BioInvent International AB announced further promising early signs of single agent efficacy and a robust safety profile for the company's anti-TNFR2 program BI-1808. The data will be presented in a poster at the 2024 ASCO Annual Meeting (ASCO 2024) held in Chicago, Illinois from May 31 to June 4, 2024. BI-1808 is being studied as both a single agent and in combination with MSD's (Merck & Co.

Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA®? (pembrolizumab) in patients with advanced solid tumors or T-cell lymphomas, including CTCL. The ongoing Phase 1 combination part is in the final stage of the dose escalation phase.

Single agent Safety and Efficacy. Safety: Across the dose range (25 to 1000 mg dose), no Grade 3/4 adverse events (AEs) related to BI-1808 were observed. A number of potentially related Grade 1/2 AEs were evenly distributed across the dose range (no target organ class identified) with five Gr 1/2 infusion-related reactions (IRR) observed.

Of 26 evaluable patients treated with monotherapy, best clinical responses were Efficacy: one complete response (CR), one partial response (PR) and nine patients with stable. The CR was observed in the ongoing Phase 2a part of the study, in an disease (SD). ovarian cancer patient with disease progression after three previous lines of treatments.

As previously reported, the PR was observed in a heavily pre-treated patient with metastatic GIST (12 prior lines of treatment). This PR represents a robust response and is still improving. Safety: dosed, two DLTs (Dose-limiting toxicities) have been observed (1 colitis and 1 fatigue).

3 of 8 evaluable patients showed SD after combination treatment. Efficacy: Pharmacology: At doses of 675 mg every three weeks, the half-life of BI-1808 was approximately one week leading to drug accumulation, complete receptor occupancy during the treatment interval, an increase in soluble TNFR2 and a significant reduction in Tregs.oster title: 19-BI-1808-01, a Phase 1/2a Clinical Trial of BI-1808, a Tumor Necrosis Factor Receptor 2 (TNFR2) Blocker/Depleter with or without Pembrolizumab. 2641.Abstract Number: Developmental Therapeutics - Immunotherapy.

Session: June 1, 2024. Date: 9:00 AM - 12:00 PM CDT. Time: The full poster will be posted to the company's website -science/scientific-publications shortly after the presentation.