Keytruda Combination Trial Application Approval followed by Another Approval for the Vactosertib + Durvalumab Combination Trial Application
Dec 21, 2018PRESS RELEASESHit 556
MedPacto, a subsidiary of TheragenEtex, will commence several clinical trials in combination with commercial-stage immuno-oncology drugs developed by multinational pharmaceutical companies.
Combination therapy is a treatment that uses two or more drugs together that can be evaluated for safety, tolerability, and whether there is increased efficacy in comparison to individual drugs. However, such combination therapies could also result in more toxicities.
MedPacto announced on October 2nd that the Ministry of Food and Drug Safety (MFDS) approved the application for the phase 1b∙2a trials evaluating Vactosertib (TEW-7197) in combination with AstraZeneca’s durvalumab (product name: Imfinzi).
This is the second approval received for an immune checkpoint inhibitor combination trial application, following the trial evaluating MSD’s Keytruda for gastric cancer and colorectal cancer. The company will initiate the clinical trials in parallel.
MedPacto plans to conduct the trial in patients with advanced non-small cell lung cancer (NSCLC) at two sites in Korea, including Yonsei Severance Hospital and will be evaluating the safety and efficacy of the treatment regimen for up to two years.
Vactosertib (TEW-7197) is a drug candidate that has been shown to selectively inhibit TGF-β – a target that has been identified as a potential factor in reducing the therapeutic effect of immunotherapy.
The combination of vactosertib with immunotherapy drugs has the potential to improve response rates and therapeutic effects as it may modulate various aspects of the tumor microenvironment so that the activated immune cells can easily attack cancer cells.
“These clinical trials evaluating Vactosertib with two major immune checkpoint inhibitors indicates the interest of the global pharmaceutical industry in combining with our TGF-β inhibitor,” MedPacto founder and CEO Seong-Jin Kim stated. These two studies are designed to address important questions regarding the combination of Vactosertib with checkpoint inhibitors.
For these studies, TheragenEtex Bio Institute (CEO Tae-soon Hwang)’s genome analysis technology will be used to conduct extensive biomarker analysis.
In addition to this clinical trial, Vactosertib is currently being investigated as a monotherapy in a phase 1b clinical trial for gastric cancer and an investigator-initiated trial for pancreatic cancer in Korea. In the U.S., MedPacto is conducting phase 1b∙2a trials for bone marrow dysplasia and an investigator-initiated trial for multiple myeloma.
Vactosertib was discovered by a research team under the leadership of Professor Dae-kee Kim of the College of Pharmacy at Ewha Womans University with support from the Ministry of Education, Science and Technology. MedPacto conducted the phase 1 clinical trial in collaboration with National OncoVenture (designated by Ministry of Health and Welfare: HI17C2196, sponsored by: National Cancer Center).