Promising Data from Phase 1 Trial with ADP-A2AFP in Liver Cancer at the International Liver Congress Confirm Safety Profile a...
August 28 2020 - 10:30AM
Adaptimmune Therapeutics plc (“Adaptimmune”)(Nasdaq: ADAP), a
leader in cell therapy to treat cancer, presented data from its
Phase 1 trial with SPEAR T-cells targeting AFP at the virtual
International Liver Congress (ILC). One patient out of four dosed
with 5 billion or more cells had a complete response, which was
reported previously. The data also demonstrate an acceptable safety
profile in patients with hepatocellular carcinoma (HCC).
“A complete response in a patient with advanced liver cancer,
and the anti-tumor activity we have reported in other patients with
an acceptable safety profile, to date, further support the
continued investigation of ADP-A2AFP,” said Elliot Norry,
Adaptimmune’s Chief Medical Officer. “We remain encouraged by the
potential of this therapy and we are fully committed to developing
ADP‑A2AFP for people with HCC. We have reported results for four
patients at doses of 5 billion cells or more and we are looking
forward to sharing more data as we continue to treat patients in
the expansion phase of the trial. Further, we continue to review
our translational findings and are evaluating ways to improve the
therapy, if necessary.”
Dr. Bruno Sangro of Clinica Universidad de Navarra presented
data from Cohort 3 and the expansion phase of the ADP-A2AFP Phase 1
trial during an oral presentation at ILC. Tim Meyer of University
College London presented additional data from Cohorts 1 and 2
during a poster presentation. A video is available on Adaptimmune’s
website (https://youtu.be/qAHamb3Yi8Y) of Elliot Norry, and Mark
Dudley, SVP of Early Stage Development, discussing these data. The
oral presentation and poster presentation are available online
through the congress web site.
Topline data from ILC 1
- One patient had a complete response and also demonstrated a
sustained reduction in serum AFP. This patient experienced disease
progression, having developed new lesions at Week 32
- Overall, nine patients have been treated as of the data cutoff,
of those- Four patients have been treated with ~5 billion or more
transduced cells (three in Cohort 3 and one in the expansion
phase): 1 patient with the complete response, 1 with stable disease
(SD), and 2 had progressive disease (PD)- Five patients were
previously treated in the first two dose cohorts with doses of
100 million and 1 billion transduced cells, respectively,
and all patients had best responses of SD
- ADP-A2AFP SPEAR T-cells were associated with an acceptable
safety profile with no evidence of significant T-cell related
hepatotoxicity and no protocol-defined dose limiting
toxicities
- Evidence of dose-dependent persistence of ADP-A2AFP SPEAR
T-cells post-infusion
- Further translational evaluation is ongoing to understand
indicators of response
______________________________1 All data summarized are for
patients with HCC with a data cut-off of July 6, 2020. Data from
non-HCC patients to be presented at a future congress
Overview of Trial Design
- This is a Phase 1, open-label, dose escalation clinical trial
designed to evaluate the safety and anti-tumor activity of
ADP-A2AFP in patients with HCC or other AFP-expressing tumors who
are not amenable to transplant, resection, or loco-regional
therapy, and who failed or were intolerant to or refused
standard-of-care treatment
- Dose escalation is complete, and this trial is enrolling in the
expansion phase intended to treat up to 25 patients with doses up
to 10 billion cells
About AdaptimmuneAdaptimmune is a
clinical-stage biopharmaceutical company focused on the development
of novel cancer immunotherapy products for people with cancer. The
Company’s unique SPEAR® (Specific Peptide Enhanced Affinity
Receptor) T-cell platform enables the engineering of T-cells to
target and destroy cancer across multiple solid tumors.
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 SEC on August 6, 2020, 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.
Media Relations:
Sébastien Desprez — VP, Communications and Investor RelationsT:
+44 1235 430 583M: +44 7718 453
176Sebastien.Desprez@adaptimmune.com
Investor Relations:
Juli P. Miller, Ph.D. — Senior Director, Investor RelationsT: +1
215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com
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