MEdPACTO

A phase 1/2 clinical trial for adolescents between 14 and 18 years of age and adults with recurrent, refractory, or progressive osteosarcoma

On Feb 16th, MedPacto, a genome-based drug discovery and clinical-stage biotechnology company (CEO Kim SeongJin), announced that the Ministry of Food and Drug Safety of the Republic of Korea has approved the company’s investigational new drug (IND) application for its Vactosertib as a single agent in patients with recurrent, refractory, or progressive osteosarcoma.

This upcoming clinical trial is a phase 1/2 study of Vactosertib as a single agent in a total of 54 patients including adolescents (ages 14-18) and adults with recurrent, refractory or progressive osteosarcoma.

MedPacto will assess the safety and efficacy from wider patient groups as interim results are revealed by evaluating the safety, tolerability, pharmacokinetics, and antitumor activity of Vactosertib as a single agent.

“This upcoming clinical trial is to assess the safety, tolerability, pharmacokinetics, and antitumor activity of Vactosertib as a single agent in adolescents and adults with recurrent, refractory, or progressive osteosarcoma.” Stated a MedPacto representative.

MedPacto received IND approval from FDA for a phase1/2 clinical metastatic osteosarcoma trial to evaluate the safety and efficacy of Vactosertib as a single agent in August 2022. Vactosertib monotherapy also received Rare Pediatric Disease Designation(RPDD) and Fast Track Designation(FTD) from FDA.

Osteosarcoma, a malignant osseous neoplasm that usually develops in connective tissue such as bone, cartilage, or muscle, is one of the most commonly reported rare cancers, that accounts for 0.2% of malignant tumors. It can develop at any age, but around 60% of the cases occur during childhood, early adolescence, and young adulthood. 25~50% of these patients experience lung metastasis even during chemotherapy, which can lead to mortality.

Osteosarcoma treatment typically involves surgery, chemotherapy, and radiation therapy. Surgeries in parallel with chemotherapy make up roughly 45.5% of all total treatments while drug treatment makes up only 15.9%. There is an urgent need for new therapies.

Vactosertib significantly reduced osteosarcoma cancer cell growth and pulmonary transfer, improving the survival rate of a mouse by 100 percent and also restraining lung metastasis by 100 percent.