BASKING RIDGE, N.J., Sept. 19, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ: CLBS ) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, A Caladrius Company or “PCT”) with a select therapeutic development pipeline, today announces a new five-year strategic manufacturing services agreement under which PCT will produce SPEAR® T-cell therapies for Adaptimmune Therapeutics plc (NASDAQ: ADAP ) (“Adaptimmune”). PCT, through dedicated, specialized staff and facilities, will produce the SPEAR® T-cell products at its Allendale, New Jersey facility in a manner compliant with both U.S. Food and Drug Administration (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 three 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 U.S. and Europe.”
About Adaptimmune 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 1/2 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 pre-clinical 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. Adaptimmune has over 250 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com
About Caladrius Biosciences, Inc.
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 2 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 U.S. Food and Drug Administration 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 .
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.
CONTACTS: Investors: For Caladrius: Anne Marie Fields Senior Vice President, LHA Phone: +1-212-838-3777 Email: afields@lhai.com For Adaptimmune: Will Roberts Vice President, Investor Relations Phone: +215-825-9306 Email: will.roberts@adaptimmune.com Media: Caladrius Biosciences, Inc. Eric Powers Director, Communications & Marketing Phone: +1-212-584-4173 Email: epowers@caladrius.com
