Caladrius Subsidiary, PCT, Announces Five-Year Strategic Manufacturing Services Agreement with Adaptimmune
September 19 2016 - 7:30AM
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 AdaptimmuneAdaptimmune 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
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