Analyses of Phase 2 Data Suggest Correlations Between a Distinct Immune Response Triggered by CLBS20 and Overall Survival of Melanoma Patients
BASKING RIDGE, N.J. (September 30, 2015) – Caladrius Biosciences, Inc. (NASDAQ: CLBS), a company combining a leading cell therapy service 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 today that the Company will present new clinical data elucidating the mechanism of action for its lead product candidate, CLBS20, at the Alliance for Regenerative Medicine’s Stem Cell Meeting on the Mesa Scientific Symposium on October 9, 2015. Furthermore, the data suggest correlations between a distinct immune response triggered by CLBS20 and overall survival of melanoma patients.
CLBS20 is an individualized therapy developed for each patient from that patient’s own tumor and immune cells. It works by combining certain irradiated tumor cells (those thought to be the cancer-initiating cells (CICs) responsible for tumor proliferation) with the patient’s immune cells, called dendritic cells. The use of CICs exposes the patient’s immune system to the complete antigenic fingerprint of that patient’s cancer and is believed to provide the most complete and specific targeting to that patient’s immune system. The cell-based product is then admixed with an immune adjuvant that stimulates white blood cells and injected subcutaneously into the patient, essentially turning the cancer against itself. CLBS20 is currently being investigated in the Intus study, a Phase 3 clinical trial designed following on consistent, compelling results from two Phase 2 trials in identical patient populations evaluating the therapeutic vaccine that has become CLBS20.
The new data are based on recent studies on tumorigenicity, exomic analysis and serum analysis. Tumorigenicity (the ability to produce tumors) and exomic analyses (gene sequencing) of patient-derived tumor cell lines (CICs) isolated using Caladrius’ manufacturing procedure confirmed the tumor-initiating, highly antigenic nature of these cells. Analyses of serum samples from patients that participated in the Phase 2 melanoma studies of CLBS20 before and 4 weeks after the first dose administration provided evidence for a distinct immune response after administration of the immunotherapy, compared to controls. This distinct immune response suggests important components of the treatment’s mechanism of action and suggests a correlation with patient survival. The findings are considered preliminary and are expected to continue to be validated during the current Phase 3 trial.
“We find these new data exciting and enlightening. Not only have we now observed the tumor-initiating properties of the CICs we are isolating as the basis for our immunotherapy, but the data suggest the potential to identify the patients for whom the experimental treatment might be most effective,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius.
The poster, titled “Functional Properties of Patient-Derived Melanoma Cancer Stem Cells Utilized as Treatment for Metastatic Melanoma in Phase 3 Clinical Trial” will be presented by Dr. Gabriel Nistor, Vice President, Research.
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 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. 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.