On March 16, 2020 InxMed (Shanghai) Co., Ltd. ("InxMed" or "Company"), a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, reported that the company has dosed first patient in its Phase Ib clinical trial of IN10018 as monotherapy and in combination with MEKi in the patients either with metastatic uveal melanoma or NRAS mutant metastatic melanoma at The University of Texas M. D. Anderson Cancer Center, United States (Press release, InxMed, MAR 16, 2020, View Source [SID1234555618]). A few days ago, InxMed also received the approval from Human Research Ethics Committee (HREC) and the acknowledgement from Therapeutic Goods Administration (TGA) in Australia for the same protocol. IN10018 is an orally delivered proprietary focal adhesion kinase (FAK) inhibitor being developed for the treatment or various types of cancer.

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This open label phase Ib trial will include 6 study sites in the United States and 3 study sites in Australia, and evaluate the safety, tolerability, PK and antitumor activities of IN10018 as monotherapy and in combination with Roche’s MEK inhibitor Cobimetinib in subjects with metastatic uveal melanoma and NRAS mutant metastatic melanoma.

Uveal melanoma (UM) is the most common type of intraocular cancer with a dismal prognosis once it metastasizes. There is no approved medicine for metastatic uveal melanoma. NRAS mutation, occurring in approximately 15-20% of melanoma patients, is the second most common oncogenic driver mutation in advanced melanoma without targeted treatment being approved yet. With solid underling disease biology, IN10018 has shown anti-tumor effect against both uveal melanoma and NRAS-mutant metastatic melanoma preclinically and synergistic efficacy between IN10018 and MEK inhibitor has been observed in numbers of preclinical studies.

"InxMed’s IN10018 could be a promising treatment agent for the metastatic melanoma patients," Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, commented. "We feel excited to collaborate with InxMed to have first patient dosed in MD Anderson cancer center and look forward to advancing it quickly to see clinical benefit."

Anthony Joshua, Medical Oncologist, PhD, Director of Medical Oncology, Kinghorn Cancer Center, St Vincent’s Hospital and Conjoint Associate Professor with the University of New South Wales, our leading study PI in Australia said: "Ocular Melanoma, although rare, is also an area of significant unmet medical need for the 50% of patients that develop metastatic melanoma disease for which there are no established treatments. We are very pleased to see InxMed’s effort to address such real unmet medical need."

Dr. Zaiqi Wang, InxMed’s Chairman and CEO, said: "We feel very excited about the dosing of first patient of IN10018 in the U.S. and fortunate to work with leading experts from both USA and Australia. We hope that IN10018, alone or in combination with MEK inhibitor, is able to offer a new approach that improves therapeutic outcomes for the patients with deadly uveal melanoma or advanced, NRAS-mutant melanoma."

About IN10018

IN10018, formerly known as BI853520, is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor under clinical development stage in United States, Australia, and China. InxMed owns the exclusive global rights for development and commercialization. Early clinical data of IN10018 has demonstrated a favorable safety profile and promising efficacy signals against a number of tumor types. Emerging science also showed that FAK inhibitors, like IN10018, potentially overcomes fibrotic barrier and immune tolerance, boosting multi-modalities including targeted therapy, chemotherapy, immune-therapy and radiation therapy.