Mersana Therapeutics Announces Publication of Two Manuscripts Detailing Preclinical Studies of the Dolaflexin Platform and Up...
March 15 2021 - 10:15AM
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 publication
of two manuscripts in Molecular Cancer Therapeutics, a journal of
the American Association for Cancer Research (AACR). The
manuscripts describe the preclinical development of the Dolaflexin
ADC platform and XMT-1536, now called upifitamab rilsodotin (UpRi),
Mersana’s first-in-class NaPi2b-targeted ADC developed using this
platform.
The first of these articles, “Dolaflexin: A
Novel Antibody-Drug Conjugate Platform Featuring High Drug Loading
and a Controlled Bystander Effect,” provides detailed
characterization of Dolaflexin, the Company’s novel ADC technology
which is designed to overcome limitations of the most common ADC
platforms with two key features: a higher drug-antibody ratio and a
proprietary auristatin with a controlled bystander effect. The
proprietary, cell permeable DolaLock payload auristatin
F-hydroxypropylamide (AF-HPA) undergoes metabolic conversion to the
highly potent but less cell-permeable auristatin F (AF) to balance
the bystander effect through drug trapping within target cells and
is designed to improve efficacy while avoiding the severe
neutropenia, peripheral neuropathy and ocular toxicities commonly
observed with other anti-tubulin ADC payloads.
The second article, “The Dolaflexin-based
antibody-drug conjugate XMT-1536 targets the solid tumor lineage
antigen SLC34A2/NaPi2b,” describes pre-clinical discovery and
characterization of UpRi, Mersana’s lead clinical-stage Dolaflexin
ADC. NaPi2b is a sodium phosphate transporter expressed in a
variety of human tumors. The broad expression of NaPi2b in
epithelial ovarian cancer and lung adenocarcinoma is described, as
is UpRi’s ability to selectively target human NaPi2b. In vivo data
in preclinical models revealed target expression-dependent activity
in a series of NSCLC adenocarcinoma patient derived xenografts
(PDX) as well as profound activity in a panel of ovarian
adenocarcinoma PDXs. Pharmacokinetic analyses showed approximately
dose-proportional exposure across animal species as well as high
serum stability of the conjugate, and systemic free AF-HPA and AF
concentrations remaining low in all animal species.
“These studies demonstrate the differentiated
design and advantages of the Dolaflexin platform in preclinical
studies and its potential for creating a new and improved class of
ADCs,” said Timothy Lowinger, Ph.D., Chief Science and Technology
Officer of Mersana Therapeutics. “In addition, the extensive
preclinical data with UpRi, created by conjugating a
NaPi2b-targeting antibody with Dolaflexin, gave us the confidence
to proceed into the clinic. UpRi has since exhibited promising
activity and a favorable tolerability profile in ongoing
proof-of-concept studies in heavily pre-treated ovarian cancer
patients with significant unmet medical need. We are very proud of
the dedication and commitment of our team who have worked
tirelessly to bring Dolaflexin and UpRi forward.”
UpRi is in the expansion portion of a Phase 1
proof-of-concept clinical study in patients with ovarian cancer and
NSCLC adenocarcinoma. Mersana intends to initiate a single-arm
registration enabling strategy in platinum resistant ovarian cancer
(UPLIFT) in the first quarter of 2021 as well as an umbrella
combination study in earlier lines of therapy (UPGRADE) in the
third quarter of 2021. More information on the ongoing clinical
study can be found
at clinicaltrials.gov (NCT03319628).
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 in
the expansion portion of a Phase 1 proof-of-concept clinical study
in patients with ovarian cancer and 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 Statements
This 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,” “estimates,” “expects,”
“goal,” “intends,” “may,” “on track,” “opportunity,” “plans,”
“poised for,” “possible,” “potential,” “predicts,” “projects,”
“promises to be,” “seeks,” “should,” “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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