Stony Brook cancer drug begins human trials
A taxane compound originally developed at Stony Brook University is now being tested in patients with advanced colorectal cancer.
By Tomas Gonzalez ·
A new chemotherapy drug derived from a taxane compound has entered human clinical trials for patients with advanced colorectal cancer. The agent, now designated RP-001, was originally developed by researchers at Stony Brook University and is being tested by Recurv Pharma Inc. in an open-label multicenter phase 1/2a study. The trial is currently active in the United States and the United Kingdom.
The medication is a polyunsaturated fatty acid conjugate of a second-generation taxane. Taxanes are natural compounds designed to block cell division and trigger programmed cell death in solid tumors. The specific formulation used in the trial is a nanoemulsion, which allows for targeted drug delivery. Recurv Pharma received approval from the Food and Drug Administration for the Investigational New Drug Application earlier this year.
The development of the drug began with the work of Iwao Ojima, a SUNY Distinguished Professor in the Department of Chemistry at Stony Brook University. Ojima leads the Institute of Chemical Biology & Drug Discovery and spent years developing next-generation anti-cancer agents. His team created DHA-SBT-1214, a compound designed to overcome multidrug resistance. They conjugated this compound to DHA, an omega-3 fatty acid found in fish oil.
In 2016, the SUNY Research Foundation licensed the compound to TargaGenix Inc., a Stony Brook University spinout company. TargaGenix developed the nanoemulsion formulation with help from Mansoor Amiji of Northeastern University. The company later sub-licensed the drug candidate to Recurv Pharma. Recurv Pharma secured a $24 million investment from TVM Capital Life Sciences to support the development process.
Colorectal cancer remains a leading cause of cancer-related deaths in the United States. According to the National Cancer Institute, nearly two-thirds of patients reach the five-year survival mark. However, treatment is often complicated by multidrug resistance and adverse side effects associated with mainstream taxanes such as paclitaxel and docetaxel. The new compound aims to address these limitations.
James E. Egan, CEO of Recurv Pharma, stated that the company is conducting a Phase 1 safety and dose escalation study. This will be followed by a Phase 2 study in pancreatic and colorectal cancer. The company plans to seek a partner for an approval study if the Phase 2 results are positive. Recurv Pharma also intends to develop a combination therapy using RP-001 with immune-oncology treatments for pancreatic cancer.
Raymond Bergan, MD, director of the Stony Brook Cancer Center, noted that the research represents a novel form of therapy. Ojima and his team continue to investigate third- and fourth-generation Stony Brook taxanes and other classes of anti-cancer agents at the Institute of Chemical Biology & Drug Discovery.
