Geron and Cambrex Announce Contract Manufacturing Arrangement for cGMP Production of GRNVAC1 for Clinical Trials
Geron Corporation and Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation, announced 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.
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