GEN Genmab A/S

Genmab Announces Data to be Presented at SITC 35th Anniversary Annual Meeting

Genmab Announces Data to be Presented at SITC 35th Anniversary Annual Meeting

    

Media Release





Copenhagen, Denmark, October 14, 2020

  • Preliminary data from Phase 1/2a trial of DuoBody®-PD-L1x4-1BB (GEN1046) in patients with advanced solid tumors accepted for e-poster presentation
  • Pre-clinical data for DuoBody-PD-L1x4-1BB (GEN1046), tisotumab vedotin and DuoBody-CD3x5T4 will also be presented



Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts for Genmab programs were accepted for presentation at the Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting.
Accepted abstracts include preliminary data from the first-in-human Phase 1/2a study of DuoBody®-PD-L1x4-1BB (GEN1046), a bispecific antibody in joint development with BioNTech, in patients with advanced solid tumors, which was accepted for e-poster presentation. All abstracts are scheduled to be available on the website on November 9, 2020.

“We are pleased that the first clinical data for DuoBody-PD-L1x4-1BB (GEN1046), which we are developing in collaboration with BioNTech, was selected for presentation at the SITC 35th Anniversary Annual Meeting,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “The preliminary Phase 1/2a data demonstrate the potential of DuoBody-PD-L1x4-1BB (GEN1046) in solid tumors and we look forward to this first data being shared with the medical community.”

Abstracts

DuoBody-PD-L1x4-1BB (GEN1046)1:

First-in-human phase I/IIa trial to evaluate the safety and initial clinical activity of DuoBody®-PD L1×4-1BB (GEN1046) in patients with advanced solid tumors – e-poster presentation, available in the virtual poster hall from November 11 – 14, 2020.

DuoBody®-PD-L1×4-1BB (GEN1046) induces superior immune-cell activation, cytokine production and cytotoxicity by combining PD-L1 blockade with conditional 4-1BB co-stimulation – e-poster presentation, available in the virtual poster hall from November 11 – 14, 2020.

Tisotumab vedotin2:

Tisotumab vedotin shows immunomodulatory activity through induction of immunogenic cell death – e-poster presentation, available in the virtual poster hall from November 11 – 14, 2020.

DuoBody-CD3x5T43:

Pre-clinical mechanism of action and pharmacodynamic biomarker studies of DuoBody®-CD3x5T4 in vitro and in vivo in solid cancer models – e-poster presentation, available in the virtual poster hall from November 11 – 14, 2020.

Non-asset specific:

Molecular dissection of tumor-immune microenvironment factors associated with response to checkpoint inhibitor therapy in non-small cell lung cancer patients using Nanostring Digital Spatial Profiling – e-poster presentation, available in the virtual poster hall from November 11 – 14, 2020.

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 is the creator of the following approved antibodies: DARZALEX® (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA® (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra® (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's 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, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. 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. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact:          

Marisol Peron, Corporate Vice President, Communications & Investor Relations

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For Investor Relations:

Andrew Carlsen, Senior Director, Investor Relations

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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 or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at . 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® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.

1DuoBody-PD-L1x4-1BB (GEN1046) is being co-developed by Genmab and BioNTech

2Tisotumab vedotin is being co-developed by Genmab and Seattle Genetics

3DuoBody-CD3x5T4 is being co-developed by Genmab and AbbVie



Media Release no. 13

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

EN
14/10/2020

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