MedPacto withdraws vactosertib study in desmoid tumors

MedPacto said it would abandon a Phase 2 trial of vactosertib, a cancer drug candidate, in desmoid tumors because it decided to focus development of vactosertib on other types of cancer.

In a public filing Monday, the Kosdaq-listed biotech company said it would voluntarily withdraw its local Phase 2 trial, MP-VAC-206, which aimed to assess the clinical activity of vactosertib plus imatinib in desmoid tumors ( aggressive fibromatosis).

MedPacto said it would abandon a Phase 2 trial of vactosertib, a cancer drug candidate, in desmoid tumors.

The withdrawal came six months after the Ministry of Food and Drug Safety cleared the phase 2 trial.

Last year, MedPacto requested a Korean Phase 2 trial of vactosertib in desmoid tumors and said it would explore potential indications for vactosertib for rare and incurable diseases, such as osteosarcoma. He also announced that he would launch a global phase 2 study.

However, Monday’s public disclosure showed that the company had changed the plan.

MedPacto stressed that the withdrawal from the clinical trial was not due to efficacy and safety issues with vactosertib but to changes in the cancer drug’s clinical development strategies.

The company said it has not yet recruited a patient for the phase 2 trial.

The final decision was affected by the opinion of Timothy Allen. He was recently named executive vice president of clinical development at MedPacto Therapeutics, a U.S. subsidiary of MedPacto, according to the company.

A clinical development unit from the U.S. company traveled to Korea to review development progress and plans for vactosertib and concluded it would focus on more marketable areas of cancer, MedPacto said.

“So far, we have tested the potential of vactosertib in various types of cancer. But now we have revised our strategy to focus the company’s capabilities on the rapid commercialization of vactosertib for cancers with large treatment markets,” MedPacto said.

Advanced desmoid tumors require long-term observation, and the clinical trial could likely extend to 2028 when the related therapeutic market is small, the company continued.

“This is not in line with the company’s recently revised clinical development strategy for vactosertib.”

Instead, MedPacto will focus on the clinical trial of vactosertib plus pembrolizumab (Keytruda) to treat colorectal cancer, conducted in conjunction with MSD.

Just as MSD launched Keytruda in the immunotherapy market first and expanded indications later, MedPacto would focus its efforts on colorectal cancer, pancreatic cancer and osteosarcoma to gain approval first and expand indication later.

The company added that it would later disclose the contents of the desmoid tumor clinical trial in a journal.

On Monday, shares of MedPacto closed at 30,300 won ($23.97), up 3.95% from the previous trading day.

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