IOZKIOZK is an institution for translational medicine
The IOZK is a translational center that translates scientific insights from immuno-oncology directly into patient-specific therapies. Research, manufacturing and clinical application take place under one roof, allowing innovative immunotherapies as ATMPs under § 4b of the German Medicines Act (Arzneimittelgesetz, AMG) to be safely transferred from the laboratory into clinical practice.
At the IOZK, we are committed to advancing patient-centered immuno-oncology for solid malignant tumors. Our work is based on the principle that every patient is unique, and therefore requires an individualized therapeutic approach.
In Germany, the legal framework allows physicians and patients to consider an individual therapeutic attempt when standard guideline-based therapies offer no prospect of cure. This option reflects a fundamental commitment to human dignity and patient self-determination, as enshrined in the German Constitution. It enables us to integrate scientific progress from basic research into tailored treatment concepts that may provide clinical benefit, while maintaining the strict ethical boundaries that protect patients.
Our therapies involve the preparation of individualized medicinal products (ATMPs), manufactured from each patient’s own immune and tumor material. This process is scientifically demanding, highly regulated, and resource-intensive – yet essential to addressing the biological diversity of solid tumors. Unlike clinical trials, which primarily test drugs or procedures, the individual therapeutic attempt is focused exclusively on the wellbeing of the patient.
At IOZK, we see our role as bridging science, clinical responsibility, and patient autonomy. We strive to expand the horizon of therapeutic possibilities while respecting the individuality of each patient’s journey.
Manufacture and Application of Advanced Therapy Medicinal Products (ATMP) at IOZK
The IOZK holds a manufacturing authorization pursuant to § 13 of the German Medicines Act (AMG), issued by the District Government of Cologne, for the production of Advanced Therapy Medicinal Products (ATMPs).
These ATMPs are manufactured in accordance with the principles of Good Manufacturing Practice (GMP) and are subject to oversight by the Paul-Ehrlich-Institute (PEI) and the competent state authority, the District Government of Cologne.
The administration of the therapy takes place in the IOZK outpatient clinic, which is regarded as the specialized healthcare facility. The clinic is the medically responsible institution within the meaning of the Medicines Act.
National Exemption under § 4b AMG (“Hospital Exemption”)
According to § 4b (3) of the German Medicines Act (Arzneimittelgesetz, AMG), ATMPs that are not manufactured on a routine basis and that
• are produced in accordance with specific quality standards,
• in a specialized healthcare facility,
• under the professional responsibility of a physician,
• on an individual medical prescription,
• for a specific patient and are manufactured and used for this patient,
may be authorized without a central EU marketing authorization.
This provision (“hospital exemption”) provides for the individualized treatment of individual patients with patient-specific medicinal products under the continuous supervision of the national authority for vaccines and biomedicines, the Paul-Ehrlich-Institute (PEI).
In this way, it is ensured that the quality and safety of the therapy are guaranteed in accordance with applicable European and national standards, while at the same time enabling patient-specific treatments with innovative cell therapies.
The IOZK Therapy Using an Advanced Therapy Medicinal Product (ATMP)
The immunotherapy against solid tumors developed at IOZK includes an Advanced Therapy Medicinal Product (ATMP) within the meaning of the Medicines Act (§ 4b AMG). The product is manufactured on an individual basis from the patient’s own cells, which are processed in the IOZK AG laboratory in accordance with Good Manufacturing Practice (GMP). IOZK holds a manufacturing authorization for this under § 13 AMG, granted by the District Government of Cologne.
The administration of the ATMP takes place in the IOZK outpatient clinic, which is considered a specialized healthcare facility pursuant to § 4b (3) AMG. There, the individually manufactured vaccines are administered under medical responsibility.
Manufacture and Application under the Hospital Exemption (§ 4b (3) AMG)
According to § 4b (3) AMG, the so-called “hospital exemption” applies to certain ATMPs. It permits the non-routine manufacture and use of patient-specific medicinal products if the following conditions are met:
• The ATMP is manufactured in accordance with specific quality standards (GMP).
• It is not produced routinely but individually for a specific patient on the prescription of a physician at IOZK.
• Administration takes place in a specialized medical facility under the professional responsibility of a physician.
• Manufacture and administration occur within the same facility.
This exemption serves the individualized treatment of cancer patients with solid tumors when standardized or approved medicinal products are not available or are insufficiently effective. It allows the use of scientifically based innovative therapeutic approaches under medical responsibility without requiring a central EU-wide marketing authorization.
Scientific Basis of IOZK Immunotherapy
The IOZK uses a multimodal, phase-based immunotherapy that addresses various mechanisms of the tumor microenvironment and is tailored to the individual biological characteristics of the tumor.
The core of the therapy is the activation of the immune system by dendritic cell vaccines that are loaded with tumor-specific antigens and immunogenic signals, including those derived from tumor lysate and serum extracts after oncolytic virus treatment. Additional complementary procedures such as modulated electro-hyperthermia and the use of oncolytic viruses (Newcastle disease virus, NDV) induce immunogenic cell death (ICD) and enhance the antitumor immune response.
This patient-specific, multi-phase therapy follows an individualized treatment concept that is permissible within the legal and regulatory framework of the hospital exemption and at the same time meets the highest scientific standards of quality and safety.
