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Plant made Pharmaceuticals

Bayer Innovation GmbH is engaged in the field of protein expressions in plants. Our goal is to become a leading provider of plant-derived proteins for therapeutic and industrial applications. Our subsidiary Icon Genetics GmbH (Halle/Saale) cooperates to this end with groups within Bayer CropScience, Bayer HealthCare, Bayer Technology Services and external partners. Icon Genetics’ proprietary technology platform magnICON® utilizes a relative of the tobacco plant (Nicotiana benthamiana) as host plant for the production of recombinant therapeutic proteins.

With regard to “personalized medicine”, the future could provide an increased demand for small quantities - a problem which cannot readily be solved economically using today’s production processes. Plants are so closely related to humans and animals that they are able to correctly process and configure complex proteins of human or animal origin.

Scientist of Bayer's subsidiary Icon Genetics during homogenization of tobacco leaves after harvest at the pilot plant for clinical sample supply.

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Scientist of Bayer's subsidiary Icon Genetics during homogenization of tobacco leaves after harvest at the pilot plant for clinical sample supply.

With the magnICON-technology, the blueprint for desired proteins is inserted via plant-specific viral vectors which are transferred into the leaf cells with the aid of a widespread species of soil bacteria: Agrobacterium tumefaciens. A few days after the infection with the Agrobacterium, the reprogrammed protein synthesis machinery of the leaves produces mostly the desired proteins. The scope of this technology is broad: from antibodies for cancer therapy to vaccine antigens or enzymes for technical applications.

In order to be used as clinical samples, therapeutic proteins must meet stringent requirements. A GMP compliant pilot plant for the production of proteins that meet such GMP standards was inaugurated in Halle (Sachsen-Anhalt) in June 2008. In December 2009 Bayer started the clinical development of a patient-specific tumor-vaccine after successfully submitting a Phase I study protocol to the US FDA (United States Food & Drug Administration). This is the first time that proteins obtained using magnICON® technology undergo clinical testing. The patient-specific vaccines produced in the pilot plant operated by the Bayer-subsidiary Icon Genetics in Halle, Germany, are intended for the treatment of non-Hodgkin’s lymphoma (NHL).

Non-Hodgkin’s lymphoma (NHL) is a heterogeneous group of tumor diseases in which primarily a degenerate cell line of B-lymphocytes, known as the B-cells for short, multiply uncontrollably and accumulate in the lymph nodes, bone marrow and other tissues. Non-Hodgkin’s lymphomas are the fifth most common cause of death from cancer in the US. Despite initially good response rates to chemotherapy and radiation, a comprehensive form of therapy for this disease has yet to be developed because the patients’ bodies neither recognize the diseased B-cells as foreign invaders nor attempt to destroy them.

The degenerate B-cells of the NHL patient are different from healthy ones: each B-cell has unique proteins – antibodies – anchored on the surface of these cells. These are referred to as surface immunoglobulins and each B-cell line has a distinctive idiotypes, suitable to be used as the perfect tumor marker, highly specific to the degenerate B-cell line. Personalized immune therapy consists of providing patient and tumor-specific vaccines that systematically flag the tumor cells by interacting with their unique surface proteins and thus help the immune system recognize them. The immune system can then either destroy the diseased B-cells or initiate a programmed cell death, also known as apoptosis.

In the specific case of a NHL vaccine, the plant-made tumor idiotype is coupled with an immunogenic carrier molecule, a protein from a Californian limpet: the keyhole limpet hemocyanin (KLH). KLH stimulates the lymphocytes to recognize as foreign any proteins attached to it. During the immune reaction that follows repeated vaccination, lymphocytes specifically recognize and bind to the chemical structure of the attached tumor idiotype. They begin generating anti-idiotype antibodies that specifically target the tumor by attaching themselves to the patient’s degenerate cancer cells as “flags”. Thanks to this signal, the body’s own killer T-cells are then able to recognize and destroy the cancer tissue.

Further information you will find within research - The Bayer Scientific Magazine.

Contact: team Plant made Pharmaceuticals