Regardless of whether it's a pharmaceutical company or a startup, anyone who wants to bring a new drug to market must go through a multi-stage process to prove both the efficacy and safety of their active ingredient. The Munich-based biotech startup Thermosome has now taken another step along this path and Phase I Clinical trials have begun. With the help of volunteers, these tests examine whether the drug raises no relevant safety issues and can reach the target area in the body and remain there long enough to exert its effect. They also aim to provide preliminary evidence that the new drug has therapeutic value.
In the case of Thermosome, the drug in question is THE001, a temperature-sensitive nanocarrier. This is designed to release the actual active ingredients only at a specific target site, namely the tumor to be treated. To achieve this, Thermosome uses a special device to slightly heat the tumor compared to the surrounding tissue. This protects healthy tissue. Compared to conventional drug delivery, this is intended to achieve up to 15 times higher local drug concentrations in the diseased tissue.
The study, which has now begun, will enroll patients with locally advanced, inoperable or metastatic soft tissue sarcoma at the Helios Klinikum Berlin-Buch and LMU Klinikum. They will receive THE001 in three dose levels, with three to six patients treated at each dose level (3+3 design). the startup As announced recently, the first patient received the first dose in April. Additional patients are expected to follow after a 6-week observation period, which includes two treatment cycles.
“Thermosome has reached an important entrepreneurial milestone”
“We are pleased that the first patient in our Phase I study was treated at the LMU Hospital,”
says Dr. Pascal Schweizer, Co-founder and CEO/CFO of Thermosome.
"Thermosome has now reached an important corporate milestone by transitioning to a clinical-stage company. We look forward to the results of this first-in-human study."
PD Dr. Dorit Di Gioia, study director at LMU Hospital, adds:
"Locally advanced soft tissue sarcoma is a disease with a very high medical need, particularly when it comes to new therapeutic options for the neoadjuvant treatment of patients with localized high-grade tumors. While standard doxorubicin-based chemotherapy has only a modest effect, THE001, in combination with regional hyperthermia, can achieve up to 15-fold higher local doxorubicin concentrations. This offers significant potential to improve the efficacy of tumor treatment and induce an immune response."
