ST Pharm submits IND application of phase I clinical study for colorectal cancer drug ‘STP1002’ to..

On November 28, ST Pharm (President Kim Gyeong-jin) announced the submission of an IND (investigational new drug application) application to the US FDA for the phase I clinical studies of STP1002, a new drug for colorectal cancer, in the US.

In the phase I clinical study to be conducted in the US, ST Pharm will identify the safety and efficacy of STP1002 not only for patients suffering from colorectal cancer patients but also for patients with a progressive solid cancer such as non-small cell lung cancer or breast cancer, with the aim of expanding the indications of STP1002 simultaneously.

STP1002 is a first-in-class colorectal cancer treatment that inhibits the growth of cancer cells by inhibiting the enzyme Tankyrase. It can treat mutant colorectal cancer induced by the KRAS gene, which accounts for about 65% of all colorectal cancers, and shows no therapeutic effect on Erbitux, an existing colorectal cancer drug.

In contrast to the toxicity and side effects of using anti-cancer drugs with the PARP-1 and PARP-2 inhibitory mechanisms, STP1002 showed no significant toxicity or side effects in a 4-week preclinical toxicity study conducted using an animal test model transplanted with cancer cells derived from colorectal cancer patients. In addition, TGI (Tumor Growth Inhibition) of 49~70% was shown in the efficacy evaluation, which proved to be an excellent effect.

While existing anti-cancer drugs such as Erbitux and Avastin were developed as injections, STP1002 has been developed as an oral drug.

ST Pharm has derived a new drug candidate substance, STP1002, through two years (from 2014) of joint research with the Korea Research Institute of Chemical Technology (KRICT, Ph.D. Heo Jeong-nyeong Team). In 2015, STP1002 was selected as a research project of the Korea Drug Development Fund and received support for pre-clinical studies.

An official of ST Pharm said, “The new drug development strategy of ST Pharm is a low-cost, high-efficiency, virtual R&D strategy in which new drugs are developed through joint research and in-licensing by actively utilizing outsourcing capabilities, after which out-licensing is pursued via various networks. In this way, various development strategies can be implemented, such as minimizing research expenses, shortening the development period, out-licensing from the initial clinical stage, joint-venture, and joint research, as well as creating a synergy effect with the new drug API business, the basis of ST Pharm.”

In addition to the colorectal cancer treatment STP1002, ST Pharm currently has eight first-in-class new drug pipelines, including the AIDS treatment STP0404, a non-alcoholic steatohepatitis (NASH) treatment, an inflammatory bowel disease treatment, and an influenza virus treatment. Furthermore, the submission of the IND application for the phase I clinical studies of AIDS treatment STP0404 in Europe is scheduled for the end of the year.