Adaptimmune Provides Update on Clinical Study Evaluating its SPEAR® T-Cell Therapy Targeting NY-ESO-1 in Ovarian Cancer
October 12 2016 - 9:15AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced that its amended protocol
using its NY-ESO SPEAR® (Specific Peptide Enhanced Affinity
Receptor) T-cell therapy in ovarian cancer patients with treatment
resistant or refractory metastatic ovarian cancer is now actively
recruiting.
To date, no objective clinical responses have been reported in
the ovarian cancer patients who received NY-ESO SPEAR T-cell
therapy in the initial iteration of this trial. Of note, these
initial patients received a preconditioning regimen which consisted
of cyclophosphamide alone, rather than including fludarabine. Data
from Adaptimmune’s studies of its NY-ESO SPEAR T-cell therapy in
synovial sarcoma patients have indicated the importance of
including fludarabine in the preconditioning regimen. The use of
fludarabine appears to be required for expansion, response and
persistence of transduced cells. As a result, this trial will
enroll patients under a revised protocol including a
pre-conditioning regimen that includes fludarabine in combination
with cyclophosphamide.
"Based on our clinical experience to date, we have amended the
protocol for this trial to include both fludarabine and
cyclophosphamide in the conditioning regimen," said Dr. Rafael
Amado, Adaptimmune’s Chief Medical Officer. “We hope that, as
previously observed in synovial sarcoma, this lymphodepleting
regimen will enable anti-tumor immune responses mediated by NY-ESO
SPEAR T-cell therapy in these patients with advanced chemotherapy
relapsed or refractory ovarian cancer."
This is a Phase I/IIa, open-label study of autologous T-cells
genetically engineered with an enhanced affinity NY-ESO-1 T-cell
receptor in ovarian cancer patients with the HLA-A*0201,
HLA-A*0205, and/or HLA-A*0206 allele and whose tumor expresses the
NY-ESO-1 tumor antigen. Though the prevalence of HLA sub-types
varies from population to population, the most common in the
western world is HLA-A2. Among the HLA-A2 variants, the most
prevalent are HLA-A*0201 and HLA-A*0206.
This multi-center study is intended to enroll up to 10
additional patients under the revised protocol, and will assess the
safety and tolerability of Adaptimmune’s NY-ESO SPEAR T-cell
therapy in patients with treatment resistant or refractory
metastatic ovarian cancer expressing the NY-ESO-1
antigen. Secondary objectives will include the assessment of
clinical efficacy, measurements of durability of persistence of
NY-ESO SPEAR T-cells in the blood, and exploratory tumor biomarker
studies, and evaluations of the phenotype and functionality of
NY-ESO-1 SPEAR T-cells.
For more information on this clinical trial, visit
ClinicalTrials.gov at: https://clinicaltrials.gov/ (Identifier:
NCT01567891).
About Ovarian CancerAs
reported by the American Cancer Society, epithelial ovarian cancer
is the leading cause of death from gynecologic cancer in the United
States and the country’s fifth most common cause of cancer
mortality in women. It is estimated that in 2016 in the United
States, 22,280 women will receive a new diagnosis of ovarian
cancer, and approximately 14,240 women will die of this disease.
Overall, the five-year relative survival rate is 45 percent. If the
cancer is detected and treated early, at the localized stage when
the cancer is only in the part of the body where it started, the
five-year relative survival rate is 92 percent. However, only 15
percent are detected at the localized stage. No treatment is
available for patients with refractory or resistant metastatic
ovarian cancer.
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 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 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 August 8, 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 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
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Apr 2023 to Apr 2024