Theratechnologies Finalizes Patient Enrollment in Phase 1 Sudocetaxel Zendusortide Trial for Advanced Ovarian Cancer

Theratechnologies Inc., a biopharmaceutical company, has achieved a significant milestone in its Phase 1 clinical trial for sudocetaxel zendusortide, a novel peptide-drug conjugate (PDC) targeting the sortilin receptor to enhance the delivery of docetaxel into cancer cells. The company has completed the enrollment of the initial six participants in the third part of the trial, which is focused on patients with advanced ovarian cancer. This advancement is expected to boost the overall oncology clinical development program of Theratechnologies.
Christian Marsolais, the company's Senior Vice President and Chief Medical Officer, expressed optimism about the next phase of screening and the potential of the PDC to demonstrate its safety and efficacy. The Phase 1 trial's Part 3 began dosing in October 2023, and the FDA accepted an amended protocol in June 2023. This amendment aims to refine dosing, improve the therapeutic window, and extend the treatment duration for sudocetaxel zendusortide. The patient population has been narrowed to those with high-grade serous ovarian cancer, a group where the PDC has shown preliminary efficacy.
The ongoing trial is anticipated to provide valuable insights into the treatment of platinum-resistant ovarian cancer, a condition with limited effective treatment options. Preliminary antitumor activity of the PDC was presented at the 2023 American Society of Clinical Oncology annual meeting. More information on the study can be found at the provided ClinicalTrials.gov link.
Sudocetaxel zendusortide, known as TH1902, is a groundbreaking PDC that employs a cleavable linker to connect a proprietary peptide with docetaxel, an established chemotherapeutic agent. The FDA has granted Fast Track designation for the treatment of sortilin-positive recurrent advanced solid tumors that are unresponsive to standard treatments. Theratechnologies' SORT1+ Technology™ platform is designed to develop PDCs targeting SORT1, a receptor overexpressed in various tumor types and associated with aggressive disease and poor outcomes.
Theratechnologies is dedicated to developing and commercializing innovative therapies for unmet medical needs. The company's SORT1+ Technology™ platform is a significant part of their oncology pipeline. 

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