On August 31st 2021, Genhouse Bio, a biotech company focusing on development of next-generation small molecule anti-cancer therapeutics, announced today that the Center for Drug Evaluation (CDE) has recently accepted the IND application for Class I new drug GH55. At the same time, the company is actively preparing for the IND filing of this program in the U.S.
Extracellular signal-regulated protein kinases 1 and 2 are located downstream of the RAS/MAPK signaling pathway and participate in cell proliferation and survival. Inhibiting the activity of ERK1/2 could restrain tumor cell proliferation caused by activating mutations in the upstream of the pathway (i.e. KRAS mutations). There is significant unmet medical need for a variety of KRAS mutated cancers that still lack effective treatment. In addition, studies have shown that inhibition of ERK1/2 could potentially prevent or delay drug resistance of other RAS MAPK pathway inhibitors. At present, there is no ERK1/2 inhibitor been marketed worldwide.
In vitro and in vivo studies have shown that GH55 is extremely potent and highly selective. It has demonstrated great safety and in vivo efficacy against a variety of different KRAS or BRAF mutant tumors. GH55 also has good metabolic properties, high bioavailability and relatively wide safety window, which makes it a promising drug candidate.
Dr. Keifung Wang, CEO and founder of Genhouse, said: “Currently, Genhouse has moved two Pipeline 1.0 programs into clinical development, KRAS G12C inhibitor GH35 and SHP2 inhibitor GH21. The IND filing of GH55 further strengthened the portfolio strategy of our Pipeline 1.0 in targeting RAS/MAPK pathway. GH55 is a dual-mechanism ERK1/2 inhibitor which inhibits not only the kinase activity of ERK1/2, but also the activation of ERK1/2 by MEK. It thus has the potential to overcome the acquired drug resistance caused by the negative feedback loop of the RAS/MAPK pathway.”
Dr. Haidan Wang, CMO of Genhouse, said: “Preclinical studies have shown that combinations of GH55 with Genhouse’s other pipelines are effective in multiple refractory KRAS mutant animal models. We are very much looking forward to the clinical development of the combination therapies that have the potential to treat refractory KRAS mutant tumors, and delay the development of acquired drug resistance, so as to bring long-term benefits to patients.”
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Effective and Last Updated: April 15th 2021