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 SarcomaIn
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 PlanAdaptimmune 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 GSKAdaptimmune 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 PipelineAdaptimmune'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 InformationThe 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 AdaptimmuneAdaptimmune 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 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 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
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Adaptimmune Therapeutics (NASDAQ:ADAP)
Historical Stock Chart
From Sep 2023 to Sep 2024