ALLENDALE, N.J., Sept. 8, 2015 -- PCT, LLC, A Caladrius Company (PCT), the manufacturing sciences and technical operations subsidiary of cell therapy leader Caladrius Biosciences (NASDAQ:CLBS) and leading external manufacturing partner to the cell therapy industry, announced today that it will expand its current manufacturing capacity at PCT's Allendale, New Jersey facility to support IRX Therapeutics, Inc. (IRX)'s anticipated clinical trial manufacturing needs for the INSPIRE Phase 2b study in head and neck cancer patients. PCT will provide IRX with personnel and dedicated clean room capacity within its current Good Manufacturing Practices (cGMP) infrastructure and, subsequently, pursuant to European Union (EU) cell therapy manufacturing standards.
PCT has been providing manufacturing services since 2008 to support IRX's development of IRX-2, a primary cell-derived biologic with multiple active cytokine components. IRX-2 is a cancer therapeutic designed by IRX to activate a patient's immune system by unlocking the power of immunotherapy to restore immunity and overcome cancer-induced immune suppression. IRX-2 is in late-stage development in a neo-adjuvant regimen for the treatment of head and neck squamous cell carcinoma.
The expanded arrangement includes IRX's use of PCT's ISO Class 6/Class 1,000 clean room system, enabling manufacture of cell-based products that can then be shipped to Europe and, when approved, commercially distributed on the EU market.
"We are pleased to expand our relationship with IRX to manufacture their cell therapy product to EU standards from one of our US locations. The versatility of our operations and our understanding of global regulatory processes provides cell therapy developers like IRX with a distinct advantage as they advance toward commercialization and render PCT the manufacturing partner of choice," said Robert A. Preti, PhD, President of PCT, and Senior Vice President, Development and Technical Operations and Chief Technology Officer of Caladrius Biosciences.
"We are excited to both continue and expand our manufacturing partnership with PCT. With the critical support of PCT's unique expertise and capabilities, we look forward to advancing the clinical and commercial development for our important and promising IRX-2 clinical development program," said Jeffrey Hwang, President and COO, IRX Therapeutics.
About IRX Therapeutics
IRX Therapeutics is a privately held company that develops immune therapies to treat cancer and related diseases. The company's therapies are designed to target and restore the immune system in order to improve a patient's response to next-generation cancer vaccines and novel targeted therapeutics. IRX Therapeutics was founded by John W. Hadden, M.D., a pioneer in the field of Immunopharmacology. The company's product platform under development, which is based on over 30 years of research by Dr. Hadden, seeks to restore the immune system of cancer patients, which is suppressed by the onset of the disease. www.irxtherapeutics.com
About PCT, LLC, A Caladrius Company
PCT, LLC, A Caladrius Company, is an external cell therapy optimization, development, and manufacturing partner. With proven expertise and more than 16 years of experience, PCT supports the advancement of its clients' life-changing medical treatments by mitigating the risks of product development and providing efficient, cost-effective, custom manufacturing solutions to advance clinical development programs. PCT's diverse client base includes leading biotechnology and pharmaceutical companies, as well as academic research institutions. It is the only cGMP-compliant cell therapy manufacturing provider with facilities on both the East and the West Coasts of the United States, as well as the only one to see a client's cell therapy product receive approval from the US Food and Drug Administration for commercial sale. www.pctcaladrius.com
About Caladrius Biosciences
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius combines a leading cell therapy service provider with a development pipeline including late-stage clinical programs based on proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. www.caladrius.com
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