YASTEST
PHILADELPHIA and OXFORD, United
Kingdom, Sept. 07, 2017 (GLOBE NEWSWIRE) -- Adaptimmune
Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat
cancer, today announced that GlaxoSmithKline plc (LSE:GSK)
(NYSE:GSK) has exercised its option under a collaboration and
license agreement signed in 2014 to exclusively license the right
to research, develop, and commercialize Adaptimmune's NY-ESO SPEAR
T-cell therapy program. Further details will be provided in a
conference call scheduled for 8:30 AM EDT this morning; dial-in and
webcast details are provided below.
Adaptimmune will receive up to £48 million (~$61
million) from GSK over the course of the transition period. This
includes development milestones of up to £18 million (~$23 million)
and the option payment of £30 million (~$38 million), which also
allows GSK to nominate two additional targets following completion
of the transition. Successful continuation of development and
subsequent commercialization of NY-ESO would trigger additional
payments for development milestones, tiered sales milestones, and
mid-single to low double-digit royalties on worldwide net
sales.
"This is a very exciting day for Adaptimmune as
GSK has exercised its option over our NY-ESO program, earlier than
originally planned," commented James Noble, Chief Executive Officer
at Adaptimmune. "The commitment by one of the world's leading
pharmaceutical companies to the NY-ESO SPEAR T-cell program as a
new treatment modality is a testament to the strength of our data
in synovial sarcoma recently presented at ASCO. From a financial
perspective, this option exercise extends our cash runway into
2020. We anticipate the transition of NY-ESO to GSK to be completed
over the coming months, after which we will focus our clinical
resources on delivery and execution from our wholly-owned assets
MAGE-A4, MAGE-A10, and AFP."
Axel Hoos, SVP Oncology R&D, GSK said "The aim
of GSK's R&D is to develop medicines with transformational
potential for patients. We have seen compelling data for the
NY-ESO investigational cell therapy in synovial sarcoma and,
following this option exercise, we will capitalize on our in-house
Cell and Gene Therapy capabilities to support the development
program for GSK3377794. We will continue to explore the potential
for this novel cell therapy in multiple tumor types, and in
combination with other cancer therapies."
Summary of Recent Data in
Synovial Sarcoma
In June of this year, data presented in an oral presentation
at ASCO from the ongoing study of NY-ESO SPEAR T-cells in
synovial sarcoma continued to indicate a favorable risk benefit
profile in this aggressive and difficult-to-treat solid tumor.
Initial anti-tumor activity was observed in all ongoing cohorts,
including low expressors of NY-ESO. NY-ESO SPEAR T-cells continued
to be well-tolerated with all reported events of cytokine release
syndrome resolved (the majority of events were Grade 1 or 2), and
there were no reported events of seizure, cerebral edema, or
encephalopathy. Survival data was promising with a median predicted
overall survival of 120 weeks (~28 months) among the
12 treated patients in Cohort 1; or, 159 weeks (~37 months)
for the ten patients in this cohort who received the target dose of
one billion cells. In addition, 6 responses were observed in Cohort
1 patients.
Transition
Plan
Adaptimmune and GSK will work together over the coming months to
ensure a smooth transition of the NY-ESO SPEAR T-cell development
program to GSK. After the transition, GSK will assume sponsor
responsibility for all NY-ESO-related activities including ongoing
data publications regarding this program. Current plans for ongoing
and planned clinical studies are summarized below by
indication:
Sarcoma:
- Adaptimmune will continue enrollment
in the ongoing synovial sarcoma pilot study, which will ultimately
transition to GSK.
- GSK will be responsible for
continued clinical investigation including initiating the
registration study in this indication.
- Adaptimmune will continue to enroll
patients in the ongoing myxoid/round cell liposarcoma (MRCLS)
study, which will ultimately transition to GSK.
