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Gaithersburg, Maryland - MaxCyteInc., and Geron Corporation (Nasdaq: GERN) announced today a license, option, development, and supply agreement to utilize MaxCyte's proprietary cell loading system in the manufacture of mRNA-loaded dendritic cell-based vaccines, including Geron's GRNVAC1 telomerase vaccine. The agreement provides Geron with access to MaxCyte's GMP-compliant cell loading technology for use in closed-system manufacturing of GRNVAC1 and future therapeutic cancer vaccine products.
MaxCyte and Geron have initiated a research and development plan to further develop the GMP compliant MaxCyte system for use in a closed-system manufacturing process being developed by Geron for GRNVAC1. Upon completion of optimization and evaluation studies, the agreement provides an option for a commercial license to MaxCyte's technology and a supply contract, as well as rights to reference MaxCyte's FDA Master File in Geron's regulatory submissions.
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 I/II clinical trial of GRNVAC1 in metastatic prostate cancer patients was published in the Journal of Immunology (JI, 2005, 174:3798-38097). The vaccine protocol successfully generated telomerase specific T-cell responses in 19 of 20 subjects. The vaccine was well tolerated, with no major treatment-related toxicities. Peak immune responses to vaccination were remarkably high, with between 1% to 2% of circulating CD8+ T-cells demonstrating anti-telomerase specificity. Clinically, vaccination was associated with a statistically significant increase in PSA doubling time and clearance of prostate cancer cells from the patients' blood.
"The GRNVAC1 program has already produced extremely promising clinical data in Phase I/II clinical trials at Duke University. We are developing a closed system manufacturing process which will allow us to improve scalability, and reduce cost as we continue to move this program through clinical trials," said Thomas B. Okarma, Ph.D., M.D., Geron's President and CEO. "Based upon its impressive capabilities, we believe MaxCyte's cell loading technology can be an important component of our closed system."
"We are excited to be working with Geron on its telomerase vaccine. Our technology has been shown to be extremely efficient and is capable of producing cell-based therapeutics that are highly reproducible, with the scalability to support clinical trial and commercial use," said Douglas Doerfler, President and CEO of MaxCyte.
MaxCyte is a clinical-stage cell therapeutics company with a rapidly growing pipeline of partnered and internally developed therapeutic candidates. The Company's proprietary ex vivo cell loading technology overcomes critical obstacles, such as safety, scalability, and reproducibility, which are fundamental to successful cell-based therapies. MaxCyte has demonstrated the value of its versatile technology by building a pipeline of six partnered therapeutic programs in oncology, pulmonary, metabolic and infectious diseases as well as developing three drug candidates in collaboration with leading researchers: one in Phase I/II clinical trials for treatment of chronic lymphocytic leukemia and two preclinical solid tumor programs. The MaxCyte system has an FDA Master File in place at CBER.
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 I/II clinical trial in chronic lymphocytic leukemia (CLL); and GRNVAC1, a telomerase therapeutic vaccine currently in multiple Phase I/II trials at Duke University.