Full Press Release Details
SPEAR T-cells Targeting MAGE-A4 Demonstrate
New Responses in Esophagogastric Junction (EGJ),
Lung, and Head and Neck Cancers - Late Stage Development Initiated in EGJ
- New Phase 2 trial in EGJ cancer planned
for 1H 2021, after first two patients treated responded to
next-generation ADP-A2M4CD8 therapy -
- Durability and efficacy data presented
at ASCO support potential for SPEARHEAD-1 as a registrational
trial for sarcoma - commercial launch planned in the US in 2022 -
- Phase 2 trial combining ADP-A2M4 with
pembrolizumab in head and neck cancer (SPEARHEAD-2) will
be the first time a SPEAR T-cell therapy is used in sequence with first
line systemic therapy -
- The SURPASS trial (a Phase 1 trial with
ADP-A2M4CD8) will focus on lung, EGJ, head and
neck, and bladder cancers -
- Confirmed complete response in a patient
with liver cancer in the Phase 1 ADP-A2AFP trial (reported as
partial response in January) -
PHILADELPHIA, PA., and OXFORDSHIRE, U.K., May 29, 2020 (GLOBE
NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, presented updated data from
its ADP-A2M4 Phase 1 trial at the American Society for Clinical Oncology (ASCO) Annual Meeting. The data demonstrate durability
and responses in synovial sarcoma, supporting SPEARHEAD-1 as a potential registrational trial. The ASCO presentation also describes
a new response in a patient with lung cancer, and a response in a patient with head and neck cancer (reported in January).
The Company also announced new responses in the SURPASS trial,
confirming the potential for SPEAR T cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to
sarcoma. These data further support the rationale for two new Phase 2 trials - SPEARHEAD-2 in head and neck cancer, which
will begin later this year, and a second trial in esophagogastric junction (EGJ) cancer planned for 1H 2021. A webcast of Dr.
Elliot Norry, Adaptimmune's Chief Medical Officer, and Adrian Rawcliffe, Adaptimmune's Chief Executive Officer, summarizing
these and other clinical data is available here: https://bit.ly/3enqBBy.
"I am pleased to announce that we have identified a new
indication to progress into late stage development. We plan to initiate a Phase 2 trial in esophagogastric junction cancer in the
first half of 2021, with our next-generation ADP-A2M4CD8 SPEAR T-cells. In addition, the ASCO data demonstrate promising durability
for ADP-A2M4 in sarcoma bolstering our ambition to have our first marketed therapy in 2022," said Adrian Rawcliffe, CEO.
"I'm thrilled with the responses in a broad range of tumors with our programs targeting MAGE-A4 and AFP. I am confident
that we will be able to identify more indications for late stage development as more patients are treated in our trials."
During an oral presentation at ASCO, Dr. David Hong of the MD
Anderson Cancer Center reported positive durability and efficacy data in synovial sarcoma from the ADP-A2M4 Phase 1 trial. Based
on these data, the Company believes that SPEARHEAD-1 can support registration for ADP-A2M4. These positive data also supported
removal of the futility analysis from SPEARHEAD-1, reducing the sample size from 60 to 45 patients.
Outside of sarcoma, Dr. Hong shared a new RECIST response in
a patient with lung cancer, as well as the response in a patient with head and neck cancer reported earlier this year. Further,
he reported evidence of anti-tumor activity in ovarian cancer, bladder cancer, and melanoma.
In the SURPASS trial, three patients have responded out of the
first four treated with ADP-A2M4CD8. One patient with EGJ cancer treated in the first dose cohort had a confirmed partial response
(PR) reported in January, which remains ongoing approximately six months post-infusion. As reported today, a second patient in
the first dose cohort, also with EGJ cancer, has an unconfirmed PR. The third response in the trial is an unconfirmed PR in a patient
with head and neck cancer. Data from this trial will be updated and presented in the second half of 2020 at a medical conference.
Based on these data, the Company plans to initiate a Phase 2 trial in EGJ cancer in the first half of 2021.
In January, the Company reported one confirmed PR in a patient
with liver cancer from the ADP A2AFP Phase 1 trial. Subsequently, this PR has been assessed as a confirmed complete response,
which remained ongoing at the last assessment (Week 24). The next two patients with liver cancer (or hepatocellular carcinoma [HCC])
treated in Cohort 3 did not respond. A separate cohort for AFP expressing tumors other than HCC was initiated and the one patient
treated to date has not responded. Detailed data will be presented in a poster and an oral presentation at the International Liver
Congress (ILC) in August 2020 (rescheduled from April of this year).
RECIST Responses with SPEAR T-cell Monotherapy in Patients
with Late Stage Cancers*
| Indication | Responses/(n) a | SPEAR T-cell Target | SPEAR T-cell product demonstrating responses | New response reported today | ||||
| Synovial sarcoma | 8 PR b / 16 | MAGE-A4 | ADP-A2M4 | Yes | ||||
| Head and neck | 2 PR b / 4 | MAGE-A4 | ADP-A2M4/ ADP-A2M4CD8 | Yes | ||||
| EGJ | 2 PR b / 3 | MAGE-A4 | ADP-A2M4CD8 | Yes | ||||
| Lung | 1 PR / 2 | MAGE-A4 | ADP-A2M4 | Yes | ||||
| Melanoma | 1 PR c / 2 | MAGE-A4 | ADP-A2M4 | No | ||||
| Liver (HCC) | 1 CR d / 3 | AFP | ADP-A2AFP | No |
a: n=number of patients treated; b: includes one unconfirmed
PR; c: patient treated in radiation sub-study of ADP A2M4 Phase 1 trial; d: previously assessed as PR
CR=complete response; EGJ=esophagogastric junction; HCC=hepatocellular
carcinoma; PR=partial response
ADP-A2M4 clinical update
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 May 14, 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.
Adaptimmune Contacts:
S bastien Desprez - VP, Communications and Investor
Juli P. Miller, Ph.D. - Senior Director, Investor Relations