Vaccine News: Telomerase vs. Cancer; Synthetic Approach to Avian Flu; First Plant-Made Vaccine

February 16, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Cambrex (East Rutherford, NJ) to produce Geron (Menlo Park, CA) telomerase anti-cancer vaccine. Generex (Toronto, ON.) files IND for synthetic vaccine to stimulate cell-mediated immunity to avian influenza. Dow Agrosciences (Indianapolis, IN) wins USDA approval for veterinary vaccine, the first manufactured via plant cell culture. G-8 nations pledge billons for vaccine production.

Cambrex to Produce Geron’s Cell-Based Telomerase Vaccine

Biopharmaceutical developer Geron Corp. (Menlo Park, CA, www.geron.com) has established a contract manufacturing agreement with Cambrex Bio Science Walkersville Inc. (East Rutherford, NJ, www.cambrex.com), a subsidiary of Cambrex Corp., to manufacture its GRNVAC1 telomerase vaccine. Cambrex will apply its cell therapy technologies to advance the development and CGMP manufacture of GRNVAC1 for clinical studies.

As a therapeutic cancer vaccine, GRNVAC1 comprises autologous dendritic cells loaded ex vivo with telomerase mRNA. In an ex vivo process, dendritic cells (the most efficient antigen-presenting cells) are isolated from the patient’s blood, pulsed with RNA for the telomerase protein component, and then returned to the patient’s body where they “instruct” cytotoxic T-cells to kill tumor cells that express telomerase.

GRNVAC1 is undergoing multiple Phase 1-2 trials at Duke University Medical Center where researchers are evaluating “various strategies” to optimize its performance in prostate cancer patients.

Generex, Antigen Express Prepare IND for Synthetically Manufactured Avian Flu Vaccine

Antigen Express, Inc. (www.antigenexpress.com), the wholly-owned immunotherapeutics subsidiary of Generex Biotechnology Corp. (www.generex.com, Toronto, ON, Canada) has concluded a pre-investigational new drug application (IND) meeting with the US Food and Drug Administration regarding its vaccine to protect against H5N1 avian influenza.

As a consequence of the pre-IND meeting, Antigen Express has clarified the development path, including clinical study design, and regulatory timetable for its vaccine. Before submitting its IND, Antigen Express will conduct a toxicology study and a preclinical study to establish the vaccine’s dosing regimen.

The avian influenza vaccine is based on a “platform technology” presently in the form of a breast cancer vaccine currently undergoing human clinical trials at Walter Reed Army Medical Center.

The vaccine is designed to induce a strong T-helper cell response using a synthetically manufactured peptide. According to the company, “A strong T-helper cell response plays a major role in helping the body to develop neutralizing antibodies to viral infections. The induction of a good T helper response is expected to greatly reduce the amount of classically produced vaccine necessary to achieve protective immunity in prime/boost regimens. The study will attempt to establish whether application of the vaccine on its own will provide a significant degree of protection in humans who have received no other vaccination.”

Because the vaccine can be manufactured synthetically in large quantities and in existing facilities, its associated development costs are expected to be lower than those of cell-culture or hen-egg produced vaccines.

World’s First Plant-Made Vaccine Wins USDA Approval

Dow AgroSciences (www.dowagro.com, Indianapolis, IN), a wholly owned subsidiary of The Dow Chemical Company, has won approval from the US Department of Agriculture (USDA) Center for Veterinary Biologics for its plant-made vaccine. The “Concert” system uses plant cells, instead of whole plants, in a secure biocontained environment. Although the vaccine’s current applications are intended for animal health, the company reports that its use for treating human diseases is “a real possibility.”

G-8 Nations Plan Financial Support of Vaccine Production

During a February meeting held in Moscow, Russia, finance ministers from the Group of Eight major industrialized nations discussed an advance market commitment plan to promote the development of vaccines for diseases that primarily affect developing countries. The plan would call for G8 nations (The United States, Britain, Russia, Germany, France, Italy, Japan, and Canada) to provide between $800 million and $6 billion to subsidize the purchase of new vaccines, according to a Feb. 13 Wall Street Journal article (M. Phillips, “G8 Nations Shape Plan to Fight Diseases,” www.wsj.com).

Under the plan, G8 nations would provide funding to pharmaceutical companies that show they can produce safe and effective vaccines. In turn, the companies would sell the vaccines at reduced prices in developing countries. The total amount of the G8 pledge and the price per dose of each vaccine will be determined ahead of time.

The WSJ article quotes a report by Italy’s finance minister Giulio Tremonti: “By restoring appropriate incentives, [advance market commitments] can stimulate private research and investment, accelerate the discovery of new vaccines, save lives, and contribute to economic development in a cost-effective way.”

Although G8 officials are expected to approve the plan during its April 2006 meeting in Washington, DC, many details remain to be finalized. G8 officials, the World Bank, and other organizations must not only decide how much each nation should contribute to sponsor the vaccine project, but also decide on the initial focus or “test case” disease. Under discussion are the six major health concerns affecting developing nations: HIV/AIDS, malaria, tuberculosis, pneumococcus (which causes pneumonia and meningitis), rotavirus (which causes fatal diarrhea in infants and children), and human papillomavirus (which causes cervical cancer).