Mersana Therapeutics Announces Initiation of UPLIFT Single-Arm Registration Strategy for UpRi in Platinum-Resistant Ovarian C...
April 09 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 UPLIFT, a single-arm registration strategy to
evaluate the safety and efficacy of upifitamab rilsodotin (UpRi,
XMT-1536) in patients with platinum-resistant ovarian cancer who
have received up to four lines of therapy.
“UpRi has demonstrated clinically meaningful
activity, a biomarker-response relationship and a differentiated
tolerability profile without severe neutropenia, peripheral
neuropathy or ocular toxicity in heavily pretreated ovarian cancer
patients who have limited options and poor prognosis. The UPLIFT
strategy is critical to bringing this promising agent to patients
waiting for new therapies,” said Anna Protopapas, President and
Chief Executive Officer of Mersana Therapeutics.
UPLIFT will evaluate the safety and efficacy of
UpRi in patients with platinum-resistant ovarian cancer who have
received up to four lines of therapy. Consistent with the
bevacizumab label, patients previously treated with three or four
lines of therapy may enroll without regard to prior bevacizumab
treatment. There is no exclusion for patients with baseline
peripheral neuropathy. Patients may enroll without regard to NaPi2b
expression; however, the role of the biomarker will be evaluated.
The primary endpoint will be the objective response rate (ORR) in
the high NaPi2b population and the secondary endpoints will be the
ORR regardless of NaPi2b expression, as well as duration of
response and safety.
“We believe this study design, which is an
amendment to the ongoing Phase 1 expansion study, allows for
significant operational efficiencies and leverages our current
momentum in patient enrollment. The study design also allows us the
opportunity to fully evaluate the role of the biomarker with
endpoints in both the high NaPi2b and overall populations. We are
excited to open this cohort to this heavily pretreated patient
population with few options,” said Arvin Yang, M.D., Ph.D., Senior
Vice President and Chief Medical Officer of Mersana
Therapeutics.
The single-arm registration strategy is an
amendment to the ongoing multinational, multi-center, open label
study protocol, and the Company expects to enroll approximately 100
patients with high NaPi2b expression and up to 180 patients
overall.
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 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 and the design,
progression and timing of its clinical trials, the ability of the
single-arm UPLIFT cohort to enable registration, and expectations
regarding future clinical trial results based on data achieved to
date, and the sufficiency of the Company’s cash on hand.
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 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-K filed on
February 26, 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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