Theratechnologies Reports Early Trial Data on Sudocetaxel Zendusortide for Advanced Ovarian Cancer

Theratechnologies Inc., a biopharmaceutical company, has announced promising data from Part 3 of its ongoing Phase 1b trial of sudocetaxel zendusortide (TH1902), its lead investigational peptide drug conjugate (PDC), targeting advanced ovarian cancer. The trial focuses on dose optimization using a weekly dosing schedule in patients who have undergone extensive prior treatments.

Thirteen patients with advanced ovarian cancer, who had not responded to platinum-based and taxane chemotherapy, participated in two different dosing arms. Seven patients in Arm A received a dose of 1.75 mg/kg/week, while six patients in Arm B received a higher dose of 2.5 mg/kg/week, both following a three-weeks-on, one-week-off schedule.

Investigators reported no dose-limiting toxicities in either group. Although there were no responses in the five evaluable patients in Arm A, encouraging signs of activity were observed in three of the six evaluable patients in Arm B. Notably, one patient experienced complete resolution of a liver lesion, and two others had significant tumor shrinkage of more than 25%. Additionally, Arm B participants showed a significant reduction in the CA-125 ovarian tumor marker, receiving an average of 10.25 weeks of treatment compared to 7.6 weeks in Arm A.

Based on these findings, the Medical Review Committee has recommended continued evaluation and exploration of higher doses. The results suggest that sudocetaxel zendusortide can effectively deliver a cytotoxic agent to cancer cells with minimal impact on non-cancerous tissues, potentially leading to further clinical benefits at higher doses.

The trial also revealed that the patients in Arm B received at least two cycles of treatment, with some completing up to four cycles, ranging from 4 to 18 weeks of treatment duration. The trial's protocol was initially amended in 2023 to shift focus to weekly dosing for ovarian cancer patients, following the promising outcomes of Parts 1 and 2 which used an every-three-week dosing schedule. These previous analyses had shown durable disease stabilization in various solid tumors and early indications of efficacy in female cancers such as ovarian, endometrial, and triple-negative breast cancer.

Dr. Ira Winer, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Teams at Karmanos Cancer Center, emphasized the significance of these results. Dr. Winer highlighted the rarity of observing promising efficacy alongside favorable safety and tolerability in such a heavily pre-treated patient group. He advocated for continued investigation and further dose escalation.

Theratechnologies also underscored the extensive preclinical data supporting their SORT1+ Technology™ platform. This platform targets the sortilin receptor (SORT1) and aims to deliver toxic payloads directly into cancer cells. SORT1, expressed in various aggressive tumors, plays a crucial role in protein internalization and trafficking.

Sudocetaxel zendusortide is the first compound from Theratechnologies' SORT1+ Technology™ platform. It employs a cleavable linker to attach a proprietary peptide to docetaxel, a well-known chemotherapeutic agent. The FDA has granted Fast Track designation to sudocetaxel zendusortide for the treatment of sortilin-positive recurrent advanced solid tumors.

Theratechnologies continues to seek partners to advance its oncology program, leveraging the promising clinical and preclinical data collected thus far. The company remains committed to developing innovative therapies that address unmet medical needs in cancer treatment.