Media Release

COPENHAGEN, Denmark; May 23, 2024

• Six oral and poster presentations will highlight breadth of clinical program and potential utility of epcoritamab-bysp in patients with difficult-to-treat lymphomas across multiple lines of therapy and histologies where high unmet needs exist
• Results from two studies evaluating tisotumab vedotin in patients with head and neck squamous cell carcinoma and recurrent or metastatic cervical cancer accepted for oral and poster presentations, respectively
• First presentation of Phase 2 study of acasunlimab (also known as GEN1046/BNT311) in patients with previously treated metastatic non-small cell lung cancer (mNSCLC)
  
  

Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024.

“The data being presented this year at ASCO demonstrate Genmab’s significant progress towards our mission to develop novel antibody therapies with the goal of improving the lives of people impacted by cancer,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.

Presentations will include data from multiple clinical trials evaluating the efficacy and safety of epcoritamab in a variety of treatment settings and patient populations, including a rapid oral presentation evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with previously untreated follicular lymphoma (FL) and a second rapid oral presentation showcasing results from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory (R/R) FL.

Data from the Phase 2 innovaTV 207 trial, evaluating tisotumab vedotin in pretreated patients with relapsed/metastatic head and neck squamous cell carcinoma will be presented during a rapid oral session. Additionally, results from the Phase 3 innovaTV 301 trial evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy will be presented.

Finally, data from the Phase 2 clinical trial evaluating acasunlimab as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic non-small cell lung cancer (mNSCLC) will be presented for the first time during a poster presentation.

The safety and efficacy of these investigational medicines have not been established for these uses.

Virtual mid- to late-stage pipeline update at ASCO 2024
On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO from its mid- to late-stage pipeline. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASCO Annual Meeting.

All abstracts accepted for presentation have been published and may be accessed online via the ASCO Meeting Library.

Abstracts accepted for presentation at ASCO:

Epcoritamab:

Tisotumab Vedotin:

Acasunlimab:

About Epcoritamab
Epcoritamab-bysp is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody^® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells and induces T-cell mediated killing of CD20+ cells.ⁱ Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses.

About Tisotumab Vedotin
Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. Tisotumab vedotin is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis.

Tisotumab vedotin has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU.

About Acasunlimab (GEN1046/BNT311)
Acasunlimab (GEN1046/BNT311) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab's proprietary DuoBody^® technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.
Acasunlimab is being developed in collaboration with BioNTech SE under a license and collaboration agreement and is currently in Phase 2 of development.

Please visit www.clinicaltrials.gov for more information about Genmab’s clinical trials.

About Genmab
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO^®) antibody medicines.  
  
Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit  Genmab.com and follow us on LinkedIn and X. 

Contact:        
David Freundel, Senior Director, Product Communications
T: +1 609 430 2481; E: dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

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 www.genmab.com 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 www.sec.gov. 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^® and HexElect^®. EPKINLY^® and EPCORE^® are owned by AbbVie Biotechnology Ltd.

i Engelberts et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625

Media Release no. 07
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark