European Commission Designates UpRi as an Orphan Medicinal Product for the Treatment of Ovarian Cancer
December 14 2022 - 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 that the European
Commission (EC) has designated upifitamab rilsodotin (UpRi) as an
orphan medicinal product for the treatment of ovarian cancer. UpRi
is Mersana’s first-in-class NaPi2b-targeting ADC with a novel
scaffold-linker-payload that is designed to enable a high
drug-to-antibody ratio and controlled bystander effect.
“Receiving this orphan designation in the European Union is an
important regulatory milestone for Mersana as we seek to expedite
UpRi’s global development,” said Anna Protopapas, President and
Chief Executive Officer of Mersana Therapeutics. “This designation
reinforces the unmet needs that patients with ovarian cancer
continue to face today. We look forward to advancing our ongoing
clinical trials, which aim to establish UpRi as a foundational
medicine in ovarian cancer.”
The European Commission designates drugs as orphan medicinal
products based on positive opinions adopted by the European
Medicines Agency (EMA) Committee for Orphan Medicinal Products
(COMP). Orphan designations are granted for potential treatments
for rare diseases that are life-threatening or chronically
debilitating that affect fewer than five in 10,000 people across
the European Union. Medicines designated as orphan medicinal
products by the EMA may qualify for financial and regulatory
incentives, including protocol assistance at reduced fees during
product development, access to centralized marketing authorization
and 10 years of marketing exclusivity in the European Union after
product approval.
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; UPGRADE-A, a Phase 1/2 clinical trial evaluating
UpRi in combination with carboplatin; and UP-NEXT, a Phase 3
clinical trial of UpRi as monotherapy maintenance following
treatment with platinum doublets in recurrent platinum-sensitive
ovarian cancer. Mersana is also advancing XMT-1660, a Dolasynthen
ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a
novel epitope of human epidermal growth factor receptor 2 (HER2),
in addition to other earlier-stage assets. In addition, multiple
partners are using Mersana’s platforms to advance their ADC
pipelines. Mersana routinely posts information that may be useful
to investors on the “Investors & Media” section of its website
at www.mersana.com.
Forward-Looking StatementsThis 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, those concerning the
therapeutic potential of Mersana’s product candidates, including
UpRi; Mersana’s efforts to expedite the global development of UpRi;
Mersana’s advancement of the clinical development of UpRi; and the
potential advantages of designation as an orphan medicinal product.
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 the
clinical development of Mersana’s product candidates; whether the
outcomes of preclinical studies will be predictive of clinical
trial results; whether initial or interim results from a clinical
trial will be predictive of the final results of the trial or the
results of future trials; the risk that UpRi’s designation as an
orphan medicinal product may not result in a faster development or
regulatory review or approval process compared to products
considered for approval under conventional EMA procedures; the risk
that the EMA may later decide that UpRi no longer meets the
conditions for designation as an orphan medicinal product or decide
that the time period for EMA review or approval will not be
shortened; risks to clinical trial site initiation, patient
enrollment and follow-up, as well as to Mersana’s and its
collaborators’ 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 Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission
(“SEC”) on November 7, 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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