Basking Ridge, NJ (September 22, 2015) – Caladrius Biosciences, Inc. (“Caladrius” or the “Company”, NASDAQ:CLBS), a cell therapy company combining an industry-leading external development and manufacturing provider (PCT) with a development pipeline in immunotherapy, announced today that it has entered into a collaboration agreement with Sanford Research (“Sanford”) to develop the Company’s T regulatory cell therapy product candidate, CLBS03, for the treatment of adolescents with recent-onset type 1 diabetes (T1D). The initial focus of the collaboration will be the execution of a prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents. The Phase 2 study (The Sanford Project Trutina Study) has an open and active IND in place and subject enrollment is expected to commence as early as the first quarter of 2016.
Sanford Research, a non-profit research organization that is part of Sanford Health and supports an emerging translational research center focused on finding a cure for T1D, called The Sanford Project, will provide and cover the costs of two initial clinical performance sites. Sanford will enroll study subjects for the trial across its nine-state footprint. Sanford will support the trial by providing funding as well as operational resources to execute subject recruitment, enrollment, treatment and monitoring along with corresponding support services. PCT will provide CLBS03 for the study.
The Sanford Project Trutina Study has a planned enrollment of 111 subjects across approximately 12-15 US sites. Subjects will be randomized to placebo or one of two active arms receiving either 10 or 20 million cells/kg. The primary endpoint of the trial is preservation of C-peptide (a measure of the preservation of beta-cell function) in comparison to placebo.
“We are delighted to join forces with Sanford Research and share the goal of identifying and developing new therapies with the potential to become major advances in the treatment of type 1 diabetes,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “This collaboration represents a significant strategic milestone for our immune modulation program and the next step in its advancement into the diabetes market. We are focused on establishing collaborations like this to advance our programs without creating significant additional burden on our balance sheet.”
“Finding a cure for type 1 diabetes is a cornerstone of Sanford Research and one of the key initiatives of Sanford Health,” said David Pearce, PhD, President of Sanford Research. “We hope this collaboration with Caladrius can improve the lives of the approximately 18,000 people under the age of 20 who are newly diagnosed with type 1 diabetes in the United States every year.”
CLBS03 is a personalized medicine consisting of each patients’ own regulatory T cells which have been expanded in number and functionally enhanced by a proprietary method developed by PCT. A Phase 1, open-label, uncontrolled dose-escalating study conducted at University of California, San Francisco and Yale University provided evidence for safety and tolerability of autologous expanded polyclonal Treg cell therapy (produced in a comparable way to CLBS03) in 14 adults with established T1D.
About Sanford Research
Sanford Research is a non-profit research organization and is part of Sanford Health, an integrated health system headquartered in the Dakotas. Sanford Health is one of the largest health systems in the nation with a presence in nine states and three countries. More than $600 million in gifts from Denny Sanford has provided for an expansion of research initiatives in type 1 diabetes, breast cancer and genomics in internal medicine. With a team of more than 200 researchers, Sanford Research comprises several research centers, including Children’s Health Research, Edith Sanford Breast Center, Cancer Biology, Center for Health Outcomes and Prevention and Sanford Sports Science Institute. For more information, visit http://www.sanfordresearch.org/
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.