2021-09-28On September 28th 2021, Genhouse Bio, a biotech company focusing on development of next-generation anti-cancer therapeutics, announced today that the first patient has completed first dose in phase I clinical trial of GH35. This is a multi-center, open-label phase I clinical trial to evaluate the safety, tolerability and PK profile of GH35 in patients with KRAS mutated late stage solid tumors. This is the first-in-human clinical trial of Genhouse Bio in China.
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 blood-brain barrier penetration, which makes it possible to treat brain-metastasis patients.
“In the preclinical studies, we have obtained preliminary proof of the efficacy and safety of GH35 in KRAS G12C mutated malignancies,” said Dr. Qinhui Song, Chief Medical Officer of Genhouse, “moving GH35 forward in human studies could help us better evaluate its clinical value. Until today, no KRAS G12C inhibitor has been approved in China yet. We hope GH35 could be accessible to KRAS G12C mutated cancer patients as soon as possible.”
“FPFD of GH35 is another critical milestone of Genhouse. This is our first time to initiate a clinical study,” said Dr. Kuifeng Wang, founder and Chief Executive Officer of Genhouse, “we have high expectation and confidence in the clinical value of GH35. Genhouse Bio will continuously devote to provide broader and better therapeutic options for global cancer patients.”
About KRAS
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 bumpy, 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.
About Genhouse
Genhouse Bio is an innovative biotech company focusing on the development of global next-generation small molecule anti-cancer therapeutics, which has a clear focus on overcoming those “undruggable” target and original innovation. Genhouse is dedicated to establishing a specialized new drug development system, with a SAR research platform based on structural biology, a Drug Screening platform based on target research and a Druggability Evaluation platform including efficacy, metabolic and safety profile evaluation.
By virtue of these platforms, Genhouse has built a highly innovative anti-cancer pipeline and successfully out-licensed the ex-China right of its SHP2 inhibitor GH21 to HuYa Bioscience International, a global biotech company. Genhouse will continue to advance more innovative programs into global development.
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