Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 36

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 36
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 or endometrioid platinum-resistant ovarian cancer. Phase II data of Rina-S in platinum-resistant ovarian cancer (“PROC”) was presented at the European Society of Medical Oncology Congress 2024 (“ESMO”). Rina-S showed manageable safety with no signals of ocular toxicities, neuropathy or interstitial lung disease. It also showed encouraging antitumor activity with a confirmed overall response rate of 50% at the recommended Phase II dose of 120mg/m2. 
Solid Tumors. A Phase I/II trial of Rina-S in advanced solid tumors is ongoing. 
Ongoing Phase III Trial
The first Phase III trial of Rina-S was initiated in December 2024. The randomized open-label trial is evaluating Rina-S versus treatment of investigator's choice chemotherapy in patients with PROC. The trial is currently recruiting. 
DuoBody-CD40x4-1BB (GEN1042/BNT312)
DuoBody-CD40x4-1BB is a proprietary bispecific antibody designed to conditionally activate both CD40-expressing antigen-presenting cells and 4-1BB-expressing T-cells using an inert DuoBody format. In pre-clinical settings DuoBody-CD40x4-1BB was shown to conditionally increase proliferation of activated T cells in the presence of CD40-expressing cells in vitro. DuoBody-CD40x4-1BB induced T-cell proliferation upon crosslinking of CD40- and 4-1BB-expressing cells and the binding of only the CD40 arm or the 4-1BB arm had no effect on T-cell proliferation. We are co-developing DuoBody-CD40x4-1BB in collaboration with BioNTech under an agreement in which the companies share all costs and future potential profits for DuoBody-CD40x4-1BB on a 50:50 basis. DuoBody-CD40x4-1BB is being developed for the treatment of solid tumor malignancies using Genmab’s proprietary DuoBody technology platform and BioNTech’s CD40 and 4-1BB antibodies. 
HexaBody-CD38 (GEN3014)
HexaBody-CD38 is a novel human CD38 monoclonal antibody product incorporating our HexaBody technology. In pre-clinical models of hematological malignancies HexaBody-CD38 demonstrated enhanced complement-dependent cytotoxicity (“CDC”) and showed potent anti-tumor activity.