Company: GNMSF
Filing Date: 2025-08-07
Form Type: 6-K
Source: 0001434265-25-000063
Chunk: 12

Company: GENMAB A/S
Filing Date: 2025-08-07
Form: 6-K
Chunk 12
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. Dose expansion data suggests that Rina-S has robust single agent activity in various cancers across a broad range of FRα expression levels. In January 2024, Rina-S was granted Fast Track Designation by the FDA for the treatment of FRα-expressing high-grade serous or endometrioid PROC. A Phase 3 trial in second line plus platinum PROC is recruiting.

#### Second Quarter 2025 Update
• June: The first disclosure of data from the Phase 1/2 RAINFOL™-01 trial (NCT05579366, B2 cohort) in patients with recurrent/advanced endometrial cancer was presented at the 2025 ASCO Annual Meeting. Results showed that with a median on-study follow-up of 7.7 months, treatment with Rina-S 100 mg/m 2 every 3 weeks (Q3W) resulted in a 50% confirmed objective response rate (ORR), including two CRs, in heavily pre-treated advanced endometrial cancer patients who experienced disease progression on or after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor. The median duration of response (mDOR) was not reached.

Acasunlimab (GEN1046) – Bispecific next-generation immunotherapy

• Bispecific antibody targeting PD-L1 and 4-1BB, created using Genmab’s DuoBody technology platform

• A Phase 3 trial (NCT06635824, ABBIL1TY ™ NSCLC-06) in NSCLC is recruiting

Acasunlimab (GEN1046, DuoBody-PD-L1x4-1BB) is a proprietary bispecific antibody, created using Genmab’s DuoBody technology platform. Originally developed in collaboration with BioNTech, in 2024 Genmab assumed sole responsibility for the continued development and potential commercialization of acasunlimab. The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech. Acasunlimab is designed to induce an antitumor immune response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using an inert DuoBody format. A Phase 3 trial of acasunlimab in combination with pembrolizumab compared to docetaxel in checkpoint inhibitor (CPI)-experienced, PD-L1 positive metastatic NSCLC is recruiting.

#### Second Quarter