News

• 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. „Of note, there were no signs of renal or cardiac impairment and no dedicated formulation-related adverse events such as infusion-related reactions due to the innovative liposomal formulation. No trial participant had to discontinue treatment due to adverse events. Together with the previously reported pharmacokinetic and anti-tumor activity data, the overall data from the trial look very encouraging as of now. They underline the great potential of THE001 plus regional hyperthermia in STS as a tolerable, innovative treatment modality that has significantly improved local clinical activity with non-inferior systemic exposure to doxorubicin, but with a favorable pharmacokinetic profile.“
„Overseeing various programs from the past, present and future of local treatment modalities, the initial clinical data of THE001 plus regional hyperthermia look very encouraging – not only from a clinical activity perspective in a heavily pre-treated patient population suffering from soft tissue sarcoma, but also from a pharmacokinetic and safety perspective,” said Prof. Alexander Eggermont, Professor of Clinical and Translational Immunotherapy at the University Medical Center Utrecht (The Netherlands) and a member of Thermosome’s Clinical Advisory Board. „For such innovative approaches, it is crucial to first demonstrate that there are no specific risks to patients, which the independent Data Safety Monitoring Board´s safety clearance indicates not only for DL1 but now also for DL2. I look forward to seeing the further development in DL3 and beyond. In my view, THE001 plus regional hyperthermia has great potential to be a promising tumor-targeted approach in STS and beyond.” 

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 the Phase I Study
The Phase I, open-label, interventional dose-escalation trial enrolling patients with locally advanced unresectable or metastatic STS (NCT05858710) is being conducted at two German clinical sites testing THE001 at 3 different dose levels in initially up to 6 cycles every 3 weeks. The initial dose level of 20 mg/m² (DL1) was well tolerated and progressed to 40 mg/m² (DL2) in February 2024. At the last dose level, patients will receive 50 mg/m² (DL3). Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity. Initial clinical data were presented at the CTOS 2024 Annual Meeting (link).

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 not having a common driver mutation, 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

• THE001 safe and well tolerated in first two dose level, demonstrating encouraging signs of clinical activity
• Data presented at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024

Munich, Germany – November 19, 2024 – Thermosome, a drug development company focused on targeted tumor therapies, today announced encouraging initial clinical data from the ongoing Phase I study of its lead compound THE001 in patients with heavily pre-treated, locally advanced unresectable or metastatic soft tissue sarcoma (STS). The data were presented as a poster (#P410) titled “Phase I study of THE001 (DPPG2-TSL-DOX) combined with regional hyperthermia in patients with locally advanced or metastatic soft tissue sarcoma” at The Connective Tissue Oncology Society (CTOS) Annual Meeting 2024, in San Diego, USA.

The Phase I, open-label, interventional dose-escalation study enrolling patients with locally advanced unresectable or metastatic STS is being conducted at two German clinical sites. THE001 is planned to be administered at three dose levels at 20 mg/m² (DL1), 40 mg/m² (DL2), and 50 mg/m² (DL3), respectively, in initially up to 6 cycles every 3 weeks (main study phase). Earlier this year, the independent Data Safety Monitoring Board confirmed the safety of DL1, and the study progressed to DL2. Based on durable clinical benefit in two out of four patients, the study duration has been extended to a total maximum of up to 12 cycles in spring 2024 (treatment continuation phase) in patients with stable disease per RECIST criteria. Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity.

Following the data cut-off for the CTOS poster, further encouraging clinical data were reported in these heavily (including Doxorubicin) pre-treated patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS). The safety profile observed so far was favorable in both DL1 and DL2, and the study treatment is generally well-tolerated with the majority of adverse events being low-grade as well as expected for doxorubicin with no evidence of adverse events related to the innovative liposomal formulation. With regards to anti-tumor activity, an overall 5 out of 6 efficacy-evaluable patients in DL1 and DL2 achieved local disease control and 4 out of 6 achieved stable disease (SD) per RECIST. In DL2, all 3 out of 3 patients were evaluated as stable disease (SD) per RECIST after the initial tumor restaging (3 cycles). While two patients have not yet reached the tumor staging after 6 cycles (end of the main study period), one patient remained in stable disease per RECIST for 9 cycles (representing a progression-free survival of 7 months) and showed evidence of a pathological response in MRI/PET-CT imaging at the end of the main study period, representing a partial response (PR) per Choi. To put this in context, systemic doxorubicin monotherapy at the standard dose (75 mg/m²) in the first-line setting, which is a 2-4x higher dose compared to THE001 in DL1 and DL2, respectively, is reported with a median progression-free survival of 2.7 months in the MEDISARC Phase 2 study.

