Innovent Announces the First Patient Dosed in the Phase I/II Study of IBI351 (KRAS G12C inhibitor) in Patients with Advanced Malignant Tumors

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced a phase I/II clinical study of KRAS G12C inhibitor IBI351 in Chinese patients with solid tumors (ClinicalTrials.gov, NCT05005234) completed dosing of the first subject.

This study is an open-label, multi-center Phase I/II clinical study in Chinese patients with advanced solid tumors (non-small cell lung cancer (NSCLC) and gastrointestinal cancer) harboring KRAS G12C mutation, with the primary objective to assess the safety/tolerability, pharmacokinetics and efficacy of IBI351.

Professor Yilong Wu, principal investigator of the study, tenured director of Guangdong Provincial People's Hospital and honorary director of Guangdong Lung Cancer Institute, stated: "KRAS is the most common RAS protein subtype, with a high mutation rate in non-small cell lung cancer, pancreatic cancer, colorectal cancer and other cancer cells. Preclinical data showed that IBI351 is sufficiently differentiated from competitors already or about to enter the clinic, and we look forward to positive results in the safety/tolerability and efficacy data of IBI351. We will also continue to explore the application of precision therapy and potential combination therapy to benefit more cancer patients with KRAS G12C mutations."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "KRAS G12C is one of the most commonly mutated oncogenes in human cancer and was well known as a non-druggable target. At present, there are limited clinical treatments for this mutation, and there is a great unmet clinical need. We are pleased that the first patient has already received the first dose of IBI351 and this is an important milestone for the clinical development of IBI351 in China. Based on preclinical data, we hope that the development of IBI351 in China will benefit more patients with lung cancer and solid tumors carrying KRAS G12C mutation and bring more treatment options to clinicians."

Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet Therapeutics, stated, "Current data demonstrates the higher response to selective KRAS G12C inhibitors in population of lung cancer patients with KRAS G12C mutation. The first patient with KRAS G12C mutation administrated after precision screening is a key milestone in the clinical development of GFH925 (Innovent R&D code: IBI351). Thanks to our joint efforts with investigators from our sites, we have completed program initiation and began patient screening in a very short amount of time. We are also confident that our collaboration with Innovent, with its successful track records of developing and commercializing novel therapies, will speed up the study process in order to bring this life-saving treatment to patients across the globe."

About IBI351 (KRAS G12C Inhibitor)

IBI351 (GenFleet's R&D code: GFH925) is a highly effective oral new molecular, independently developed by GenFleet Therapeutics Inc. and has complete intellectual property rights. By covalently and irreversibly modifying the cysteine residue of KRAS G12C mutant, it effectively inhibits the protein-mediated GTP/GDP exchange and thus down-regulates the KRAS protein activation level. Preclinical cysteine selectivity test also shows the highly selective inhibitory potency of IBI351 on this mutation point. In addition, inhibition of KRAS protein by IBI351 inhibited downstream signaling pathways, profoundly induced tumor cell apoptosis and cell cycle arrest, and achieved anti-tumor effect.

In September 2021，Innovent and GenFleet Therapeutics  (Shanghai) Inc. ("GenFleet"), entered into an exclusive license agreement in which Innovent will be responsible for clinical development and commercialization of IBI351 in China including mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China with additional option-in rights for global development and commercialization.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing in China, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

Sintilimab is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

Disclaimer: 

1. This indication hasn't been approved in China.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professionals only.

Forward-Looking Statements

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Source: Innovent Biologics