Bayer starts trials with personalised vaccine from tobacco plants

Bayer has begun a clinical Phase I study in humans of a vaccine developed from tobacco plants for the treatment of non-Hodgkin's lymphoma.

Gene immersion bath: Dr Sylvestre Marillonnet places tobacco plants upside down in a vacuum tank filled with a bacterial solution. The bacteria transport genes into the plants, which are then capable of producing medicinal active substances

Bayer has begun a clinical Phase I study in humans of a vaccine developed from tobacco plants for the treatment of non-Hodgkin's lymphoma.

The German firm says this is the first time proteins obtained from tobacco plants using its magnICON technology have undergone clinical testing.

The patient-specific idiotype vaccines are produced in a pilot plant operated by Bayer subsidiary Icon Genetics in Halle, Germany. The objective of the treatment is to activate the patient's immune system, enabling the malignant cells to be targeted and destroyed by the body's own defence system.

"This personalised vaccine is being developed with the aim of keeping patients who have responded well to chemotherapy in complete remission," said Detlef Wollweber, head of Bayer Innovation.

The magnICON process is used for the rapid production of high yields of recombinant proteins such as biopharmaceuticals in tobacco plants. The plant is not genetically modified: the blueprint for the product is inserted temporarily into the plant using a species of Agrobacterium and distributed throughout the plant cells. The protein is subsequently extracted from the plant's leaves in a very pure form. The process can also be carried out in a large-scale closed facility.

"The goal of cancer therapy in the future will be to tailor treatment to the individual patient as far as possible," said John Butler-Ransohoff, project manager for plant-made pharmaceuticals at Bayer. "Haematological tumours such as B-cell lymphomas are a good starting point for the further development of personalised medicine because the idiotypic antibodies formed by the lymphomas are highly specific tumour markers."

The focus of the first clinical study at the University of Texas Southwestern Medical Centre in Dallas, US in volunteers who have NHL is on the safety, tolerability and - to the extent that this can be determined from laboratory tests - immunological effects of the vaccine. If the results are sufficiently promising, an application will be made to carry out a Phase III study for registration purposes.




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