TIDMMPH
RNS Number : 6095Z
Mereo BioPharma Group plc
13 January 2020
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED UNDER
THE MARKET ABUSE REGULATION (EU) NO. 596/2014. UPON PUBLICATION OF
THIS ANNOUNCEMENT THIS INFORMATION IS NOW CONSIDERED IN THE PUBLIC
DOMAIN.
Mereo BioPharma and Oncologie Enter into Global Licensing
Agreement for Navicixizumab
Oncologie receives exclusive global license to develop and
commercialize navicixizumab
London, Redwood City, Calif., and Boston, January 13, 2020 -
Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), "Mereo" or the
"Company," and Oncologie, Inc. ("Oncologie") today announced a
global license agreement (the "License Agreement") for the
development and commercialization of navicixizumab, an
anti-DLL4/VEGF bispecific antibody currently being evaluated in an
ongoing Phase 1b study in combination with paclitaxel in patients
with advanced heavily pretreated ovarian cancer. Navicixizumab
previously completed a Phase 1a monotherapy study in patients with
various types of refractory solid tumors and is one of two product
candidates Mereo acquired through its 2019 merger with OncoMed
Pharmaceuticals, Inc. In October 2019, the U.S. Food and Drug
Administration ("FDA") granted Fast Track designation to
navicixizumab and has agreed in principle on the design of a study
that could potentially support accelerated approval for
navicixizumab in a heavily pretreated, platinum-resistant ovarian
cancer patient population.
Under the terms of the License Agreement, Oncologie will receive
an exclusive worldwide license to develop and commercialize
navicixizumab. Mereo will receive an upfront payment of $4 million
with an additional payment of $2 million conditional on a CMC
(Chemistry, Manufacturing and Controls) milestone. Oncologie will
be responsible for all future research, development and
commercialization of navicixizumab. Additionally, Mereo will be
eligible to receive up to $300 million in future clinical,
regulatory and commercial milestones, tiered royalties ranging from
the mid-single-digit to sub-teen percentages on global annual net
sales of navicixizumab, as well as a negotiated percentage of
sublicensing revenues from certain sublicensees.
"We believe Oncologie is expertly positioned to further advance
navicixizumab through clinical development and towards potential
commercialization," said Dr. Denise Scots-Knight, Chief Executive
Officer of Mereo. "While we believe navicixizumab is an exciting
oncology asset, we continue to focus our primary efforts on the
development of our innovative rare disease portfolio including our
lead product candidate setrusumab for the treatment of osteogenesis
imperfecta, which continues to advance towards a pivotal Phase 3
pediatric study."
"We believe navicixizumab is a strong strategic fit with our
portfolio of innovative oncology assets, and we are excited to
enter into this agreement with Mereo," said Laura E. Benjamin,
Ph.D., Chief Executive Officer of Oncologie. "Navicixizumab has
demonstrated robust activity when combined with paclitaxel in a
Phase 1b study in platinum-resistant ovarian cancer patients
including those who received prior bevacizumab. Navicixizumab has
also demonstrated promising activity in a Phase 1b monotherapy
study of heavily pretreated ovarian cancer patients, as well as in
other tumor types. We seek to leverage the strong development and
regulatory progress Mereo has already made to continue its
development and ultimately make this investigational therapy
available to patients as quickly as possible."
