Mersana Therapeutics Announces Initiation of the UPGRADE Phase 1 Platinum Combination Cohort for UpRi in Platinum-Sensitive Ovarian Cancer
July 28 2021 - 8:00AM
Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage
biopharmaceutical company focused on discovering and developing a
pipeline of antibody-drug conjugates (ADCs) targeting cancers in
areas of high unmet medical need, today announced the initiation of
patient dosing in UPGRADE, a Phase 1 combination dose escalation
umbrella study to evaluate the safety and efficacy of upifitamab
rilsodotin (UpRi, previously XMT-1536) in combination with other
ovarian cancer therapies. The initial arm of this umbrella study is
evaluating carboplatin in combination with UpRi followed by
continuation of UpRi monotherapy in patients with
platinum-sensitive ovarian cancer.
“The initiation of UPGRADE is another important
milestone for Mersana as we work to build UpRi into a foundational
medicine in the treatment of ovarian cancer,” said Anna Protopapas,
President and Chief Executive Officer of Mersana Therapeutics. “To
date, UpRi data has demonstrated clinically meaningful activity and
a differentiated tolerability profile without severe neutropenia,
peripheral neuropathy or ocular toxicity in patients with heavily
pretreated platinum-resistant ovarian cancer. The initiation of the
UPGRADE umbrella study is a critical first step in evaluating the
potential of UpRi in earlier lines of therapy.”
The UPGRADE Phase 1, open-label, dose-escalation
portion of the study will determine the maximum tolerated dose
(MTD) and safety and tolerability of a once-every-four-week (Q4W)
administration of UpRi in combination with carboplatin for six
cycles followed by continuation of UpRi monotherapy in patients
with platinum-sensitive high-grade serous ovarian cancer following
1-2 prior platinum-based regimens. Patients will not be
preselected for NaPi2b expression; however, archival or fresh
tissue will be required for retrospective assessment of
expression. Upon completion of the dose-escalation portion of
the study, the Company plans to initiate the expansion portion to
assess both tolerability and efficacy and inform the further
development of UpRi in a broader and earlier-line patient
population.
“We are excited to initiate UPGRADE and are
beginning with a platinum combination because platinum remains the
mainstay therapy in earlier-line platinum-sensitive ovarian cancer.
UPGRADE is intended to allow us to assess the advantages of
combining with carboplatin for six cycles and replacing paclitaxel,
an agent that carries significant toxicities. We will also evaluate
the benefit of continuing treatment with UpRi as a single agent
beyond the six cycles of combination therapy,” said Arvin Yang,
M.D., Ph.D., Senior Vice President and Chief Medical Officer of
Mersana Therapeutics. “In the future, we plan to evaluate
non-platinum-based combinations in this umbrella study to assess
the potential of bringing UpRi to patients who do not benefit from
platinum. We believe UpRi’s differentiated tolerability profile
without the overlapping toxicities commonly seen with other ADC
platforms may provide a significant advantage as a combination
therapy for people living with ovarian cancer.”
About Mersana
TherapeuticsMersana Therapeutics is a clinical-stage
biopharmaceutical company using its differentiated and proprietary
ADC platforms to rapidly develop novel ADCs with optimal efficacy,
safety and tolerability to meaningfully improve the lives of people
fighting cancer. Mersana’s lead product candidate, upifitamab
rilsodotin (UpRi), is a Dolaflexin ADC targeting NaPi2b and is
being studied in UPLIFT, a single-arm registration strategy in
patients with platinum-resistant ovarian cancer, as well as in the
expansion portion of a Phase 1 proof-of-concept clinical study in
patients with NSCLC adenocarcinoma. XMT-1592, Mersana’s second ADC
product candidate targeting NaPi2b-expressing tumors, was created
using Mersana’s customizable and homogeneous Dolasynthen platform
and is in the dose escalation portion of a Phase 1 proof-of-concept
clinical study. The Company’s early-stage programs include
XMT-1660, a Dolasynthen ADC targeting B7-H4, as well as XMT-2056, a
STING-agonist ADC developed using the Company’s Immunosynthen
platform. In addition, multiple partners are using Mersana’s
Dolaflexin platform to advance their ADC pipelines.
Forward-Looking StatementsThis
press release contains “forward-looking” statements within the
meaning of federal securities laws. These forward-looking
statements are not statements of historical facts and are based on
management’s beliefs and assumptions and on information currently
available to management. Forward-looking statements include
information concerning the Company’s business strategy, the design,
progression and timing of its clinical trials, and the development
and potential of our pipeline of innovative ADC candidates.
Forward-looking statements generally can be identified by terms
such as “aims,” “anticipates,” “believes,” “contemplates,”
“continues,” “could,” “designed to,” “efforts,” “estimates,”
“expects,” “goal,” “intends,” “may,” “on track,” “opportunity,”
“plans,” “poised for,” “possible,” “potential,” “predicts,”
“projects,” “promises to be,” “seeks,” “should,” “strategy,”
“target,” “will,” “would” or similar expressions and the negatives
of those terms. Forward-looking statements represent management’s
beliefs and assumptions only as of the date of this press release.
The Company’s operations involve risks and uncertainties, many of
which are outside its control, and any one of which, or combination
of which, could materially affect its results of operations and
whether the forward-looking statements ultimately prove to be
correct. Factors that may materially affect the Company’s results
of operations and whether these forward-looking statements prove to
be correct include, among other things, that the results of our
ongoing or future clinical studies may be inconclusive with respect
to the efficacy of our product candidates, that we may not meet
clinical endpoints with statistical significance or there may be
safety concerns or adverse events associated with our product
candidates, that preclinical testing or early clinical results may
not be predictive of the results or success of ongoing or later
preclinical or clinical studies, that the identification,
development and testing of the Company’s product candidates and new
platforms will take longer and/or cost more than planned, and that
our clinical studies may not be initiated or completed on schedule,
if at all, as well as those listed in the Company’s Annual Report
on Form 10-Q filed on May 10, 2021, with the Securities and
Exchange Commission (“SEC”), and subsequent SEC filings. In
addition, while we expect that the COVID-19 pandemic might
adversely affect the Company’s preclinical and clinical development
efforts, business operations and financial results, the extent of
the impact on the Company’s operations and the value of and market
for the Company’s common stock will depend on future developments
that are highly uncertain and cannot be predicted with confidence
at this time, such as the ultimate duration of the pandemic, travel
restrictions, quarantines, physical distancing and business closure
requirements in the U.S. and in other countries, and the
effectiveness of actions taken globally to contain and treat the
disease. Except as required by law, the Company assumes no
obligation to update these forward-looking statements publicly, or
to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new
information becomes available in the future.
Contact:Investor & Media ContactSarah
Carmody, 617-844-8577scarmody@mersana.com
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