Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX), a biopharmaceutical leader focused on innovative therapy developments, has revealed Phase 1 clinical data suggesting long-term efficacy and a manageable safety profile for its novel peptide drug conjugate (PDC), sudocetaxel zendusortide (TH1902). The findings will be shared during a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, which will take place from May 31 to June 4, 2024.

Durable Disease Stabilization and Multimodal Action

The ongoing Phase 1 trial’s updated analysis from Parts 1 and 2 indicated that sudocetaxel zendusortide could sustain disease stabilization for up to 45 weeks post-treatment, an outcome that underscores its potential as a transformative cancer therapy. Notably, the drug demonstrated a multimodal mechanism of action, differentiating it from existing cancer treatments. This includes the induction of immune cell infiltration in tumor environments typically resistant to such responses, targeting chemotherapy-resistant cancer stem cells, and stimulating the cGAS/STING immune pathway.

Prominent Efficacy in Female-Related Cancers

A compelling aspect of the trial’s results was the observed efficacy in cancers predominantly affecting women, such as ovarian, endometrial, and triple-negative breast cancer (TNBC). Out of 16 evaluated participants, 44% benefited clinically from the treatment, with responses ranging from complete and partial remissions to stable disease, as confirmed via the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Expert Insights and Future Directions

“The durability of disease stabilization seen with sudocetaxel zendusortide, even after treatment cessation, is highly unusual and promising, particularly in patients with advanced-stage diseases,” noted Dr. Ira Winer, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Associate Professor of Oncology at Wayne State University. This robust data set serves as a foundation for the next phase of trials, focusing on optimizing dosage for patients with platinum-resistant ovarian cancer.

Phase 1 Trial Design and Implications

The trial consists of three parts: initial dose escalation, dose expansion targeting cancers with high sortilin (SORT1) receptor expression, and ongoing dose optimization specifically for advanced ovarian cancer. These structured segments are crucial for precisely assessing the treatment’s safety, tolerability, and efficacy across different tumor types and treatment histories.

A Novel Approach to Cancer Treatment

Sudocetaxel zendusortide stands out as a first-in-class SORT1-targeting PDC, incorporating a cleavable linker to attach a proprietary peptide to docetaxel, a widely used chemotherapeutic agent. This innovative approach, bolstered by Fast Track designation from the FDA for treating all sortilin-positive recurrent advanced solid tumors, marks a significant advancement in targeted cancer therapy.

Theratechnologies is committed to further developing its SORT1+ Technology platform, aimed at creating PDCs that effectively target SORT1, a receptor linked to aggressive cancers and poor prognosis. The ongoing Phase 1 trial continues to provide vital insights into the potential of sudocetaxel zendusortide in revolutionizing cancer treatment, with forthcoming trials poised to explore deeper into its therapeutic efficacy and safety profile.

  ASCO 2024, cancer therapy innovation, oncology research, peptide drug conjugate, Phase 1 Clinical Trial, solid tumor treatment, sudocetaxel zendusortide, Theratechnologies