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Title Phase 2 clinical trial approved for a candidate substance for immunotherapy based on Korean medicine
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Writer Manager Date 2021-06-23 Hits 134

Phase 2 clinical trial approved for a candidate substance for immunotherapy based on Korean medicine

World’s first clinical trial approval for the checkpoint inhibitor effect of a KM-based substance



The first phase 2 clinical trial for the verification of the immunotherapy effect of a substance based on Korean medicine will be carried out soon.

The Korea Institute of Oriental Medicine (KIOM / president: Lee Jin-Yong) announced the approval of its phase 2 clinical test plan for KIOM-ICI-1, a Korean medicine-based candidate substance for immunotherapy (immune checkpoint inhibitor),* by the Ministry of Food and Drug Safety on June 3.
Immunotherapy: Cancer treatment that disables cancer cells from escaping the immune system or helps immune cells to attack cancer cells better, using immune checkpoint inhibitors, cancer vaccines, immune cell therapeutics, etc.

It is the first case of clinical trial approval after the immune checkpoint* inhibitor effect was found in a herbal substance, instead of therapeutic antibody.
Immune checkpoint: A mechanism in the human body that stimulates immune checkpoint protein and reduces activation of immune cells to suppress excessive immune response. Cancer cells turn this mechanism to their own advantage to escape the attacks of immune cells.

The immune therapeutics, which treat cancer by improving immune function unlike conventional anticancer drugs that attack cancer cells, are drawing attention as the next-generation anticancer drugs.

Immune checkpoint inhibitors are the most widely used immunotherapeutics, and seven items in this category have been approved. However, they are still showing low response rates (two out of ten patients) and have side effects such as immune hypersensitivity, thus requiring the development of new substances to complement these weaknesses.

Therefore, the approval of the phase 2 clinical trial of KIOM-ICI-1, a Korean medicine-based substance whose safety has been confirmed, is even more significant.

The research team will conduct randomized controlled trial on colon cancer patients, for whom surgery and standard anticancer treatments using anticancer drugs and radiotherapy were not effective, to confirm the safety and efficacy of immune checkpoint inhibitor KIOM-ICI-1.

In a previous study, the research team verified that KIOM-ICI-1 inhibits immune checkpoint, a mechanism with which cancer cells escape the immune system, improves the activation of immune cells (T-cells), and suppresses the size of tumor by more than 50%.

In addition, the team will show the increase in the treatment effect of KIOM-ICI-1 when it is co-administered with oxaliplatin, a conventional cytotoxic anticancer agent. It also plans to carry out clinical trial on the co-administration with other conventional anticancer drugs in the future.

Jeong Hwan-seok, Chief Researcher of the Korean Medicine Application Center, who will lead the research, said, “The immunotherapeutic candidate material is meaningful because it was developed based on herbal materials whose safety have been validated. We will do our best to get everything ready for the follow-up research so that KIOM-ICI-1 can be developed as the first Korean medicine-based immunotherapeutic agent.”

President Lee Jin-Yong of KIOM commented, “This is the result of our scientific verification of the benefits of treatments in Korean medicine that improve internal balance and promotes health by strengthening immunity. We will dedicate ourselves to overcome chronic and intractable diseases by developing new drugs based on herbal materials.

The study on the immunotherapeutic agent based on Korean Medicine targeting immune checkpoint was conducted as a major program of KIOM.

The study was selected as one of the 2020 Outstanding Research Outcomes in the Field of Science and Technology.


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