• Leveraging the transformative potential of TSL-based tumor targeting
• Supporting the progress of Thermosome's clinical candidate THE001

Munich, Germany – September 19, 2023 – Thermosome, a drug development company specializing in targeted tumor therapies, today announced the formation of a Clinical Advisory Board to support the advancement of its lead compound THE001 through clinical development.

The board consists of leading international cancer specialists in the fields of soft tissue sarcoma and bladder cancer, experts in hyperthermia, immunotherapy, and surgery/neoadjuvant therapy:

• Prof. Lars Lindner (Chairman) is co-founder of Thermosome and an experienced oncologist with a strong professional focus on sarcoma, regional hyperthermia, and liposomes. He is a Senior Consultant in Hematology and Oncology, Head of the Sarcoma Center and the Hyperthermia Unit at the University Hospital of Ludwig-Maximilians-University (LMU) Munich. Moreover, he leads/co-leads the European Society of Hyperthermic Oncology, the Sarcoma and GIST Working Group of the AIO, the Sarcoma Study Group of the Bavarian Cancer Research Center (BZKF), the Certification Commission of the German Sarcoma Centers, and the Project Group Bone and Soft Tissue Sarcoma of the Munich Cancer Center. Prof. Lindner has published more than 130 peer-reviewed papers and has been appointed Full Professor of Sarcoma Treatment in 2019.
• Prof. Alexander Eggermont specializes in preclinical and clinical / translational oncology and is a specialist in immunotherapy research and the treatment of melanoma and sarcoma. He is Professor of Clinical and Translational Immunotherapy, University Medical Center, and Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, Utrecht (The Netherlands). He is also a Fellow of the National Institutes of Health’s National Cancer Institute (NIH-NCI), a strategic advisor to the Comprehensive Cancer Center Munich CCCM (Germany) and is currently Editor-in-Chief of the European Journal of Cancer. He previously served as the General Director of the Gustave Roussy Cancer Center Campus Grand Paris, is a Professor Emeritus of Oncology at the Paris-Sud University, and a Professor Emeritus of Oncological Surgery at the Erasmus University Rotterdam. Dr. Eggermont has served as President of ECCO, EORTC, the European Academy of Cancer Sciences and of Cancer Core Europe and was a member of the Board of Directors of ASCO. He also served on the Editorial Board of the Journal of Clinical Oncology. He has published more than 900 peer-reviewed papers and received numerous professional awards throughout his career.
• Prof. Antoine Italiano  is an experienced expert in sarcoma and immuno-oncology with a keen interest in translational research aspects related to sensitivity and resistance to targeted therapies, notably in soft-tissue sarcoma models. He is Head of Early Phase Trials and Sarcoma Units, Institut Bergonié, Bordeaux, and Head of Precision Medicine, Gustave Roussy, Paris (France). Antoine Italiano has been a Principal Investigator of more than 120 Phase I  trials in solid tumors during the past 5 years as well as more than 50  Phase II and Phase III trials. He is a member of ASCO, AACR, and ESMO, a peer reviewer for several oncology journals and has contributed to more than 450 peer-reviewed publications.
• Prof. Shreyaskumar Patel  is a medical oncologist focusing on soft tissue sarcomas (STS), with clinical research interests including systemic therapy for sarcomas, GISTs, and other tumors originating in bone and soft tissues. He is the Robert R. Herring Distinguished Professor of Medicine and Medical Director of the Sarcoma Center at The University of Texas MD Anderson Cancer Center, Houston TX (USA). Prof. Patel is a member of the SARC Scientific Steering Committee, Chair of the Medical Advisory Board and a member of the Board of Directors of the Chordoma Foundation. He has served as President of the Connective Tissue Oncology Society (CTOS), has authored or co-authored more than 300 articles in peer-reviewed journals and has been Section Editor for the Sarcoma Section of Current Oncology Reports since 2000.
• Prof. Peter Reichardt focuses on neoadjuvant therapy and hyperthermia and is the Principal Investigator of Thermosome's ongoing Phase 1 study. He is Medical Director and Chief Physician Oncology and Palliative Medicine at the Clinic for Interdisciplinary Oncology, Helios Clinic, Berlin-Buch (Germany), and Head of the clinic's Sarcoma Center Berlin-Brandenburg. Previously, Prof. Reichardt held several positions of increasing responsibility with a focus on hematology, oncology, and tumor immunology at Charité Universitätsmedizin Berlin, including senior physician at Robert-Rössle-Klinik, Charité Campus Buch. He also held medical positions at Heidelberg University Hospital and M.D. Anderson Cancer Center, Houston, Texas, USA. Prof. Reichardt is a member of several international societies, including the guideline commissions for STS, Bone Sarcoma and GIST of the German Society for Hematology and Oncology (DGHO). Prof. Reichardt has published nearly 200 peer-reviewed papers.
• Prof. Fred Witjes is an experienced urologist and a specialist in bladder cancer, prostate cancer, and testicular cancer, including hyperthermia therapy for bladder cancer. He is Professor of Oncological Urology at Radboud UMC, Nijmegen (The Netherlands). Prof. Witjes is a member of several international societies, and chairs, among others, the EAU Guidelines Committee on Metastatic and Muscle-Invasive Bladder Cancer. He is an editor of several urological and oncological journals. Prof. Witjes has given numerous lectures and published nearly 700 peer-reviewed publications, reviews, and book chapters.

“We are very pleased to have such an experienced international group of oncology experts with diverse backgrounds joining our Clinical Advisory Board,” said Dr. Pascal Schweizer, co-founder and CEO/CFO of Thermosome. “Their outstanding expertise will be a tremendous asset in advancing our products through clinical development.”

“Thermosome is pursuing a very promising approach in targeted tumor therapy combined with immune stimulation,” said Prof. Lars Lindner, Chairman of Thermosome's Clinical Advisory Board and co-founder of Thermosome. “I am therefore very pleased to chair a Clinical Advisory Board that includes so many recognized and respected international experts with outstanding research and clinical track records. Thermosome is now in a position to access the vast experience and network that these experts bring to the table.“

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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: www.thermosome.com

About THE001

Thermosome’s clinical-stage 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.

Company Contact
Thermosome GmbH
Am Klopferspitz 19
82152 Planegg/Martinsried
phone + 49 89 7167760 31
media@thermosome.com

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