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, patients may gain access to TT125-802 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. For TT125-802, access outside of clinical trials may be considered through expanded access or compassionate use programs, where permitted by applicable regulations

Therefore, TOLREMO may consider requests for expanded access or compassionate use on a case-by-case basis, in accordance with applicable laws and regulations. Use of our investigational medicine outside of well-controlled clinical trials may involve additional risks, as safety and effectiveness are still being evaluated. 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.