Oral presentation of monotherapy data from phase I/II trial of GFH375, an oral KRAS G12D (ON/OFF) inhibitor, in advanced cholangiocarcinoma and colorectal cancer
Poster presentation of clinical data from phase I trial of GFS202A, a first-in-class GDF15/1L-6 bispecific antibody, in cancer cachexia
GenFleet Therapeutics (2595.HK) announced clinical updates of two investigational candidates will be featured at the 2026 ASCO annual meeting. The preliminary results of GFH375 monotherapy treating patients with KRAS G12D-mutant cholangiocarcinoma and colorectal cancer have been selected for oral presentation. The presentation will feature the world’s first dedicated clinical data of a RAS inhibitor for cholangiocarcinoma, demonstrating clinical potential of GFH375 in this patient population. Additionally, preliminary clinical data of GFS202A, the world’s first GDF15/IL-6 bispecific antibody developed for cachexia, will be unveiled in a poster session during the conference. The 2026 ASCO annual meeting is slated to take place in Chicago, USA, from May 29 to June 2 local time.
Oral presentation: Preliminary efficacy of GFH375 in patients with advanced cholangiocarcinoma or colorectal cancer harboring KRAS G12D mutation
Session title: Developmental Therapeutics-Molecularly Targeted Agents and Tumor Biology
Date and time: Jun.1, 8:00 a.m-11:00 a.m. local time
Abstract No.: 3008
GenFleet initiated a phase I/II trial evaluating the safety and efficacy of GFH375 monotherapy in KRAS G12D-mutant solid tumors in June 2024, with initial findings selected in a rapid oral presentation at last year’s ASCO annual meeting. The oral presentation this year will feature preliminary efficacy and safety data of GFH375 as monotherapy in advanced cholangiocarcinoma and colorectal cancer.
Poster presentation: A first-in-human (FiH) phase I study of GFS202A, a GDF15/IL-6 bispecific antibody, in advanced cancer patients (pts) with pre-cachexia or cachexia
Session title: Symptom Science and Palliative Care
Date and time: May 30, 1:30 p.m-4:30 p.m. local time
Abstract No.: 12055
GFS202A, the world’s first GDF15/IL-6 bispecific antibody, entered phase I trial in March 2025. Cachexia is a metabolic syndrome commonly seen in various chronic diseases. Preliminary clinical data demonstrated GFS202A’s favorable safety and encouraging efficacy, capable of raising patients' body weight and muscle mass, improving appetite and lowering modified Glasgow Prognostic Score (mGPS).About GenFleet TherapeuticsWith a focus on cutting-edge therapies, GenFleet Therapeutics is dedicated to serving significant unmet medical needs globally in oncology and immunology. Leveraging its deep understanding of disease biology and translational medicine, GenFleet has established a proprietary and fully integrated R&D system that yields a robust pipeline of multiple cutting-edge products with novel mechanisms and global IP.Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates spanning small molecules and biologics. Its pipeline comprises numerous programs that have advanced to later-stage or pivotal clinical trials across China, the United States and Europe. The company has set up a highly differentiated RAS-targeted matrix including selective and pan-RAS inhibitors of diverse molecular types, with most assets leading their categories in clinical progress in China or globally. In addition, the company has pioneered a series of first-in-class combination therapies based on dual-target synergistic mechanisms. By integrating clinical needs and insights, GenFleet is dedicated to expanding its portfolio into major therapeutic areas including pancreatic cancer, NSCLC, and cachexia. Furthermore, it's strengthening its commercial collaborative network through strategic out-licensing agreements or clinical cooperations with prestigious listed companies across the world.
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