GenFleet Therapeutics (Shanghai) (2595) Study update presentation summary

GFH375 efficacy in previously treated PDAC

• In 66 patients with advanced KRAS G12D-mutant PDAC, ORR was 40.7% (24/59; 90% CI 30%–52%) and DCR was 96.7% (57/59; 90% CI 90%–99%); 91.5% had target-lesion reductions.

• Median PFS was 5.52 months (90% CI 4.27–7.20); 4-month PFS was 78.2% (90% CI 69.8%–87.5%), at median follow-up of 5.65 months.

• Among patients with measurable disease, ORR was 58.33% in 2L (n=12) and 36.17% in 3L+ (n=47); DCR was 100% and 95.74%, respectively.

• Median PFS was not reached in 2L (n=12) and was 5.52 months in 3L+ (n=54); overall median PFS follow-up was 5.65 months.

GFH375 safety and cross-trial context

• Common treatment-related AEs were mainly gastrointestinal and hematological, mostly grade 1–2 and manageable with supportive care; diarrhea occurred in 56.1%, neutrophil count decrease in 48.5%, and vomiting and nausea in 47.0% each.

• No new safety signal was reported; the sole grade 4 liver toxicity was treatment-emergent but not treatment-related, and grade 4 neutropenia occurred in a participant previously treated with immunotherapy.

• In a cross-trial comparison with daraxonrasib in 2L+ PDAC, GFH375 had 31.8% grade 3+ TRAEs, 3.0% discontinuations, 6.1% dose reductions, 27.3% interruptions and 93% mean dose intensity.

• Cross-trial AE comparisons showed lower grade 3+ liver enzyme abnormalities with GFH375; grade 3+ hematological toxicity was described as not significantly different.

VS-7375 study design and update

• The Phase 1/2a study evaluates monotherapy dose escalation from 300–900 mg QD, with expansion cohorts in 2L+ PDAC, NSCLC and other solid tumors, plus combination regimens across PDAC, NSCLC and CRC.

• The 400 mg and 600 mg QD monotherapy dose levels cleared with no reported DLTs; preliminary anti-tumor activity was observed across solid tumors, including advanced PDAC.

• No nausea, vomiting or diarrhea above grade 1 was observed; enrollment began for combination treatment with cetuximab in advanced KRAS G12D-mutant solid tumors, including CRC.

• An interim Phase 1/2a safety and efficacy update was planned for H1 2026; combination dose-escalation cohorts were planned for Q4 2025, with expansion cohorts contingent on results.

• Fast Track designation was granted for 1L locally advanced or metastatic KRAS G12D PDAC and for locally advanced or metastatic disease after at least one prior standard systemic therapy.