Basel, Switzerland – October 17, 2025, TOLREMO therapeutics AG (TOLREMO) today announced encouraging clinical data from 34 patients with advanced solid tumors treated with TT125-802 in the dose escalation part of an ongoing first-in-human study (NCT06403436). The data will be presented on October 19 at the European Society of Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, and highlights TT125- 802’s confirmed clinical activity and favorable safety profile.
”We will now initiate a combination study investigating the efficacy of TT125-802 in combination with an EGFR inhibitor and a KRAS-G12C inhibitor in the respective oncogene-driven NSCLC populations, and with docetaxel in squamous NSCLC patients. We look forward to demonstrating the full therapeutic potential of TT125-802 for patients in need.
Stefanie Flückiger-Mangual, Ph.D.CEO and co-founder of TOLREMO
TT125-802 is an orally available small-molecule inhibitor that selectively blocks the bromodomains of CBP/p300, transcriptional co-activators implicated in non-oncogene addiction – a key driver of cancer and drug resistance that functions in parallel to oncogenic pathways. This update expands on initial data presented at ASCO earlier this year, establishing TT125-802 as the first CBP/p300 bromodomain inhibitor to report clinical activity across a variety of solid tumors, including durable confirmed responses in non-small cell lung cancer (NSCLC).
In the now completed dose escalation part of the study, 34 heavily pre-treated solid tumor patients received TT125-802 across 5 dose escalation cohorts (15 mg QD – 60 mg BID) and 2 cohorts examining the role of food on exposures. No MTD was reached and TT125-802 was safe and well tolerated.
About TOLREMO
TOLREMO therapeutics is redefining cancer treatment by targeting non-oncogene addiction – a fundamental driver of cancer and drug resistance that functions in parallel to oncogenic pathways. We uncovered the epigenetic regulator CBP/p300’s role as a key mediator in this process, in addition to being a validated target in liquid tumors. Our small molecule inhibitor of CBP/p300’s bromodomain, TT125-802, is differentiated from other agents in the class by lack of significant hematologic toxicities, specifically thrombocytopenia, which allows for higher dosing required for anti-tumor activity. It is the first CBP/p300 bromodomain inhibitor to report single-agent activity in solid tumors. By selectively blocking CBP/p300’s multi-modal functions, TT125-802 has transformative potential across solid tumors and hematologic malignancies, both as monotherapy and in combination with standard-of-care therapies. Enabled by TT125-802’s broad applicability, TOLREMO strives to deliver an impactful and durable clinical benefit to cancer patients in need. Visit tolremo.com.
