On September 23rd 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 National Medical Products Administration (NMPA). At the same time, the company has received positive feedback from the U.S. FDA upon its pre-IND submission of GH55.
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’s Pipeline 1.0 has a main focus on RAS/MAPK pathway. Our KRASG12C inhibitor GH35 and SHP2 inhibitor GH21 are already at clinical development stage. The IND clearance for GH55 further strengthened the portfolio strategy of our Pipeline 1.0 in targeting RAS/MAPK pathway and provided more opportunities for subsequent development of combination therapies. GH55 plus GH21 would be a possible combination to open the vast blue ocean market for KRAS mutations that currently lack effective treatment.”
Dr. Haidan Wang, CMO of Genhouse, said: “Preclinical studies have shown that the combination of GH55 and GH21 is safe and effective in multiple refractory KRAS mutant animal models. In the upcoming clinical studies, GH55 will be tested in patients with mutations in RAS/MAPK signaling pathway. The combination of GH21 and GH55 is expected to overcome or delay the development of acquired drug resistance. We hope these innovative therapies can bring more lasting benefits to the patients.”
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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