Mersana Therapeutics Announces Option Agreement with GSK for the Co-Development and Commercialization of XMT-2056, an Immunosynthen ADC Targeting HER2
08 Agosto 2022 - 05:02PM
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 a global
collaboration that provides GSK plc (LSE/NYSE: GSK) an exclusive
option to co-develop and commercialize XMT-2056, an Immunosynthen
ADC that targets a novel epitope of HER2. XMT-2056 is designed to
activate the innate immune system through STING signaling in both
tumor-resident immune cells and in tumor cells.
“GSK brings highly complementary development and commercial
capabilities, a wealth of immuno-oncology experience, a deep
knowledge of the STING pathway and a shared vision for XMT-2056’s
broad potential,” said Anna Protopapas, President and Chief
Executive Officer of Mersana Therapeutics. “We believe this
agreement solidifies Mersana’s position as a partner of choice
during this momentous period in the ADC space and serves as
validation for our Immunosynthen platform, which takes ADCs beyond
the cytotoxic realm by enabling a targeted stimulation of the
innate immune system. Additionally, the agreement structure
demonstrates our ability to generate meaningful non-dilutive
capital upfront to support the development of our innovative
candidates while also providing the potential for meaningful
downstream economics.”
In preclinical models, XMT-2056 demonstrated robust anti-tumor
activity as a monotherapy in both HER2-high and HER2-low expressing
models, and enhanced efficacy has been shown when used in
combination with multiple approved agents, including trastuzumab,
pertuzumab, anti-PD-1, or trastuzumab deruxtecan. Preclinical data
also suggest that XMT-2056 has the potential to enable
immunological memory for prolonged anti-tumor activity.
Mersana expects to initiate a Phase 1 clinical trial of XMT-2056
to investigate its potential in a range of HER2-expressing tumors
such as breast, gastric and non-small-cell lung cancers. The U.S.
Food and Drug Administration recently granted an orphan drug
designation to XMT-2056 for the treatment of gastric cancer.John
Lepore, Senior Vice President of Research, GSK, said, “At GSK, our
goal is to bring transformational treatment options to patients
with cancer, so we are pleased to be able to enter into this
agreement for XMT-2056. Its preclinical data demonstrate how it
might work to harness the immune system by activating the STING
pathway, and its differentiated mechanism of action offers the
potential for additional clinical benefit in patients with
HER2-expressing tumors.”
Under the terms of the agreement, Mersana will receive an
upfront option purchase fee of $100 million. Mersana also is
eligible to receive up to $1.36 billion in the form of an option
exercise payment and development, regulatory and commercial
milestone payments if GSK exercises its option.
Mersana has retained options to profit-share and to co-promote
in the United States. If it exercises its profit-share option,
Mersana will be eligible to receive tiered royalties on net sales
outside of the United States. If Mersana does not elect to
profit-share, it is eligible to receive double-digit tiered
royalties on global net sales.
If GSK opts into the license, the effectiveness of the license
grant may be subject to customary closing conditions, including
review under the Hart-Scott-Rodino Act.
Conference Call ReminderMersana will host a
conference call today at 4:30 p.m. ET to discuss this
collaboration, other business updates and its financial results for
the second quarter of 2022. To access the call, please dial
646-307-1963 (domestic) or 800-715-9871 (international) and provide
the Conference ID 4656534. A live webcast of the presentation will
be available on the Investors & Media section of the Mersana
website at www.mersana.com, and a replay of the webcast will be
available in the same location following the conference call for at
least 90 days.
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 earlier stage programs include 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, multiple partners are using Mersana’s platforms to
advance their ADC pipelines. Mersana Therapeutics was 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 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 Mersana’s
collaboration with GSK; the development and potential
commercialization of XMT-2056; the therapeutic potential of
Mersana’s product candidates, including XMT-2056; the expected
receipt of an up-front option payment from GSK; the potential to
receive future option and milestone payments and royalties pursuant
to the collaboration with GSK; Mersana’s options to share in U.S.
profits/losses and to co-promote XMT-2056, if approved, in the
United States; the terms and conditions of and conditions related
to the ability to consummate the negotiated license transaction
with GSK; and Mersana’s expected initiation of a Phase 1 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 and its
collaboration partners’ abilities to meet other anticipated
deadlines and milestones, whether presented by the ongoing COVID-19
pandemic or otherwise; risks related to Mersana’s ability to
maintain existing collaborations and realize the benefits thereof;
expectations for regulatory approvals to conduct trials or to
market products; 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 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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