Leverages Company Expertise in Cell Therapy Manufacturing to Support Process Improvements for Platform Cancer Technology
Basking Ridge, NJ (September 24, 2015) – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”, NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider with a development pipeline including a Phase 3 clinical program in immuno-oncology and a portfolio of projects in immune modulation and ischemic repair, announces that it has received a $300,000 contract from the National Institutes of Health’s (NIH) National Cancer Institute (NCI) to wholly fund the first phase of a project for process optimization of its therapeutic agent targeting tumor-initiating cells (often referred to as cancer stem cells). The contract anticipates an additional $2 million in funding for the project should both the government and Caladrius agree to proceed at the conclusion of the first phase which is expected in June 2016. Hans Keirstead, PhD, Chief Science Officer of Caladrius, is the principal investigator for the project.
The goal of the government-funded project is to investigate the use of technology to improve the efficiency of the Company’s tumor cell/dendritic cell incubation process to reduce the number of tumor-initiating cells required as an antigen source and, therefore, reduce the duration of ex-vivo culture required to produce the treatment. The project will also look at potential optimizations through the elimination of process steps and the enhancement of antigen processing and presentation.
“We are excited to receive this prestigious award to support our immuno-oncology program and thank the NCI for their review and consideration. This grant underscores the value of our unique capability to leverage PCT, our world-class cell therapy processing and manufacturing subsidiary, to enhance our proprietary product development efforts,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “Importantly, this project supports our continued commitment to the optimization of our technologies, and we expect the project will have a direct impact on both feasibility and cost of our product candidates.”
The Company’s technology platform is currently under investigation in a Phase 3 study (the Intus Study) for the treatment of stage III recurrent or stage IV metastatic melanoma. Compelling and consistent results from two Phase 2 trials for metastatic melanoma, as well as data from a Phase 1 trial for hepatocellular carcinoma and patient data from investigations in renal cell carcinoma, provide evidence supporting the application of the platform to additional solid tumor types, including ovarian cancer, lung cancer, colon cancer and glioblastoma multiforme. The Company has previously received FDA clearance on the protocol for a Phase 2 clinical trial for CLBS23 in ovarian cancer and will continue to pursue partnership opportunities to enable the launch of that trial.
About the National Cancer Institute (NCI)
The National Cancer Institute leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website at http://www.cancer.gov or call NCI’s Cancer Information Service at 1-800-4-CANCER.
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius combines a leading cell therapy service provider with a development pipeline including late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. For more information, visit www.caladrius.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Immuno-Oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry, and the performance and planned expansion of the Company’s wholly-owned subsidiary and its center of excellence for cell therapy process development, engineering and manufacturing, PCT, as well as its efforts to expand its capabilities into the cell therapy tools market. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 2, 2015, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control.