TOLREMO therapeutics AG (TOLREMO) has announced the initiation of its Phase 1 clinical trial, with the dosing of the first patient taking place. This trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TT125-802, the company's lead candidate, in patients with diverse solid tumor indications. TT125-802, an orally administered small molecule CBP/p300 bromodomain inhibitor, is strategically developed to combat non-genetic resistance to cancer drugs, ultimately aiming to enhance response rates and treatment durability for targeted cancer therapies. In preclinical evaluations, the compound has shown efficacy in blocking critical transcriptional resistance pathways responsible for early resistance to targeted therapies in cancer.

TOLREMO, emphasized the significance of this Phase 1 trial, considering it a pivotal milestone for the company. She underscored that TT125-802 represents a strategic effort to develop a potent CBP/p300 inhibitor capable of preventing resistance mechanisms across a broad spectrum of targeted cancer treatments. The commencement of the trial marks the beginning of a promising phase for the company in its quest to overcome transcriptionally mediated cancer drug resistance.

The Phase 1 dose-escalation study will enroll patients with various solid tumor indications, focusing primarily on assessing the safety of TT125-802 as a monotherapy. Secondary objectives include analyzing the drug's biological activity, pharmacokinetics, pharmacodynamics, and target engagement. Additionally, the trial aims to identify the recommended dosing regimen and potential biomarkers for future patient stratification. Initially conducted at clinical centers in Europe, the trial may expand to include U.S. sites through an open Investigational New Drug (IND) application with the Food and Drug Administration (FDA). TOLREMO plans to progress TT125-802 into clinical testing in combination with targeted therapies, such as KRAS, EGFR, or AR inhibitors, for specific advanced solid tumor indications.

TOLREMO therapeutics, highlighted the differentiated profile of TT125-802 based on in-depth preclinical analyses. The compound's potency, selectivity, and safety data provide a solid foundation for translating these findings into the clinical setting. By specifically inhibiting transcriptional resistance pathways to targeted treatments, TT125-802 holds the potential to significantly enhance response rates and durability for various therapeutic interventions, representing a promising advancement in cancer treatment.

 

Source: businesswire.com

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