MPG spin-off Thermosome starts Phase I trial

First patient dosed with lead program THE001 for the treatment of soft tissue sarcoma

Thermosensive liposomes loaded with active substances (© Thermosome)

Thermosome, a drug development company specializing in targeted tumor therapies, today announced that the first patient has been dosed in April 2023 in the ongoing Phase 1 trial with its lead program THE001. Additional patients will be enrolled following a 6-week monitoring period that includes two treatment cycles. With this lead candidate, the spin-off from the Max Planck Institute for Biophysical Chemistry (now MPI for Multidisciplinary Sciences) is ideally positioned to improve conventional DOX confirmed as  gold standard for the neoadjuvant treatment of LA-STS (locally advanced soft tissue sarcoma).

Thermosome is developing thermosensitive tumor targeting systems that can be used to release active substances enclosed in liposomes in a targeted manner by heating the tissue at the desired site of action. THE001 is a thermosensitive liposomal formulation of doxorubicin (DOX) for the treatment of anthracycline sensitive tumors with locally advanced soft tissue sarcoma (LA-STS) as the lead indication.

The trial will further enroll patients with locally advanced unresectable or metastatic soft tissue sarcoma at two clinical sites in Germany: Helios Klinikum Berlin-Buch and LMU Klinikum, Munich. THE001 will be administered at three dose levels, with three to six patients treated at each dose level (3+3 design). The primary endpoints of the Phase 1, open-label, interventional dose-escalation study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is to evaluate anti-tumor activity.

"We are delighted that the first patient in our Phase I study has been dosed at LMU Klinikum," said Dr. Pascal Schweizer, co-founder and CEO/CFO of Thermosome. "Thermosome has now reached a key corporate milestone by transitioning into a clinical-stage company. We are looking forward to the results of this first-in-human study."  

PD Dr. Dorit Di Gioia, Principal Investigator at LMU Klinikum, added: "Locally advanced soft tissue sarcoma is a disease with a very high unmet medical need, especially when it comes to novel 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 enhance the treatment efficacy of the tumor and for inducing an immune response.”

Patent protected technology

Thermosome´s approach is based on a patent-protected phospholipid (DPPG2), which is incorporated into its thermosensitive liposomes. DPPG2 was invented by Prof. Dr. Hansjoerg Eibl, formerly Professor at the Max Planck Institute for Biophysical Chemistry who focused his research career on novel phospholipids and lipid-based nanocarrier systems. Dr. Florian Kirschenhofer, Start-up and Portfolio Manager at Max Planck Innovation, stated: "We are thrilled to see that research results from basic research at the Max Planck Society have been further developed by Thermosome, resulting in the dosing of the first patient with THE001 and the transition of the company into the clinical stage. This is an important milestone and we hope that this will lead to an improved treatment option for patients in the future."

About Thermosome

Thermosome is a clinical-stage drug development company focused on targeted tumor therapy combined with immune stimulation for improved cancer therapy. At its core is a novel, proprietary tumor targeting approach that allows for significantly increased local drug concentrations and improved tumor penetration to achieve improved clinical treatment efficacy.
The first clinical indication for its lead drug candidate THE001 is soft tissue sarcoma, where the Company aims to improve the current standard of care (free doxorubicin). Thermosome´s approach enables targeted tumor treatment independent of specific molecular targets and covers patient populations across all tumor subtypes. More information:

About LMU Klinikum

"Together. caring. Pioneering." is our claim and our mission. Around 500,000 patients are treated every year at our two locations, Campus Großhadern and downtown Munich. Together with the medical faculty of the Ludwig-Maximilians-University (LMU) Munich, we are one of the leading medical locations nationally and internationally . Our clinic is divided into 28 specialist clinics, thirteen institutes and seven departments. To this end, 53 interdisciplinary centers work together across disciplines. In addition to the outpatient care facilities, around 2,000 beds are available for partial and full inpatient treatment. 1,800 physicians and 3,300 nursing staff take care of the care of our patients directly.
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About MPI for Multidisciplinary Sciences

The Max Planck Institute for Multidisciplinary Sciences was founded on 1 January 2022 through the merger of two existing Göttingen institutes, the MPI for Biophysical Chemistry and the MPI for Experimental Medicine. The two locations of the institutes remained as City Campus and Faßberg Campus. At the Institute, we explore scientific issues ranging from physics and chemistry to structural and cell biology, neuroscience and biomedical research. Basic research in the natural sciences can thus be linked even more effectively with medical research approaches. We are guided by the conviction that great scientific discoveries can be achieved when scientists from different disciplines and research cultures - such as physics, chemistry and biology - work together and exchange ideas in an unbiased way.
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About THE001

Thermosome’s lead drug candidate THE001 is a thermosensitive liposomal formulation of the chemotherapeutic drug doxorubicin (DPPG2-TSL-DOX). It has a different mode of action than conventional liposomes. Thermosome's technology enables intravascular drug release initiated by a mild heat trigger using clinically established hyperthermia devices. This results in up to 15-fold higher local drug concentrations in the tumor and aims to improve clinical treatment efficacy by creating a local boost at the desired site of action. These high local concentrations, which also reach less well perfused areas, are intended to overcome drug resistance. This effect cannot be achieved by administration of conventional doxorubicin due to systemic toxicity. Thermosome intends to further enhance treatment efficacy through an additive immune response induced by regional hyperthermia. THE001 has potential for further development in other anthracycline-sensitive solid tumors, such as breast, bladder, and ovarian cancer.

About Soft Tissue Sarcomas (STS)

STS is an atypical tumor with a patient population that includes many young patients. Locally advanced STS (LA-STS) are large invasive tumors that are difficult or impossible to resect. Neoadjuvant therapy is used to shrink these tumors preoperatively to allow tumor surgery with curative intent. Free doxorubicin in combination with ifosfamide or dacarbazine has been the gold standard for neoadjuvant therapy of all chemo sensitive LA-STS for several decades. Guidelines also recommend combining DOX-based therapy with regional hyperthermia. However, with response rates of less than 30%, there is a significant unmet need for improved treatment options.
Soft tissue sarcomas occur in more than 50 different subtypes, making biologic targeting more difficult than physically controlled targeting with the most active agent. THE001 has been granted European Orphan Drug Designation for STS.

About Max Planck Innovation

As the technology transfer organization of the Max Planck Society, Max Planck Innovation is the link between industry and basic research. With our interdisciplinary team, we advise and support scientists at the Max Planck Institutes in evaluating inventions, filing patents and starting businesses. We offer industry central access to the innovations of the Max Planck Institutes. We are therefore fulfilling an important task: The transfer of results from basic research into commercially and socially useful products.

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