On June 10th 2021, Genhouse Bio, a biotech company focusing on development of next-generation anti-cancer therapeutics, announced today that the Center for Drug Evaluation (CDE) has recently approved IND application for Class I new drug GH35. This is the first IND approval of Genhouse in China.
“Drug development is a challenging but exciting process,” said Dr. Kuifeng Wang, founder and CEO of Genhouse, “Genhouse is honored to enter a new stage of development, in which we have more work to do. Our preclinical data have shown that, GH35 is a highly active KRAS G12C inhibitor with strong brain penetration, which effectively inhibited tumor growth in NCI-H358-Luc Brain Orthotropic CDX Model. At the same time, multiple drug candidates around the RAS signaling pathway we have developed, including an allosteric SHP2 inhibitor, GH21, will all enter clinical development in the near future. We hope these drug candidates and their combination therapies will provide cancer patients, especially patients with brain metastasis, with better and broader therapeutic choices.”
GH35 is a KRAS G12C irreversible inhibitor. Both in vivo and in vitro studies have shown that GH35 has very high inhibitory activity and selectivity against KRAS G12C mutant but has no obvious effect on wild type KRAS or other safety-related targets, thus has very low off-target effect. GH35 monotherapy showed significant efficacy against lung cancer, colorectal cancer and pancreatic cancer in CDX/PDX models. Moreover, GH35 has substantial brain penetration, which makes it possible to treat brain-metastasis patients.
The ras gene is the first oncogene discovered in history, which is also the most commonly mutated gene in cancer—about 30% of tumors have ras mutations. KRAS is the predominant subtype of the RAS family; mutations in kras count for about 85% of all ras mutations. Although KRAS has been heavily studied for 40 years, the development of targeted therapies for KRAS is quite challenging, which granted KRAS the name of “undruggable target”. Until recently, the study of KRAS G12C mutants have made breakthrough progress, which makes it possible to design small molecule therapeutics to target KRAS.
Genhouse Bio is a clinical-stage biotech company focusing on the development of global next-generation anti-cancer therapeutics, headquartered in the Suzhou Industry Park . The senior management team of Genhouse has multiple years of experience in new drug development, clinical research, and corporate management. Genhouse has a clear focus on original innovation and overcoming those “undruggable” targets.
Genhouse has established intergrated in-house drug development platforms. With these platforms, Genhouse has started to build a highly innovative anti-cancer pipeline and out-licensed the ex-China rights of its SHP2 inhibitor GH21 to HUYABIO , an international biotech company. Genhouse will continue to advance more innovative pipeline programs into global development.
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Effective and Last Updated: April 15th 2021