Icon Genetics successfully completes Phase I clinical study with personalized vaccines for treatment of non-Hodgkin's lymphoma

Munich, January 31, 2014 

Munich, January 31, 2014 - Icon Genetics GmbH (ICON) successfully completed a Phase I clinical study on the safety and immunogenicity of personalized vaccines to treat patients with follicular non-Hodgkin's lymphoma. The vaccines, which consist of monoclonal antibodies derived from each patient's own tumor and serve as disease-specific markers, were administered to induce a tumor-specific immune reaction. The vaccines were manufactured in tobacco plants using magnICON® technology in the facility owned and operated by ICON in Halle, Germany. Results of the 27-patient study demonstrated the safety, tolerability and tumor-specific immunogenicity of the plant-made vaccines. Cancer patients receiving ICON's vaccines did not exhibit the types of side effects that are typically associated with more traditional approaches for cancer treatment. Thus, these vaccines have the potential of offering patients improved quality of life throughout their therapeutic regimen. While not designed to assess efficacy, the study evaluated immune responses to vaccination. Of the patients evaluated at study completion, 73% were found to have mounted a tumor-specific immune response. The Phase I trial was sponsored by Bayer Innovation GmbH and conducted under US FDA IND at 3 clinical centers in the United States, with primary treatment at the University of Texas Southwestern Medical Center and Baylor Medical Center, both in Dallas, Texas, with local coordination and oversight provided by DAVA Oncology, LP.

The study was carried out in close cooperation with the group of Professor Maurizio Bendandi (University of Navarra, Spain). Dr. Bendandi's team had previously succeeded in a groundbreaking study with hybridoma-produced vaccines that triggered an immune response to each patient's tumor-specific idiotypic antibody (surface immunoglobulin) in subjects who had previously achieved complete remission with chemotherapy. ICON's study was based on Dr. Bendandi's work and that of other lymphoma researchers, but used plant-based technology to custom-manufacture the vaccines more rapidly and efficiently than is possible by other approaches.

Being the owner of the lymphoma vaccines program upon completion of the study, ICON plans to further develop the product in order to bring this promising new treatment to market.

"Our study followed the original concept of personalized cancer vaccination developed by Professor Ronald Levy at Stanford University. Its successful completion brings the powerful concept of individualized cancer medicines closer to patients," said Yuri Gleba, CEO of ICON. "Completion of this program required resolution of multiple technical and logistical challenges, including manufacture, release and administration of 27 different recombinant proteins in a single clinical trial. It was the first clinical test of the company's magnICON® technology, which required the coordinated efforts of several organizations. Success would not have been possible without the contributions of the many ICON professionals who participated in this project, the leadership and support provided by Dr. John Butler of Bayer Innovation, planning and analytical support from University of Navarra (http://www.unav.edu), clinical coordination by DAVA Oncology (http://www.davaonc.com), and the excellent product development and regulatory support provided by DT/Consulting Group (http://www.dt-cg.com), Bayer HealthCare Pharmaceuticals (http://biotech.bayerhealthcare.com/locations/berkeley.asp) and CBR International (http://www.cbrintl.com)," Dr. Gleba added.

Dr. Victor Klimyuk, ICON's COO, elaborated: "This study was pivotal for ICON because not only did we confirm the safety and immunogenicity of plant-produced vaccines, we also established a completely scalable manufacturing process. The technoeconomic advantages of our approach to producing individualized products are strikingly superior to conventional methods used to produce biopharmaceuticals. We have found that the magnICON® manufacturing platform is very well-suited for high-throughput processing of multiple small batches containing different molecular compositions, as exemplified by the idiotypic lymphoma vaccines employed in this study."

About idiotype vaccination
Idiotype vaccination is a new type of therapy that has not yet been given regulatory approval. It is referred to as active immunotherapy and, unlike most other biological therapies, is specific to the individual patient. This means that each patient is treated with a product tailored to his or her specific needs. The vaccine consists of an antibody - an immunoglobulin - which is present only on the diseased lymphocytes and not on healthy lymphocytes or other cells in the body. This protein is known as an "idiotype." The goal is to produce an individual drug product for each patient and administer it as a vaccine. The objective of the new therapy is to activate the patient's immune system, enabling the malignant cells to be targeted and destroyed by the body's own defense system with minimal side effects.

