Genhouse Received IND Clearance from U.S. FDA for Its ERK1/2 Inhibitor GH55


On December 1st 2022, Genhouse Bio, a biotech company focusing on development of next-generation small molecule anti-cancer therapeutics, announced today that it has obtained IND clearance for its ERK1/2 inhibitor, GH55, from the Food and Drug Administration (FDA) in the U.S. GH55 is Genhouse’s second innovative drug that got approved to initiate clinical studies in the U.S.


GH55 is a dual-mechanism inhibitor of Extracellular signal-regulated protein kinases 1/2 (ERK1/2), 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. Preclinical 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. At present, there is no ERK1/2 inhibitor been marketed worldwide.


Dr. Keifung Wang, CEO and founder of Genhouse, said: “Genhouse has built a robust pipeline targeting RAS/MAPK pathway. Among which the SHP2 inhibitor GH21 has already been advanced to clinical development in the U.S. by our strategic partner HUYABIO International. The IND clearance for GH55 marks another important milestone of the ‘In China for Global’ strategy at Genhouse.”


Dr. Haidan Wang, CMO of Genhouse, said: “The IND clearance of GH55 in the U.S. has opened up more choices in exploring the combination therapies for cancers with mutations in the RAS/MAPK pathway. The combination of GH21 and GH55 has great potential to treat patients with KRAS mutations and/or mutations downstream of KRAS which currently lack effective treatment. We hope these innovative therapies can bring more lasting benefits to global patients.”


About ERK1/2

ERK1/2 (Extracellular signal-regulated protein kinases 1/2) is an extracellular regulated protein kinase located downstream of RAS/MAPK signaling pathway, participates in cell proliferation and survival and is involved in many cell functions including meiosis, mitosis and post-mitosis regulation of differentiated cells. Many different stimuli, including growth factors, cytokines, viral infections, ligands of heterotrimeric G protein-coupled receptors, transforming agents and carcinogens, can activate ERK protein. Inhibiting the activity of ERK1/2 can put a break on the tumor proliferation caused by upstream activated mutations (such as KRAS mutations). There is a huge unmet clinical need for many KRAS mutations that still lack effective treatments now.

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