Adaptimmune Announces FDA Acceptance of Investigational New Drug (IND) Application for MAGE-A10 T in Patients With Non-Small Cell Lung Cancer
(Thomson Reuters ONE) -
PHILADELPHIA and OXFORD, England, July 2, 2015 (GLOBE NEWSWIRE) -- Adaptimmune
Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company
focused on the use of T-cell therapy to treat cancer, today announced that the
U.S. Food and Drug Administration (FDA) has accepted the Company's
investigational new drug (IND) application for autologous genetically modified
T-cells expressing enhanced T cell receptors (TCRs) specific for MAGE A10 (MAGE-
A10 T) in patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC), and that the IND is now active.
The acceptance of this IND allows Adaptimmune to initiate an open label Phase
I/II study designed to evaluate its wholly-owned MAGE-A10 T therapeutic
candidate in NSCLC. Site initiation activities are now underway, and the Company
anticipates that enrollment will begin in 2015.
MAGE-A10 (melanoma antigen family A10) is a member of the MAGE-A family of
cancer/testis tumor-associated antigens. It is believed to be expressed in
approximately 30 percent of lung (squamous cell carcinoma), bladder and skin
melanomas, and at a lower incidence in many other cancers. Adaptimmune's
proprietary technology enables the Company to routinely generate TCRs which
address intracellular targets, such as MAGE-A10, that are not accessible to
certain other experimental modalities.
"The FDA's acceptance of this IND represents an important step in our strategy
to identify and develop new T-cell-based immunotherapeutics to combat non-small
cell lung cancer and other cancers, and we are excited to be working toward
initiating clinical development of another of our promising TCR therapeutic
candidates," said James Noble, Adaptimmune's Chief Executive Officer. "In
addition, this validates the progress we are making in applying our platform to
develop a broad pipeline of novel proprietary TCR therapeutics."
This will be an open label phase I/II dose escalating study of three doses of
genetically engineered MAGE-A10 T-cells in HLAA*0201 and HLA-A*02:06 patients
with advanced (stage IIIB or stage IV) NSCLC whose tumors express this antigen.
The study will assess the safety and tolerability of MAGE-A10 T in these
patients. Secondary objectives will include the assessment of efficacy of MAGE-
A10 T, measurements of durability of persistence of MAGE-A10 T-cells in the
blood, and evaluations of the phenotype and functionality of MAGE-A10 T-cells.
About Adaptimmune's TCR Technology
Adaptimmune's proprietary TCR technology enables the Company to genetically
optimize T-cell receptors (TCR) in an effort to equip them to recognize and bind
cancer antigens that are presented in small quantities on the surface of a
cancer cell, whether of intracellular or extracellular origin, thus initiating
cell death. The Company's differentiated, proprietary technology allows it to
reliably generate parental TCRs to naturally presented targets, affinity
optimize its TCRs to bind cancer proteins from solid and hematologic cancers
that are generally unavailable to naturally occurring TCRs, and to significantly
reduce the risk of side effects resulting from off-target binding of healthy
tissues.
About NSCLC
Lung cancer is the third most common form of cancer in the US after prostate
cancer in men and breast cancer in women. However, it is by far the leading
cause of cancer deaths in both men and women in the United States. Non-small
cell lung cancer or NSCLC is the most common type of lung cancer, representing
approximately 85 percent of lung cancers. The 1- and 5-year relative survival
rates for lung cancer are 44 percent and 17 percent, respectively. More than
half of lung cancer patients (57 percent) are diagnosed at a late stage of
cancer development, for which the 1- and 5-year survival is only 26 percent and
4 percent, respectively.
About Adaptimmune
Adaptimmune is a clinical stage biopharmaceutical company focused on novel
cancer immunotherapy products based on its T-cell receptor 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 T-cell
receptors (TCRs) as a means of strengthening natural patient T-cell responses.
Adaptimmune's lead program is an affinity enhanced TCR therapeutic targeting the
NY-ESO cancer antigen. Its NY-ESO TCR therapeutic candidate has demonstrated
signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in
hematologic cancer types. In June 2014, Adaptimmune announced that it had
entered into a strategic collaboration and licensing agreement with
GlaxoSmithKline (GSK) for the development and commercialization of the NY-ESO
TCR program in partnership with GSK. In addition, Adaptimmune has a number of
proprietary programs and its next TCR therapeutic candidate, directed at MAGE
A10, is scheduled to enter the clinic in 2015. The Company has identified over
30 intracellular target peptides preferentially expressed in cancer cells and is
currently progressing eight of these through unpartnered research programs.
Adaptimmune has over 100 employees and is located in Oxfordshire, UK and
Philadelphia, USA. For more information: http://www.adaptimmune.com
Forward-Looking Statements
This press release contains "forward-looking statements," as that term is
defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
which statements may be identified by words such as "believe," "may", "will,"
"estimate," "continue," "anticipate," "intend," "expect" and other words of
similar meaning. 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; our ability to submit an IND and
successfully advance our technology platform to improve the safety and
effectiveness of our existing TCR therapeutic candidates; the rate and degree of
market acceptance of T-cell therapy generally and of our TCR therapeutic
candidates; government regulation and approval, including, but not limited to,
the expected regulatory approval timelines for TCR therapeutic candidates; and
our ability to protect our proprietary technology and enforce our intellectual
property rights; amongst others. 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 final Prospectus filed with the
Securities and Exchange Commission on May 7, 2015. We urge you to consider these
factors carefully in evaluating the forward-looking statements herein and are
cautioned not to place undue reliance on such forward-looking statements, which
are qualified in their entirety by this cautionary statement. 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. We
intend that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
CONTACT: Adaptimmune Contacts
Will Roberts
Vice President, Investor Relations
T: (215) 966-6264
E: will.roberts(at)adaptimmune.com
Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mob: +44 (0)7710 304249
E: margaret.henry(at)adaptimmune.com
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Source: Adaptimmune LLC via GlobeNewswire
[HUG#1933619]
Unternehmensinformation / Kurzprofil:
Datum: 02.07.2015 - 12:00 Uhr
Sprache: Deutsch
News-ID 404505
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contact information:
Town:
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