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Platinum-Resistant Ovarian Cancer therapy receives breakthrough therapy

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InxMed Co., Ltd. announced that IN0018 had been granted with Breakthrough Therapy Designation by the China National Medical Products Administration. This designation is based on the results of a Phase Ib/II clinical trial of IN10018 for platinum-resistant ovarian cancer, with the proposed indication for the treatment of platinum-resistant ovarian cancer in combination with PEG-liposomal doxorubicin. InxMed plans to disclose more data on IN10018 at the Annual Meeting of the American Society of Clinical Oncology in June 2022 and initiate a pivotal trial in the second half of the year. 

Breakthrough Therapy Designation aims to help companies work closely with authorities to accelerate research, development, and approval of innovative therapies that can address unmet medical needs. IN10018 received fast track designation from the U.S. Food and Drug Administration for the treatment of patients with platinum-resistant ovarian cancer in August 2021. InxMed will live up to the high expectations and strive to deliver the benefits of innovative drugs to patients as quickly as possible.

FAK is a non-receptor tyrosine kinase and transmitter that plays an important role in cell adhesion, migration, and regulation. It exhibits expression upregulation in multiple tumor types. Researchers have found that inhibiting the FAK signaling pathway can effectively reverse previously failed chemotherapy and targeted therapy caused by drug resistance and enhance the response and efficacy of immunotherapy for solid tumors.

IN10018 is a potent and highly selective adenosine triphosphate competitive FAK inhibitor, and InxMed has its exclusive global development and commercial operation rights. InxMed Nanjing Translational Medicine Center has conducted extensive original exploratory research on IN10018 and FAK targets and has published research results in renowned academic journals. Early clinical data on IN10018 showed its safety and efficacy in multiple tumor types, and the latest research results and preclinical data demonstrated that IN10018 can also be effective in combination therapies. It is expected to overcome the tumor-associated fibrosis barrier and improve local immunity, and therefore has the potential to act as an important anchor molecule in synergy with different therapeutic modalities including immunotherapy, chemotherapy, and targeted therapy.

InxMed set up a global clinical development program for IN10018. Clinical trials currently underway in the US and China are designed for platinum-resistant ovarian cancer, NRAS mutant metastatic melanoma, triple-negative breast cancer, head and neck cancer, pancreatic cancer, and other solid tumors that are still lacking effective treatment.

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