Adaptimmune Granted Access to PRIority MEdicines (PRIME) Regulatory Support by the European Medicines Agency for ADP-A2M4 for...
Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell
therapy to treat cancer, announced that the European Medicines
Agency (EMA) has granted access to the PRIME initiative to the
Company for ADP-A2M4 for the treatment of synovial sarcoma. PRIME
access provides enhanced scientific and regulatory support by the
EMA to developers of medicines with the potential to significantly
address unmet medical needs.
“We are thrilled that the EMA has acknowledged the potential of
ADP-A2M4 to address an unmet medical need for more effective
treatment options for patients with advanced synovial sarcoma,”
said Dennis Williams, PharmD, Adaptimmune’s Senior Vice President,
Late Stage Development. “Access to the enhanced EMA support and
guidance offered in the PRIME scheme will facilitate the
development of ADP-A2M4 to ensure this important medicine reaches
patients with sarcoma as early as possible.”
Access to the PRIME initiative for ADP-A2M4 was granted based on
clinical data from the Phase 1 trial demonstrating compelling
efficacy and early promising durability, with tolerable safety in
patients with synovial sarcoma. Based on these data the Company
initiated the SPEARHEAD-1 trial with ADP-A2M4, enrolling people
with advanced synovial sarcoma and myxoid/ round cell liposarcoma
(MRCLS) at clinical sites in Canada, France, Spain, the United
Kingdom, and the United States (US). The SPEARHEAD-1 trial is
intended to support the registration of ADP‑A2M4 for the treatment
of advanced synovial sarcoma and MRCLS.
In recent months, the US Food and Drug Administration granted
Orphan Drug Designation (ODD) to SPEAR T-cells targeting MAGE-A4
for the treatment of soft tissue sarcomas and Regenerative Medicine
Advanced Therapy designation for the treatment of synovial sarcoma.
In addition, The EMA’s Committee for Orphan Medicinal Products
adopted a positive opinion for ODD for ADP-A2M4 for the treatment
of soft tissue sarcomas.
The PRIME program aims to optimize development plans and speed
up evaluation of medicines that may offer a major therapeutic
advantage over existing treatments or benefit patients without
treatment options. The PRIME designation is awarded by the EMA to
promising medicines that target an unmet medical need. To be
eligible and accepted for PRIME, a medicine must show potential to
benefit patients with unmet medical needs based on early clinical
data coupled with non-clinical data. Through the PRIME program, the
EMA offers enhanced support to medicine developers including early
interaction and dialogue, and a pathway for accelerated evaluation
by the agency. The program is intended to optimize development
plans and expedite the review and approval process so that these
medicines may reach patients as early as possible.
About Synovial SarcomaSoft tissue sarcomas can
develop from soft tissues like fat, muscle, nerves, fibrous
tissues, blood vessels, or deep skin tissues. There are
approximately 50 types of soft tissue sarcomas, including synovial
sarcoma, which accounts for approximately 6% to 10% of all soft
tissue sarcomas. There remains a large unmet medical need for
synovial sarcoma, and approximately one-third of synovial sarcomas
occur in childhood and the peak incidence is in the third decade of
life. The most common locations for this cancer are the hip, knee,
ankle, and shoulder.
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 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.
Sébastien Desprez — VP, Communications and Investor RelationsT:
+44 1235 430 583M: +44 7718 453
Juli P. Miller, Ph.D. — Senior Director, Investor RelationsT: +1
215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com