Mereo BioPharma Group plc Update on Etigilimab (TIGIT) Partnership (1243C)
13 June 2019 - 10:00PM
UK Regulatory
TIDMMPH
RNS Number : 1243C
Mereo BioPharma Group plc
13 June 2019
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 Group plc
("Mereo" or the "Company" or the "Group")
Update on Etigilimab (TIGIT) Partnership
London and Redwood City, Calif., June 13, 2019 - Mereo BioPharma
Group plc (NASDAQ: MREO, AIM: MPH), a clinical stage
biopharmaceutical company focused on rare diseases, today announces
that Celgene Corporation ("Celgene") has notified OncoMed
Pharmaceuticals, Inc. ("OncoMed", a subsidiary of Mereo), pursuant
to the Master Research and Collaboration Agreement, dated December
2, 2013, by and among OncoMed, Celgene and Celgene Alpine
Investment Company II, LLC (the "Collaboration Agreement") of
Celgene's decision, for strategic product portfolio considerations,
not to exercise its option to license etigilimab, the anti-TIGIT
antibody, one of two product candidates Mereo acquired through its
April 2019 merger with OncoMed.
Mereo and Celgene are working to finalize the termination of the
Collaboration Agreement with respect to etigilimab, upon which
Mereo expects to retain the worldwide rights to etigilimab and to
initiate discussions with other potential partners for this
program. Etigilimab successfully completed the Phase 1a
dose-escalation portion of a clinical study in patients with a
variety of late stage metastatic cancers and is currently being
evaluated in a fully-enrolled Phase 1b combination portion with
nivolumab in patients with select tumor types.
Denise Scots-Knight, Chief Executive Officer of Mereo
commented:
"While we continue to prioritize the development of our rare
disease product portfolio including setrusumab (BPS-804) for
osteogenesis imperfecta (OI) and alvelestat (MPH-966) for alpha-1
antitrypsin deficiency, we believe our anti-TIGIT program is a
promising approach to immuno-oncology and look forward to the
completion of the Phase 1b study evaluating etigilimab in
combination with nivolumab in selected tumor types. While we
respect Celgene's decision not to exercise its option for this
program due to strategic considerations, we look forward to
initiating partnering discussions for this asset while also
continuing to advance partnering discussions for our other non-rare
disease assets acumapimod, navicixzumab and leflutrozole in
accordance with our corporate and commercial strategy."
As a consequence of the forthcoming termination of the
Collaboration Agreement, and in accordance with the terms and
conditions of the Contingent Value Rights Agreement, dated April
23, 2019, by and among Mereo and Computershare Inc., as rights
agent, (the "CVR Agreement"), it is not expected that holders of
contingent value rights pursuant to the CVR Agreement will be
entitled to receive the TIGIT Milestone Payment (as defined in the
CVR Agreement). In addition, it is not expected that holders of
contingent value rights pursuant to the Contingent Value Rights
Agreement, dated March 14, 2019, by and among OncoMed and
Computershare, Inc. as rights agent (as amended, the "OncoMed CVR
Agreement") will be entitled to receive any TIGIT Payment Amounts
(as defined in the OncoMed CVR Agreement).
About TIGIT
TIGIT (T-cell immunoreceptor with Ig and ITIM domains) is a next
generation checkpoint receptor shown to block T-cell activation and
the body's natural anti-cancer immune response. Etigilimab is an
IgG1 monoclonal antibody which binds to the human TIGIT receptor on
T-cells with a goal of improving the activation and effectiveness
of T-cell and NK cell anti-tumor activity. The Phase 1a/b clinical
trial with etigilimab enrolled patients with advanced solid tumors
into either a Phase 1a single-agent portion (dose escalation in all
patients and expansion in selected tumor types) or Phase 1b
combination portion with nivolumab in selected tumor types.18
patients were treated in the Phase 1a dose escalation study with
doses up to 20mg/kg Q2W. Tumor types included colorectal cancer
(6), endometrial cancer (2), pancreatic cancer (1) and 8 other
tumor types. No dose limiting toxicities were observed with the
recommended Phase 2 dose of 20mg/kg Q2W.
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 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
dose ranging data 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 recently announced dosing of the first patient in a Phase 2
dose ranging study in the U.S. with data expected 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 enrolment; 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
Cantor Fitzgerald Europe (Nominated Adviser
and Joint Broker to Mereo) +44 (0)20 7894 7000
Phil Davies
Will Goode
RBC Capital Markets (Joint Broker to Mereo) +44 (0)20 7653 4000
Rupert Walford
Jamil Miah
FTI Consulting (Public Relations Adviser to
Mereo)
Simon Conway +44 (0)20 3727 1000
Brett Pollard
Ciara Martin
Burns McClellan (US Public Relations Adviser +01 (0) 212 213
to Mereo) 0006
Lisa Burns
Steve Klass
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