Press Release – Villeneuve d’Ascq, May 27th 2024

Brain cancer: First patient treated in the U.S.A. with innovative therapy developed by French start-up Hemerion

A first patient was treated in Pittsburgh, Pennsylvania in the United States in early April 2024 as part of the new clinical trial sponsored by Hemerion, a French start-up.
The study, called HTX-GBM-01, is designed to confirm the safety and feasibility of the Pentalafen® / Heliance® combination therapy in the treatment of glioblastoma, the most common and aggressive form of brain cancer. This is the first time this therapy has been used in an operating room in the United States.

Glioblastoma (GBM) is the most common and aggressive form of brain cancer. It affects nearly 50,000 people each year in the United States and Europe.

This tumor is a real challenge for neurosurgery. It infiltrates very deeply into the brain tissue, in places that are inaccessible to all current techniques. Despite resection, the remaining cancer cells remain active and systematically recur, even after radiotherapy and chemotherapy.

At the time of diagnosis, the prognosis is very poor: more than half of patients die within 15 months.

Pentalafen® / Heliance®: a therapeutic solution that complements existing treatments to improve patient survival and quality of life

Hemerion, founded in 2020, is developing a therapeutic solution that combines a photosensitizing drug (Pentalafen®) and an illumination platform (Heliance®).
This combination therapy is used in the operating room immediately after tumor resection, to destroy as many tumor cells as possible deep in the tissue, without damaging healthy cells. It could significantly reduce the risk of recurrence and improve patient survival and quality of life.

A significant clinical advancement

The clinical trial, sponsored by Hemerion, is designed to confirm the safety and feasibility of intraoperative photodynamic therapy (PDT), using the drug Pentalafen® and the Heliance® device. Additionally, the trial will assess the efficacy of increasing light doses to optimize the parameters of the therapy.

This is a crucial step in preparing for the pivotal study that will confirm the therapeutic efficacy of the treatment and pave the way for its use as a new standard of care.

A first in the USA

The clinical trial is being conducted at UPMC Presbyterian Hospital and UPMC Hillman Cancer Center, in Pittsburgh, PA.

The first patient underwent tumor resection surgery on April 11, 2024. This marks the first instance of the Pentalafen® / Heliance® combination therapy being used in the United States.

The operation was meticulously prepared by the Hemerion team, which introduced the latest versions of the Pentalafen® / Heliance® combination to the United States.

Hemerion also provided comprehensive training to the neuro-oncology and neurosurgery teams involved in the clinical trial.

They were led by Jan Drappatz, M.D., director of the Neuro-oncology Program at UPMC and Associate Professor at the University of Pittsburgh School of Medicine and Costas Hadjipanayis, M.D., Ph.D., executive vice chair of UPMC Neurological Surgery, director of the UPMC Center for Image-Guided Neurosurgery and co-director of the department’s Brain Tumor Program .

The procedure involved:

• The administration of Pentalafen® to the patient was conducted six hours prior to surgery.
• Following tumor removal, the illumination sequence was set up, including dosimetry, the illumination sequence, and the placement of the diffuser in the surgical cavity.

The next patients will be included in the coming weeks, at the conclusion of the observation period scheduled after the first treatment.

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“This inaugural significant clinical development represents a pivotal moment in the introduction of our technology to the American market, where over 40% of global expenditure on glioblastoma treatment is concentrated.”

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“Our team was eager to expand the clinical trials in the US since the initial studies in  France since 2017 have yielded promising results. If approved, we think this  therapy could represent a genuine source of hope for our patients and their families.”

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“Given its potential to address  the primary challenge currently faced by surgical teams, namely the eradication of infiltrating cancer cells in the vicinity of the operating cavity, we are hopeful this new technology may be a significant advancement in glioblastoma surgery.”

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“This clinical trial is being conducted with the latest version of our Pentalafen®/Heliance® combination therapy, which includes an optimized formulation of the photosensitizing drug and an advanced illumination platform that is more effective than that used in previous studies conducted in France. We anticipate that the results of this study will demonstrate the complete safety of the therapy and confirm the initial efficacy results obtained in 2021.”

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“Passing the torch of our technology to one of the best neurosurgical teams in the United States is obviously a source of great pride for our team. The start of this trial is the reward for many years of clinical research in France with teams from the University Hospital of Lille, the University of Lille and INSERM. We look forward to the work of the Americans in advancing this therapeutic solution that could finally change the game in the treatment of glioblastoma.”