GENFLEET-B (02595.HK): Oral KRAS G12D Inhibitor Advances, 44% ORR in CRC Combo and 41% cORR in PDAC

NewTimeSpace News: GenFleet Therapeutics (Shanghai) Inc. (stock code: 02595) voluntarily announced on 15 October 2026 that GFH375/VS-7375, an oral KRAS G12D inhibitor, had made positive progress across multiple domestic and overseas clinical studies, with latest data disclosed. GFH375 has obtained three Breakthrough Therapy Designations in China for KRAS G12D-mutant pancreatic cancer, non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and has entered two registrational Phase III studies as monotherapy in pancreatic cancer and NSCLC. Its overseas partner Verastem Oncology expects to start a registrational Phase III study of VS-7375 in multiple combination regimens as first-line treatment of pancreatic ductal adenocarcinoma (PDAC) by the end of the year, having reached consensus with the US Food and Drug Administration (FDA) on the study protocol.

In the Company's domestically led combination study (GFH375X1202), GFH375 (600 mg QD) combined with cetuximab (500 mg/m2 Q2W) showed preliminary efficacy in previously treated CRC and first-line PDAC. As at 16 September 2026, 54 CRC patients who had completed at least one post-treatment assessment all had distant metastases at enrolment (57% lung, 50% liver, 46% peritoneum) and 94% had received three or more prior lines, with an overall objective response rate (ORR) of 44%, disease control rate (DCR) of 89%, median progression-free survival (PFS) of 7.3 months (median follow-up 5.4 months) and four-month PFS rate of 78%. Among 24 first-line PDAC patients assessed, overall ORR was 71% and DCR 100%, with 21 patients still on treatment. On safety, 78 patients had received the combination as at 22 July 2026; the most common treatment-related adverse events (TRAEs) were diarrhoea, vomiting, nausea and rash, mostly Grade 1-2, with each Grade 3 TRAE incidence not exceeding 5% and no Grade 4-5 TRAEs.

Overseas, in the VS-7375 studies led by Verastem, monotherapy (900 mg QD) in PDAC showed a confirmed ORR (cORR) of 41% and DCR of 86% among 22 patients as at 7 October 2026 (median follow-up 6.4 months), with two patients achieving complete response (CR) and most patients (16/22) still on treatment; among the eight patients who received second-line treatment after enrolment, cORR was 50%. As at 29 September 2026, 48 solid tumour patients had received VS-7375 monotherapy at a median relative dose intensity of 97%, with good and controllable safety across tumour types; TRAEs were mostly low-grade gastrointestinal reactions, with no clinically significant cytopenia or liver function abnormalities, and no overlapping adverse events observed when combined with anti-EGFR therapy.

The Company introduced GFH375 as an oral, highly potent and highly selective small-molecule KRAS G12D (ON/OFF) inhibitor that binds the KRAS G12D protein non-covalently, blocking its interaction with downstream effector proteins and thereby inhibiting tumour cell proliferation. The Company and Verastem have entered into a licence and early collaboration development agreement covering three RAS/MAPK-driven cancer products, under which Verastem holds exclusive option rights; in December 2023 Verastem selected GFH375/VS-7375 as the lead programme and licensed GFH375 in January 2025, the first licence arising under that framework, granting Verastem development and commercialisation rights outside China while the Company retains rights in China.