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Therakos Secures EU MDR Approval for Immunotherapy Solution to Combat Steroid-Resistant Adverse Events

Therakos Development Limited, a leading global player in immunomodulatory therapies, has announced a significant advancement with the recent EU MDR approval of its THERAKOS™ CELLEX™ photopheresis system. This certification is groundbreaking as it allows the system to treat immune-related adverse events (irAEs) linked to immune checkpoint inhibitor (ICI) therapies in adults who do not respond adequately to corticosteroids. This move positions the THERAKOS™ CELLEX™ system as the first and only approved therapy of its kind in Europe.

The landscape of cancer treatment has been transformed by ICI therapy, which leverages the body's immune system to achieve lasting antitumor responses. However, these therapies can lead to severe immune-mediated side effects that may complicate ongoing treatments and negatively impact patient outcomes. Traditionally, corticosteroids have remained the standard first-line treatment for clinically significant irAEs, often leading to interruptions in ICI therapy. For patients who do not respond sufficiently to steroids, additional immunosuppressive treatments may be required, further jeopardizing their antitumor immunity.

Prof. Dr. Lucie Heinzerling, a dermatologist from Ludwig-Maximilians-University, comments on this approval, emphasizing the challenges in treating steroid-resistant irAEs due to limited data on various medications' effectiveness and potential adverse impacts on tumor responses. She highlights that the THERAKOS™ CELLEX™ system represents a significant step forward in addressing these complications effectively.

Sandra Thompson, Co-CEO of Therakos, expresses the company's commitment to meeting the needs of patients experiencing complications from ICI therapies. As the only approved therapy for this application, the THERAKOS™ CELLEX™ system offers a vital new tool for oncologists across Europe in managing their patients' care.

Unlike conventional methods that broadly suppress the immune system, ECP focuses on restoring immune balance using the patient's own immune cells, thus alleviating toxicity without generalized immunosuppression. Experts in the field agree that suppressing the immune system can hinder cancer treatment itself. Prof. Dr. Robert Zeiser of Freiburg University highlights how immune-related toxicity has incorrectly been perceived as a systemic issue, suggesting it is more about localized tissue responses. He emphasizes a targeted approach with ECP to combat inflammation effectively.

With this latest MDR approval, healthcare professionals now have access to the THERAKOS™ CELLEX™ photopheresis system through an extensive network of over 190 centers in Europe that will treat irAEs arising from ICI therapies for adults who show inadequate responses to corticosteroids.

Overview of Therakos

Therakos is at the forefront of pioneering autologous immunomodulatory therapies delivered via ECP directly at the bedside. With more than four decades of clinical experience, the Therakos ECP system was among the first cell-based immunomodulatory therapies approved by the FDA. The mission persists to restore and protect the human immune response by leveraging the body's own immune cells to restore balance, rather than broadly suppressing the system. Continuous research, evidence production, and innovation efforts are dedicated to advancing the science of immunomodulation and improving outcomes for patients with complex immune-mediated conditions. Find out more at Therakos Website.

Understanding Extracorporeal Photopheresis (ECP)

ECP is a bedside immunomodulatory therapy where a small quantity of white blood cells is extracted from the patient, treated with photoactive agents and UVA light, then reintroduced back into the body. This technique aims to address immune imbalances rather than general suppression.

Important Safety Information for the THERAKOS™ CELLEX™ Photopheresis System

Indications

The THERAKOS™ CELLEX™ photopheresis system is indicated for patients over 18 years of age for the administration of photopheresis in cases including:

• - Cutaneous T-cell lymphoma (CTCL)
• - Transplant rejection (heart, lung)
• - Treatment of immune-related adverse events (irAEs) linked to immune checkpoint inhibitor therapy in patients with inadequate responses to corticosteroids.

Contraindications

The system is contraindicated for:

• - Patients with a specific history of light sensitivity diseases.
• - Patients unable to tolerate extracorporeal volume loss or with leukocyte counts exceeding 25,000/mm³.
• - Patients with coagulation disorders or prior splenectomy.

Warnings and Precautions

Employ the THERAKOS™ CELLEX™ photopheresis system in settings equipped with essential emergency medical supplies, ensuring continuous monitoring for hypotension throughout the treatment process. Additionally, take caution against possible thromboembolic events in treating graft-versus-host disease. A comprehensive list of warnings and precautions is found in the device’s manual.