Adaptimmune Announces Favorable Review of Safety from One Billion Cell Dose Cohort in MAGE-A10 SPEAR T-cell Study and Initiat...
July 18 2018 - 7:29AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced favorable review of safety
data from the second dose cohort of patients who received one
billion transduced SPEAR T‑cells targeting MAGE-A10 in the
non-small cell lung cancer (NSCLC) study. Based on these data, the
Safety Review Committee (SRC) has endorsed dose escalation to the
third dose cohorts in both MAGE-A10 pilot studies (i.e., the NSCLC
and the triple tumor studies).
To date, eight patients have received 100 million transduced
MAGE‑A10 SPEAR T-cells in the first dose cohorts of both studies,
and three patients have received one billion cells in the second
cohort of the NSCLC study. No evidence of toxicity related to
off-target binding or alloreactivity has been reported. Most
adverse events were consistent with those typically experienced by
cancer patients undergoing cytotoxic chemotherapy or other cancer
immunotherapies.
“We are pleased that the SRC has recommended proceeding with
dose escalation to the final dose group, as our MAGE-A10 SPEAR
T-cells appear to be well-tolerated without evidence of off-target
or non-specific reactivity,” said Rafael Amado, Adaptimmune’s
Chief Medical Officer. “These studies will continue dosing up to 6
billion cells in conjunction with a higher intensity
preconditioning regimen, which, based on our data from the NY-ESO
trials, may result in greater therapeutic potential. This final
dose escalation represents excellent progress toward our goal of
delivering response data by the end of 2018. As we get more data
throughout 2018, we will share meaningful safety and response data
from this and our other wholly owned programs.”
Overview of Study Design MAGE-A10 Pilot
Studies
- These are first-in-human, open-label studies utilizing a
modified 3+3 design in up to 28 patients with escalating doses
of 100 million (Cohort 1), 1 billion (Cohort 2), and
1.2‑6 billion (Cohort 3) transduced SPEAR T-cells to evaluate
safety, including dose limiting toxicities (DLTs) followed by a
possible expansion phase with doses of up to 10 billion SPEAR
T-cells
- One study is in NSCLC and the other study is in bladder,
melanoma, and head & neck cancers (the “triple tumor”
study)
- Patients are screened under a separate protocol (Screening
Protocol: NCT02636855) to identify those who have the relevant
HLA-A*02 alleles and MAGE-A10 tumor expression
- There was a 21-day stagger between patients in Cohort 1, with
this stagger dropping to 7 days in Cohorts 2, 3, and also in the
potential expansion phase
- Cohorts 1-3 were intended to enroll 3 patients each with an
expansion to 6 patients if DLTs were observed
- The expansion phase can enroll up to 10 patients
- The lymphodepletion regimen for:• Cohort 1 (NSCLC only) -
cyclophosphamide (cy) (1800 mg/m2/day) for 2 days;• Cohorts 1
(triple tumor) and 2 (both studies) - fludarabine (flu)
(30mg/m2/day) and cy (600 mg/m2/day) for 3 days• Cohorts
3 and expansion phase - flu (30mg/m2/day) for 4 days and cy
(600 mg/m2/day) for 3 days
- For NSCLC - efficacy is assessed by overall response rate,
duration of response, progression-free survival, and overall
survival at weeks 4, 8, and 12, month 6, and then every 3 months
(for 2 years) and then every 6 months until confirmation of disease
progression
- For Triple Tumor - efficacy is assessed by overall response
rate, best overall response, time to response, duration of
response, duration of stable disease, progression-free survival,
and overall survival at weeks 6, 12, 18, and 24 weeks, and then
every 3 months until confirmation of disease progression
Adaptimmune’s PipelineAdaptimmune's proprietary
technology enables the Company to consistently generate affinity
enhanced T-cell receptors (TCRs) that address intracellular targets
on solid tumors that may not accessible to certain other
immunotherapy treatment modalities. Adaptimmune has three wholly
owned SPEAR T‑cells in active clinical trials, with additional
first and next generation SPEAR T‑cells being evaluated by means of
Adaptimmune’s proprietary preclinical testing platform in advance
of proceeding to the clinic.
Adaptimmune’s wholly owned SPEAR T-cells targeting MAGE‑A10,
MAGE‑A4, and AFP are being evaluated in four active clinical trials
across ten solid tumor indications:
- MAGE-A10: Two active trials, one in NSCLC, and a triple tumor
study in urothelial (bladder), melanoma, and head & neck
cancers
- MAGE-A4: One active trial across nine solid tumor indications
including urothelial, melanoma, head and neck, ovarian, NSCLC,
esophageal, and gastric cancers; as well as synovial sarcoma and
myxoid/round cell liposarcoma (MRCLS)
- AFP: One active study in hepatocellular (liver) cancer
Patients are receiving doses of 1 billion SPEAR T-cells and
above across all the MAGE-A4 and MAGE‑A10 trials as there has been
no evidence of off-target toxicity, to date, which has supported
dose escalation
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 filed
on form 10-Q with the Securities and Exchange Commission (SEC) on
May 9, 2018 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:
Media Relations:Sébastien Desprez – VP,
Communications and Investor RelationsT: +44 1235 430 583M: +44 7718
453 176 Sebastien.Desprez@adaptimmune.com
Investor Relations: Juli P. Miller, Ph.D. –
Director, Investor RelationsT: +1 215 825 9310M: +1 215 460
8920Juli.Miller@adaptimmune.com
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