On September 15, 2026 TOLREMO therapeutics AG (TOLREMO), a clinical-stage biotechnology company pioneering therapies targeting non-oncogene addiction in cancer, reported the completion of its Phase I study of monotherapy TT125-802 (NCT06403436) and the presentation of final clinical data from the study at the 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea. The data highlights TT125-802’s confirmed clinical activity as monotherapy in drug-resistant NSCLC and supports CBP/p300 inhibition as a novel therapeutic strategy to address transcriptional drug resistance in solid tumors.
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The completed study enrolled 45 patients with advanced solid tumors, including 24 patients with NSCLC. 10 of 24 patients (42%) experienced tumor shrinkage, including three confirmed partial responses observed in distinct resistance settings: primary resistance to first-line EGFR inhibition (osimertinib), acquired resistance to KRAS-G12C inhibition (elironrasib), and in SOX2-amplified squamous NSCLC following progression on chemo-immunotherapy.
"The completion of our Phase I marks an important milestone for TOLREMO and provides strong clinical evidence supporting our strategy of targeting non-oncogene addiction and transcriptional resistance mechanisms in cancer," said Stefanie Flückiger-Mangual, Ph.D., Chief Executive Officer and Co-founder of TOLREMO therapeutics. "The final data show durable monotherapy anti-tumor activity across biologically distinct forms of drug resistance in NSCLC. This validates our core scientific platform and positions TT125-802 as a foundational therapy capable of extending the reach and durability of existing targeted regimens."
TT125-802 demonstrated a favorable and differentiated safety profile without thrombocytopenia across the 45-patient study population. 98% of treatment-related adverse events were Grade 1 or Grade 2, reversible and manageable. The most frequently reported treatment-related adverse events included dysgeusia and low grade hyperglycemia.
"The recommended dose of 60 mg once a day without food restriction delivers continuous target coverage and anti-tumor activity in drug-resistant NSCLC, while the favorable safety profile and absence of thrombocytopenia support the development of TT125-802 as a combination partner for targeted therapies," said Alessandra Cesano, MD, Ph.D., CMO of TOLREMO therapeutics. "We are now positioned to evaluate whether simultaneously inhibiting oncogenic signaling and CBP/p300-dependent transcriptional escape can generate deeper and more durable therapeutic responses in our next study."
The final Phase 1 monotherapy dataset was presented at WCLC in the poster "TT125-802, a Selective Clinical Bromodomain Inhibitor of CBP/p300, Targeting Transcriptional Resistance Mechanisms in NSCLC." First author Martina Imbimbo, M.D., Medical Oncologist at the Oncology Institute of Southern Switzerland (IOSI) in Bellinzona, provides expert commentary on the findings and the emerging role of CBP/p300 inhibition in drug-resistant NSCLC in a video discussion available on the TOLREMO website.
(Press release, TOLREMO, SEP 15, 2026, View Source [SID1234670867])