“Presenting the first clinical data for THE001 in combination with regional hyperthermia is an important milestone for Thermosome,” said Dr. Frank Hermann, CMO of Thermosome. “The data not only confirm the galenic principle of thermosensitive liposomes releasing almost complete doxorubicin upon heat-triggered regional hyperthermia in humans, but also the safe application to date with no formulation-related adverse events. In addition, the first signs of clinical activity in these heavily pre-treated palliative patients are very encouraging and support our efforts to accelerate the clinical development program in soft tissue sarcoma.”

“We are very pleased with these encouraging data, in particular with the signs of efficacy shown in our first clinical trial,” added Pascal Schweizer, CEO of Thermosome. “The findings clearly demonstrate that THE001 is an innovative approach for tumor-targeted drug enhancement in STS.” 

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 not having a common driver mutation, 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

• Experienced biopharma professional focused on drug product development

Munich, Germany – June 11, 2024 – Thermosome, a drug development company focused on targeted tumor therapies, today announced the appointment of Dr. Sabine Hauck as Chief Technology Officer (CTO).

Dr. Sabine Hauck is a highly experienced biopharmaceutical professional. She has been working in the field of drug product development in biopharma and specialty pharma for more than 20 years. Notably, she brings more than a decade of experience with liposomal products. Her expertise covers process development, chemistry, manufacturing and controls as well as bioanalytics, quality management and regulatory affairs. Sabine joins Thermosome from Leukocare AG, where she was Executive Vice President Corporate Development. During her professional career, which has included roles at Medigene AG and IDEA AG, Sabine was actively involved in bringing liposomal drug candidates into clinical Phase III studies and registration. She was also responsible for regulatory affairs and international registration procedures. She succeeds Thermosome’s former Chief Operating Officer, Dr. Uwe Michaelis.

“We are very pleased to welcome Sabine at Thermosome as Chief Technical Officer,” said Dr. Pascal Schweizer, co-founder and CEO/CFO of Thermosome. “With her impressive track record in developing liposomal drug candidates and managing CMC for late-stage clinical studies, including quality assurance and regulatory affairs, she joins Thermosome as it transitions to the next development stage. I am sure Sabine´s expertise will be an invaluable asset to the entire organization.”

“I am excited to join Thermosome and to support the further clinical development of THE001,” said Dr. Sabine Hauck, Chief Technology Officer of Thermosome. “I am fascinated by the technology that enables hyperthermia-induced, intra-tumoral release of anti-cancer therapeutics. Thermosome’s approach holds great promise for targeted tumor therapies.”

Pascal Schweizer added: “I would like to express my deepest gratitude to Uwe Michaelis, who has been instrumental in transforming Thermosome into a clinical-stage biotech company. He joined our team four years ago, overseeing all CMC activities and contributing to our development from research to development stage. Under his guidance, we established the GMP manufacturing processes for our proprietary lipid DPPG2 and THE001, our temperature-sensitive liposomal formulation of Doxorubicin. Without Uwe’s expertise, dedication and passion, THE001 would not be in Phase I clinical development for the treatment of soft tissue sarcoma.” 

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 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

• First dose level rated as safe by independent Data Safety Monitoring Board
• Second dose level to be administered according to plan
• THE001 designed as targeted tumor treatment independent of specific molecular targets or tumor subtypes

Munich, Germany – February 6, 2024 – Thermosome, a drug development company specializing in targeted tumor therapies, today announced that it received clearance by the independent Data Safety Monitoring Board (DSMB) to proceed as planned with the dose escalation in its ongoing Phase I trial of its lead program THE001. The first dose level was safe and well tolerated as assessed by the DSMB.

The Phase I, open-label, interventional dose-escalation trial is enrolling patients with locally advanced unresectable or metastatic soft tissue sarcomas at two German clinical sites: Helios Klinikum Berlin-Buch and LMU Klinikum, Munich. THE001 is planned to be administered at three dose levels. The first dose level was 20mg/m², the second, recently initiated dose level is 40mg/m². Primary endpoints of the study are the safety and tolerability of THE001 and the determination of the maximum tolerated dose. A secondary objective is the evaluation of anti-tumor activity.

