Adaptimmune Announces FDA Acceptance of IND Application for Affinity Enhanced T-Cell Therapy Targeting MAGE-A4 in Multiple So...
January 09 2017 - 8:00AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced that the US Food and
Drug Administration (FDA) has accepted the Company’s
investigational new drug (IND) application for autologous
genetically modified T-cells expressing an affinity optimized
T-cell receptor (TCR) specific for MAGE-A4 in patients with
multiple malignant solid tumors. This will be Adaptimmune’s third
wholly-owned therapeutic candidate to enter clinical trials. The
IND is now active.
Under this IND, Adaptimmune will initiate a Phase I, open-label,
modified 3+3 dose escalation study of autologous T-cells
genetically engineered with an affinity optimized MAGE-A4 TCR in
HLA*02 positive patients with inoperable locally advanced or
metastatic melanoma, and urothelial, head and neck, ovarian,
non-small cell lung, esophageal, and gastric cancers expressing
MAGE-A4. Patients will receive preconditioning with modified
fludarabine and cyclophosphamide as used in the Company’s ongoing
synovial sarcoma study. This multi-tumor study will enroll up to
32 patients.
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 multiple
proprietary programs. These include SPEAR T-cell therapies
targeting the MAGE-A10, AFP, and MAGE-A4 cancer antigens, which all
have open INDs. The Company has identified over 25 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 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 November 10, 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
Investor Relations
Will Roberts
T: (215) 825-9306
E: will.roberts@adaptimmune.com
Juli P. Miller, Ph.D.
T: (215) 825-9310
E: juli.miller@adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Mobile: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
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