Caladrius Subsidiary, PCT, Announces 5-Year Strategic Manufacturing Services Agreement

Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, A Caladrius Company) with a select therapeutic development pipeline, recently announced a new 5-year strategic manufacturing services agreement under which PCT will produce SPEAR T-cell therapies for Adaptimmune Therapeutics plc. PCT, through dedicated, specialized staff and facilities, will produce the SPEAR T-cell products at its Allendale, NJ, facility in a manner compliant with both US FDA and European Medicines Agency (EMA) regulations.

PCT’s relationship with Adaptimmune is intended to provide Adaptimmune with operational flexibility for the manufacture of its SPEAR T-cell products from development through clinical manufacturing and, ultimately, subject to marketing authorizations, into commercialization.

“PCT is an elite contract manufacturing organization in the field of patient-specific cell therapies, and we are very pleased to strengthen and develop our existing relationship,” said Dr. Gwendolyn Binder-Scholl, Adaptimmune’s Chief Technology Officer. “We have worked with PCT over the past 3 years and their commitment to high-quality manufacturing, allied to timely delivery, makes them an ideal manufacturing partner for Adaptimmune. This arrangement will complement well our new manufacturing plant currently under construction in Philadelphia.”

“We are delighted to expand our relationship with Adaptimmune. This extension is a perfect example of our ability to service our clients’ needs from earlier-phase clinical trials through development toward commercialization,” said Robert A. Preti, PhD, President of PCT and Senior Vice President, Manufacturing and Technical Operations of Caladrius Biosciences. “We appreciate Adaptimmune’s continued confidence in PCT’s ability to support their groundbreaking technologies in the US and Europe.”

Adaptimmune is a clinical-stage biopharmaceutical company focused on novel cancer immunotherapy products based on its SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform. Established in 2008, the company aims to utilize the body’s own machinery – the T-cell – to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is a SPEAR T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO SPEAR T-cell therapy has demonstrated signs of efficacy and tolerability in Phase I/II trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. Adaptimmune has a strategic collaboration and licensing agreement with GlaxoSmithKline for the development and commercialization of the NY-ESO TCR program. In addition, Adaptimmune has a number of proprietary programs. These include SPEAR T-cell therapies targeting the MAGE-A10 and AFP cancer antigens, which both have open INDs, and a further SPEAR T-cell therapy targeting the MAGE-A4 cancer antigen that is in preclinical phase with IND acceptance targeted for 2017. The company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. For more information, visit www.adaptimmune.com.

Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of T regulatory cells as an innovative therapy for recent onset type 1 diabetes. The product candidate, CLBS03, is the subject of an ongoing Phase II clinical trial (The Sanford Project: T-Rex study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the US FDA and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency. The company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry. PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services, including product and process development, GMP manufacturing, engineering, and automation, cell and tissue processing, logistics, storage, and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more information, visit www.caladrius.com.