Press Release – Villeneuve d’Ascq, February 25, 2025

Hemerion Therapeutics Receives FDA Fast Track Designation for Pentalafen® / Heliance® Combination Therapy for the Treatment of Glioblastoma

Hemerion, a French clinical-stage healthtech company developing novel therapeutic approaches for the treatment of cancer, has been granted Fast Track designation by the FDA for its combination therapy Pentalafen® / Heliance® to improve outcomes in the treatment of glioblastoma.

The Hemerion combination therapy targets glioblastoma (GBM), the most common and aggressive form of brain cancer, which affects approximately 150,000 people worldwide each year. At the time of diagnosis, the prognosis is very poor, with more than half of patients dying within 15 months.

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

A promising therapy to prevent recurrence and prolong survival

The Hemerion 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.

This approach could ultimately simplify the treatment protocol by removing the need for radiation therapy as a first-line adjuvant treatment after surgery—a long treatment phase that is particularly burdensome for patients, both physically and financially.

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“Our therapy meets all the criteria for fast-track designation. We are targeting a very serious disease and addressing a completely unmet medical need. The standard of care for glioblastoma has not evolved in more than 20 years and continues to produce unsatisfactory clinical outcomes. The FDA Fast Track designation gives our team the means to accelerate its clinical development and bring patients a potentially game-changing therapy that could save their lives…”

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“This new status will enable our teams to work more closely and efficiently with the U.S. Food and Drug Administration. This collaboration gives us greater flexibility to adapt our clinical strategy and save time. For example, priority review will save us several months in the approval process. Our goal has always been to bring our technology to neurosurgeons and patients as quickly as possible. The FDA’s decision is a major step in that direction!”

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An important step in accelerating Hemerion’s clinical development

The Fast Track designation follows the Orphan Drug Designation received in 2021 and the initiation of a Phase I/II clinical trial in 2024.

It provides Hemerion with several benefits, including more frequent meetings and
communications with the FDA to optimize clinical trial designs, eligibility for accelerated approval and priority review, and the option for rolling review, which allows for a more expedited submission and review of the application.

This is a critical step that ideally paves the way for the rapid conduct of a clinical trial to evaluate the efficacy of the treatment and support a marketing application.