GenFleet Therapeutics

Announcements & Circulars

GenFleet Therapeutics develops first-in-class therapies in oncology and immunology, aiming to improve patient access to treatments worldwide.

GenFleet Therapeutics obtains regulatory approvals in China and Australia to advance clinical trials testing GFH276, an oral pan-RAS inhibitor, in combination therapies. The studies target patients with RAS-mutant pancreatic, lung, and colorectal cancers. GFH276 aims to address unmet needs in treating these aggressive tumor types by inhibiting a key driver of cancer progression.

Nov 2026MarketScreenerNews article

GenFleet Therapeutics presents early clinical data for GFH276, a drug candidate targeting pretreated RAS-mutant solid tumors. The study shows partial patient responses beginning at a 40 mg daily dose, with no dose-limiting toxicities reported across doses of 40–160 mg. The findings were highlighted in a late-breaking oral presentation at the 2026 ESMO Annual Meeting.

Oct 2026MarketScreenerNews article

GenFleet Therapeutics advances GFH375/VS-7375 in clinical trials, securing **three Breakthrough Therapy Designations** in China for KRAS G12D-mutant pancreatic cancer, NSCLC, and colorectal cancer. The drug’s monotherapy phase enters **two registrational Phase III trials** for pancreatic cancer and NSCLC. Overseas clinical progress is also reported.

Oct 2026MarketScreenerNews article

GenFleet Therapeutics secures its third **Breakthrough Therapy Designation (BTD)** from China’s **National Medical Products Administration (NMPA)** for **GFH375**, an oral **KRAS G12D inhibitor**, when combined with **cetuximab** for treating **KRAS G12D-mutant metastatic colorectal cancer (CRC)** in patients who have failed prior chemotherapy. GFH375 is the first oral KRAS G12D inhibitor approved in China. The designation applies to patients resistant to oxaliplatin, fluoropyrimidine, and irinotecan-based regimens.

Sep 2026MarketScreenerNews article