Theratechnologies(US:THTX) globenewswire.com·2024-05-23 21:00Core Insights - Theratechnologies Inc. announced promising Phase 1 data for its investigational peptide drug conjugate, sudocetaxel zendusortide (TH1902), showing long-term efficacy and manageable safety in patients with solid tumors [1][2][9] Study Results - The updated analysis from the Phase 1 clinical trial indicated durable disease stabilization lasting up to 45 weeks after treatment completion, with a clinical benefit rate of 44% in female cancers [2][5] - Sudocetaxel zendusortide demonstrated a unique mechanism of action, including immune cell infiltration in "cold" tumor models and targeting chemotherapy-resistant cancer stem cells [2][7] - The safety profile of sudocetaxel zendusortide was manageable, with few Grade 3 adverse events reported at a dosage of 300 mg/m² [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][10] - The study included patients with prior exposure to taxane-containing regimens, highlighting the significance of the results in a heavily pretreated population [5] Pharmacokinetics - Pharmacokinetic measures showed 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] Company Overview - Theratechnologies is focused on developing innovative therapies to address unmet medical needs, with sudocetaxel zendusortide being the first compound from its SORT1+ Technology™ platform targeting sortilin receptors in various cancers [10][11][12]