About non-Hodgkin's lymphoma
Non-Hodgkin's lymphoma is a type of malignant disease that occurs within the lymphatic system, and it is the fifth most common cause of death due to cancer after breast, prostate, lung, and colon cancer. It originates from lymphocytes, a type of white blood cells. There are two main types of lymphocytes: B lymphocytes and T lymphocytes (also called B-cells and T-cells). Non-Hodgkin's lymphoma can be divided into two general clinical categories: indolent lymphomas, the most common forms of which include follicular lymphomas which tend to grow relatively slowly; and aggressive lymphomas, which include diffuse large B-cell lymphomas (DLBCL), which grow more rapidly. The overall prevalence of NHL in the European Union is approximately 230,000, with an annual incidence of about 70,000 new cases. Follicular lymphoma is one of the most common types of indolent NHL, accounting for 25-30 percent of all NHL lymphomas. It is a type of cancer that can be treated in the short-term but is persistent and ultimately difficult to cure.



About Icon Genetics GmbH

ICON is a wholly owned subsidiary of Nomad Bioscience GmbH, Munich, Germany (http://www.nomadbioscience.com). The Company discovers and develops new biopharmaceuticals and high-value protein products using green plants as production hosts. ICON offers new plant manufacturing technologies that address speed, yield, precision, expression control and safety of product manufacturing in plants. ICON operates its own cGMP-compliant manufacturing facility in Halle, Germany. ICON's own pipeline includes several 'biobetter' anti-cancer antibodies (pre-clinical stage) and vaccines. More information about the company can be obtained by visiting http://www.icongenetics.com.

Contact
For additional information about the contents of this press release, please contact info@icongenetics.de

Icon Genetics and Bayer CropScience successfully completed the development of a plant host system with designer glycosylation needed for manufacturing biopharmaceuticals in green plants

Munich, December 17, 2013 

Icon Genetics GmbH, Munich, Germany (ICON) and Bayer CropScience have successfully created a novel plant host system for the production of biopharmaceuticals. Bayer has delivered a Nicotiana plant that is deficient in plant-specific sugar residues resulting in different plant glycosylation patterns. The plant host is already being used by ICON as a new component in its protein production platform and as a basis for the development of a further improved production host with more complex “humanized” glycan structures that also include sialylation pathway. The availability of these plant host systems providing different glycosylation patterns of recombinant proteins are necessary for manufacturing of novel and more potent biopharmaceuticals in green plants.

Since its inception in 1999, ICON has developed a number of plant-based manufacturing technologies with strong emphasis on plant virus-based transient expression systems. Production host engineering was an essential part of the development as it allowed to generate comprehensive technology and IP package providing for manufacturing biopharmaceuticals in plants. Completion of contract development agreement provides ICON and its customers with technologies package that has many advantages in comparison with more traditional approaches.

Dr. Victor Klimyuk, COO of ICON, said: "The availability of plant production hosts with novel and useful glycosylation, will further enhance ICON’s dominant position as the leading technology provider in the field of plant-made biopharmaceuticals. Long-lasting doubts about ability of plant production host to provide biopharmaceuticals with desired human-like or designer glycosylation can be put to rest.”



About ICON:

ICON is a wholly owned subsidiary of Nomad Bioscience GmbH, Munich, Germany. The Company discovers and develops new biopharmaceuticals and high-value protein products using green plants as production hosts. ICON offers new plant manufacturing technologies which address speed, yield, precision, expression control and safety of product manufacturing in plants. ICON operates its own cGMP-compliant manufacturing facility in Halle, Germany. ICON's own pipeline includes several 'biobetter' anti-cancer antibodies (pre-clinical stage) and vaccines. More information at http://www.icongenetics.de