On May 14, 2023 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, reported that 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 (Press release, Innovent Biologics, MAY 14, 2023, View Source [SID1234631631]).
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This BTD for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC patients that received IBI351 monotherapy. Favorable safety and tolerability and promising antitumor activity of IBI351 monotherapy were observed. The study results will be published at the upcoming American Society Of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2023.
IBI351 is the first KRASG12C inhibitor that received NMPA BTD for advanced CRC. In January 2023, IBI351 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.
"We are glad to see the NMPA grants another Breakthrough Therapy Designation based on the preliminary results of IBI351 monotherapy in advanced colorectal carcinoma," said Dr. Hui Zhou, Senior Vice President of Innovent. "The prognosis of advanced colorectal carcinoma patients with KRASG12C mutation is worse than KRAS wild type patients with limited therapeutic options. Currently, there are no approved drugs targeting KRASG12C available on the market in China. The preliminary data of IBI351 monotherapy has shown outstanding efficacy and favorable safety in previously treated advanced colorectal carcinoma. We look forward to obtaining more data from the ongoing clinical trials, and further validating the clinical benefits of IBI351 as monotherapy or combination therapy in patients with advanced colorectal carcinoma."
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. Click here for the published list of drugs which have been granted BTD by NMPA.
About Colorectal Carcinoma (CRC)
According to GLOBOCAN 2020 report, there were about 1.14 million new cases and 580,000 deaths of colorectal cancer worldwide in 2020. In the past 30 years, the number of CRC cases and deaths has continued to increase in China. In 2015, there were 376,000 new cases and 191,000 deaths, and the numbers will continue to increase in the next 25 years, which is a major public health problem that China is faced with. KRASG12C is a specific KRAS mutation subtype that causes KRAS to be in a state of sustained GTP-binding activation. KRASG12C mutation occurs in about 3% of colorectal cancer patients in the Western population and 2.33% of Chinese colorectal cancer patients.
About IBI351/GFH925 (KRASG12C Inhibitor)
Discovered by GenFleet Therapeutics, GFH925 (Innovent R&D code: IBI351) 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 IBI351 towards KRASG12C. Subsequently, IBI351 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.
In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of IBI351 in China (including mainland China, Hong Kong, Macau and Taiwan) with additional option-in rights for global development and commercialization.