Caladrius Biosciences and Cognate BioServices Establish Manufacturing Agreement for Phase 3 Confirmatory Pivotal Clinical Trial of CLBS14
Thursday, August 08, 2019
Caladrius Biosciences, Inc., a late-stage therapeutics development biopharmaceutical company pioneering advancements of cell therapies in select cardiovascular and autoimmune diseases, and Cognate BioServices, Inc. (“Cognate”), a leading contract development and manufacturing organization in the global cellular therapies industry, announced today that they have entered into a manufacturing agreement for the production of CLBS14, Caladrius’ CD34+ cell therapy. Under the terms of the agreement, Cognate will manufacture CLBS14 for Caladrius’ Phase 3 confirmatory pivotal clinical trial in subjects with no-option refractory disabling angina (“NORDA”).
“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, Chief Executive Officer of Caladrius. “In addition to Cognate’s capabilities to support our Phase 3 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 by the U.S. Food and Drug Administration (“FDA”), Regenerative Medicine Advanced Therapy (“RMAT”) designation for CLBS14. Since then, the Company has worked closely with the FDA to finalize details of a Phase 3 trial that would satisfy the requirements, in combination with previously submitted Phase 1, 2 and 3 clinical data, for filing a biologics license application (“BLA”) for CLBS14 in NORDA.
“We are incredibly excited to be selected as the manufacturer of CLBS14 at this important phase of clinical development,” commented J. Kelly Ganjei, Chief Executive Officer of Cognate. “With patients at the heart of Cognate’s mission and culture, we believe our teams will deliver high quality products for Caladrius. Our U.S. and EU cell therapy experience, and the recent investments in capacity and quality are nicely aligned with Caladrius’ commercial goals.”
