GenFleet Therapeutics announced that multiple study data from its RAS-focused pipeline have been selected for an oral presentation or accepted for full submission of Late-breaking Abstract (LBA), at major international academic conferences in the second half of the year. The updated data of GFH375 for KRAS G12D-mutant non-small cell lung cancer (NSCLC) will be presented in an oral presentation at the IASLC 2026 World Conference on Lung Cancer (WCLC); the event will take place from September 12 to 15 in Seoul, with accepted abstracts to be released on the official WCLC website by late August.
Additionally, the 2026 European Society for Medical Oncology (ESMO) Congress will be held on October 23 to 27 in Madrid. The preliminary data of another two studies from GenFleet's pipeline have been accepted for full submission of LBA, including one study evaluating GFH375 combined with cetuximab and the other investigating GFH276 monotherapy in solid tumor patients.
GFH375 is currently advancing into the world's first phase III trial of an oral KRAS G12D inhibitor. It has also obtained the first two Breakthrough Therapy Designations (BTD) in China for monotherapy in KRAS G12D-mutant pancreatic cancer and NSCLC, alongside two Fast Track Designations (FTD) from the U.S. FDA for GFH375/VS-7375 treating metastatic pancreatic ductal adenocarcinoma and unresectable locally advanced or metastatic NSCLC harboring G12D mutations. Developed from non-degrading molecular glue technology, GFH276 is positioned in first-tier development of oral Pan RAS inhibitor in China; the upcoming ESMO annual meeting will feature the debut of GFH276’s preliminary clinical data.
“As the products within our RAS-targeted portfolio progressing into diverse monotherapy and combination regimens, we are pleased to see their data continually selected for presentations at premier global academic conferences. Enrollment for GFH375’s registrational trial is advancing as planned, and we are confident that our innovative regimens with potent efficacy and solid clinical benefit, will improve patient outcomes while capturing market potential. Meanwhile, clinical data of GFH276 will make its debut at an international academic conference, and we also look forward to its differentiated protocol further expanding GenFleet’s global footprint for its innovative RAS therapy portfolio.”stated Yu Wang, M.D., Ph.D., Chief Medical Officer of GenFleet.
About GFH375/VS-7375
GFH375 is an orally active, potent, highly selective small-molecule KRAS G12D (ON/OFF) inhibitor designed to target the GTP/GDP exchange, thereby disrupting the activation of downstream pathways and effectively inhibiting tumor cell proliferation. Preclinical studies demonstrated dose-dependent inhibition in models bearing KRAS G12D mutation; GFH375 also demonstrated low off-target risk in kinase selectivity and safety target assays.
GenFleet entered into a discovery and development collaboration with Verastem Oncology (Nasdaq: VSTM) to advance three novel oncology discovery programs related to RAS/MAPK pathway-driven cancers. The collaboration provides Verastem with an exclusive option to obtain a license for each of the three compounds in the collaboration after the successful completion of pre-determined milestones in a Phase I trial. Verastem selected GFH375/VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, as its lead program from the collaboration, in December 2023 and the license for GFH375 that was exercised in January 2025 is the first one from this collaboration. The licenses would give Verastem development and commercialization rights outside of China while GenFleet would retain rights inside of China.
About RAS and GFH276
RAS proteins, in active GTP-bound or inactive GDP-bound form, are binary molecular switches controlling cellular responses in signaling pathways including RAF-MEK-ERK
and PI3K-AKT-mTOR. Three RAS genes encode for protein isoforms, namely Kirsten Ras (KRAS), Harvey Ras (HRAS) and Neuroblastoma Ras (NRAS), and KRAS is the most frequently mutated oncogene in humans.
GFH276 is an oral novel small-molecule Pan RAS (ON) inhibitor hijacking Cyp A to target active, GTP bound RAS proteins of most wild/mutant subtypes, including most commonly found KRAS mutant (G12C, G12D, G12V, etc.) proteins. Preclinical research of GFH276 demonstrates dose-dependent anti-tumor activity and drives tumor regression in multiple KRAS mutant tumor models. GFH276 also holds the potential to outperform the mainstream SIIP (switch II pocket)-based KRAS inhibitors in overcoming adaptive and acquired resistance.
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