Adaptimmune Provides Update on Study of NY-ESO SPEAR® T-cell Therapy in Synovial Sarcoma at the European Society for Medical...
October 09 2016 - 10:00AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced a poster presentation of
updated data on its lead clinical program, an NY-ESO SPEAR®
(Specific Peptide Enhanced Affinity Receptor) T-cell receptor
therapy, in patients with synovial sarcoma at the European Society
for Medical Oncology (ESMO) 2016 Congress.
“These data help clarify the design of our upcoming pivotal
studies in sarcoma,” said Dr. Rafael Amado, Adaptimmune’s Chief
Medical Officer. “We have seen durable tumor responses to our SPEAR
T-cells and the preliminary benefit:risk profile appears favorable.
Further, although the data are preliminary, we do see activity
against tumors with lower levels of NY-ESO expression, which we
hope will further expand the utility of this therapy, and we have
evidence that fludarabine is required in the pre-conditioning
regimen. With these data in hand, we will initiate Cohort 4 with
our modified fludarabine pre-conditioning regimen, and continue
toward our goal of bringing this novel TCR-based immunotherapy to
sarcoma patients.”
In a poster presentation entitled, "Open Label Non-Randomized
Multi-Cohort Pilot Study of Genetically Engineered NY-ESO-1
Specific NY-ESO SPEAR T-cells in HLA-A*02+ Patients with Synovial
Sarcoma," Crystal Mackall, M.D., Professor of Pediatrics and
Medicine; Associate Director of the Stanford Cancer Institute,
provided an update on the following synovial sarcoma cohorts:
- Cohort 1: Subjects with high (≥50 percent 2+/3+ by IHC)
NY-ESO-1 antigen expression and lymphodepletion with
cyclophosphamide and fludarabine
- Cohort 2: Subjects with low (>1 percent to <50 percent
2+/3+ by IHC) NY-ESO-1 antigen expression and lymphodepletion with
cyclophosphamide and fludarabine
- Cohort 3: Subjects with high (≥ 50 percent 2+/3+ by IHC)
NY-ESO-1 antigen expression and lymphodepletion with
cyclophosphamide alone (no fludarabine)
- Cohort 4: Subjects with high (≥ 50 percent 2+/3+ by IHC)
NY-ESO-1 antigen expression and lymphodepletion with a modified
(lower) dose than Cohort I of cyclophosphamide and fludarabine
Cohort 1Adaptimmune has previously announced
that in the first cohort of synovial sarcoma patients, NY-ESO SPEAR
T-cells demonstrated a robust clinical response, including a 50
percent (6/12) response rate, and a 60 percent response rate (6/10)
in those who received the target dose of at least 1x109 transduced
cells. The median duration of response is reported to be
approximately 31 weeks (August 31 data cutoff). Ongoing NY-ESO
SPEAR T-cell persistence has been observed for up to 36 months.
Cohort 2Four subjects of a targeted 10 are
currently enrolled in the second cohort; three patients have been
treated with NY-ESO SPEAR T-cells. As of August 31, 2016 best
responses seen in these three patients were: one partial response
(PR), one stable disease (SD), and one progressive disease
(PD).
Cohorts 3 and 4Five patients are currently
enrolled in the third cohort; no objective responses have been
observed to date. As pre-specified in the protocol, enrollment in
cohort 3 has ceased, and company has initiated enrollment in Cohort
4.
TolerabilityNY-ESO SPEAR T-cells continue to
demonstrate a generally acceptable benefit: risk profile in all
treated patients to date. The most common (>30%) related adverse
events include pyrexia, lymphopenia, decreased white blood cell
(WBC), nausea, anemia, neutropenia, fatigue, decreased platelet
count (PLT), sinus tachycardia, and rash. Most common toxicities
related to therapy can be monitored and managed with medical
intervention and supportive care. While there are differences in
the patient populations, incidence of cytokine release syndrome
(CRS) with NY-ESO-1c259 SPEAR T appears to be of lower frequency
and severity than reported with CD19 CAR-T therapy. As previously
reported at the 2016 Annual American Society of Clinical Oncology
(ASCO) Meeting, there was one fatal SAE of bone marrow failure in
Cohort 2 of our synovial sarcoma trial. Internal investigations
have not identified a mechanism by which NY-ESO SPEAR T-cells may
have caused bone marrow failure.
Adaptimmune’s SPEAR T-cell candidates are novel cancer
immunotherapies that have 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 multiple therapeutic
candidate, significantly impact cancer treatment and clinical
outcomes of patients with solid and hematologic cancers.
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
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