GSK Exercises Option over SPEAR T-cell Therapy Program Targeting NY-ESO
(Thomson Reuters ONE) -
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(at)adaptimmune.com
Media Relations
Margaret Henry
T: +44 (0)1235 430036
Cell: +44 (0)7710 304249
E: margaret.henry(at)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
Unternehmensinformation / Kurzprofil:
Datum: 07.09.2017 - 13:30 Uhr
Sprache: Deutsch
News-ID 559152
Anzahl Zeichen: 11296
contact information:
Town:
Philadelphia
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 209 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"GSK Exercises Option over SPEAR T-cell Therapy Program Targeting NY-ESO"
steht unter der journalistisch-redaktionellen Verantwortung von
Adaptimmune Therapeutics plc (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
