Adaptimmune Announces Data From Clinical Studies of NY-ESO-1 Specific T-Cells in Multiple Cancers at the 2015 Annual American Society of Clinical Oncology (ASCO) Meeting
(Thomson Reuters ONE) -
OXFORD, England and PHILADELPHIA, May 30, 2015 (GLOBE NEWSWIRE) -- Adaptimmune
Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company
focused on the use of TCR engineered T-cell therapy to treat cancer, today
announced a poster presentation of data on its lead clinical program, an
affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1
cancer antigen, in both solid and hematologic cancers. Eighty-two (82) patients
have been treated to date with NY-ESO-T; 44 under Adaptimmune's IND, and 38
under a National Cancer Institute IND (Robbins et al., CCR, 2014). The data from
Adaptimmune's clinical studies in synovial sarcoma, multiple myeloma and ovarian
cancer were presented at the 2015 Annual American Society of Clinical Oncology
(ASCO) Meeting.
In this poster presentation, entitled: "Genetically Engineered NY-ESO-1 Specific
T-Cells in HLA-A201+ Patients with Advanced Cancers," Melinda Merchant, M.D.,
Ph.D., Clinical Director of the Pediatric Oncology Branch of the National Cancer
Institute, National Institutes of Health, in Bethesda, MD described the early
clinical experience of the NY-ESO TCR therapeutic (NY-ESO-T) in 44 patients
across indications.
The authors of the poster concluded:
* NY-ESO-T demonstrated robust clinical responses in solid and hematologic
tumors, including a 60 percent (6/10) confirmed response rate in synovial
sarcoma, and a 59 percent (13/22) response rate (Complete Response + near
Complete Response, per International Myeloma Working Group guidelines) in
myeloma in the context of autologous stem cell transplant. Approximately 62
percent (8/13) of responders had tumors with abnormal cytogenetics; 4/8 of
these abnormalities are associated with high risk disease.
* In addition, a response was seen in an initial ovarian patient and patient's
tumor markers were observed to be falling during this period of response.
The response was abrogated by the use of systemic steroids to treat cytokine
release syndrome. Reduction in pre-conditioning chemotherapy intensity in
the subsequent four ovarian patients was associated with short T-cell
persistence and lack of a meaningful antitumor effect. New studies are being
conducted to identify the optimal dosage of pre-conditioning chemotherapy
for NY-ESO-1 T-cell function.
* Durability of response ranged from 2 to 9 months, and from 3 months to
ongoing response at 2.5 years in the sarcoma and myeloma studies
respectively.
* NY-ESO-T has been generally well-tolerated with no long term side-effects
detected to date. In the 44 patients treated under the Adaptimmune IND, the
most common adverse events include diarrhea, pyrexia, and fatigue. Grade 3
cytokine release syndrome was observed in two patients, which was manageable
with supportive care measures and resolved without sequelae.
* Importantly, NY-ESO-1 T-cells exhibited durable persistence without the
requirement for IL-2 support in vivo, and cells were detectable for up to
three years in peripheral blood by PCR. Additionally, the data show
continued expression of the NY-ESO TCR for up to two years and continued NY-
ESO-T function in a subset of patients, without accumulation of multiple
exhaustion markers. NY-ESO-T memory phenotype is generated in persisting
cells suggesting the programming of immunological memory for NY-ESO-T.
Dr. Rafael Amado, Adaptimmune's Chief Medical Officer, said, "These results - in
particular the response rate in a solid tumor setting and the immune correlates
of NY-ESO-T persistence, function, and the absence of T-cell exhaustion
- represent important fundamental findings heretofore not observed in the field
of T-cell receptor gene therapy for cancer. The data support the promise of our
engineered T-cell platform as a means of augmenting a patient's immune system to
fight cancer, and provide a rationale for the clinical development of additional
TCR specificities across a spectrum of tumor types. We look forward to building
on these findings to develop TCR-based therapeutics which may one day offer an
important treatment option to patients with diverse solid and hematologic
malignancies."
Data from the multiple myeloma and synovial sarcoma clinical studies were
initially presented on April 21 at the 2015 annual meeting of the American
Association for Cancer Research (AACR) in Philadelphia, PA by lead principal
investigators, Aaron Rapoport, M.D., Professor of Medicine and Director of
Lymphoma Gene Medicine, Marlene and Stewart Greenebaum Cancer Center (AACR
abstract number 4701), and Dr. Merchant (AACR abstract number 4707).
Adaptimmune's NY-ESO TCR therapeutic candidate is a novel cancer immunotherapy
that has 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 NY-ESO TCR therapeutic
candidate, significantly impact cancer treatment and clinical outcomes of
patients with cancers, including synovial sarcoma, multiple myeloma, melanoma,
ovarian cancer, lung cancer and esophageal cancer.
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 A-
10, is scheduled to enter the clinic in late 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
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(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 LLC via GlobeNewswire
[HUG#1925166]
Unternehmensinformation / Kurzprofil:
Datum: 30.05.2015 - 18:30 Uhr
Sprache: Deutsch
News-ID 396954
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