Dose Escalation in Liver Cancer Study with ADP-A2AFP (AFP) SPEAR T-cells and Moving to Expansion Phase in ADP-A2M10 (MAGE-A10...
January 07 2019 - 7:30AM
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell
therapy to treat cancer, today announced that the Safety Review
Committee (SRC) has endorsed dose escalation in the ongoing
ADP-A2AFP (AFP) study in patients with hepatocellular carcinoma
(liver cancer) to the second dose cohort. The SRC has also endorsed
moving to the expansion phase of the ADP-A2M10 (MAGE-A10) lung
cancer study.
Across both studies, most adverse events have been consistent
with those typically experienced by cancer patients undergoing
cytotoxic chemotherapy or other cancer immunotherapies with no
evidence of alloreactivity or toxicity related to off-target
binding.
In the ADP-A2AFP study, two patients have received 100 million
transduced SPEAR T-cells targeting AFP in the first dose cohort,
and there was no evidence of hepatotoxicity. The SRC endorsed dose
escalation after evaluating the first two patients and taking into
consideration the benefit:risk profile observed across programs in
Cohort 1.
In the ADP-A2M10 lung cancer study, ten patients have been
treated in the first three cohorts (up to six billion transduced
cells), and the expansion phase will allow for doses of up to ten
billion transduced cells (range 1.2 to 10 billion).
“We are pleased that the SRC has endorsed moving to the
expansion phase of the ADP-A2M10 lung cancer study. Additionally,
our ADP-A2AFP study has progressed to the next dose level of 1
billion transduced cells. Importantly, we did not observe liver
toxicity in the two patients treated at a dose of 100 million
transduced cells. In our other studies, we continue to enroll in
the expansion phases and, as we previously have said, we are on
track to report our next clinical data by May this year,”
said Rafael Amado, Adaptimmune’s President of Research &
Development.
Overview of ADP-A2AFP (AFP) Study Design
- This is a first-in-human, open-label study utilizing a modified
3+3 design in up to 36 patients with escalating target 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 an expansion phase with doses of up to 10 billion
SPEAR T-cells
- This trial is being conducted in patients with hepatocellular
carcinoma
- There was a 21-day stagger between patients in Cohort 1, with
this stagger dropping to 7 days in Cohorts 2, and 3 in the
absence of DLTs. There is no pre-determined stagger in the
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 30 patients
- The lymphodepletion regimen is fludarabine (flu) (20mg/m2/day)
and cyclophosphamide (cy) (500 mg/m2/day) for 3 days
- Efficacy is assessed by overall response rate, time to
response, duration of response, progression-free survival, and
overall survival at weeks 4, 8, and 16, month 6, and then every 3
months until confirmation of disease progression
Overview of ADP-A2M10 (MAGE-A10) Lung Cancer Study
Design
- This is a first-in-human, open-label study utilizing a modified
3+3 design in up to 28 patients with escalating target 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 DLTs followed by an expansion phase with
doses of up to 10 billion SPEAR T-cells
- This trial is being conducted in patients with non-small cell
lung cancer (NSCLC)
- There was a 21-day stagger between patients in Cohort 1, with
this stagger dropping to 7 days in Cohorts 2, and 3 in the
absence of DLTs. There is no pre-determined stagger in the
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 is cyclophosphamide (1800
mg/m2/day) for 2 days in Cohort 1, fludarabine (flu)
(30mg/m2/day) and cyclophosphamide (cy) (600 mg/m2/day) for 3
days in Cohort 2, and Cy (600 mg/m2/d) x 3 days + Flu (30 mg/m2/d)
X 4 days in Cohort 3
- Efficacy is assessed by 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
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, MAGE-A10, and
AFP across multiple solid tumor indications. 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 6, 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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