TIDMMPH
RNS Number : 4835C
Mereo BioPharma Group plc
19 October 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 Announces FDA Clearance to Proceed into a Phase
1b/2 study for Etigilimab (Anti-TIGIT)
On track to initiate Phase 1b/2 basket study of etigilimab in
combination with an anti-PD-1 in a series of tumor types in Q4
2020
Plans to host virtual R&D day to review etigilimab
development program and rare disease product pipeline in November
2020
London and Redwood City, Calif., October 19, 2020 - Mereo
BioPharma Group plc (NASDAQ: MREO, AIM: MPH) ("Mereo" or "the
Company"), a clinical stage biopharmaceutical company focused on
oncology and rare diseases, today announced that the U.S. Food and
Drug Administration has cleared an investigational new drug (IND)
application to proceed with a Phase 1b/2 study for the Company's
lead oncology product candidate etigilimab. Etigilimab is a novel
IgG1 monoclonal antibody against TIGIT (T-cell immunoreceptor with
Ig and ITIM domains), a next generation checkpoint receptor shown
to block T-cell activation and the body's natural anti-cancer
immune response.
Mereo is on track to initiate the Phase 1b/2 basket study in the
fourth quarter of 2020. The study will evaluate etigilimab in
combination with an anti-PD-1 initially in approximately 100
patients with a defined series of tumor types, including biomarker
enriched and rare tumor cohorts. The study will incorporate flat
dosing (for patients 50 kg and higher) which is based on data from
Mereo's previous Phase 1a and Phase 1b combination studies with
etigilimab.
Dr. John Lewicki, Chief Scientific Officer of Mereo, said:
"Recent clinical data regarding anti-TIGIT therapies in combination
with PDL-1/PD-1 inhibition have been promising. We designed
etigilimab as a novel IgG1 which blocks TIGIT signalling while
retaining an intact effector function and we believe our
development approach is differentiated. We have selected the tumor
types for our planned Phase 1b/2 basket combination study based on
biomarker screening of large collections of different tumor samples
and correlating these with suboptimal responses to anti-
PDL-1/PD-1. We've also included tumor types where we saw evidence
of activity in our previous Phase 1a/1b study. We look forward to
initiating the study this quarter and providing additional details
during our planned virtual R&D day."
In November 2020, Mereo plans to host a virtual R&D day
featuring external experts to review the etigilimab development
program, including the design and biomarker strategy of the Phase
1b/2 basket combination study. Mereo also plans to provide an
overview of its rare disease product pipeline. Further information
including the date/time of the virtual R&D day will be
announced in the coming weeks.
About Etigilimab
Etigilimab is an antibody against TIGIT (T-cell immunoreceptor
with Ig and ITIM domains). TIGIT 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 immune cells
with a goal of improving the activation and effectiveness of T-cell
and NK cell anti-tumor activity. Mereo completed a Phase 1a dose
escalation clinical trial with etigilimab in patients with advanced
solid tumors and enrolled patients in a Phase 1b study in
combination with nivolumab in selected tumor types.
23 patients were treated in the Phase 1a dose escalation study
with doses up to 20 mg/kg Q2W. Tumor types included colorectal
cancer, endometrial cancer, pancreatic cancer and other tumors. No
dose limiting toxicities were observed. In the Phase 1b combination
study, a total of ten patients, nine of whom had progressed on
prior anti-PD-1/PD-L1 therapies were enrolled at doses of 3, 10,
and 20 mg/kg. Eight patients were evaluable for tumor growth
assessment, and all of these patients had progressed on PD-1/PD-L1
therapies with best responses including one patient with a partial
response another with stable disease. These patients remained on
study for up to 224 days. No dose limiting toxicities (DLTs) were
observed and the most common related adverse events included
fatigue, rash, and pruritis.
Mereo plans to initiate a Phase 1b/2 study of etigilimab in
combination with an anti-PD-1 in a series of tumor types in Q4
2020.
About Mereo BioPharma
Mereo BioPharma is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics that
aim to improve outcomes for oncology and rare diseases. Mereo's
lead oncology product candidate, etigilimab (Anti-TIGIT), has
completed a Phase 1a dose escalation clinical trial in patients
with advanced solid tumors and has been evaluated in a Phase 1b
study in combination with nivolumab in select tumor types. Mereo's
rare disease product portfolio consists of setrusumab, which has
completed a Phase 2b dose-ranging study in adults with osteogenesis
imperfecta (OI), as well as alvelestat, which is being investigated
in a Phase 2 proof-of-concept clinical trial in patients with
alpha-1 antitrypsin deficiency (AATD) and in a Phase 1b/2 clinical
trial in COVID-19 respiratory disease.
Additional Information
The person responsible for arranging the release of this
information on behalf of the Company is Charles Sermon, General
Counsel.
Forward-Looking Statements
This Announcement contains "forward-looking statements." All
statements other than statements of historical fact contained in
this Announcement are forward-looking statements within the meaning
of Section 27A of the United States Securities Act of 1933, as
amended and Section 21E of the United States Securities Exchange
Act of 1934, as amended. 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.
All of the Company's forward-looking statements involve known
and unknown risks and uncertainties some of which are significant
or beyond its control and involve assumptions that could cause
actual results to differ materially from the Company's historical
experience and its present expectations or projections. These
forward-looking statements are subject to risks and uncertainties,
including, among other things, those described in the Company's
latest 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 Company wishes to
caution investors 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 forward-looking statements, 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
N+1 Singer (Nominated Adviser and Broker to Mereo ) +44 (0)20 7496 3081
Phil Davies
Will Goode
Burns McClellan (US Investor Relations Adviser to Mereo ) + 01 212 213 0006
Lisa Burns
Steve Klass
FTI Consulting (UK Public Relations Adviser to Mereo ) +44 (0)20 3727 1000
Simon Conway
Ciara Martin
Investors investors@ mereo biopharma.com
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Mereo Biopharma (LSE:MPH)
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