Collaboration Will Explore Next-Generation Strategies for Caladrius’ Core Cancer Technology
New York, June 18, 2015 — Caladrius Biosciences, Inc. (Nasdaq:CLBS), (“Caladrius” or the “Company”, formerly NeoStem, Inc.), a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today that it has entered into a material transfer agreement with the University of Southern California and the California Institute of Technology, concerning next-generation strategies for its core cancer technology.
This research collaboration will build on Caladrius’ highly successful manufacturing protocol for its lead cancer program, CLBS20 (aka NBS20), by exploring techniques to further enhance the isolation of cancer initiating cells with the goal of increasing the number of cancer patients that might benefit from treatment.
CLBS20 is the subject of a Phase 3 clinical trial investigating its efficacy in the treatment of late-stage melanoma, the Intus Study. The trial has been granted a Special Protocol Assessment by the US Food and Drug Administration (FDA) and the CLBS20 development program has been granted Orphan Drug and Fast Track designations by FDA. Randomization of the first patient in the Intus trial occurred in April 2015.
“This collaboration illustrates Caladrius’ continued commitment to the optimization of our technologies through association with two prominent research universities,” said Dr. David J. Mazzo, Caladrius’ Chief Executive Officer.
Advanced melanoma is exceedingly difficult to treat, with a five-year survival rate of approximately 15%. There are 20,000 estimated new cases, and an estimated 10,000 deaths, from metastatic melanoma each year in the United States. The US melanoma market is approximately $1 billion per year, which is predominantly spent to treat metastatic melanoma. The platform on which CLBS20 is based is potentially applicable across multiple solid tumor types, including lung, colon and ovarian cancer, hepatocellular carcinoma and glioblastoma multiforme.
CLBS20 uses the patient’s own immune cells and tumor-initiating cells to create an immunotherapy therapeutic vaccine. It is unique in targeting these cancer- or tumor-initiating cells; other therapies, which target different tumor cells, may treat existing cancer but may not be as likely to prevent tumor recurrence.
For more information on the Intus Study, which will be enrolling at approximately 50 sites across the US, Canada, Australia and New Zealand, please visit www.theintusstudy.com or www.clinicaltrials.gov/ct2/show/NCT01875653.
About Caladrius Biosciences, Inc. (formerly NeoStem, Inc.)
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 is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. 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. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company’s other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.