GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, today announced the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI351 (GFH925) for the treatment of previously treated advanced colorectal carcinoma (CRC) patients with KRASG12C mutation.
This BTD for GFH925 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC patients that received GFH925 monotherapy. Favorable safety and tolerability and promising antitumor activity of GFH925 monotherapy were observed. The study results will be published at the upcoming American Society Of Clinical Oncology (ASCO) Annual Meeting 2023.
GFH925 is the first KRASG12C inhibitor that received NMPA BTD for advanced CRC. In January 2023, GFH925 has received NMPA BTD for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring KRASG12C mutation who have received at least one systemic therapy.
NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace.
Discovered by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRASG12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRASG12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards KRASG12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’apoptosis and cell cycle arrest. In September 2021, Innovent and GenFleet entered into an exclusive license agreement for the development and commercialization of GFH925 in China (including the Chinese mainland, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.