Adaptimmune Presents Study Designs for Ongoing MAGE-A4 and NY-ESO SPEAR T-cell Clinical Trials at the Society for Immunothera...
November 10 2017 - 8:58AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, is presenting two trials in progress
posters summarizing study designs for ongoing clinical trials with
MAGE-A4 and NY-ESO SPEAR T-cells at the 2017 SITC annual meeting at
the Gaylord National Hotel & Convention Center in National
Harbor, Maryland, United States.
Overview of Study Designs:
- MAGE-A4 SPEAR T-cells targeting multiple solid tumors1:
- Open-label, non-randomized pilot study evaluating the
safety, tolerability, and antitumor activity of MAGE-A4 SPEAR
T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable
locally advanced or metastatic tumor(s) - This dose
escalation study utilizes a modified 3+3 design:
• Group 1: to enroll 3-6 patients; dose of
100 million transduced SPEAR T-cells, 21-day interval for safety
review • Group 2: to enroll
3-6 patients; dose of 1 billion transduced SPEAR T-cells, 7-day
interval for safety review2
• Group 3: to enroll 3-6 patients; dose of 1-5 billion
transduced SPEAR T-cells, 7-day interval for safety review2
• Study allows for expansion at
optimal dose range up to 20 patients across tumors -
Patients must be: ≥ 18 yrs old; HLA-A*02 positive; have MAGE-A4
positive inoperable locally advanced or metastatic tumor(s) at ≥1+
intensity in ≥ 10% of tumor cells MAGE-A4 expression by
immunohistochemistry (IHC); have ECOG status 0 or 1; and adequate
organ function - Lymphodepletion regimen: fludarabine
(30 mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3
days - Efficacy assessed by overall response rate, time
to response, duration of response, progression-free survival, and
overall survival at weeks 4, 8, and 12, month 6, and then every
3 months until confirmation of disease progression
- The study is open and enrolling
- NY‑ESO SPEAR T-cells with or without
KEYTRUDA® (pembrolizumab) in multiple myeloma: -
Open-label, randomized pilot study evaluating the safety,
tolerability, and antitumor activity of NY-ESO SPEAR T-cells with
or without KEYTRUDA in patients with multiple myeloma -
Eligible patients will be randomly assigned to a treatment arm:
NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in
combination with KEYTRUDA (Arm 2) - Target enrollment
is 20 patients with 10 in each arm; eligible patients who do not
receive the T‑cell infusion may be replaced. - Patients
must be: ≥ 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive;
have histologically confirmed diagnosis of multiple myeloma with
either primary refractory or relapsed/refractory disease
expressing NY-ESO-1 and/or LAGE-1a; have received prior
therapies including IMiD and a proteasome inhibitor as separate
lines or a combined line of therapy; have ECOG status 0 or 1; and
adequate organ function - Lymphodepletion regimen:
fludarabine (30 mg/m2/day) and cyclophosphamide
(600 mg/m2/day) for 3 days, followed by granulocyte-colony
stimulating factor - For patients in Arm 2, KEYTRUDA
will be administered every 3 weeks, starting at week 3 following
T-cell infusion until week 108 - Target dose of 1 – 8 ×
109 transduced SPEAR T-cells - Efficacy will be
assessed by the International Myeloma Working Group (IMWG) Uniform
Response Criteria. Overall response rate, time to response,
duration of response, progression-free survival, and overall
survival will be determined. - The study is open and
enrolling
About
AdaptimmuneAdaptimmune is a
clinical-stage biopharmaceutical company focused on the development
of novel cancer immunotherapy products. The Company’s unique SPEAR
(Specific Peptide Enhanced Affinity Receptor) T-cell platform
enables the engineering of T-cells to target and destroy cancer,
including solid tumors. Adaptimmune is currently conducting
clinical trials with SPEAR T-cells targeting MAGE-A4, -A10, and AFP
across several solid tumor indications. GlaxoSmithKline
plc (LSE:GSK) (NYSE:GSK) exercised its option to exclusively
license the right to research, develop, and commercialize
Adaptimmune’s NY-ESO SPEAR T-cell therapy program in September
2017. Transition of this program to GSK is ongoing. The Company is
located in Philadelphia, USA and Oxfordshire, U.K. For more
information, please visit 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 2, 2017, 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 ContactsInvestor Relations:Juli P.
Miller, Ph.D.T: (215) 825-9310E: juli.miller@adaptimmune.com
Media Relations:Sébastien DesprezT: +44 1235 430 583M: +44 7718
453 176E: Sebastien.Desprez@adaptimmune.com
__________________________________1 Urothelial cancer
(transitional cell cancer of the bladder, ureter or renal pelvis),
melanoma, squamous cell carcinoma of the head and neck, ovarian
cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal
(squamous and adenocarcinoma) or gastric cancer
2 If, in Group 1 or Group 2, 1 out of 3 patients experiences a
dose limiting toxicity (DLT) requiring expansion of an additional 3
patients (n=6), the subsequent observation periods in Group 2 or
Group 3 will be increased from 7 days to 14 days for the respective
groups.
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