MEdPACTO

Collaboration will evaluate combination of MedPacto’s TGF-β type I receptor inhibitor, vactosertib (TEW-7197) with AstraZeneca’s durvalumab in a Phase I/II study for patients with NSCLC

 

SUWON, South Korea, July 24, 2018 – MedPacto, Inc. (“MedPacto”, the “Company” or “we”), a subsidiary of TheragenEtex (KOSDAQ:066700), is a genome-based drug discovery and clinical-stage biotechnology company that announced today a clinical collaboration with AstraZeneca to evaluate the safety and efficacy of MedPacto’s vactosertib (TEW-7197), a small molecule, oral inhibitor of TGF-β type I receptor (TGFBRI), in combination with durvalumab, a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1) in patients with metastatic non-small cell lung cancer (NSCLC).

 

Under the terms of the agreement, MedPacto and AstraZeneca will collaborate on a non-exclusive basis to evaluate the combination of the two drugs in NSCLC. MedPacto expects to initiate a Phase 1b/2a study in the second half of 2018 to establish the safety and efficacy of vactosertib in combination with durvalumab. MedPacto will sponsor and fund the study and AstraZeneca will supply durvalumab for the study. The trial will be conducted in several sites in South Korea including Yonsei Severance Hospital and National Cancer Center and is expected to be completed within two years.

 

“We are pleased to initiate this exciting trial collaboration with AstraZeneca,” said Dr. Seong-Jin Kim, Founder and Chief Executive Officer of MedPacto. “Although TGF-β has a complex mechanism of action, recent developments have further reinforced the importance of targeting this pathway particularly to overcome resistance to immune checkpoint inhibitors. We believe this collaboration is very timely since preliminary data on the combined targeting of PD-L1 and TGF-β with a bispecific has shown promise in increasing response rates in patients with NSCLC.”

 

About Durvalumab:

 

Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response.

 

As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.

 

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. Preclinical data suggests 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

sarahskim@medpacto.com

 

Information about TheragenEtex’s shares:

 

KOSDAQ ticker: 066700