“This is an important milestone in our ongoing trial, and we are happy to have reached the second dose level according to plan,” said Dr. Frank Hermann, MD, Chief Medical Officer (CMO) of Thermosome. “The independent Data Safety Monitoring Board has assessed that our lead candidate is safe and well tolerated at the first dose level. We are now looking forward to the results of the next dose level.”

Prof. Dr. Peter Reichardt, Principal Investigator of the trial, Head, Department of Oncology and Palliative Care, and Director of the Cancer Center Berlin-Buch, added: “We are very pleased to see safety and tolerability of THE001 in the first patients. Soft tissue sarcomas are large invasive tumors that are difficult to treat and are associated with a very poor prognosis. The response rate with available therapies is less than 30%, leaving a huge unmet medical need. I am excited to take part in this promising effort to develop a safe and effective treatment for STS patients that today have a very poor prognosis.”

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 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

Munich, Germany – September 19, 2023 – Thermosome, a drug development company specializing in targeted tumor therapies, today announced the appointment of Dr. Frank Hermann, MD, as Chief Medical Officer (CMO) and the expansion of its Clinical Advisory Board with the addition of Prof. Alessandro Gronchi, MD.

Dr. Frank Hermann, MD, is a proficient clinical oncology professional with extensive experience in medical affairs, clinical research, and development. Before joining Thermosome, Frank Hermann was Vice President Clinical Development at CatalYm GmbH. Prior to that, he was Senior Director Clinical Development Oncology at BioNTech SE and Chief Development Officer at 4SC AG. Earlier in his career, Frank Hermann worked in medical affairs and clinical development at Bristol-Myers Squibb, most recently as Associate Medical Director Immuno-Oncology. Frank Hermann studied medicine at Johannes Gutenberg University Mainz, where he also obtained his Board Certification in Pediatrics and worked for several years as an assistant physician and research assistant in the field of pediatric oncology, hematology and radiology at the University Hospital Giessen and Marburg. He succeeds Thermosome´s previous Chief Development Officer Dr. Klaus Fischer, who has held a freelance, part-time role and will continue to work as a consultant for Thermosome.

Prof. Alessandro Gronchi, MD, is a surgeon specializing in sarcomas (STS). He is Chair of the Surgical Department at the Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan (Italy) and has been Chief of the Sarcoma Service at the institute since 2001. Prof. Gronchi serves on the board of directors of the Italian Sarcoma Group (ISG) and of the European Society of Surgical Oncology (ESSO) and the executive council of the Society of Surgical Oncology (SSO). Moreover, he is past President of the Connective Tissue Oncology Society (CTOS) and the Italian Society of Surgical Oncology (SICO) and past Chair of the European Organization for Research and Treatment in Cancer (EORTC) – Soft Tissue and Bone Sarcoma Group (STBSG). Finally, he is one of the initiators of a global collaborative effort on retroperitoneal sarcoma (Trans-atlantic Australasian RetroPeritoneal Sarcoma Working Group, TARPSWG), which involves over 200 institutions worldwide. Prof. Gronchi is Principal Investigator of several international controlled clinical trials on sarcomas, fibromatosis and gastrointestinal stromal tumors and has authored more than 500 scientific publications (Scopus h-index 96). He serves as Associate Editor of Annals of Surgical Oncology, Critical Reviews in Oncology/Hematology, Therapeutics Advances in Medical Oncology and Updates in Surgery.

“We are very pleased that Frank is joining Thermosome as Chief Medical Officer,” said Dr. Pascal Schweizer, co-founder, and CEO/CFO of Thermosome. “He has a strong twenty-year track record as a clinician and in development and is very experienced in advancing novel cancer drugs through clinical development. Moreover, it is an honor to welcome Prof. Alessandro Gronchi to our Clinical Advisory Board. He is one of the leading European sarcoma experts and is a widely recognized authority in this field. Finally, I would like to express my sincere gratitude to Klaus, who has developed and led the transformation of Thermosome into a clinical-stage biotech company.”

“I am excited to join Thermosome at this important development stage,” added Dr. Frank Hermann, Chief Medical Officer at Thermosome. “I look forward to further advancing the Company´s lead program THE001 through clinical development. There is a significant unmet medical need for targeted tumor therapies that are designed to eliminate soft tissue sarcomas with improved precision and potency – and this is exactly where THE001 comes into play.”

