried out by Janssen.

    In 2021, Janssen received approval from the U.S. FDA for amivantamab-vmjw (RYBREVANT®) for the treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

    This is the first regulatory approval for a therapy that was created using Genmab’s proprietary DuoBody® bispecific technology platform.

    Indication and Safety

    For more information related to the U.S. FDA approval, including indication, click here.

  • Teclistamab (JNJ-64007957)

    Partnership: Janssen Biotech, Inc.

    Target: BCMA, CD3

    Relapsed or refractory multiple myeloma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. (Janssen) to create and develop bispecific antibodies using Genmab’s DuoBody® technology platform. One of the products subsequently discovered and developed by Janssen is teclistamab, a bispecific antibody that targets CD3, which is expressed on T-cells and BCMA, which is expressed in mature B lymphocytes.

    In August 2022, Janssen received conditional marketing authorization from the European Commission for subcutaneously administered teclistamab (TECVAYLI®) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. Patients must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. In October 2022, Janssen received U.S. Food and Drug Administration approval of TECVAYLI™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. 

    TECVAYLI is the second therapy created using Genmab’s proprietary DuoBody bispecific technology platform to receive regulatory approval.

    Clinical Trials

    Please consult the European Summary of Product Characteristics and the U.S. Prescribing Information for TECVAYLI for the labeled indication and safety information. 

  • Inclacumab

    Partnership: Global Blood Therapeutics

    Target: P-selectin

    Vaso-occlusive crises in sickle cell disease:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Inclacumab is a human monoclonal antibody against P-selectin. Inclacumab was created under a collaboration with Roche. In August 2018, Roche entered into an exclusive worldwide licensing agreement with Global Blood Therapeutics for the development and commercialization of inclacumab.

    Clinical Trials

    Global Blood Therapeutics has initiated two pivotal phase 3 trials evaluating the safety and efficacy of inclacumab in patients with sickle cell disease for the reduction of vaso-occlusive crisis (VOC) frequency and VOC-related hospital readmissions, respectively.

  • Talquetamab (JNJ-64407564)

    Partnership: Janssen Biotech, Inc.

    Target: GPRC5D, CD3

    Relapsed or refractory multiple myeloma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Talquetamab (JNJ-64407564) is a bispecific antibody that targets CD3, which is expressed on T-cells, and GPRC5D, which is highly expressed in multiple myeloma cells.

    Clinical Trials

    Talquetamab (JNJ-64407564) is being investigated in a Phase 1 clinical study to treat relapsed or refractory multiple myeloma.

  • Camidanlumab tesirine

    Partnership: ADC Therapeutics

    Target: CD25

    Relapsed or refractory Hodgkin lymphoma:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Camidanlumab tesirine (ADCT-301) is an antibody-drug conjugate (ADC) combining Genmab’s HuMax®-TAC antibody and ADC Therapeutics’ PBD-based warhead and linker technology. Camidanlumab tesirine targets CD25, which is expressed on a variety of hematological tumors and shows limited expression on normal tissues, except for regulatory T cells (Tregs), which are known to be immunosuppressive.

    Clinical Trials

    A Phase 2 study of camidanlumab tesirine to treat relapsed or refractory Hodgkin lymphoma is ongoing. Camidanlumab tesirine is also being tested in a Phase 1b in multiple solid tumors.

  • Mim8

    Partnership: Novo Nordisk

    Target: FIXa, FX

    Haemophilia A:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Mim8 is a novel, next-generation factor VIII mimetic human bispecific antibody. Mim8 is a highly potent molecule bridging factor IXa (FIXa) and factor X (FX) in development for subcutaneous treatment of people with haemophilia A.

    Clinical Trials

    Mim8 is being investigated in a clinical study in subjects with haemophilia A.

  • PRV-015 (AMG 714)

    Partnership: Provention Bio

    Target: IL-15

    Celiac disease:

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    PRV-015 (AMG 714) is a human monoclonal antibody that binds to Interleukin-15 (IL-15), a cytokine molecule appearing early in the cascade of events that ultimately leads to inflammatory disease. AMG 714 was created under a collaboration with Amgen.

    Clinical Trials

    In November 2018, Amgen entered into a licensing and co-development agreement with Provention Bio, Inc. to run a Phase 2b clinical trial of AMG 714, now known as PRV-015, for the treatment of gluten-free diet non-responsive celiac disease (NRCD).

  • Lu AF82422

    Partnership: H. Lundbeck A/S

    Target: alpha-Synuclein

    Multiple System Atrophy (MSA):

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

    Overview

    Lu AF82422 is a human monoclonal antibody (mAb) targeting the toxic alpha-synuclein protein known to be a pathological hallmark of MSA. As it targets the underlying biology of the disease, Lu AF82422 may potentially slow or stop the progression of MSA.

    Clinical Trials

    Lu AF82422 is being investigated in a Phase 2 clinical study in patients with MSA.

  • Multiple active pre-clinical programs

    Partnership: 

    Target: 

    Partnered & proprietary programs (DuoBody®, DuoHexaBody® and HexaBody®):

    • Pre-clinical
    • 1
    • 1/2
    • 2
    • 3

Out-licensed products marketed by partner

Tisotumab vedotin – 50:50 partnership with Seagen Inc.; DuoBody-PD-L1x4-1BB and DuoBody-CD40x4-1BB – 50:50 partnership with BioNTech; Epcoritamab and DuoHexaBody-CD37 – 50:50 partnership with AbbVie Inc.

Products under development by a third-party incorporating Genmab technology and innovation

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