On December 24, ST Pharm (President Kim Gyeong-jin) announced that the US FDA had approved the phase I IND (investigational new drug application) of STP1002, a new drug for the treatment of colorectal cancer, in the US.
Under the IND approval, ST Pharm will recruit participants from three clinical sites in the US starting from next year, and begin administering the drug to the first group of patients in April.
The phase I clinical study will be conducted to identify the safety and efficacy of STP1002 not only for colorectal cancer patients, but also for patients suffering from a progressive solid cancer such as non-small cell lung cancer, breast cancer or liver cancer, in order to expand 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 and 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 to be ingested once a day for ease of taking.
ST Pharm has derived a new drug candidate substance, STP1002, through two years of joint research (from 2014) 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 executive of ST Pharm said, “I believe that the development strategy of STP1002, which targeted a currently unmet demand, namely the absence of an oral dosage format for colorectal cancer treatment, was the basis for the rapid IND approval. We will continue to work with KCRN Research, a CRO company based in the US, so as to conclude our clinical studies successfully.”
Meanwhile, ST Pharm currently owns eight new drug projects developed in-house through virtual R&D, a low-cost high-efficiency drug development strategy. Of these, the first document submission of IMPD (Investigational Medicinal Product Dossier) for the phase I clinical studies of the AIDS treatment STP0404 in Europe has already been completed, and the application process will be finalized by mid-January of next year.