바이오스펙테이터

by Jongwon Jang

The Ministry of Food and Drug Safety approved Phase 1b/2a Clinical Trial … Seven Cohorts comprising 420 Patients suffering Breast Cancer and Ovarian Cancer etc. will be participating in Clinical Trial

Idience, the affiliate of Ildong Holdings established for the development of new drugs, enters into Phase 1b/2a Clinical Trials of 'IDX-1197', a PARP inhibitor. A total of 420 patients suffering seven kinds of carcinomas will be participating in the large scaled ‘basket’ clinical trials to verify the safety and efficacy of IDX-1197.

Idience recently announced that Phase 1b/2a Clinical Trials of new candidate material of IDX-1197 of the company, the anticancer agent, were approved by the Ministry of Food and Drug Safety. Idience was founded by Ildong Holdings, the holding company of Ildong Pharmaceutical Co., Ltd., as the company in the form of NRDO (No Research, Development Only), specialized for developing new drugs.

A total of 420 patients suffering from solid cancers having mutation of homologous recombination will be participating in the Phase 1b/2a Clinical Trials of basket type, wherein IDX-1197 will be opened to several medical institutions. Clinical trial of basket type is the one designed to verify that a single drug can be prescribed against genetic drift observed from various kinds of carcinomas.

Phase 1b Clinical Trial will be conducted with 7 cohorts of breast cancer, ovarian cancer, small cell lung cancer, bile duct cancer, urothelial cancer, pancreatic acinar cancer, and solid cancers who experienced failure of antitumor treatment of platinum series, whereas the Phase 2a Clinical Trial will be carried out with patients of solid cancers entered into Phase 2a among cohorts.

IDX-1197 is a candidate material for curing cancers by exploiting characteristics of DNA of cancer cells and action mechanism of enzyme called ‘PARP (Poly ADP-ribose polymerase)’. PARP plays a role in helping recovery of the damage of single strand of DNA of cancer cell. IDX-1197 inhibits the action of PARP by inducing death of cancer cell spontaneously.

Previously, Ildong Pharmaceutical Co., Ltd. has conducted a Phase 1a Clinical Trial of IDX-1197 for patients suffering from progressive solid cancer with ‘National Onco Venture’ (supported by Ministry of Health and Welfare, hosted by National Cancer Center). Results obtained therefrom demonstrated the potential of IDX-1197. It exhibited effects superior to other PARP inhibitors for diverse kinds of cancers. Thus, it can be used as a new drug with expansive applicability.

Idience will take charge of conducting Phase 1b/2a Clinical Trials approved by the Ministry of Food and Drug Safety. Idience acquired the right of development associated with IDX-1197 from Ildong Pharmaceutical Co., Ltd. last August and started subsequent development. Recently, the company concluded an MOU with NGeneBio for the development of accompanying diagnostic technology optimized for IDX-1197.