MedPacto Receives US FDA Approval for Phase 1/2 Clinical Trials of Bactosertib Monotherapy in Osteosarcoma

[Asia Economy Reporter Lee Gwan-joo] MedPacto announced on the 8th that it has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for single-agent use of Bexotarcept in patients with recurrent and refractory osteosarcoma.

This clinical trial is a Phase 1/2 study of single-agent Bexotarcept in 54 adolescent and adult patients aged 14 and older with recurrent, refractory, or progressive osteosarcoma. The trial will be conducted at institutions including Case Western Reserve University and UH Rainbow Babies & Children's Hospital.

MedPacto plans to evaluate the safety, tolerability, pharmacokinetics, and anticancer efficacy of single-agent Bexotarcept in this clinical trial and, based on interim analysis results, will assess safety and efficacy in a larger patient population.

Osteosarcoma is a malignant tumor arising from 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 in children and adolescents. Notably, 25-50% of osteosarcoma patients experience metastasis to the lungs, and pulmonary metastasis often progresses during chemotherapy, leading to death.

In preclinical studies on osteosarcoma, Bexotarcept 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 suppress lung metastasis of osteosarcoma cancer cells.

A MedPacto official stated, “The clinical trial will confirm the safety of single-agent Bexotarcept in osteosarcoma patients,” adding, “Depending on the clinical results, we expect to take a step closer to the early commercialization of Bexotarcept.”