Adaptimmune Announces Strategic Manufacturing Agreement with PCT to Support Development of SPEAR® T-cell Therapies Towards C...
September 19 2016 - 7:30AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced that it has entered into a
new five-year strategic manufacturing agreement with PCT, a
Caladrius company, (“PCT”) a subsidiary of Caladrius Biosciences
(Nasdaq:CLBS) for the supply of Adaptimmune’s SPEAR® T-cell
therapies. Under the contract, Adaptimmune will benefit from
exclusive access to an EU and FDA compliant manufacturing unit at
PCT as well as dedicated, specialist staff.
Adaptimmune’s relationship with PCT, a contract manufacturer of
patient cell therapy products, is intended to provide Adaptimmune
with maximum 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 also complement well our new
manufacturing plant currently under construction in
Philadelphia.”
“We are pleased to significantly advance our relationship with
Adaptimmune, which began with earlier-phase clinical trials.
PCT is committed to adapting our service arrangements to support
our client’s evolving needs as they proceed through late-stage
trials and into commercial manufacturing,” said Robert A. Preti,
PhD, President of PCT and Senior Vice President, Manufacturing and
Technical Operations of Caladrius Biosciences. “We appreciate
Adaptimmune’s continued trust in PCT’s ability to support the
distribution of their groundbreaking technologies in the U.S. and
Europe.”
Adaptimmune’s SPEAR T-cell therapies are novel cancer
immunotherapies that use enhanced affinity T-cell receptors (TCRs)
to target and destroy cancer cells by strengthening a patient’s
natural T-cell response. T-cells are a type of white blood cell
that play a central role in a person’s immune response to
disease.
The manufacturing process for Adaptimmune’s SPEAR T-cell
therapies consists of isolating T-cells from the blood of cancer
patients; transferring affinity enhanced TCRs, which have been
modified to recognize cancer cells, into the cells; activating and
expanding the T-cells; and, introducing the affinity enhanced cells
back into the patient to enable the patient's immune system to
attack cancer.
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 PCT, a Caladrius CompanyPCT, a Caladrius
Company (PCT), a subsidiary of Caladrius Biosciences, Inc., is a
leading contract development and manufacturing organization in the
cellular therapy industry that works with clients to achieve
commercial-readiness for their products. PCT and Hitachi Chemical
Co. 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 than 17 years, PCT has provided
pre-clinical and clinical cGMP development and manufacturing
services to more than 100 clients, advancing cell therapy and
immunotherapy product candidates from the development stage all the
way through to commercialization. PCT offers manufacturing of cell
therapy products, engineering and innovation services, process and
analytical development, cell and tissue processing, consulting,
collection and storage. These services enable clients to focus on
quality, cost of goods, scalability and sustainability as key mile
markers as they think beyond regulatory approval. For more
information: http://www.pctcaladrius.com
Forward-Looking StatementsThis release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 (PSLRA). These
forward-looking statements involve certain risks and uncertainties.
Such risks and uncertainties could cause our actual results to
differ materially from those indicated by such forward-looking
statements, and include, without limitation: the success, cost and
timing of our product development activities and clinical trials
and our ability to successfully advance our TCR therapeutic
candidates through the regulatory and commercialization processes.
For a further description of the risks and uncertainties that could
cause our actual results to differ materially from those expressed
in these forward-looking statements, as well as risks relating to
our business in general, we refer you to our Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC)
on August 8, 2016, and our other SEC filings. The forward-looking
statements contained in this press release speak only as of the
date the statements were made and we do not undertake any
obligation to update such forward-looking statements to reflect
subsequent events or circumstances.
Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 825-9306
E: will.roberts@adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mobile: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
Caladrius Biosciences, Inc. Contact
Eric Powers
Director, Communications and Marketing
Phone: +1-212-584-4173
Email: epowers@caladrius.com
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