In 2014, Icon Genetics successfully completed a Phase I clinical study on the safety and immunogenicity of an innovative, personalized vaccine to treat patients with follicular 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. The individual, patient-specific vaccines consisted of monoclonal antibodies derived from each patient’s own malignant B-cells (antibody producing lymphocytes). This vaccine serves as cancer cell-specific marker to induce an immune reaction directed against the lymphoma. The patient-specific vaccines were manufactured in Nicotiana benthamiana plants using magnICON® technology in the facility owned and operated by Icon Genetics in Halle/Saale, Germany. The Phase I trial was sponsored by Bayer Innovation GmbH and conducted under US FDA IND at three clinical centers in the United States. Results of the 27-patient study demonstrated the safety, tolerability and tumor-specific immunogenicity of the plant-made vaccines. Notably, 73% of the cancer patients receiving the individualized vaccines mounted a tumor-specific immune response without exhibiting side effects typically associated with more traditional approaches for cancer treatment (Tusé et al., 2015). Therefore, this innovative approach has the potential of offering patients improved quality of life throughout their therapeutic regimen. As the owner of the lymphoma vaccines program, Icon Genetics plans to further develop the product in order to bring this promising new treatment to market.
In 2014, the largest Ebola outbreak in history started in West Africa. At its end more than 28,000 Ebola cases were reported (Guinea, Liberia and Sierra Leone) with more than 11,000 deaths. At the time of the outbreak, no medications for treatment or prevention of the Ebola disease was available. However, the experimental Ebola treatment ZMapp was under development by Mapp Biopharmaceutical Inc., San Diego, California in collaboration with Defyrus Inc., Toronto, the U.S. government and the Public Health Agency of Canada. ZMapp is composed of three humanized monoclonal antibodies against Ebola virus surface glycoprotein. The monoclonal antibodies, which are the core component of ZMapp, were produced in plants by our partner Kentucky Bioprocessing, Owensboro, Kentucky using Icon Genetics magnICON® technology. Due to the pressing need for an Ebola treatment, ZMapp received permission to treat urgently sick people under the FDA’s expanded access program.