Geron And Cambrex Announce Contract Manufacturing Arrangement For cGMP Production Of GRNVAC1
Menlo Park, CA - Geron Corporation and Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation, announced recently 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."
SOURCE: Cambrex