Recurv Pharma starts phase 1/2a trial of Stony Brook taxane RP-001 in colorectal cancer

According to newswise.com, Stony Brook University announced on November 5, 2026 that the investigational agent RP-001, originally coded NE-DHA-SBT-1214, has entered human clinical trials. Recurv Pharma Inc. launched the trial in patients with advanced colorectal cancer. The compound was originally developed by researchers at the university. newswise.comnewswise.comnewswise.comOpen source ↗

RP-001 is a polyunsaturated fatty acid conjugate of a second-generation Stony Brook taxane in a nanoemulsion formulation. Taxanes are anti-cancer agents designed to block cell division and trigger programmed cell death in solid tumors. newswise.comnewswise.comnewswise.comOpen source ↗

Trial design and plans

Earlier this year the U.S. Food and Drug Administration approved Recurv Pharma's Investigational New Drug Application. It covers an open-label multicenter phase 1/2a trial of the safety, tolerability and anti-tumor activity of RP-001 in adults with advanced and metastatic disease. The trial is based in Texas and the United Kingdom, and the company plans additional trials in the UK. newswise.comnewswise.comnewswise.comOpen source ↗

James E. Egan, CEO of Recurv Pharma, said the company is conducting a phase 1 safety and dose-escalation study, to be followed by a phase 2 study in pancreatic and colorectal cancer. If phase 2 results are positive, the company will seek a partner to conduct an approval study. It also plans to develop a combination of RP-001 with immuno-oncology therapy for pancreatic cancer. newswise.comnewswise.comnewswise.comOpen source ↗

Colorectal cancer remains a leading cause of cancer incidence and death in the United States. According to the National Cancer Institute, nearly two-thirds of patients reach the five-year survival mark. Multidrug resistance and adverse effects, including those of the mainstream taxanes paclitaxel and docetaxel, continue to reduce treatment effectiveness. newswise.comnewswise.comnewswise.comOpen source ↗

From laboratory to licensing

The work began with Iwao Ojima, SUNY Distinguished Professor in the Department of Chemistry and Director of the Institute of Chemical Biology & Drug Discovery at Stony Brook. His group developed a potent second-generation taxane that overcame multidrug resistance. Conjugated to DHA, an omega-3 fatty acid, it became DHA-SBT-1214. newswise.comnewswise.comnewswise.comOpen source ↗

The nanoemulsion was developed by TargaGenix together with Mansoor Amiji of Northeastern University. In mouse models, it was effective against multidrug-resistant solid tumor xenografts and xenografts initiated by cancer stem cells. Ojima said the formulation enabled tumor-selective delivery through the enhanced permeability and retention (EPR) effect characteristic of nanosize particles. newswise.comnewswise.comnewswise.comOpen source ↗

In 2016 the SUNY Research Foundation licensed the conjugate to TargaGenix, a Stony Brook spinout. TargaGenix later sub-licensed the candidate to Recurv Pharma, which received a $24M investment from TVM Capital Life Sciences. Ojima's team continues to develop third- and fourth-generation Stony Brook taxanes and other classes of anti-cancer agents. newswise.comnewswise.comnewswise.comOpen source ↗