Bli medlem
Bli medlem

Du är här


Adaptimmune Therapeutics plc: U.S. Food and Drug Administration Grants Breakthrough Therapy Designation for Adaptimmune's Affinity Enhanced T-cell Therapy Targ

PHILADELPHIA and OXFORD, United Kingdom, Feb. 09, 2016 (GLOBE NEWSWIRE) --
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in the use of TCR
engineered T-cell therapy to treat cancer, today announced that the U.S. Food
and Drug Administration (FDA) has granted Breakthrough Therapy designation
for the company's affinity enhanced T-cell therapy targeting NY-ESO in
synovial sarcoma for HLA-A*201, HLA-A*205 or HLA-A*206 allele-positive
patients with inoperable or metastatic synovial sarcoma who have received
prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigen.

"We are committed to investigating the potential of our NY-ESO-1-T cell
therapy across a variety of cancers. We are pleased that the FDA has granted
Breakthrough Therapy designation for our T-cell therapy in synovial sarcoma,
recognizing both the unmet need for patients suffering from this disease as
well as the promise of these early data," said Dr. Rafael Amado,
Adaptimmune's Chief Medical Officer. "We look forward to working closely with
the FDA to expedite the clinical development of this therapeutic candidate."

The Breakthrough Therapy designation was based on the results of a phase I/II
trial in patients with unresectable, metastatic or recurrent synovial sarcoma
who have received prior chemotherapy. Patients were treated with
lymphodepleting chemotherapy followed by immunotherapy with T-cells
engineered to recognize an HLA-A2 restricted NY-ESO-1 peptide.

Data from this study were most recently presented at the 2015 Annual Meeting
of the Society of Immunotherapy for Cancer (SITC) in November 2015. In the
primary efficacy analysis, 60 percent of the 10 patients receiving the target
dose of cells responded, and there was a 50 percent overall response rate in
the 12 patients receiving any dose of cells. 90 percent (9/10) of those
patients who received the target dose and 75 percent (9/12) of all patients
were alive and on long term follow-up. The most common adverse events
included nausea, anemia, pyrexia, lymphopenia and neutropenia. Cytokine
release syndrome (CRS) was seen in four of twelve subjects, with grade 3 CRS
observed in two subjects; no grade 4 CRS events were observed.

Adaptimmune recently announced that it will aim to initiate pivotal studies
with its affinity enhanced T-cell therapy targeting NY-ESO in synovial
sarcoma around year end 2016, and that it will also explore development in
myxoid round cell liposarcoma. Studies with this therapy are also under way
in myeloma, melanoma, ovarian cancer and non-small cell lung cancer.

About Breakthrough Therapy Designation

The breakthrough therapy designation was enacted as part of the Food and Drug
Administration Safety and Innovation Act of 2012 and is intended to expedite
the development and review of drugs for serious or life-threatening
conditions. The criteria for breakthrough therapy designation require
preliminary clinical evidence that demonstrates the drug may have substantial
improvement on at least one clinically significant endpoint over available
therapy. According to the FDA, breakthrough therapy designation conveys all
of the fast track program features, more intensive FDA guidance on an
efficient drug development program, an organizational commitment involving
senior managers, and eligibility for rolling review and priority review of
the company's Biologic License Application when submitted.

About Soft Tissue Sarcoma

Soft tissue sarcomas can develop from soft tissues like 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 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) is added in
selected cases. The American Cancer Society estimates 11,930 new soft tissue
sarcoma diagnoses (6,610 cases in males and 5,320 cases in females) in the
United States in 2015, representing approximately 2 percent of all cancers,
and approximately 4,870 Americans (2,600 males and 2,270 females) are
expected to die of soft tissue sarcomas.

About Adaptimmune

Adaptimmune is a clinical stage biopharmaceutical company focused on novel
cancer immunotherapy products based on its T-cell receptor (TCR) 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 an affinity enhanced T-cell therapy
targeting the NY-ESO cancer antigen. Its NY-ESO TCR affinity enhanced 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. 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 200 employees and is located in Oxfordshire, U.K. and Philadelphia,
USA. For more information:

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 Annual Report on Form 20-F filed with the
Securities and Exchange Commission on October 13, 2015. 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

Margaret Henry
Head of PR
T: +44 (0)1235 430036
Mob: +44 (0)7710 304249


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Adaptimmune Therapeutics plc via Globenewswire


Författare WKR

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.