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 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

• 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.“

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 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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68

• IMAGIO consortium of clinical partners coordinated by Philips receives EUR 24 million grant from the Innovative Health Initiative (IHI) and additional funding from industry partners to support the research tracks
• Consortium aims to improve clinical outcomes through less invasive treatments for lung cancer, liver cancer and soft tissue sarcomas

Munich, Germany – May 24, 2023 – June 20, 2023 – Thermosome, a drug development company specializing in targeted tumor therapies, today announced its participation in the IMAGIO consortium set out to develop innovations in interventional oncology focused on lung cancer, liver cancer and soft tissue sarcomas (STS). The IMAGIO consortium, consisting of approximately 30 clinics, academic institutes, healthcare companies, and patient organizations, has been awarded a EUR 24 million grant from the Innovative Health Initiative, complemented by additional funding from industry partners to conduct research on less invasive cancer treatments.

Thermosome will receive EUR 1.3 million of funding and will participate in the work package “Multimodal MR-HIFU (Magnet Resonance-High Intensity Focused Ultrasound) enabled therapy for sarcoma”, which will be carried out by a group of partners coordinated by Prof. Dr. Holger Grüll, Chair of Experimental Imaging and Image-Guided Therapy at the University Hospital of Cologne, Germany. Further participants in the work package are Profound Medical, Philips, Turku University Hospital, and Gremse IT.

As part of the work package, the University Hospital of Cologne will conduct an investigator-initiated trial (IIT) to demonstrate the feasibility of targeted doxorubicin administration to tumors in combination with the Sonalleve® MR-HIFU system (Profound Medical). The Sonalleve® MR-HIFU system consists of Profound’s high intensity focused ultrasound system integrated into a Philips magnetic resonance imaging (MRI) device and allows focal heating of tumor tissue to hyperthermic temperatures. The objectives of the trial in soft tissue sarcoma patients will be the evaluation of the novel hyperthermia feature with respect to safety and performance, and tumor targeting following THE001 treatment in combination with the MR-HIFU technology. The trial will be conducted in the second half of the 4-year program, following animal studies of THE001 in combination with MR-HIFU.

“We are delighted to be part of the IMAGIO consortium, and we look forward to expanding our collaboration with the University Hospital of Cologne,” said Dr. Pascal Schweizer, co-founder and CEO/CFO of Thermosome. “We have been working with Prof. Dr. Holger Grüll and his group since the inception of Thermosome, including a highly successful, joint predecessor program called temperature-sensitive liposomes – low-intensity focused ultrasound (TSL-LIFU) from 2016 to 2020 which was funded by the German Federal Ministry of Education and Research (BMBF). IMAGIO will build on this project and also consider the results of our ongoing Phase I trial of THE001, which was initiated earlier this year.”

“Based on more than a decade of experience with thermosensitive liposomes and MR-HIFU, I am convinced that Thermosome’s innovative tumor targeting technology is best-in-class,” said Prof. Dr. Holger Grüll. “It has always been the goal of my work to provide MR-HIFU-enabled hyperthermia for image-guided tumor targeting using temperature-sensitive liposomes. I strongly believe that this project will nicely integrate these components, paving the way for broader clinical use of this approach.”

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 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 the IMAGIO Consortium
The IMAGIO consortium – IMaging and Advanced Guidance for workflow optimization in Interventional Oncology – includes the following partners: Philips, UMC Utrecht, LUMC, University Hospital of Cologne, TU Delft, Radboudumc, Luxium Solutions, Flash Pathology, Vrije Universiteit Amsterdam, Profound Medical, Gremse-IT, Thermosome, MUMC+, Nederlandse Leverpatiënten Vereniging, Fondazione IRCCS Istituto Nazionale Dei Tumori, Eberhard Karls University Tübingen, European Cancer Patient Coalition, Stichting Longkanker Nederland, ImaginAb Inc., Pfizer Inc., Universiteit Twente, Nanovi, Turku University Hospital, SIOP Europe, Janssen Pharmaceutica; and associated partners Eidgenössische Technische Hochschule Zürich and The Newcastle Upon Tyne Hospitals NHS Foundation Trust. The IMAGIO industry partners are members of COCIR, EFPIA, EuropaBio and MedTech Europe.
This project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112053. The JU receives support from the European Union’s Horizon Europe research and innovation program and life science industries represented by COCIR, EFPIA, EuropaBio, MedTech Europe and Vaccines Europe.

Disclaimer
IMAGIO is funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.

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

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 / +49 30 23 63 27 68