As a consequence of the License Agreement with Oncologie, and in
accordance with the terms and conditions of the Contingent Value
Rights Agreement for former stockholders of OncoMed
Pharmaceuticals, Inc. ("OncoMed"), dated April 23, 2019, by and
among Mereo and Computershare Inc., as rights agent, (the "Mereo
CVR Agreement"), holders of contingent value rights ("CVRs")
pursuant to the Mereo CVR Agreement will be entitled to receive
certain eligible cash milestone payments made to Mereo under the
License Agreement relating to navicixizumab. Details of the amount
payable to holders of CVRs from the upfront payment will be
announced within thirty days of the effective date of the License
Agreement. Pursuant to the terms of the Mereo CVR Agreement, if a
milestone occurs prior to the fifth anniversary of the closing of
Mereo's merger with OncoMed, then holders of CVRs will be entitled
to receive an amount in cash equal to 70% of the aggregate
principal amount received by Mereo after deduction of costs,
charges and expenditures set out in detail in the Mereo CVR
Agreement. Such milestone payments are also subject to a cash
consideration cap, pursuant to which the aggregate principal amount
of all cash payments made to holders of CVRs under the Mereo CVR
Agreement shall in no case exceed $79.7 million.
About Navicixizumab
Navicixizumab is an anti-DLL4/VEGF bispecific antibody designed
to inhibit both Delta-like ligand 4 ("DLL4") in the Notch cancer
stem cell pathway as well as vascular endothelial growth factor
("VEGF") and thereby induce potent anti-tumor responses while
mitigating certain angiogenic-related toxicities. In preclinical
studies, navicixizumab demonstrated robust in vivo anti-tumor
activity across a range of solid tumor xenografts, including colon,
ovarian, lung and pancreatic cancers, among others. In a Phase 1a
study with single-agent navicixizumab, 19 of 66 patients with
various types of refractory solid tumors had tumor shrinkage
following treatment with navicixizumab. Notably, 3 of the 12 (25%)
ovarian cancer patients treated in the trial achieved an
unconfirmed partial response with single-agent navicixizumab
therapy.
A Phase 1b dose escalation and expansion study of navicixizumab
plus paclitaxel has completed enrollment of 44 platinum resistant
ovarian cancer patients who had failed >2 prior therapies and/or
received prior bevacizumab. As of the last interim data analysis at
the end of Q1 2019, the unconfirmed response rate was 41%. The
unconfirmed ORR for bevacizumab-naïve patients was 64% and 30% for
bevacizumab pre-treated patients. The median PFS for all patients
was 7.3 months. The most common related adverse events of any grade
were hypertension (68%), fatigue (46%), headache (25%), neutropenia
(21%), diarrhea (18%), pulmonary hypertension (14%), dyspnea (14%)
and peripheral edema (14%). Other related adverse events of special
interest were one Grade 1 related heart failure, one Grade 3 and
one Grade 4 related thrombocytopenia, and one Grade 4 related
gastrointestinal perforation.
The FDA has granted Fast Track designation to navicixizumab for
the treatment of high grade ovarian, primary peritoneal or
fallopian tube cancer in patients who have received at least 3
prior therapies and/or prior bevacizumab. Following a Type B End of
Phase 1 meeting with the FDA held in July 2019, the FDA agreed in
principle on an outline for a Phase 2 clinical trial that could
potentially support accelerated approval of navicixizumab in this
ovarian cancer patient population.
About Oncologie
Oncologie is a next generation, oncology therapeutics company.
Oncologie leverages its unique biomarker platform to develop
targeted therapies that are matched to individual tumors based on
the dominant biology of the tumor microenvironment. The current
pipeline is focused on mid-stage clinical programs that modify the
immune system to enhance efficacy of current standards of care and
emerging immunotherapy agents. Headquartered in Boston,
Massachusetts and Shanghai, China, Oncologie is working with global
partners to acquire and develop innovative drugs for cancer
patients around the world. For more information on Oncologie, Inc.,
please visit WWW.ONCOLOGIE.INTERNATIONAL.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics that
aim to improve outcomes for patients with rare diseases. Mereo's
strategy is to selectively acquire product candidates for rare
diseases that have already received significant investment from
pharmaceutical and large biotechnology companies and that have
substantial preclinical, clinical and manufacturing data packages.
