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MedPacto Announces Clinical Collaboration with MSD to Evaluate Vactosertib, an Investigational TGF-β Type I Receptor Inhibitor, in combination with KEYTRUDA® (pembrolizumab)

Jul 24, 2018PRESS RELEASESHit 1311

SUWON, South Korea, July 24, 2018 – MedPacto, Inc. a subsidiary of TheragenEtex (KOSDAQ:066700), 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), through a subsidiary, 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 metastatic or locally advanced colorectal (mCRC) and gastric cancer/ gastroesophageal junction adenocarcinoma (GC/GEJC).

 

Under the terms of the agreement, MedPacto will conduct a Phase 1b study to establish the safety and dose of the combination agents. Following the identification of a recommended dose, MedPacto plans to initiate a Phase 2a study to explore the efficacy of the combination in mCRC and GC/GEJC. The trial, expected to be initiated the second half of 2018 and completed within two years, will be conducted in several sites in South Korea, including Asan Medical Center, National Cancer Center and Samsung Medical Center.

 

“The revitalization of TGF-β for drug development further reinforces the importance of this pathway. We believe that Vactosertib’s immuno-modulatory role in combination with Keytruda is very promising for increasing responses in mCRC and GC/GEJC,” 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.

 

About Vactosertib (TEW-7197)

 

Vactosertib is a potent and highly selective, orally available inhibitor of TGF-β type I receptor to block the SMAD-mediated and non-canonical TGF-β signaling pathway. TGF-β inhibition enables immune infiltration to confer susceptibility to immuno-oncology therapies for treatment of cancers that grow in TGF-β rich environment. Vactosertib was proven to be safe and well-tolerated in a Phase 1 study conducted in the US. Therefore, vactosertib is currently being evaluated in Phase 1b/2a trials to treat a variety of solid tumors and hematological malignancies including gastric cancer, pancreatic cancer, desmoid sarcomas, myelodysplastic syndrome and multiple myeloma.

 

Vactosertib was originally discovered by Ewha Womans University with support from the Ministry of Education and Science Technology (2008-2013) and Phase 1 clinical development was conducted in collaboration with National OncoVenture (NOV, supported by National Cancer Center, designated by the Ministry of Health and Welfare).

 

About MedPacto, Inc.

 

MedPacto is a genome-based drug discovery and clinical-stage biotechnology company dedicated to developing innovative therapeutics targeting cancer and autoimmune diseases. MedPacto’s expertise lies in utilizing genome-based methods to identify novel targets and to develop first-in-class and best-in-class drugs.

 

MedPacto is based in Suwon, South Korea and is a subsidiary of TheragenEtex, a KOSDAQ-listed Korean company that is a leading player in the genomics industry. Learn more about MedPacto at www.medpacto.com and TheragenEtex at www.theragenetex.com.

 

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains certain forward-looking statements that involve risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “target,” “potential,” “will,” “could,” “should,” “seek” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on MedPacto’s expectations and assumptions as of the date of this press release. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements due to many factors including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or changes in the regulatory environment, failure of MedPacto’s collaborators to support or advance collaborations and unexpected ligation or other disputes.

 

Except as required by law, MedPacto assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

Investors & Media Contact

 

MedPacto, Inc.

Sarah Kim

Chief Licensing & Planning Officer

+82-10-4213-3926

sarahskim@medpacto.com

 

Information about TheragenEtex’s shares:

 

KOSDAQ ticker: 066700

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