Mersana Announces FDA Lifts Partial Clinical Hold for XMT-1522
September 17 2018 - 7:00AM
Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage
biopharmaceutical company focused on discovering and developing a
pipeline of antibody drug conjugates (ADCs) based on its
Dolaflexin® and other proprietary platforms, today announced that
the U.S. Food and Drug Administration (FDA) has lifted the partial
clinical hold on the Phase 1 study of XMT-1522.
Mersana and the FDA reached alignment on changes
to the protocol, including increased monitoring as well as the
exclusion of patients with advanced hepatic impairment.
Although XMT-1536, Mersana’s Dolaflexin ADC targeting NaPi2b, was
not subject to a clinical hold, Mersana has decided to implement
similar modifications to the XMT-1536 protocol.
In addition, alternative dosing regimens will be
evaluated for both clinical trials. The XMT-1522 trial will begin
with a once-every-four-week dose regimen. This dosing regimen has
already been implemented in the XMT-1536 trial at previously
explored dose levels in order to enable a comparison of relevant
doses and their impact on the safety, efficacy and PK profile of
the drug candidate. The company may evaluate additional regimens as
well. Data on XMT-1536 is expected in the first half of
2019.
“We are excited to resume enrollment on the
XMT-1522 trial and to work with investigators to explore the full
potential of both promising drug candidates in the solid tumor
setting,” said Anna Protopapas, Chief Executive Officer of
Mersana.
About XMT-1522
XMT-1522 is a Dolaflexin ADC targeting HER2-expressing tumors.
XMT-1522 contains a proprietary HER2 antibody which is conjugated
with Mersana’s Dolaflexin platform – a Fleximer polymer linked with
a proprietary auristatin payload. XMT-1522 provides a drug load of
approximately 12 molecules per antibody, specifically designed to
improve potency while simultaneously increasing tolerability.
XMT-1522 has the potential to extend HER2-targeted therapy beyond
the current “HER2-positive” populations into patients with lower
levels of HER2 expression. The Phase 1 protocol will evaluate
XMT-1522 in patients with advanced HER2-positive breast and gastric
cancer, as well as advanced breast cancer with low HER2 expression
and non-small cell lung cancer (NSCLC). More information on the
ongoing Phase 1 clinical trial can be found at
clinicaltrials.gov.
About XMT-1536
XMT-1536 is a highly potent immunoconjugate targeting the
sodium-dependent phosphate transport protein (NaPi2b) and is
comprised of an average of 10-15 DolaLockTM payload molecules
conjugated to XMT-1535, a proprietary humanized anti-NaPi2b
antibody, via the Dolaflexin ADC platform. NaPi2b is an antigen
highly expressed in the majority of non-squamous NSCLC and
epithelial ovarian cancer. XMT-1536 is in Phase 1 clinical trials
in patients with tumors expressing NaPi2b, including ovarian
cancer, NSCLC and other cancers. More information on the
ongoing Phase 1 clinical trial can be found at
clinicaltrials.gov.
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical
company using its differentiated and proprietary ADC platforms to
develop highly targeted drugs with the potential for increased
efficacy and tolerability and expanded opportunities to deliver
meaningful clinical benefit to patients. Mersana’s product
candidate XMT-1522 is in Phase 1 clinical trials in patients with
tumors expressing HER2, including breast cancer, NSCLC and gastric
cancer patients. The company’s second drug candidate, XMT-1536, is
in Phase 1 clinical trials in patients with tumors expressing
NaPi2b, including ovarian cancer, NSCLC and other cancers. In
addition, multiple partners are using Mersana’s platform to advance
their ADC pipelines.
Forward-Looking Statements
This press release contains “forward-looking” statements within
the meaning of federal securities laws. These are not statements of
historical facts and are based on management’s beliefs and
assumptions and on information currently available. They are
subject to risks and uncertainties that could cause the actual
results and the implementation of the Company’s plans to vary
materially, including the risk that our clinical trials will not be
completed on schedule, if at all, and the risk that our early
encouraging preclinical results for XMT-1522 and XMT-1536 are not
necessarily predictive of the results of our ongoing or future
discovery programs or clinical studies. These risks are discussed
in the company’s filings with the U.S. Securities and Exchange
Commission (SEC) including, without limitation, the company’s
Annual Report on Form 10-K filed on March 28, 2018, the company’s
Quarterly Report on Form 10-Q filed on August 14, 2018, and
subsequent SEC filings. Except as required by law, the Company
assumes no obligation to update these forward-looking statements
publicly, even if new information becomes available in the
future.
Media ContactPaul Kidwell pkidwell@mersana.com
617-680-1088
Investor Contact Stern Investor Relations, Inc.
Christina Tartaglia christina@sternir.com 212-362-1200
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