MedPacto Announces Clinical Collaboration with MSD to Evaluate Vactosertib, an Investigational TGF-β Type I Receptor Inhibitor, in combination with KEYTRUDA® (pembrolizumab) in a Phase 3 Trial with Registrational Intent
Dec 14, 2021
Seoul, South Korea, December 14, 2021 – MedPacto, Inc. (KOSDAQ: 235980), a genome-based drug discovery and clinical-stage biotechnology company, announced today that it has entered into a clinical collaboration agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada), for a global phase 3 study to evaluate the safety and efficacy of vactosertib (TEW-7197), MedPacto’s investigational small molecule oral inhibitor of TGF-β type I receptor (TGFBRI), in combination with MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with microsatellite stable (MSS) metastatic or locally advanced colorectal cancer (MSS-mCRC) in the 3rd line setting.
Under the terms of the agreement, MSD will supply KEYTRUDA® to MedPacto for conducting a global, randomized, double-blind, placebo-controlled registrational trial for MSS-mCRC. The experimental arms of the trial will be treated with a combined regimen of Vactosertib and KEYTRUDA, compared with the physician’s choice of the standard of care. The trial, expected to be initiated early 2022 and completed by 2026, will include approximately 500-600 patients at about 40 sites in the United States and South Korea.
This subsequent collaboration follows promising results from a phase 1b/2a MSS-mCRC study, MP-VAC-204, initiated in 2018. At the 2021 American Society of Clinical Oncology (ASCO) Annual Conference, updated efficacy results from the MP-VAC-204 trial was shared, which showed that the combination resulted in a median overall survival (mOS) of 15.8 months – a promising improvement of on the current standard regimen which was approved with a mOS of less than 7 months. “We look forward to advancing Vactosertib into a pivotal Phase 3 trial, following the positive results observed from the MP-VAC-204 trial. We hope that this trial could support a submission of a new drug application,” said Dr. Seong-Jin Kim, Founder and Chief Executive Officer of MedPacto.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.