Caladrius Biosciences Inc (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. (Original Source)
Shares of Caladrius Biosciences Inc. closed yesterday at $1.88 . CLBS has a 1-year high of $7.22 and a 1-year low of $1.10. The stock’s 50-day moving average is $1.57 and its 200-day moving average is $2.26.
On the ratings front, Maxim Group analyst Jason Kolbert reiterated a Buy rating on CLBS, with a price target of $12, in a report issued on June 24. The current price target represents a potential upside of 538.3% from where the stock is currently trading. According to TipRanks.com, Kolbert has a total average return of -8.4%, a 36.0% success rate, and is ranked #3739 out of 3768 analysts.
Caladrius Biosciences Inc isa biopharmaceutical company. It develops novel proprietary cell therapy products. It is engaged in the preservation & enhancement of human health through the development of cell based therapeutics.