Theratechnologies(US:THTX) Newsfilter·2024-05-23 21:00Core Insights - Theratechnologies Inc. announced Phase 1 data showing long-term efficacy and manageable safety profile of its lead investigational peptide drug conjugate, sudocetaxel zendusortide (TH1902), in patients with solid tumors [1][2] Study Results - Sudocetaxel zendusortide induced durable disease stabilization lasting up to 45 weeks beyond treatment completion, with a clinical benefit rate of 44% in female cancers [2][5] - The drug demonstrated a unique multimodal mechanism of action, including immune cell infiltration in "cold" tumor models and targeting chemotherapy-resistant cancer stem cells [2][7] - The safety profile was manageable at a dose of 300 mg/m2, with few Grade 3 adverse events reported [2][6] Clinical Trial Details - The Phase 1 trial consists of three parts: Part 1 focused on safety and tolerability with 18 patients, Part 2 involved dose expansion with another 18 patients, and Part 3 is ongoing for dose optimization in platinum-resistant ovarian cancer [4][9] - The study included patients with prior exposure to taxane-containing regimens, highlighting the significance of prolonged disease stabilization in this heavily pretreated population [5][6] Pharmacokinetics - Pharmacokinetic measures indicated that exposure to free docetaxel was significantly lower than that for sudocetaxel zendusortide, which may explain the reduced incidence and severity of adverse events [8] - The maximum concentration (Cmax) of sudocetaxel zendusortide was 30.4 μM, compared to 0.58 μM for free docetaxel, indicating a favorable pharmacokinetic profile [8] Future Outlook - The company is well-positioned for Part 3 of the study, aiming to optimize the dose for further efficacy while limiting toxicity [9][10] - Sudocetaxel zendusortide is the first compound from the SORT1+ Technology™ platform, targeting sortilin receptors expressed in various aggressive cancers [10][11]