BASKING RIDGE, N.J.—Caladrius Biosciences Inc., a cell therapy company combining an external development and manufacturing provider (PCT) with a development pipeline in immunotherapy, has entered into a collaboration agreement with Sanford Research 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 and subject enrollment is expected to commence as early as the first quarter of 2016.
“Our wholly owned subsidiary, PCT (acquired in 2011), is Caladrius Biosciences’ Center of Excellence for process development, engineering and manufacturing of cell therapies,” states Caladrius CEO Dr. David J. Mazzo. “We are providing these services for an impressive and growing list of established cell therapy leaders. With proven expertise and more than 16 years of experience, PCT supports the advancement of its clients’ life-changing medical treatments by mitigating the risks of product development and providing efficient, cost-effective, custom manufacturing solutions to advance clinical development programs towards commercialization and beyond. To date, PCT has worked with more than 120 clients and more than 20,000 products.”
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.
“We entered into a collaboration agreement with Sanford Research to develop our T regulatory cell therapy product candidate, CLBS03, for the treatment of adolescents with recent-onset type 1 diabetes,” Mazzo notes. “The initial focus of the collaboration will be the execution of a clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents. The Phase 2 study has an open and active IND in place and subject enrollment is expected to begin as early as the first quarter of 2016.”
“CLBS03 is a personalized medicine consisting of each patient’s own regulatory T cells that have been expanded in number and functionally enhanced by a proprietary method developed by our manufacturing subsidiary, PCT,” Mazzo explains.
The Sanford Project Trutina Study has a planned enrollment of 111 subjects across approximately 12-15 U.S. 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 Mazzo. “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 Dr. David Pearce, 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.”
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 T1D, breast cancer and genomics in internal medicine.
With a team of more than 200 researchers, Sanford Research consists of 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.
Caladrius Biosciences Inc. has proven expertise 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.