NEW CANAAN, CT—Treatment options for a variety of cancers are expanding to include an array of exciting new approaches. Along with well-established companies, newer biotechnology and biopharmaceutical firms are looking to break into an emerging market that would provide vaccines for both solid cancers—such as melanoma, prostate, breast, lung, cervical, colon, brain, and ovarian—and blood borne cancers—such as lymphoma, leukemia, and myeloma.
The Sabin Vaccine Institute has organized a Cancer Vaccine Consortium, composed of public and private companies with an interest in development of vaccines for cancer. The goal of the consortium is to accelerate the process of bringing cancer vaccines from the development stage to the clinic. A variety of cancer vaccine therapies are in the pipeline, but each of these must proceed through the rigorous, lengthy licensing pathway in several well-defined stages. “There is really no time to lose when a person is facing a cancer diagnosis,” said H.R. Shepherd, chairman of the Institute, and a cancer survivor.
Traditional pediatric vaccines—like those for polio and measles—provide protective immunity before the disease occurs, averting its full impact. Cancer vaccines seek to boost the immune system and are used after disease onset; therefore, they currently remain therapeutic rather than preventive and are often referred to as “immunotherapies” rather than vaccines. Their goal is to produce strong anti-tumor immunity in order to combat cancer cells, shrinking or delaying growth of tumors and initiating periods of remission and improved quality of life, while avoiding the traumatic side effects associated with surgery, radiation, or chemotherapy
The companies launching various potential cancer vaccines are looking to each other for collaborative encouragement to achieve licensing and commercialization of this new wave of therapies. Earlier this month, in Eldred, New York, the Sabin Institute convened the first meeting of the new Cancer Vaccine Consortium. Members came from the U.S., Canada, Germany, and Austria to consider vaccine development and regulatory steps to turn their novel scientific discoveries into products.
For the past five years, the Sabin Vaccine Institute has been a proponent of cancer vaccines, having sponsored a series of scientific meetings to bring together researchers from universities, government, and private sector companies to address the challenges of cancer vaccines and immunotherapy. The Cancer Vaccine Consortium is focused on the ultimate goal of vaccine development—licensure and commercialization into a medical standard-of-care—and so is looking at advancing products through all phases of the process.
Seventeen companies engaged in cancer vaccine development have already joined the Cancer Vaccine Consortium. Larger pharmaceuticals like Aventis Pasteur, GlaxoSmithKline, Pfizer, and MedImmune are represented, as are smaller-scale biotechnology companies, including Antigenics, BioVex, Cell Genesys, Coley Pharmaceutical Group, Dendreon, EMD Pharmaceuticals, Favrille, Igeneon, Medarex, MediGene, Northwest Biotherapeutics, Shire Biologics, Stressgen Biotechnologies, and Therion Biologics. Combined, these companies represent numerous cancer vaccine clinical trials underway. Each participating company has appointed a representative on the Consortium’s Leadership Council and on its Scientific Advisory Board.
The New York meeting was chaired by Malcolm S. Mitchell, MD, a clinical oncologist and cancer researcher. Other organizers and facilitators were Cohava Gelber, PhD, MBA, a vaccine researcher with pharmaceutical developer MannKind BioPharmaceuticals, Michael Salgaller, PhD, an immunologist with long experience in cancer vaccines, and Cort Wrotnowski, a management consultant in the field of biomedical research. Dr. Mitchell was chosen as chairman pro tem to guide the Consortium through its early phases. He is strongly committed to the goals of the Consortium, and has been involved for many years in moving his melanoma vaccine through clinical trials to FDA approval. His research in tumor immunology and immunotherapy of melanoma led to numerous discoveries, such as his development of the therapeutic anti-melanoma vaccine, Melacine. Melacine is the only cancer vaccine thus far approved by a regulatory agency, the Health Protection Branch in Canada.
“We hope that our Consortium will be able to bring to regulatory agencies the novel agents continually being introduced by biotechnology and pharmaceutical companies,” he said. “With our attention firmly on cancer vaccines and concrete aims, we will focus on identifying vaccines in advanced clinical trials that might be ripe for approval within the near term, perhaps the next two years.”
In order to expedite the approval process, industries must learn to dialog with government regulatory agencies. This was the theme of a presentation by Lucio Miele, MD, PhD, a former FDA official now at the University of Illinois Chicago Cancer Center. According to Miele, research scientists must communicate frequently with their review team at the FDA and develop a close working relationship to get through the clinical trials that prove the safety and efficacy of new products.
Shepherd envisions the Cancer Vaccine Consortium moving discoveries forward the way that the Human Genome Project brought together scientists and biotechnology companies to quickly unravel the human genome map. “We can do far more for cancer vaccine discovery by working together than by going it alone,” he said. “We have great new science in the field of immunology at our disposal and many vaccine therapy options to pursue.”
To solidify the concepts of “consortium” among the participants, Charles Wessner, a National Research Council expert on the SEMATECH consortium that helped the U.S. semiconductor industry regain worldwide preeminence in the 1980s, presented key concepts of how companies with strong self-interest could work together in a consortium arrangement. SEMATECH may well provide a blueprint for the organization and function of the new Cancer Vaccine Consortium. Some advantages of a consortium approach would be establishment of common research goals and directions and a means of sharing expertise, along with expediting the development of new technologies, research tools and methods, and coordination of research across the institutional infrastructure. He said that the goal for the Cancer Vaccine Consortium is to combine individual action in a common framework.
The companies of the consortium hope to benefit from dynamic exchanges of data, standardization of assays, potential identification of combination therapies, and shared knowledge management. An overall benefit will be accelerated vaccine development and reduced costs, as the Cancer Vaccine Consortium fosters networking among its members.
Seth Rudnick, MD, of Canaan Partners, based in Rowayton, Connecticut, presented an analysis of the healthcare market, providing a practical perspective on where companies developing new cancer vaccines might draw their financial backing. “I think this is a very valuable enterprise and I hope it succeeds,” Rudnick said about the formation of new Consortium. Rudnick’s assessment was important information for all of the members of the Consortium, whose companies are hopeful that the next wave of approved treatments for cancer will be vaccines. Rudnick described some of the scientific advances in biology and technology that are fueling the healthcare sector. While there is much room for optimism, the investment environment will have to improve to achieve greater support of investors.
The next meeting of the Cancer Vaccine Consortium is scheduled for early November in Bethesda, Maryland, when the group hopes to include essential insight on the regulatory and political aspects of the licensing process for new cancer vaccines and immunotherapies.
The mission of the Albert B. Sabin Vaccine Institute is to save lives by stimulating development of new vaccines and increasing immunization rates throughout the world. Founded in 1993, the Institute pursues Dr. Albert Sabin’s vision of a world protected from disease by vaccines.