InxMed IN10018 Receives U.S. FDA Fast Track Designation for the Treatment of Platinum-resistant Ovarian Cancer
Nanjing, China—InxMed (Nanjing) Co., Ltd. (“InxMed” or “Company”), a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, announced today the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IN10018 for the treatment of platinum-resistant ovarian cancer patients. The Fast Track designation for IN10018 underscores the urgent need for new treatment options for platinum-resistant ovarian cancer patients worldwide and the treatment potential of IN10018.
Ovarian cancer is the second most common cause of gynecologic cancer death in women in the world, with 23,820 new cases and 14,359 deaths in the United States and 55,342 new cases and 37,519 deaths in China in 2020. (GLOBOCAN 2020) Ovarian cancer is usually diagnosed at advanced stages. Surgery and platinum based chemotherapy are the main treatment regimens for ovarian malignant tumors. Although chemotherapy has a significant impact on patients primarily treated, these patients eventually develop platinum drug resistance and leading to a rapid progression. The response rate of first-line platinum combined with taxanes based regimen chemotherapy for ovarian epithelial carcinoma is more than 80%, and more than half of them achieve complete tumor response, but even if the patients achieve complete response, 50 to 70% of them still relapse. (Chinese Health Commission diagnosis and treatment standards) Both preclinical and clinical data from InxMed demonstrated a promising efficacy signal that IN10018 is combined with standard chemotherapy to treat platinum-resistant ovarian cancer patients.
Dr. Zaiqi Wang, InxMed’s Chairman and CEO, said “The U.S. FDA granted the Fast Track designation to IN10018 demonstrated the urgent needs for new drug development for platinum resistance patients in ovarian cancer. This is an important milestone for InxMed. We will leverage the advantage of Fast Track status and work closely with US FDA to speed up the clinical development. InxMed will fully accelerate global clinical development of IN10018 to better serve our patient’s needs.”
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.
InxMed is a clinical-stage biotech company established in the end of 2018. Our innovations are inspired by patients and driven by in-depth understanding of disease biology. InxMed is committed to building an efficient engine for clinical translational science and proof of concept platform and being a China based biotech company with global impact. InxMed has built translational medicine and clinical development team across Shanghai, Beijing, Nanjing, United States, Canada and Australia focusing on tumor resistance and metastasis especially new drug development on anti PD-1/PD-L1 treatment drug resistance. We have built a highly differentiated pipeline driven by “Best-in-Disease Combination” and owned the patent right globally and established licensing or co-development partnership with various multinational pharmaceutical companies including Merck, Roche and Boehringer Ingelheim.