MedPacto Applies for IND for Phase 1/2 Clinical Trial of Single-Agent Bexotarcept in Osteosarcoma

[Asia Economy Reporter Lee Gwan-joo] MedPacto announced on the 21st that it has applied to the Ministry of Food and Drug Safety for clinical trial approval (IND) for Bactosertib monotherapy in patients with recurrent and refractory osteosarcoma.

This clinical trial is a Phase 1/2 study of Bactosertib monotherapy in patients with recurrent, refractory, or progressive osteosarcoma. It will be conducted on adolescents aged 14 and older and adult patients suffering from recurrent, refractory, or progressive osteosarcoma. MedPacto will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of Bactosertib monotherapy in this clinical trial. Previously, in August, MedPacto received approval from the U.S. Food and Drug Administration (FDA) for a Phase 1/2 clinical trial of Bactosertib monotherapy in osteosarcoma patients.

Osteosarcoma is a malignant tumor that occurs in bone or bone-related cartilaginous tissues and accounts for 5.6% of sarcomas, making it a rare cancer. It is one of the representative pediatric cancers with a high incidence rate in children and adolescents. Notably, 25-50% of cases metastasize to the lungs, and lung metastasis progresses even during chemotherapy, often leading to death.

Currently, treatments for osteosarcoma include surgery, chemotherapy, and radiation therapy. Combined surgery and chemotherapy account for about 45.5%, while treatment with drugs alone accounts for only 15.9%. Chemotherapy is conducted using conventional methods, and immune checkpoint inhibitors are known to be ineffective, leading to a steady demand for new treatment options.

In preclinical studies on osteosarcoma, Bactosertib significantly inhibited the growth of osteosarcoma cancer cells and lung metastasis, improving the survival rate of mice by 100%. It was also confirmed to completely inhibit lung metastasis of osteosarcoma cancer cells.

A MedPacto official stated, "Following the confirmation of the efficacy of Bactosertib monotherapy in osteosarcoma, which is not treatable with immune checkpoint inhibitors, in preclinical studies, we are conducting clinical trials domestically following the U.S. This is expected to provide clinical opportunities for osteosarcoma patients in Korea as well."