TOLREMO therapeutics has dosed the first subject in a Phase I clinical trial of its lead candidate, TT125-802, in individuals with various types of solid tumours.

The first-in-human, dose-escalation trial will analyse the tolerability, safety, pharmacodynamics, and pharmacokinetics of TT125-802.

In the initial stage, the trial will be carried out at study sites in Europe and, following the receipt of clearance for an investigational new drug (IND) application from the Food and Drug Administration (FDA), will be extended to US sites.

Following this, the company also plans to clinically analyse TT125-802 along with targeted treatments, such as KRAS, EGFR, or AR inhibitors, in particular advanced solid tumours.

A new therapeutic agent for overcoming transcriptional cancer drug resistance, TT125-802 is a small molecule inhibitor of the CBP/p300 bromodomain.

Created to prevent non-genetic cancer drug resistance, the product candidate could potentially increase the response rates and durability of targeted cancer therapies. 

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By GlobalData

TOLREMO therapeutics co-founder and CEO Stefanie Flückiger-Mangual said: “Initiating our Phase I clinical trial is an important corporate milestone for TOLREMO. 

“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.”

In preclinical assessments, the compound showed the potential to hinder key transcriptional resistance pathways that are responsible for the initial escape mechanisms of cancer to targeted treatments.

TOLREMO therapeutics consulting chief medical officer Alessandra Cesano said: “TOLREMO’s in-depth preclinical analyses have showcased potency, selectivity, and safety data that demonstrate that TT125-802 has a highly differentiated profile, providing the foundation for translating these 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.”

In September this year, the company secured $39m in a Series A funding round led by BioMedPartners. 

The financing round also saw participation from Pierre Fabre Invest, a new investor, along with current investors.