FDA Clears First Clinical Study of OBI-3424 in Prostate and Other Cancers

FDA Clears First Clinical Study of OBI-3424 in Prostate and Other Cancers

OBI Pharma is launching a Phase 1/2 trial in the United States to evaluate the safety and effectiveness of using OBI-3424 to treat solid cancers that are positive for the AKR1C3 enzyme.

This follows the recent approval of an investigational new drug (IND) application for OBI-3424 by the U.S. Food and Drug Administrations (FDA).

The trial will enroll patients with local solid tumors, including hepatocellular carcinoma (HCC) and castrate-resistant prostate cancer (CRPC), two tumor types linked to increased AKR1C3 levels.

“We are delighted to conduct this first-in-man clinical trial at the University of Texas M.D. Anderson Cancer Center and The James Cancer Hospital and Solove Research Institute of Ohio State University, two of America’s leading academic oncology research institutions,” Tillman Pearce, OBI Pharma’s chief medical adviser, said in a press release.

OBI-3424 is an investigative small-molecule prodrug that is broken down in the presence of the AKR1C3 enzyme, releasing a potent agent that binds to the DNA and induces cancer-cell death. OBI Pharma holds worldwide rights over OBI-3424, with the exception of some Asian and other countries, where its rights are held by Ascenta Pharma.

Because its anti-cancer activity depends on AKR1C3 levels, patients that benefit the most from OBI-3424 can be easily identified with a simple analysis of tumor biopsies or circulating tumor cells. Also, its selective mode of action distinguishes OBI-3424 from other traditional DNA alkylating agents, such as cyclophosphamide, potentially leading to fewer adverse events.

“OBI Pharma is proud to further develop our unique targeted cancer pipeline,” said Amy Huang, OBI Pharma’s general manager. “OBI-3424 enhances OBI’s pipeline in solid and liquid tumors for cancer patients who over-express AKR1C3.”

“OBI is taking a first-step towards testing the safety and initial efficacy of a new class of AKR1C3 targeted therapy. We are excited to develop novel targeted therapeutics in the fight against cancers of unmet need,” she added.

Preclinical results presented at the AACR 2016 Annual Meeting in New Orleans showed that OBI-3424 has promising anti-tumor activity against several types of solid and blood cancers.

The treatment effectively induced the death of several human cancer cell lines, including esophageal, liver, and lung, and leukemia cells. Also, it significantly delayed tumor growth in animal models of liver cancer and T-cell leukemia.

These finding supported the IND application and its approval by the FDA.