Theratechnologies has pumped the brakes on a phase 1 trial of its lead cancer asset after a glimpse at the data raised efficacy concerns.
The trial, which started in March 2021, was designed to enroll 70 participants with a range of solid tumors and cancers who would receive the peptide-drug conjugate, dubbed TH1902, according to ClinicalTrials.gov.
However, the Canadian biotech decided to pause enrollment after consulting with investigators. “Efficacy results observed thus far were not convincing enough to pursue enrolling patients and did not outweigh the adverse events seen in some patients,” the company said in a postmarket release Dec. 1. Neuropathy and eye toxicity were the most common adverse events, Theratechnologies added.
The company plans to submit an amendment to its trial protocol to the FDA to modify the dose regimen. The hope is that a lower dose given at more frequent intervals than once every three weeks will optimize delivery.
“While we are disappointed with these developments, we remain committed to advancing our SORT1+ technology platform and will continue investigating its potential in the treatment of advanced cancers,” said Chief Medical Officer Christian Marsolais, Ph.D.
Thearatechnologies’ pipeline is centered around its platform of proprietary peptides called SORT1+ Technology. The aim is to create cancer therapies targeting receptors of the SORT1 protein. These receptors are expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers, according to the biotech, with the protein associated with aggressive disease and decreased chances of survival.
TH1902 combines Theratechnologies’ proprietary peptide with the commonly used chemotherapy docetaxel. In February 2021, the FDA granted fast-track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy.