Expanded Access Policy

TOLREMO therapeutics AG (TOLREMO) is a clinical-stage biotechnology company developing TT125-802, a novel small-molecule CBP/p300 bromodomain inhibitor designed to block transcriptional networks that drive cancer and drug resistance. We are conducting clinical trials, carefully controlled research studies in patients, to evaluate whether TT125-802 is safe and effective and to obtain regulatory approval from health authorities. Clinical trials are an essential step toward making new treatments widely available. TOLREMO encourages patients, families, and healthcare providers to learn more about our studies. Information about TOLREMO-sponsored clinical trials can be found at www.clinicaltrials.gov by searching for “TOLREMO”.

At present, the only way for patients to gain access to TT125-802 is through participation in our clinical trials. Before regulatory approval by health authorities, investigational treatments may sometimes be provided outside of trials under special programs known as expanded access or compassionate use.

Currently, TOLREMO does not offer an expanded access program. Using our investigational medicine outside of well-controlled clinical trials could put patients at unnecessary risk. We believe that the safest and most appropriate way for patients to receive TT125-802 at this stage of development is within clinical trials, where safety, tolerability, and effectiveness can be closely monitored.