Geron and Cambrex Announce Contract Manufacturing Arrangement for cGMP Production of GRNVAC1 for Clinical Trials
Monday February 13, 4:30 pm ET
MENLO PARK, Calif. & East Rutherford, N.J.--(BUSINESS WIRE)--Feb. 13, 2006--Geron Corporation (Nasdaq:GERN - News) and Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation (NYSE:CBM - News), announced today an agreement for the manufacture of Geron's GRNVAC1 telomerase vaccine. The agreement provides for the transfer of Geron's vaccine production process to Cambrex and the cGMP manufacture of GRNVAC1 by Cambrex.
GRNVAC1 is a therapeutic cancer vaccine comprised of autologous dendritic cells loaded ex vivo with telomerase mRNA. In March 2005, results of the first completed Phase 1-2 clinical trial of GRNVAC1 in metastatic prostate cancer patients was published in the Journal of Immunology (JI, 2005, 174:3798-38097). The vaccine was well tolerated with no major treatment-related toxicities. In addition, telomerase specific T-cell responses were generated in 19 of 20 subjects and vaccination was associated with a statistically significant increase in PSA doubling time and clearance of prostate cancer cells from the patients' blood, indicative of potential clinical response. The telomerase vaccine is currently in multiple Phase 1-2 trials at Duke University where different strategies to optimize vaccine performance are under evaluation.
"Cambrex is a leader in the cell therapy manufacturing field and we are extremely pleased to have this important partnership in place," said Melissa A. Kelly Behrs, Geron's vice president of oncology. "The capabilities and expertise at Cambrex position them well to serve as our central manufacturing facility, producing GRNVAC1 vaccine product for all patients in our contemplated clinical trials."
"Our agreement with Geron strengthens our reputation as the industry leader in cell therapy process development, manufacturing, regulatory compliance and related commercialization services," commented Shawn Cavanagh, Cambrex's senior vice president and general manager, Bioproducts. "We will leverage our cell therapy expertise and cGMP manufacturing capabilities to enable Geron to advance the development of GRNVAC1 in the clinic."
About Geron
Geron is a biopharmaceutical company developing and commercializing three groups of products: i) therapeutic products for oncology that target telomerase; ii) pharmaceuticals that activate telomerase in tissues impacted by senescence, injury or degenerative disease; and iii) cell-based therapies derived from its human embryonic stem cell platform for applications in multiple chronic diseases.
Geron has two anti-cancer products in the clinic that target telomerase: GRN163L, a potent and specific telomerase inhibitor drug that is in a Phase 1-2 clinical trial in chronic lymphocytic leukemia (CLL); and GRNVAC1, a telomerase therapeutic vaccine currently in multiple Phase 1-2 trials at Duke University.
About Cambrex
Cambrex is a global, diversified life sciences company dedicated to providing products and services to accelerate and improve the discovery and commercialization of human therapeutics. The Company employs approximately 1900 worldwide. For more information, please visit cambrex.com.
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Geron's and Cambrex's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, need for future capital, dependence on collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. |
