Mersana Therapeutics Announces FDA Grant of Orphan Drug Designation to XMT-2056 for the Treatment of Gastric Cancer
May 19 2022 - 7:00AM
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 that the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation to XMT-2056, the company’s lead Immunosynthen
STING-agonist ADC, for the treatment of gastric cancer.
According to the American Cancer Society,
gastric cancer (also referred to as stomach cancer) accounts for
approximately 1.5 percent of all new cancers diagnosed in the
United States each year, with an estimated 26,560 new cases
reported in 2021. The FDA grants orphan drug designation to a drug
or biologic intended to treat a rare disease or condition impacting
fewer than 200,000 individuals in the United States. This
designation qualifies Mersana for potential incentives, including
tax credits for certain trials, exemption from user fees and the
potential for seven years of market exclusivity following approval
(if granted).
“The FDA’s decision to grant orphan drug
designation to XMT-2056 for the treatment of gastric cancer is an
important recognition of its potential in this area of high unmet
medical need,” said Anna Protopapas, President and Chief Executive
Officer of Mersana Therapeutics. “We are eager to bring XMT-2056
and its unique mechanism of action into the clinic mid-year to
investigate its safety, tolerability and anti-tumor activity in
gastric and other cancers.”
XMT-2056 is designed to offer a differentiated
and complementary therapeutic approach to existing and emerging
solid tumor treatments. The company developed XMT-2056 leveraging a
differentiated antibody that binds to a novel HER2 epitope,
providing the opportunity, as demonstrated in preclinical studies,
for treatment both as monotherapy and in combination with a variety
of agents, including other anti-HER2 therapies. Mersana plans to
initiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing
tumors, such as breast, gastric and non-small-cell lung cancers, in
mid-2022.
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 that is
being studied in UPLIFT, a single-arm registrational trial in
patients with platinum-resistant ovarian cancer, as well as in
UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combination
with other ovarian cancer therapies. Mersana’s early-stage programs
include XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056,
a STING-agonist ADC developed using the company’s Immunosynthen
platform and targeting a novel epitope of human epidermal growth
factor receptor 2 (HER2). In addition, multiple partners are using
Mersana’s platforms to advance their ADC pipelines. Mersana
Therapeutics was recently named among the 2021 Top Places to Work
in Massachusetts by The Boston Globe. Mersana routinely posts
information that may be useful to investors on the “Investors and
Media” section of its website at www.mersana.com.
Forward-Looking Statements
This press release contains “forward-looking”
statements and information within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “aims,” “anticipates,” “believes,”
“could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,”
“may,” “plans,” “possible,” “potential,” “seeks,” “will” and
variations of these words or similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements in this press release include, but are not limited to,
statements concerning the therapeutic potential of Mersana’s
product candidates, including XMT-2056 as potential monotherapy or
in combination with other agents; the potential incentives that may
be available to Mersana as a result of the FDA’s grant of orphan
drug designation to XMT-2056 for the treatment of gastric cancer;
and the design, initiation, timing and objectives of Mersana’s
anticipated clinical trial of XMT-2056. Mersana may not actually
achieve the plans, intentions or expectations disclosed in these
forward-looking statements, and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions and expectations
disclosed in these forward-looking statements as a result of
various factors, including, among other things, uncertainties
inherent in research and development, in the initiation of clinical
trials and in the clinical development of Mersana’s product
candidates; the risk that Mersana’s anticipated clinical trials may
not be initiated on schedule, if at all; the risk that Mersana may
not realize the intended benefits of its platforms, technology and
collaborations; whether the outcomes of preclinical studies will be
predictive of clinical trial results; risks to clinical trial site
initiation, patient enrollment and follow-up, as well as to
Mersana’s abilities to meet other anticipated deadlines and
milestones, whether presented by the ongoing COVID-19 pandemic or
otherwise; and other important factors, any of which could cause
Mersana’s actual results to differ from those contained in the
forward-looking statements, that are described in greater detail in
the section entitled “Risk Factors” in Mersana’s Annual Report on
Form 10-Q filed with the Securities and Exchange Commission (“SEC”)
on May 9, 2022, as well as in other filings Mersana may make with
the SEC in the future. Any forward-looking statements contained in
this press release speak only as of the date hereof, and Mersana
expressly disclaims any obligation to update any forward-looking
statements contained herein, whether because of any new
information, future events, changed circumstances or otherwise,
except as otherwise required by law.
Contact:Jason Fredette
617-498-0020jason.fredette@mersana.com
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