- Independent Data Safety Monitoring Board declared dose level 2 as safe and recommended escalation to final dose level 3

Munich, Germany – December 4, 2024 – Thermosome, a drug development company focused on targeted tumor therapies, today announced its ongoing Phase I trial has progressed to dose level 3 (DL3) after the independent Data Safety Monitoring Board (DSMB) declared dose level 2 (DL2) as safe and recommended escalation to the final dose level (DL3). In the trial, the Company’s lead compound THE001 is tested in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS) in combination with regional hyperthermia. To date, the safety profile remains favorable with no dose-limiting toxicities and no suspected unexpected serious adverse event (SUSAR) seen at DL1 and DL2, respectively. Most adverse events were low-grade (CTCAE ≤ grade 2), reversable, and were to be expected for the active pharmaceutical ingredient doxorubicin.

„After observing early signs of efficacy in our ongoing trial, this is another important milestone for our company, as it proves that THE001 can be administered safely,“ said Dr. Frank Hermann, CMO of Thermosome.