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 UPLIFT
clinical trial of upifitamab rilsodotin (UpRi) did not meet its
primary endpoint. UpRi is an ADC targeting the sodium-dependent
phosphate transport protein NaPi2b and was developed utilizing the
company’s Dolaflexin platform.
UPLIFT was a single-arm clinical trial that enrolled
platinum-resistant ovarian cancer patients with one to four prior
treatment regimens. The primary endpoint for UPLIFT was the
investigator-assessed objective response rate (ORR) in the
NaPi2b-positive population. NaPi2b-positive status was defined by a
tumor proportion score (TPS) of ≥75%. Secondary endpoints for the
trial included the investigator-assessed ORR among all patients in
the trial, duration of response (DOR), and safety and tolerability.
The trial also included an assessment of ORR and DOR by independent
radiology review (IRR).
UPLIFT enrolled a total of 268 patients, 141 of whom were
determined to be NaPi2b positive. The median prior lines of
systemic therapy among all patients was three, with 31% of the
population having received four prior lines of treatment.
Additionally, 84% of patients received prior bevacizumab and 69%
received prior PARP inhibitor treatment.
Top-line results from UPLIFT as of the May 31, 2023 data cutoff
date are as follows:
NaPi2b-Positive Population (n=141)
|
Investigator Assessment |
IRR Assessment |
ORR, n (%) [95% confidence interval] |
22 (15.6%) [10.0%, 22.7%] |
23 (16.3%) [10.6%, 23.5%] |
Partial Response, n (%) |
20 (14.2%) |
16 (11.3%) |
Complete Response, n (%) |
2 (1.4%) |
7 (5.0%) |
Median DOR, months |
7.4 |
Not Reached |
Total Population (n=268)
|
Investigator Assessment |
IRR Assessment |
ORR, n (%) |
35 (13.1%) |
35 (13.1%) |
Partial Response, n (%) |
32 (11.9%) |
24 (9.0%) |
Complete Response, n (%) |
3 (1.1%) |
11 (4.1%) |
Median DOR, months |
7.4 |
10.7 |
Safety and tolerability data in UPLIFT were generally consistent
with prior disclosures. Following the completion of its analyses,
the company plans to share detailed efficacy and safety data with
the medical and scientific community in an appropriate forum.
“We are deeply disappointed that UPLIFT’s efficacy failed to
replicate previous data from approximately 100 patients in the dose
expansion portion of our Phase 1b clinical trial,” said Dr. Arvin
Yang, Senior Vice President and Chief Medical Officer of Mersana
Therapeutics. “While the duration of response was longer than that
from the dose expansion portion of UpRi’s Phase 1b clinical trial,
the lower bound of the confidence interval for the primary endpoint
did not meet our goal of excluding a 12% ORR seen with
standard-of-care single-agent chemotherapy. We are in the process
of conducting an in-depth analysis of various factors to better
understand the results as well as the characteristics of patients
who responded to UpRi therapy, particularly those whose responses
were deep and durable. We extend our deepest gratitude to all of
the patients, family members, caregivers and investigators who
contributed to UPLIFT.”
Strategic Reprioritization and Financial
Update
“As an organization driven by a mission to discover and develop
potentially life-changing ADCs for patients fighting cancer,
UPLIFT’s outcome is clearly disappointing and requires us to
reprioritize our areas of focus,” said Anna Protopapas, President
and Chief Executive Officer of Mersana Therapeutics. “In recent
years, Mersana has advanced new product candidates and developed
new partnerships utilizing its next-generation ADC platforms,
Dolasynthen and Immunosynthen. These will be our primary focus
moving forward. We plan to complete the dose escalation portion of
our Phase 1 clinical trial of XMT-1660 in 2023 and initiate the
dose expansion portion of the trial in 2024. Our team continues
working diligently to address the clinical hold on the Phase 1
clinical trial of XMT-2056. Additionally, we intend to strongly
support Mersana’s collaborators as they leverage our
next-generation ADC platforms and advance their product
candidates.”
“We also are taking decisive action to extend our cash runway
and ensure we have the resources to evaluate the clinical potential
of our next-generation ADC product candidates,” Ms. Protopapas
continued. “Unfortunately, this necessitates reducing our workforce
by approximately 50%. A very talented group of employees who helped
to build Mersana will be departing as a result of this strategic
reprioritization. We are grateful for their many contributions and
intend to provide strong support through their transition.”
Mersana’s restructuring plan includes a wind-down of
UpRi-related development activities, including its UP-NEXT and
UPGRADE-A clinical trials and the company’s regulatory and
commercial readiness efforts. If analyses of data enable the
identification of a path forward for UpRi, the company will
consider strategic alternatives for the asset, including
partnering.
Mersana estimates that its balance of cash, cash equivalents and
marketable securities as of June 30, 2023 was $286.6 million. This
figure is preliminary and is subject to completion of the company’s
financial closing procedures. The company expects to report its
cash, cash equivalents and marketable securities, as well as other
information necessary for a complete understanding of its financial
position, in its Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023. The company expects that its available funds
will be sufficient to support its current operating plan
commitments into 2026.
Conference Call NoticeMersana will host a
conference call today at 8:00 a.m. ET. To access the call, please
dial (877) 270-2148 (domestic) or (412) 902-6510 (international). 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 approximately 90 days.
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
Mersana’s further data analysis related to its clinical evaluation
of UpRi and the presentation of UPLIFT trial data; its strategic
priorities; its restructuring plans, including with respect to
discontinuing clinical development of UpRi and related efforts and
reducing its workforce; any potential path forward for UpRi and
consideration of potential strategic alternatives for this asset;
plans regarding the clinical development of XTM-1660; Mersana’s
efforts to address the clinical hold on XMT-2056; Mersana’s cash
runway; Mersana’s financial closing procedures and its expectations
to report additional financial information for the period ended
June 30, 2023; and the development and potential of Mersana’s
product candidates, platforms, technology and pipeline of ADC
candidates. 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 advancement, progression and completion of
clinical trials and in the clinical development of Mersana’s
product candidates, including XMT-1660 and XMT-2056; the risks that
Mersana may be unable to resolve the clinical hold with respect to
its Phase 1 clinical trial of XMT-2056 and may not be able to
resume that trial or to develop or commercialize XMT-2056; the
occurrence of impediments to Mersana’s ability to execute its
planned restructuring and strategic reprioritization as currently
contemplated; the risk that restructuring costs and charges may be
greater than anticipated; the risk that Mersana’s restructuring
efforts may adversely affect its ability to retain skilled and
motivated personnel and may be distracting to employees and
management; the risk that Mersana’s restructuring efforts may
negatively impact its business operations and reputation; the risk
that Mersana’s restructuring efforts may not generate their
intended benefits to the extent or as quickly as anticipated; the
risk that Mersana may not realize the intended benefits of its
platforms, technology and collaborations; 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, 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
Fredette617-498-0020jason.fredette@mersana.com
Mersana Therapeutics (NASDAQ:MRSN)
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