Non-small Cell Lung Cancer (NSCLC):
- Adaptimmune will cease enrollment in
the ongoing NSCLC study, whilst GSK develops plans for its own
study of NY-ESO SPEAR T-cells in this indication.
Ovarian:
- Adaptimmune will cease enrollment in
the ongoing ovarian study, and GSK will assume responsibility for
any additional work in this indication.
Multiple Myeloma:
- GSK will take on responsibility for
the ongoing multiple myeloma combination study with KEYTRUDA®
(pembrolizumab), an anti-PD-1 inhibitor marketed by Merck
& Co., Inc., Kenilworth, NJ, USA (known as MSD outside the
US and Canada).
About the Collaboration and
License Agreement between Adaptimmune and GSK
Adaptimmune and GSK announced their strategic
collaboration and license agreement in June 2014 for up
to five programs including the first program, NY-ESO. The terms of
the agreement were expanded in February 2016 to accelerate
development of NY-ESO SPEAR T-cell therapy toward registration
trials in synovial sarcoma, to explore development in MRCLS and to
enable combination studies.
In January 2017, GSK nominated PRAME as a second
target and, as a consequence of this option exercise for NY-ESO,
GSK will have the right to nominate its third and fourth targets
and Adaptimmune will take these programs through preclinical
testing to IND. The agreement excludes targets on which work is
already under way, including Adaptimmune's wholly owned MAGE-A10,
MAGE-A4, and AFP clinical programs and its active preclinical
pipeline.
Adaptimmune's
Pipeline
Adaptimmune's proprietary technology enables the Company to
consistently generate affinity enhanced T-cell receptors (TCRs)
which address intracellular targets on solid tumors that are not
accessible to certain other experimental modalities. Adaptimmune
has three wholly-owned SPEAR T-cells in active clinical trials,
with further first and next generation SPEAR T-cells being
developed and evaluated by means of Adaptimmune's proprietary
preclinical testing platform.
As stated above, GSK does not have the right to
nominate any additional targets on which work is already under way,
including Adaptimmune's wholly-owned SPEAR T-cells targeting
MAGE-A10, MAGE-A4, and AFP that are being evaluated in four active
clinical trials across eight solid tumor indications., These
ongoing studies are described in more detail below:
- MAGE-A10: Two active trials, one in
NSCLC, and a triple tumor study in urothelial (bladder), melanoma,
and head and neck cancer
- MAGE-A4: One active trial across
seven solid tumor indications including urothelial, melanoma, head
and neck, ovarian, NSCLC, esophageal, and gastric cancers
- AFP: One active study in
hepatocellular (liver) cancer
Initial safety and efficacy data across each of
these studies is anticipated through 2017 and 2018.
Conference Call
Information
The Company will host a live teleconference and webcast to provide
additional details at 8:30 a.m. EDT (1:30 p.m. BST) today,
September 7, 2017. The live webcast of the conference call will be
available via the events page of Adaptimmune's corporate website
at www.adaptimmune.com. An archive will be available after the
call at the same address. To participate in the live conference
call, if preferred, please dial (877) 280-1254 (U.S.) or +44 (0)20
3427 1909 or 0800 279 4992 (U.K.). After placing the call, please
ask to be joined into the Adaptimmune conference call and provide
the confirmation code (1257702).
About
Adaptimmune
Adaptimmune 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 has
a number of proprietary clinical programs, and is also developing
its NY-ESO SPEAR T-cell program under a strategic collaboration and
license agreement with GlaxoSmithKline. The Company is located in
Philadelphia, USA and Oxfordshire, U.K. For more information,
please visit http://www.adaptimmune.com
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 Securities and Exchange
Commission (SEC) on August 3, 2017, 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
Investor Relations
Juli P. Miller, Ph.D.
T: (215) 825-9310
E: juli.miller@adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Cell: +44 (0)7710 304249
E: margaret.henry@adaptimmune.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Adaptimmune Therapeutics plc via
Globenewswire
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Apr 2023 to Apr 2024