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Therakos Achieves MDR Approval in Europe

Therakos Development Limited, a leading innovator in immunomodulatory therapy, has recently announced that its THERAKOS™ CELLEX™ system has successfully attained MDR certification in Europe. This new approval grants the system an expanded indication to treat immune-related adverse events (irAEs) for adult patients who have demonstrated an inadequate response to standard corticosteroid treatments. This marks a significant breakthrough as it is the first therapy of its kind globally approved for this specific purpose.

Transforming Cancer Care

The rise of immune checkpoint inhibitors (ICIs) has been revolutionary in oncology, helping to leverage the body’s immune system for durable anti-tumor responses. However, this robust immune activation can paradoxically lead to irAEs that complicate treatment regimens and affect patient health significantly. Currently, corticosteroids are the initial go-to treatment for significant irAEs, but this often leads to treatment interruptions or complete cessation of ICIs, posing challenges in ongoing cancer therapies.

For patients who do not respond adequately to steroids, additional immunosuppressive treatments may be required, potentially further hampering anti-tumor immunity. These hurdles underline the pressing need for effective therapeutic approaches that manage immune-related toxicities while retaining the benefits of cancer immunotherapy.

Expert Perspectives

Professor Lucie Heinzerling, an esteemed specialist in dermatology and venerology at LMU University Hospital, stated, “Managing steroid-refractory irAEs presents a challenge, with limited data supporting the efficacy of various medications, and the risk of immunosuppression potentially obstructing tumor responses. The approval of the THERAKOS™ CELLEX™ photopheresis system for this indication in Europe represents a significant advance in the management of steroid-refractory irAEs.”

Sandra Thompson, Co-Managing Director at Therakos, reinforced the company’s commitment to tackling the needs of patients facing immune complications associated with ICIs. She emphasized that the CELLEX™ system is a pivotal treatment option, now available to European oncology teams.

Innovative Approach with Photopheresis

Unlike traditional immunosuppressive therapies that broadly dampen immune activity, the THERAKOS™ CELLEX™ employs a unique extracorporeal photopheresis (ECP) method. This treatment selectively uses the patient's own white blood cells, combined with a photoactive agent, to restore immune balance without extensive suppression of the immune system. By directly targeting inflammation at its source, this therapy aims to alleviate toxicity while preserving the essential anti-tumor defenses of the immune system.

Professor Robert Zeiser, Director of Tumor Immunology at the University Medical Center of Freiburg, explained, “Immune-related toxicity is no longer viewed simply as a systemic issue; it is increasingly recognized as tissue-specific. The ECP effectively addresses localized inflammation through the body’s innate anti-inflammatory signaling rather than through generalized immune suppression.” As immunotherapy continues to evolve, managing its associated toxicities without sacrificing its advantages will be crucial for future advancements.

Accessibility of the CELLEX System

Following the MDR approval, clinicians can now access the THERAKOS™ CELLEX™ system for managing immune-related adverse events in adults who have shown inadequate responses to corticosteroids. This therapy is available through a robust network of over 190 centers across Europe, ensuring that many patients can benefit from this innovative approach.

About Therakos

Therakos, a trailblazer in autologous immunomodulatory therapy deployed at the bedside, boasts over four decades of clinical experience rooted in evidence-based medicine. The THERAKOS™ PEC system was one of the first cellular immunomodulatory therapies authorized by the FDA, aimed at restoring and protecting immune health. This unique therapeutic approach seeks to leverage the patient’s own cells to redress immune balance rather than broadly suppressing it. By investing in continuous research and showcasing data-driven outcomes, Therakos endeavors to enhance the field of immunomodulation and improve patient outcomes in complex immune-mediated diseases.

To learn more about Therakos and its innovative offerings, visit therakos.eu.

About Extracorporeal Photopheresis (ECP)

ECP is a bedside immunomodulatory therapy involving the collection of a small volume of the patient's white blood cells, which are then treated with a photoactive agent and UVA light before being reinfused. Unlike global immune suppression, ECP is designed to reset immune equilibrium using the patient's own cells.

Important Safety Information

The THERAKOS™ CELLEX™ system is certified for use in the EU for patients aged 18 and older for various indications. The system must be utilized in emergency facility-equipped sites, ensuring safety during procedures. Specific contraindications and precautions must be adhered to, and patients should be closely monitored for adverse effects such as hypotension or fever following treatment.

For a complete list of warnings and precautions, consulting the THERAKOS™ CELLEX™ user manual is essential.