Lille, November 17, 2025
Brain cancer: following the United States, Hemerion opens a new investigation site in Europe and accelerates its clinical development
In July 2025, Hemerion Therapeutics opened a new investigation site at Lille University Hospital dedicated to phase 1/2 clinical validation of its Pentalafen®/Heliance® therapy for the treatment of glioblastoma.This opening demonstrates Hemerion’s ability to accelerate its clinical development simultaneously in Europe and the US.
The first therapy developed by Hemerion based on its Pentalafen® / Heliance® technology platform targets the most aggressive form of brain cancer: glioblastoma.
To accelerate the clinical development of this innovative therapy for this indication, Hemerion has obtained authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to open a new clinical investigation site at the Lille University Hospital (CHU).
Double the capacity for patient enrollment
As Europe’s largest university hospital campus, Lille University Hospital is a major player in clinical trials in France, with more than 8,000 patients per year.
This clinical research activity is particularly focused on cancer and neuroscience: a strategy that led it to play a major role in the development of Hemerion’s technology, starting in 2017, with the launch of the first Indygo and Dosindygo clinical trials.
Opened in July, the Lille site increases the capacity to enroll new patients for the HTX-GBM-01 clinical study initiated by Hemerion in the US in collaboration with the University of Pennsylvania Medical Center (UPMC) in Pittsburgh.
The principal investigator is Dr. Enora Vauléon from the neuro-oncology department at Lille University Hospital. The Lille site is equipped with the latest versions of the Heliance® platform, which benefit from the significant improvements made by Hemerion Therapeutics to its technology over the past five years.
Clinical development conducted on two continents
The opening of this site demonstrates Hemerion’s ability to work effectively with European and US health regulations: a rare asset in the healthtech sector, essential for conducting future market access operations in these two major territories.
Phase 1/2: Final stretch for the Pentalafen®/Heliance® combination therapy
The Lille center has successfully enrolled the last patients in the second cohort planned for this Phase 1/2 trial. This milestone has enabled consultation with the Data and Safety Monitoring Board (DSMB) to be initiated, with a view to authorizing the study to continue.
The aim is to confirm and even improve on the clinical results obtained during research conducted by Inserm, Lille University Hospital, and the University of Lille between 2017 and 2020 on this technology.
“The opening of the Lille site is a real catalyst for the clinical development of our combination therapy. This initiative has also prepared us to work closely with European and US health regulators: a real plus for the upcoming discussions with the EMA and FDA to launch the pivotal phase.“
Dr Everardo Saad
Medical Director, Hemerion
“This new participation in Hemerion’s clinical development makes Lille University Hospital a genuine global center of excellence for Pentalafen®/Heliance® combination therapy in the treatment of brain cancer.“
Prof. Nicolas Reyns
Co-inventor of Hemerion technology
Head of the Neurosurgery Department, Lille University Hospital
Member of the INSERM OncoThAI unit
“Hemerion’s technology is a valuable addition to the conventional therapeutic arsenal against one of the most difficult cancers to treat. It is a therapy in which we oncologists place a great deal of hope.“
Dr. Enora Vauléon
Neuro-oncologist
Principal Investigator
Neuro-Oncology Department, Lille University Hospital
About Hemerion Therapeutics
Hemerion was founded in 2020 with the aim of developing innovative therapeutic solutions for cancer. The technology developed by Hemerion combines a drug (Pentalafen®) with an innovative illumination platform (Heliance®). It is particularly promising in the treatment of the most common and aggressive form of brain cancer, glioblastoma, for which Hemerion has an active clinical program with very promising results in terms of safety and efficacy.
Follow Hemerion on LinkedIn: Hemerion Therapeutics
About Lille University Hospital
With a community of nearly 16,000 professionals, Lille University Hospital is one of the largest healthcare campuses in Northern Europe. As a university hospital providing emergency care, teaching, innovation, and research, it treats serious conditions requiring cutting-edge medical technology and specialized medical expertise. Nearly 1.4 million patients are treated there each year. The Lille University Hospital is deeply committed to the development of therapeutic innovation and clinical research. Its research strategy focuses on the early diagnosis and treatment of multifactorial diseases, particularly cancer, neuroscience, cardiovascular, metabolic, inflammatory, and infectious diseases.
About Pentalafen®/Heliance® combination therapy
This therapy combines a photosensitizing drug (Pentalafen®) and an illumination platform (Heliance®). It aims to eliminate residual tumor cells after surgical resection in order to minimize the risk of recurrence.
Before the operation, Pentalafen® is administered to the patient in an oral solution. Within a few hours, the components of Pentalafen® accumulate in cancer cells but not in healthy cells.
Immediately after removing the tumor in the operating room, the surgeon uses Heliance® to emit a very specific light that activates the components accumulated in the cancer cells and causes their destruction. Cancer cells are destroyed wherever the light penetrates, deep within the tissue.
Used in the operating room immediately after tumor resection, it could redefine the standard of care for several types of cancer and minimize the need for radiation therapy. The first clinical development aims to improve the treatment of glioblastoma, the most common and aggressive form of brain cancer.