Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug
discovery and development company advancing therapies for Duchenne
muscular dystrophy ("DMD") and Clostridium difficile infection,
announces a multi-year extension of its exclusive strategic
alliance with the University of Oxford until November 2019, with an
option to extend it for a further 12 months, to support and
accelerate development of future generation utrophin modulators for
the treatment of the progressive muscle wasting disorder, DMD.
Utrophin modulation is a therapeutic approach that has the
potential to slow or even stop the progression of DMD in all
patients with this genetic disorder. DMD is caused by the absence
of functional dystrophin protein and utrophin is a naturally
occurring protein that is functionally similar to dystrophin.
Utrophin modulation aims to maintain the production of utrophin to
compensate for the missing dystrophin.
"Summit's strategic alliance with the University of Oxford is an
important part of our DMD programme that seeks to discover and
develop a strong pipeline of utrophin-based therapies for the
treatment of all patients with DMD behind our lead clinical
candidate SMT C1100," commented Glyn Edwards, Chief
Executive Officer of Summit. "This is an incredibly
exciting time for the field of utrophin modulation with SMT C1100
poised to enter a Phase 2 proof of concept trial and the recent
publication of positive preclinical efficacy data on our second
generation candidates. The extension of our alliance will allow us
to invest further in utrophin modulation in partnership with the
world-leading academic research groups at Oxford. This will help to
accelerate the development of future generation molecules towards
clinical trials, as we seek to maintain our leadership position in
this field and potentially allow DMD boys to live longer and more
fulfilled lives."
The strategic alliance is a collaboration between Summit and the
research teams of Professor Kay Davies, an internationally
acclaimed expert in DMD at the University of Oxford, Professor
Stephen Davies, Waynflete Professor of Chemistry at the University
of Oxford and a director of Summit, and Professor Angela Russell,
an expert in medicinal chemistry and pharmacology at the University
of Oxford. To date, the collaboration has identified a number of
new series of utrophin modulator compounds that are structurally
distinct from the clinical candidate SMT C1100. Work is on-going
towards selection of one or more of these differentiated series for
progression into lead optimisation studies.
Linda Naylor, Managing Director of Isis Innovation, the
University of Oxford's technology commercialisation company,
said, "This is great progress from our committed
commercial partners who are applying this important Oxford research
with the potential to impact many lives for the better."
Terms of the Alliance Extension
Under the terms of the alliance extension, Summit retains an
exclusive option to arising intellectual property ("IP") in the
field of utrophin modulation generated during the term of the
collaboration. Summit will also continue to sponsor a drug
discovery and development programme in the University of Oxford
research laboratories to identify and develop oral utrophin
modulators for the treatment of DMD. This research programme,
originally running to November 2016, will now continue until
November 2019 with an option to extend it for a further 12 months.
As part of the extension, Summit will increase the funding to £0.83
million a year starting in November 2015. Isis Innovation Limited
("Isis") continues to hold warrants over 354,090 ordinary shares
that were granted as part of the original alliance agreement signed
in 2013. All the warrants may be exercised by Isis by February
2020, three months after the end of the alliance extension, subject
to achieving key research, development and regulatory
milestones.
About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around
50,000 boys in the developed world. The disease is caused by
different genetic faults in the gene that encodes dystrophin, a
protein that is essential for the healthy function of all muscles.
There is currently no cure for DMD and life expectancy is into the
late twenties. Utrophin protein is functionally and structurally
similar to dystrophin. In preclinical studies, the continued
expression of utrophin has a meaningful, positive effect on muscle
integrity and performance. Utrophin modulation has the potential to
slow down or even stop the progression of DMD, regardless of the
underlying dystrophin mutation. It is also expected that utrophin
modulation could potentially be complementary to other therapeutic
approaches for DMD. Summit's most advanced utrophin modulator is
the oral small molecule SMT C1100, which it is preparing to enter a
Phase 2 proof of concept trial. DMD is an orphan disease, and the
US Food and Drug Administration and the European Medicines Agency
have granted orphan drug status to SMT C1100. Orphan drugs receive
a number of benefits including additional regulatory support and a
period of market exclusivity following approval.
About Isis Innovation
Isis is the research and technology commercialisation company of
the University of Oxford. It provides access to technology from
Oxford researchers through intellectual property licensing,
spin-out company formation and material sales, and to academic
expertise through Oxford University Consulting. Isis is the highest
university patent filer in the UK and is ranked 1st in the UK for
university spin-outs, having created over 110 new companies in 25
years. In the last financial year it completed 529 licenses and
consulting agreements. Isis Enterprise, its innovation management
consultancy, works with university, government and industrial
clients from offices around the world.
Isis was named 'Technology Transfer Unit of the Year 2014' by
Global University Venturing and in 2015 Isis Enterprise was awarded
a Queens Award for Enterprise (International Trade). For updates on
innovations from Oxford, follow Isis on LinkedIn and
Twitter or subscribe at www.isis-innovation.com
About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery,
development and commercialisation of novel medicines for
indications for which there are no existing or only inadequate
therapies. Summit is conducting clinical programs focused on the
genetic disease DMD and the infectious disease Clostridium
difficile infection. Further information is available at
www.summitplc.com and Summit can be followed on Twitter
(@summitplc).
For more information, please contact:
Summit |
|
Glyn Edwards / Richard Pye (UK office) |
Tel: +44 (0)1235 443 951 |
Erik Ostrowski / Michelle Avery (US
office) |
+1 617 225 4455 |
|
|
Cairn Financial Advisers
LLP |
|
(Nominated Adviser) |
|
Liam Murray / Tony Rawlinson |
Tel: +44 (0)20 77148 7900 |
|
|
N+1 Singer |
|
(Broker) |
|
Aubrey Powell / Jen Boorer |
Tel: +44 (0)20 7496 3000 |
|
|
Peckwater PR |
|
(Financial public relations, UK) |
Tel: +44 (0)7879 458 364 |
Tarquin Edwards |
tarquin.edwards@peckwaterpr.co.uk |
|
|
MacDougall Biomedical
Communications |
|
(US media contact) |
Tel: +1 781 235 3060 |
Chris Erdman |
cerdman@macbiocom.com |
Forward-looking Statements
Any statements in this press release about Summit's future
expectations, plans and prospects, including but not limited to,
statements about the clinical and preclinical development of
Summit's product candidates, the therapeutic potential of Summit's
product candidates, and the timing of initiation, completion and
availability of data from clinical trials, and other statements
containing the words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "plan," "potential,"
"predict," "project," "should," "target," "would," and similar
expressions, constitute forward looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: the uncertainties inherent in the initiation of
future clinical trials, availability and timing of data from
on-going and future clinical trials and the results of such trials,
whether preliminary results from a clinical trial will be
predictive of the final results of that trial or whether results of
early clinical trials or preclinical studies will be indicative of
the results of later clinical trials, expectations for regulatory
approvals, availability of funding sufficient for Summit's
foreseeable and unforeseeable operating expenses and capital
expenditure requirements and other factors discussed in the "Risk
Factors" section of filings that Summit makes with the Securities
and Exchange Commission including Summit's Annual Report on Form
20-F for the fiscal year ended January 31, 2015. Accordingly
readers should not place undue reliance on forward looking
statements or information. In addition, any forward looking
statements included in this press release represent Summit's views
only as of the date of this release and should not be relied upon
as representing Summit's views as of any subsequent date. Summit
specifically disclaims any obligation to update any forward-looking
statements included in this press release.
-END-
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