Full Press Release Details
Adaptimmune Provides Full Contents of
its SITC Abstract for the Phase 1 SURPASS Trial
PHILADELPHIA, Pa. and OXFORDSHIRE, UK., October 15, 2020
- Adaptimmune Therapeutics plc ("Adaptimmune") (Nasdaq: ADAP), a leader in cell therapy to treat cancer is aware
of the early release of the abstract entitled "Initial safety, efficacy, and product
attributes from the SURPASS trial with ADP-A2M4CD8, a SPEAR T-cell therapy incorporating
an affinity optimized TCR targeting MAGE-A4 and a CD8 co-receptor"
by the Society for the Immunotherapy of Cancer ("SITC") Conference.
The full abstract is attached to this release.
The Company will update on the full dose escalation cohort of
the SURPASS trial (6 patients in total) at the virtual SITC conference on November 11, 2020 at 9 AM EST when posters are made
Adaptimmune 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
Forward-Looking Statements
This 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.
S bastien Desprez - VP, Communications and Investor
Juli P. Miller, Ph.D. - Senior Director, Investor
Initial safety, efficacy, and product attributes from the SURPASS trial with ADP-A2M4CD8,
a SPEAR T-cell therapy incorporating an affinity optimized TCR targeting MAGE-A4 and
David S. Hong1, Jeffrey
Clarke2, Tanner Johanns3, Partow Kebriaei1, John V. Heymach1, Ahmed Galal2,
Samuel D. Saibil4, Adrian Sacher4, Francine E. Brophy5, Gareth Betts6, Natalie Bath6,
Will Spinner6, Alex Tipping6, Jessica Tucci5, Raymond Luke5, Trupti Trivedi5,
Quan Lin5, Jean-Marc Navenot5, Paula M. Fracasso5, Karen Miller6,
Elliot Norry5, Mark Dudley5, Marcus O. Butler4
Affiliations (Institution, City, State, Country):
1The University of Texas MD Anderson Cancer Center,
Houston, TX, United States of America, 2Duke Cancer Center, Durham, NC, United States of America, 3Washington
University School of Medicine, St. Louis, MO, United States of America,4Princess Margaret Cancer Centre, Toronto, Ontario,
Canada, 5Adaptimmune, Philadelphia, PA, United States of America, 6Adaptimmune, Abingdon, United Kingdom
ongoing SURPASS trial (NCT04044859) evaluates safety and efficacy of next-generation
ADP-A2M4CD8 SPEAR T-cells co-expressing the CD8 co-receptor with the engineered MAGE-A4c1032 T-cell receptor
First-in-human trial in HLA-A*02 positive patients (pts) with advanced
cancers expressing MAGE-A4 antigen by immunohistochemistry. Eligible
pts undergo apheresis, T-cells are isolated, transduced with a Lentiviral vector containing the MAGE-A4c1032 TCR and
CD8 co-receptor, and expanded. Expansion, transduction level, cellular composition and function of the manufactured product
(MP) are assessed in vitro. Prior to infusion, pts receive lymphodepletion with fludarabine 30 mg/m2/day
for 4 days and cyclophosphamide 600 mg/m2/day for 3 days.
As of 16 July 2020, 5 pts (1
with MRCLS, 2 with esophagogastric junction [EGJ] cancers, 1 with ovarian cancer, and 1 with head and neck cancer) were treated
with ADP-A2M4 CD8 (range ~1 to 5.7 billion transduced cells). No DLTs or SAEs have been reported. To date, 1 pt with EGJ cancer
had a partial response (PR per RECIST) and has had progression-free survival >6 months. One pt with head and neck cancer also
had a PR. All other pts have had best overall response of stable disease.
MP expanded by an average of 15.3-fold during manufacturing
(range 5.9 to 25.6-fold). On average, 43% of T-cells in the MP expressed the TCR (range 23 to 63%). The fraction of CD4+ cells
in the final MP varied (range 45 to 84%). Co-expression of the MAGE-A4
TCR and CD8 in CD4+ T-cells in the patient MP enabled CD4+ T-cells to kill tumor target cells directly
in vitro. MAGE-A4 expression in tumor biopsies varied (H-score range 55 to 300). Transduced T-cells were detected
in peripheral blood of all pts. IFN-gamma increased transiently in the serum of 1 pt who responded.
ADP-A2M4CD8 SPEAR T-cells have shown an acceptable safety profile and pts with EGJ cancer and head and neck cancer have
demonstrated evidence of antitumor activity. Translational data and early clinical results indicate that co-expression of the CD8
co-receptor on CD4+ SPEAR T-cells may increase the potency of the product by conferring additional killing activity
to the helper T-cell subset. This dose escalation trial is ongoing and updated clinical and translational data will be presented.