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MedPacto Announces Execution of a Clinical Trial Agreement for a NK Cell Combination Trial for Colorectal Patients

Feb 14, 2022

- University Hospitals Cleveland Medical Center, NK Cells + Vactosertib combination trial

- To confirm the safety and persistence of NK cells

- Expect to understand the potential of NK cell therapy combination

 

February 14, 2022 – MedPacto, Inc (KOSDAQ: 235980), a genome-based drug discovery and clinical-stage biotechnology company, announced that it has entered into a clinical trial agreement with University Hospitals Cleveland Medical Center to pursue an investigator-initiated clinical trial in patients with colorectal cancer. 

 

The trial, which will be led by Dr. J. Eva Selfridge of University Hospitals Seidman Cancer Center,  the Case Comprehensive Cancer Center and an assistant professor at the Case Western Reserve University School of Medicine, is designed to evaluate the safety and persistence of ex vivo expanded universal donor NK cells in combination with IL-2 and vactosertib in patients with locally advanced/metastatic colorectal cancer and relapsed/refractory hematologic malignancies. 

 

Non-HLA-matched universal-donor NK cells will be co-administered with vactosertib and IL-2 (aldesleukin) to activate NK cells while limiting the inhibitory effect of TGF-β for the ultimate goal of increasing the anti-cancer effect. The objectives will be to determine safety and clinical efficacy of the NK cells in combination with vactosertib and IL-2. MedPacto will supply Vactosertib for this trial. 

 

NK cells are a type of white blood cell in the blood responsible for innate immunity and function to directly attack and destroy virus-infected cells or cancer cells. For this reason, they are also called 'natural killer cells'.

 

Normally, cell therapy can only be administered to the same individual from which the cells were harvested as it can cause immune rejection, however, for this study, the NK cells will be extracted from healthy volunteers and then administered to the patients. 

 

Vactosertib is a drug candidate that inhibits transforming growth factor-beta (TGF-β) signaling, a pathway that is known to inhibit the therapeutic effect of immunotherapy. By modulating the tumor microenvironment, Vactosertib plays a synergistic role in improving the response of various drugs and suppressing the proliferation and metastasis of cancer cells. 

 

This study will be the first trial that vactosertib is used in combination with NK cell therapy for the treatment of cancer patients.

 

If the trial produces significant clinical results, it can confirm the potential of using NK cell therapy combined with Vactosertib for treatment in patients with colorectal cancer.

 

The main collaborator of this trial, Dr. David Wald, of University Hospitals Seidman Cancer Center and an associate professor at the Case Western Reserve School of Medicine, previously showed that the combined treatment of NK cells and a TGF-β inhibitor can effectively suppress the growth of cancer cells.

 

“Clinical studies have shown that Vactosertib is effective in combination with immunotherapy, chemotherapy and targeted therapy. This upcoming trial will be an opportunity to explore the potential of vactosertib in combination with NK cell therapy,” sated a MedPacto representative. 

 

According to Grand View Research, the global colorectal cancer drugs market is expected to grow from 8.6billion USD in 2016 to 10.8billion USD in 2022, at a compound annual growth rate of 3.3%

 

* About TGF-β
TGF-β is one of the main regulators involved in various physiological processes, and is known to play a critical role in the development of various diseases such as cancer, immune disease, and inflammatory disease. In a normal cell function, TGF-β plays a tumor suppressor role by inhibiting cancer cell formation, however in the process of carcinogenesis, TGF-β is produced in large quantities which promotes metastasis, immunosuppression, and anti-cancer drug resistance.

 

About University Hospitals Seidman Cancer Center
UH Seidman Cancer Center is the only freestanding cancer hospital in Northeast Ohio, where all clinicians and staff are dedicated to the prevention, diagnosis and treatment of cancer while researching new and innovative treatment options through clinical trials. Nationally ranked cancer care is also available to patients through the 11-county region at 16 community-based locations. Our UH Seidman specialists make up 14 cancer-specific teams focused on determining integrated care plans tailored to patient’s needs. UH Seidman Cancer Center is part of the National Cancer Institute (NCI)-designated Case Comprehensive Cancer Center at Case Western Reserve University, one of 51 comprehensive cancer centers in the country. Patients have access to advanced treatment options, ranging from a pioneering stem cell transplant program founded more than 40 years ago and a wide range of immunotherapy to the first and only proton therapy center in northern Ohio for adults and children. Go to UHhospitals.org/Seidman for more information.