Mersana Therapeutics Announces FDA has Lifted Clinical Hold on Phase 1 Clinical Trial of XMT-2056
31 10월 2023 - 9:00PM
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 lifted the clinical hold on
the company’s Phase 1 clinical trial of XMT-2056. XMT-2056 is a
systemically administered Immunosynthen STING-agonist ADC that is
designed to target a novel human epidermal growth factor receptor 2
(HER2) epitope and locally activate STING signaling in both
tumor-resident immune cells and in tumor cells, providing the
potential to treat patients with HER2-high or -low tumors as
monotherapy and in combination with standard-of-care agents.
“An in-depth analysis of cytokine, pharmacokinetic and other
clinical data from patients enrolled in our Phase 1 trial indicated
that XMT-2056 is a highly potent innate immune agonist,” said
Martin Huber, M.D., President and Chief Executive Officer of
Mersana Therapeutics. “Based on these data and with patient safety
at the forefront of our efforts, we have lowered the starting dose
in our Phase 1 dose escalation design. We are pleased to have
aligned with FDA on the path forward and are excited to have the
opportunity to continue to investigate the potential of XMT-2056
and our Immunosynthen ADC platform in the clinic.”
The multicenter Phase 1 open-label trial is investigating
XMT-2056 in previously treated patients with advanced/recurrent
solid tumors expressing HER2, including breast, gastric, colorectal
and non-small-cell lung cancers. The dose escalation and dose
expansion portions of the trial will evaluate and characterize the
relationship of safety, tolerability and exposure of XMT-2056 and
this candidate’s preliminary anti-tumor activity, as measured by
overall response rate, duration of response and disease control
rate.
The FDA has granted orphan drug designation to XMT-2056 for the
treatment of gastric cancer. In August 2022, Mersana entered into a
global collaboration providing GSK plc with an exclusive option to
co-develop and commercialize XMT-2056. GSK has not exercised
this option to date.
About Mersana TherapeuticsMersana Therapeutics
is a clinical-stage biopharmaceutical company focused on the
development of novel antibody-drug conjugates (ADCs) and driven by
the knowledge that patients are waiting for new treatment options.
The company has developed proprietary cytotoxic (Dolasynthen) and
immunostimulatory (Immunosynthen) ADC platforms that are generating
a pipeline of wholly-owned and partnered product candidates with
the potential to treat a range of cancers. Its pipeline includes
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). 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, statements concerning the
therapeutic potential of Mersana’s product candidates, including
XMT-2056, and its product platforms, including its Immunosynthen
platform; the design and objectives of Mersana’s Phase 1 clinical
trial of XMT-2056; and Mersana’s collaboration with GSK. 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, advancement, progression and completion of clinical
trials and in the clinical development of Mersana’s product
candidates, including XMT-2056; 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; 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 August 8, 2023, 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
Mersana Therapeutics (NASDAQ:MRSN)
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