Mereo BioPharma Announces Successful Type B Meeting with U.S. FDA and Outlines Accelerated Approval Pathway for Navicixizumab...
July 15 2019 - 8:00AM
Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH), a clinical
stage biopharmaceutical company focused on rare diseases, today
announces that it has held a successful Type B meeting with the
U.S. Food and Drug Administration (FDA) regarding a potential
pathway for accelerated approval for navicixizumab for the
treatment of patients with advanced ovarian cancer. Navicixizumab
is an anti-DLL4/VEGF bispecific antibody and one of two product
candidates Mereo acquired through its April 2019 merger with
OncoMed Pharmaceuticals, Inc. Navicixizumab has completed a Phase
1a monotherapy study in patients with various types of refractory
solid tumors and is currently being evaluated in an ongoing Phase
1b study in combination with paclitaxel in patients with advanced
platinum-resistant ovarian cancer.
In the Type B meeting, Mereo and the FDA
discussed, and agreed in principle, an outline for the design of a
Phase 2 clinical trial that could potentially support the
accelerated approval of navicixizumab in patients with ovarian
cancer (including peritoneal or fallopian tube cancer) who have
become resistant to their prior therapies. The primary endpoint of
the study will be confirmed overall response rate (ORR). Secondary
endpoints will include duration of response (DOR), safety, CA-125
response rate, progression free survival and overall survival.
Patients who receive navicixizumab will be treated Q2W on days 0,
7, and 14 of every 28-day cycle.
Jill Henrich, Senior Vice President of
Regulatory Affairs, Mereo BioPharma commented, “There are limited
treatment options for patients with platinum-resistant ovarian
cancer who have also failed multiple other therapies. We believe
the 41% (18/44) unconfirmed ORR seen in the Phase 1b study as of
the last interim data cut at the end of Q1 2019 is encouraging and
we are pleased that the FDA has recognized both the unmet medical
need in this difficult-to-treat patient population as well as the
potential of navicixizumab to provide a meaningful treatment option
for these patients. In line with our corporate strategy to focus on
the development of our rare disease product portfolio, we have
commenced partnering discussions for navicixizumab and look forward
to continued progress on this front.”
About Navicixizumab
Navicixizumab is an anti-DLL4/VEGF bispecific
antibody designed to inhibit both 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 efficacy
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 median number of
prior therapies was 4, 100% of patients had previously received
both paclitaxel and a platinum agent, 68% had previously received
bevacizumab and 41% had received a PARP inhibitor. 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%). There were no cases of Grade 3 pulmonary hypertension.
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. Navicixizumab resulted in treatment-induced ADA
formation in 5 out of 29 (17%) subjects. Accelerated clearance
and decreased exposure of navicixizumab was evident in 3 of the 5
ADA positive subjects. Two of these 3 subjects had an infusion
reaction.
About Mereo
Mereo 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 existing portfolio consists of six clinical stage product
candidates.
- Setrusumab for osteogenesis
imperfecta (OI). In October 2018, the Company announced completion
of enrollment of 112 adult patients in a Phase 2b dose ranging
study with initial positive 6-month open label data announced in
May 2019 and top-line 12-month blinded dose ranging data expected
in Q4 2019. A pediatric Phase 3 study design has also been approved
by the EMA. Setrusumab has orphan designation in the U.S. and the
EU and has been accepted into the PRIME and Adaptive Pathways in
EU;
- Alvelestat for alpha-1 antitrypsin
deficiency (AATD). The Company has initiated a Phase 2
proof-of-concept clinical trial in patients with severe AATD in the
United States and the EU and expects to report top-line data from
this trial around the end of 2019;
- Acumapimod for severe exacerbations
of COPD. The Company announced positive Phase 2 data in May
2018 and recently announced the outline of the pivotal Phase 3
study including the primary and key secondary endpoints following
the successful end of Phase 2 Type B meeting with the FDA;
- Leflutrozole for hypogonadotropic
hypogonadism (HH). The Company announced positive top-line Phase 2b
data in March 2018 and positive results from the Phase 2b safety
extension study in December 2018;
- Navicixizumab has completed a Phase
1a single-agent clinical trial in patients with advanced solid
tumors and is currently in a Phase 1b trial in combination with a
standard paclitaxel regimen in patients with platinum-resistant
ovarian cancer. This study recently completed enrollment; and
- Etigilimab has completed a
single-agent Phase 1a trial in patients with advanced or metastatic
solid tumors and the Phase 1b combination study with nivolumab has
fully enrolled and is currently in the safety monitoring
phase.
Further Enquiries
Mereo |
+44 (0)333 023 7300 |
Denise Scots-Knight, Chief
Executive Officer |
|
Richard Jones, Chief Financial
Officer |
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Cantor Fitzgerald Europe
(Nominated Adviser and Joint Broker to
Mereo) |
+44 (0)20 7894
7000 |
Phil Davies |
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Will Goode |
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RBC Capital Markets
(Joint Broker to
Mereo) |
+44 (0)20 7653
4000 |
Rupert Walford |
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Jamil Miah |
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FTI Consulting (Public
Relations Adviser to
Mereo) |
|
Simon Conway |
+44 (0)20 3727
1000 |
Brett Pollard |
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Ciara Martin |
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Burns McClellan (US
Public Relations Adviser to
Mereo) |
+01 (0) 212 213
0006 |
Lisa Burns |
|
Steve Klass |
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