Medpacto, a subsidiary of Theragen ETEX, said Tuesday that the Ministry of Food and Drug Safety (MFDS) has approved phase 1b/2a clinical trials for a combination therapy between its vactosertib (TEW-7197) and MSD’s Keytruda.
The company will conduct its clinical trial on patients with gastric cancer and colorectal cancer who had undergone second-line chemotherapy treatment but had no effect. Medpacto also plans to include other kinds of cancer hard to treat with conventional chemotherapy such as diffuse gastric cancer, gastric adenocarcinoma and colorectal cancer consensus molecular subtype four (CMS type 4).
The company plans to finish recruiting patients by the end of this year and confirm the safety and efficacy, such as tolerability, pharmacokinetics and antitumor activity, of the drug for more than two years.
Five medical institutions, including Asan Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital and Severance Hospital, will participate in the clinical trial.
Vactosertib is a drug candidate that selectively inhibits TGF-β, a mechanism that inhibits the therapeutic effect of immunotherapy.
The company expects that it will improve the response rate and therapeutic effect when combined with immunotherapeutic drugs as it enhances the surrounding environment of the tumor so that the immune cells can easily attack cancer cells.
“The importance of TGF-β signal that regulates the microenvironment around cancer has become more important, and competition for drug development is intensifying around the world,” Medpacto CEO Kim Seong-jin said. “We expect to demonstrate Korea's technology in the field of anti-cancer drugs through this clinical trial.”