Adaptimmune Receives Positive Opinion for Orphan Drug Designation in the European Union for SPEAR(TM) T-cell Therapy Targeting NY-ESO for Treatment of Soft Tissue Sarcoma

ID: 1442511
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(Thomson Reuters ONE) -


PHILADELPHIA and OXFORD, United Kingdom, June 20, 2016 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat
cancer, today announced that the European Medicines Agency''s (EMA) Committee for
Orphan Medicinal Products (COMP) has adopted a positive opinion recommending the
company''s SPEAR(TM) T-cell therapy targeting NY-ESO for designation as an orphan
medicinal product for the treatment of soft tissue sarcoma, a solid tumor
cancer. Adaptimmune previously received orphan drug destination from the U.S.
Food and Drug Administration for its NY-ESO SPEAR T-cell therapy in this
indication.

"While unresectable or metastatic soft tissue sarcomas are rare, they are
associated with a high mortality rate," said Dr. Rafael Amado, Adaptimmune''s
Chief Medical Officer. "We are pleased to have received an opinion from the
Committee for Orphan Medicinal Products which recognizes the unmet medical need
that soft-tissue sarcomas represent. We look forward to working with them to
advance our NY-ESO SPEAR T-cell therapeutic candidate through clinical
evaluation, with the goal of one day bringing it to patients throughout Europe
suffering from this disease."

The COMP adopts an opinion on the granting of orphan drug designation, after
which the opinion is submitted to the European Commission for endorsement.
Orphan drug designation by the European Commission provides certain regulatory
and financial incentives for companies to develop and market therapies that
treat a life-threatening or chronically debilitating condition affecting no more
than five in 10,000 persons in the European Union, and where no satisfactory
treatment is available. Orphan drug designation provides incentives for
companies seeking protocol assistance and scientific advice from the EMA during
the product development phase and a 10-year period of marketing exclusivity in


the EU following product approval.

Data from recent published epidemiological studies estimate the prevalence of
soft tissue sarcoma in the European Union to be 2.86 per 10,000 which
corresponds to approximately 146,918 people based on the total population of
513.7 million people in the EU, Norway, Iceland, and Liechtenstein as of January
1, 2015 [EUROSTAT 2015].

Adaptimmune is developing its NY-ESO SPEAR T-cell therapy in certain soft tissue
sarcomas.  The company expects to initiate pivotal studies in synovial sarcoma
in 4Q16/1Q17, and will explore development in myxoid round cell liposarcoma.
Adaptimmune''s SPEAR T-cell candidates are novel cancer immunotherapies that have
been engineered 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. Adaptimmune''s goal is to harness the
power of the T-cell and, through its multiple therapeutic candidate,
significantly impact cancer treatment and clinical outcomes of patients with
solid and hematologic cancers.

About Soft Tissue Sarcoma
Soft tissue sarcomas can develop from soft tissues including fat, muscle,
nerves, fibrous tissues, blood vessels, or deep skin tissues. There are
approximately 50 types of soft tissue sarcomas, including synovial sarcoma, a
cancer of the connective tissue around the joints. Soft tissue sarcomas can
develop at almost any anatomic site, such as the extremities, trunk or thorax,
abdomen and retroperitoneum, pelvis and the head and neck region. The more
common soft tissue sarcomas originate from muscle, nerve tissue, fat, or deep
skin tissue. For a number of sarcomas, such as synovial sarcoma, the tissue
origin is not well characterized. Surgical resection is the standard therapy for
localized disease and radiation therapy (preoperative or postoperative) and/or
chemotherapy is added in selected cases.

About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel
cancer immunotherapy products based on its SPEAR(TM) (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

Forward-Looking Statements
This 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 May
12, 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(at)adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mobile: +44 (0)7710 304249
E: margaret.henry(at)adaptimmune.com



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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: Adaptimmune Therapeutics plc via GlobeNewswire
[HUG#2021854]






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Date: 06/20/2016 - 09:40
Language: English
News-ID 1442511
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