Mereo's lead rare disease product candidate, setrusumab, has
completed a Phase 2b dose ranging study in adult patients with
osteogenesis imperfecta ("OI"). Mereo's second lead product
candidate, alvelestat, is being investigated in a Phase 2
proof-of-concept clinical trial in patients with alpha-1
antitrypsin deficiency ("AATD") with topline data expected in
mid-2020.
Mereo's broader pipeline consists of four additional
clinical-stage product candidates; acumapimod for the treatment of
acute exacerbations of chronic obstructive pulmonary disease
("AECOPD"), leflutrozole for the treatment of hypogonadotropic
hypogonadism ("HH") in obese men, navicixizumab for the treatment
of platinum-resistant ovarian cancer, and etigilimab for patients
with advanced or metastatic solid tumors.
Mereo BioPharma Forward-Looking Statements
This document contains "forward-looking statements." All
statements other than statements of historical fact contained in
this presentation are forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as
amended (the "Securities Act"), and Section 21E of the United
States Securities Exchange Act of 1934, as amended (the "Exchange
Act"). Forward-looking statements usually relate to future events
and anticipated revenues, earnings, cash flows or other aspects of
our operations or operating results. Forward-looking statements are
often identified by the words "believe," "expect," "anticipate,"
"plan," "intend," "foresee," "should," "would," "could," "may,"
"estimate," "outlook" and similar expressions, including the
negative thereof. The absence of these words, however, does not
mean that the statements are not forward-looking. These
forward-looking statements are based on the Company's current
expectations, beliefs and assumptions concerning future
developments and business conditions and their potential effect on
the Company. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
Factors that could cause actual results to differ materially
from those in the forward-looking statements include, among others,
risks relating to unanticipated costs, liabilities or delays in
connection with the License Agreement and the development and
commercialization of navicixizumab; failure to realize anticipated
benefits of the License Agreement; failure or delays in research
and development programs; unanticipated changes relating to
competitive factors in the Company's industry; the potential
failure to achieve any of the applicable milestones and/ or
royalties under the License Agreement; the outcome of any legal
proceedings related to the License Agreement; risks related to the
ability to correctly estimate operating expenses associated with
the License Agreement; the potential impact of announcement of the
License Agreement on relationships with third parties; changes in
law or regulations affecting the Company; international, national
or local economic, social or political conditions that could
adversely affect the Company and its business; and risks associated
with assumptions the Company makes in connection with its critical
accounting estimates and other judgments.
All of the Company's forward-looking statements involve risks
and uncertainties (some of which are significant or beyond its
control) and assumptions that could cause actual results to differ
materially from the Company's historical experience and its present
expectations or projections. The foregoing factors and the other
risks and uncertainties that affect the Company's business,
including those described in its Annual Report on Form 20-F,
Reports on Form 6-K and other documents filed from time to time by
the Company with the United States Securities and Exchange
Commission (the "SEC") and those described in other documents the
Company may publish from time to time should be carefully
considered. The Company wishes to caution you not to place undue
reliance on any forward-looking statements, which speak only as of
the date hereof. The Company undertakes no obligation to publicly
update or revise any of our forward-looking statements after the
date they are made, whether as a result of new information, future
events or otherwise, except to the extent required by law.
Mereo BioPharma Contacts:
Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer
Richard Jones, Chief Financial Officer
Cantor Fitzgerald Europe (Nominated Adviser
and Broker to Mereo) +44 (0)20 7894 7000
Phil Davies
Will Goode
Burns McClellan (US Public Relations Adviser
to Mereo)
+01 (0) 212 213
Lisa Burns 0006
Steve Klass
FTI Consulting (UK Public Relations Adviser
to Mereo)
Simon Conway +44 (0)20 3727 1000
Ciara Martin
Investors:
investors@mereobiopharma.com
Oncologie Contacts:
Heather Savelle or Ryan Baker
Argot Partners
212.600.1902
oncologie@argotpartners.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
AGRFXLFFBFLFBBE
(END) Dow Jones Newswires
January 13, 2020 07:00 ET (12:00 GMT)
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