GENFLEET-B (02595) announced that preliminary Phase I clinical data for GFS202A, a GDF15/IL-6 bispecific antibody for treating cancer cachexia, was presented in a poster session at this year's ASCO (American Society of Clinical Oncology) Annual Meeting on May 30 local time. GFS202A is the world's first GDF15/IL-6 bispecific antibody. The preliminary Phase I data indicate excellent safety and tolerability in cachexia patients and demonstrate promising efficacy and pharmacodynamic characteristics. At a dose level of 200 mg every three weeks (Q3W), the treatment achieved complete and sustained inhibition of GDF15, effectively increasing patient body weight and skeletal muscle mass. Cachexia is a complex metabolic syndrome with multiple wasting symptoms, commonly associated with various chronic diseases. Cancer is a significant cause of cachexia, with 30% of cancer-related deaths linked to the condition. The incidence of cachexia exceeds 50% in gastrointestinal cancers such as pancreatic cancer. Currently, no targeted therapies for cachexia are approved by the FDA or NMPA. Previous research suggests that abnormal levels of GDF15 and IL-6 are associated with the onset and progression of cachexia, and overseas monoclonal antibody products targeting these pathways have shown positive clinical data in treating cachexia or cancer. GFS202A is expected to achieve superior efficacy compared to single-target antibodies by inhibiting both the GDF15 and IL-6 pathways. Dr. Wang Yu, Chief Medical Officer of GENFLEET, stated: "GFS202A is the world's first bispecific antibody for cachexia to enter clinical development. We are pleased that the preliminary study data demonstrate its therapeutic potential for cachexia patients, including improvements in key indicators such as body weight, skeletal muscle mass, and appetite, as well as alleviation of cancer-related inflammation and nutritional depletion. Cachexia severely impacts the tolerance to various treatments and overall survival in patients with cancer and other chronic diseases. We anticipate this product will offer new supportive treatment options and renewed hope for extended survival for cachexia patients."
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