TOLREMO therapeutics AG, the startup on a mission to prevent non-genetic cancer drug resistance, has dosed the first patient in its first-in-human clinical trial evaluating the safety and tolerability, pharmacokinetics, and pharmacodynamics of its lead candidate, TT125-802, in patients across a range of solid tumor indications.
TT125-802 is an orally available small molecule CBP/p300 bromodomain inhibitor designed to prevent non-genetic cancer drug resistance and thereby improve the response rates and durability of targeted cancer treatments. In preclinical testing, the compound has demonstrated the ability to block critical transcriptional resistance pathways responsible for cancer’s earliest escape mechanisms to targeted therapies, providing the foundation for translating the findings into the clinical setting.
“By specifically inhibiting transcriptional resistance pathways to targeted treatments, TT125-802 has the potential to profoundly improve the response rate and durability of other therapeutic interventions,” said Alessandra Cesano, MD, PhD, consulting Chief Medical Officer at TOLREMO therapeutics.
The first-in-human trial marks a key milestone for TOLREMO on its journey to addressing non-genetic cancer drug resistance. “With TT125- 802, we are leveraging our scientific insights to develop an effective CBP/p300 inhibitor with the potential to prevent resistance mechanisms across a broad spectrum of current and future targeted cancer treatments,” said Stefanie Flückiger-Mangual, PhD, Co-founder and Chief Executive Officer of TOLREMO. “We are deeply committed to overcoming transcriptionally mediated cancer drug resistance for patient benefit, and this trial marks the start of an exciting new phase for the company.”
The Phase I dose-escalation study will enrol patients across a range of solid tumor indications. The primary objective will be a safety assessment of TT125-802 as a monotherapy. Secondary objectives include the analysis of the drug’s biological activity, pharmacokinetics, pharmacodynamics, and target engagement, as well as the identification of the recommended dosing regimen and potential biomarkers for future patient stratification.
The trial will be conducted initially at clinical centers in Europe, potentially including sites in the U.S. through an open Investigational New Drug (IND) application with the Food and Drug Administration (FDA). Stepwise, TOLREMO will advance TT125-802 into clinical testing in combination with targeted therapies, such as KRAS, EGFR or AR inhibitors, in specific advanced solid tumor indications.
(Press release/RAN)
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