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
NavicixizumabNavicixizumab 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 BioPharmaMereo
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
StatementsThis 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) |
|
Lisa Burns |
+01 (0) 212 213
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 BakerArgot
Partners212.600.1902oncologie@argotpartners.com
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