MedPacto said it would drop a phase 2 trial of vactosertib, an anti-cancer drug candidate, in desmoid tumors because it decided to focus vactosertib development on other types of cancer.
In a public filing on Monday, the Kosdaq-listed biotech firm said it would voluntarily withdraw its local phase 2 trial, MP-VAC-206, which aimed to evaluate the clinical activity of vactosertib plus imatinib in desmoid tumors (aggressive fibromatosis).
The withdrawal came six months after the Ministry of Food and Drug Safety authorized the phase 2 trial.
Last year, MedPacto applied for a Korean phase 2 trial of vactosertib in desmoid tumors and said it would explore vactosertib’s potential indications for rare and intractable diseases, such as osteosarcoma. It said it would start a global phase 2 study, too.
However, the public disclosure on Monday showed that the company changed the plan.
MedPacto emphasized that the withdrawal of the clinical trial was not because of issues in the efficacy and safety of vactosertib but changes in clinical development strategies of the anti-cancer drug.
The company said it has yet to recruit a patient for the phase 2 trial.
The latest decision was affected by the opinion of Timothy Allen. He was recently appointed as executive vice president of clinical development at MedPacto Therapeutics, a U.S. subsidiary of MedPacto, according to the company.
A clinical development unit of the American company visited Korea to review the progress of vactosertib development and plans and concluded that it would focus on more marketable cancer areas, MedPacto said.
“So far, we have verified the potential of vactosertib in various cancer types. But now, we 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 prolong until 2028 while the related therapeutic market is small, the company went on to say.
“This is not in line with the company’s recently revised strategy of vactosertib clinical development.”
Instead, MedPacto will concentrate on the clinical trial of vactosertib plus pembrolizumab (Keytruda) to treat colorectal cancer, jointly conducted with MSD.
Just like MSD released Keytruda in the immunotherapy market first and expanded indications later, MedPacto would focus efforts on colorectal cancer, pancreatic cancer, and osteosarcoma to win approval first and expand indication later.
The company added that it would disclose the content of the desmoid tumor clinical trial in a journal later.
On Monday, shares of MedPacto closed at 30,300 won ($23.97), up 3.95 percent from the previous trading day.