South Korea’s ST Pharm on Thursday announced an IND filing with the U.S. Food and Drug Administration to initiate a phase 1 study of its investigational colorectal cancer drug STP1002.

The study aims to evaluate the drug’s safety and efficacy in patients with colorectal cancer and other solid tumors.

STP1002, a drug in a new class, inhibits tankyrase involved in the proliferation of cancer cells and is believed to treat patients with KRAS-mutant colorectal cancer who do not respond to existing therapy Erbitux.

In a preclinical study, STP1002 had low toxicity and few side effects compared to existing drugs with a mechanism that inhibits PARP-1 and PARP-2 across a variety of solid tumors, the company said.

In a prior efficacy test of the oral drug, tumor growth inhibition (TGI) calculated as the percentage of tumor growth relative to tumor size at the start of treatment reached 49 to 70 percent, suggesting strong cancer inhibition.

Besides STP1002, ST Pharm has eight first-in-class drugs in ins pipeline, including a nonalcoholic steatohepatitis (NASH) drug and STP0404, a drug candidate for the treatment of human immunodeficiency virus (HIV) infection. A phase 1 study of STP0404 is due to be filed by the end of this year in Europe.

By Seo Jin-woo and Minu Kim

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