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The companies have entered into a manufacturing agreement for the production of Phase III clinical trial material.
Caladrius Biosciences, a Basking Ridge, NJ-based late-stage biopharmaceutical company specializing in cell therapies for cardiovascular and autoimmune diseases, has entered into a manufacturing agreement with Memphis, TN-based Cognate BioServices, a contract development and manufacturing organization, for the production of CLBS14, Caladrius’ CD34+ cell therapy. Under the agreement, Cognate will manufacture CLBS14 for Caladrius’ Phase III confirmatory pivotal clinical trial in subjects with no-option refractory disabling angina (NORDA), the companies announced in an Aug. 7, 2019 press release.
CLBS14 is a proprietary formulation of autologous granulocyte-colony stimulating factor-mobilized peripheral blood-derived CD34+ cells, which are endothelial progenitor cells that reside naturally in the bone marrow. These cells have the preprogrammed ability to induce capillary growth to regenerate microcirculation in damaged tissue experiencing microvascular insufficiency. The therapy is formulated specifically to enhance the potency of the natural process whereby CD34+ cells repair and regenerate microvasculature.
“Selecting the right company for the manufacturing and supply of CLBS14 is critical to the success of this study. Cognate has a track record of producing personalized cellular therapy products reliably and cost-efficiently and we are excited to be working with them as we take this next step toward getting this important product to patients suffering from this terrible disease,” said David J. Mazzo, PhD, CEO of Caladrius, in the press release. “In addition to Cognate’s capabilities to support our Phase [III] program, Cognate has experience as a commercial manufacturer of cell therapies, and Cognate’s facility has passed multiple FDA inspections.”
In Spring 2018, Caladrius applied for and was subsequently granted regenerative medicine advanced therapy designation for the therapy by FDA. Since then, the company has worked closely with FDA to finalize details of a Phase III trial that would satisfy the requirements, in combination with previously submitted Phase I, II, and III clinical data, for filing a biologics license application in the NORDA indication.
“We are incredibly excited to be selected as the manufacturer of CLBS14 at this important phase of clinical development,” said J. Kelly Ganjei, CEO of Cognate, in the press release.
Source: Cognate BioServices