Mersana Announces First Patient Dosed with XMT-1536 in Phase 1 Study in Patients with NaPi2b-Expressing Tumors
December 12 2017 - 8:00AM
Trial to Study Patients in Ovarian, NSCLC and
Other Cancers
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
proprietary Dolaflexin® platform, today announced dose
administration for the first patient in a Phase 1, open-label,
dose-escalation and expansion study of XMT-1536. XMT-1536 is a
first-in-class ADC targeting NaPi2b, a clinically validated ADC
target broadly expressed in epithelial ovarian cancer and
non-squamous non-small cell lung cancer (NSCLC), as well as a
number of other tumor types.
Mersana plans to enroll an initial dose-escalation cohort in
patients with NaPi2b-expressing tumors in the Phase 1 study with
the objective of selecting the recommended Phase 2 dose followed by
three expansion cohorts. Two expansion cohorts are expected to each
enroll 30 patients with ovarian cancer and non-squamous non-small
cell lung cancer, while a third cohort is expected to consist of
patients with rarer tumors that are known to express NaPi2b, such
as papillary thyroid cancer, papillary renal cell carcinoma,
endometrial cancer and salivary duct cancer.
“The initiation of this study represents a significant milestone
for Mersana, as it marks the start of the company’s second clinical
program within the past year,” said Donald A. Bergstrom, M.D.,
Ph.D., Chief Medical Officer of Mersana. “Our rapid progress from
receiving IND clearance to initiating dosing of patients is
indicative of the expertise of our internal team as well as the
relationships with our CRO and investigator partners. Based on our
exciting preclinical data, we look forward to evaluating the
potential of XMT-1536 as a treatment for patients with
NaPi2b-expressing cancers.”
XMT-1536 is comprised of Mersana’s Dolaflexin platform
conjugated to a proprietary NaPi2b antibody. Each antibody molecule
carries 10-15 molecules of Mersana’s proprietary payload featuring
the Dolalock controlled-bystander effect, resulting in a balance of
meaningful preclinical efficacy and preclinical tolerability. In
preclinical studies, XMT-1536 induced greater than 50% median tumor
regression in 10/19 (53%) primary patient-derived ovarian cancer
xenograft models unselected for NaPi2b protein expression, with
10/12 (83%) tumor responses in NaPi2b-expressing models. In
patient-derived NSCLC xenograft models, XMT-1536 achieved durable
tumor regressions in 6/9 (75%) tested models.
For more information, please visit:
https://clinicaltrials.gov/ct2/results?cond=&term=XMT-1536&cntry1=&state1=&recrs=.
About Mersana Therapeutics Mersana Therapeutics
is a clinical-stage biopharmaceutical company using its
differentiated and proprietary ADC platforms to develop highly
targeted drugs with increased tolerability and expanded
opportunities to deliver meaningful clinical benefit to
patients. Mersana’s lead product candidate, XMT-1522, is in
Phase 1 clinical trials in patients with advanced tumors expressing
HER2, including breast cancer, non-small-cell-lung-cancer (NSCLC)
and gastric cancer patients. The Company’s second product
candidate, XMT-1536, entered clinical trials in late 2017. 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 forward-looking statements are not
statements of historical facts and are based on management’s
beliefs and assumptions and on information currently available to
management. Forward-looking statements include information
concerning the design of its clinical trials.
Forward-looking statements generally can be identified by terms
such as “anticipates,” “believes,” “could,” “seeks,” “estimates,”
“intends,” “may,” “plans,” “potential,” “predicts,” “projects,”
“should,” “will,” “would” or similar expressions and the negatives
of those terms. Forward-looking statements represent management’s
beliefs and assumptions only as of the date of this presentation.
The Company’s operations involve risks and uncertainties, many of
which are outside its control, and any one of which, or combination
of which, could materially affect its results of operations and
whether the forward-looking statements ultimately prove to be
correct. Factors that may materially affect the Company’s
results of operations include, among other things, that preclinical
testing may not be predictive of the results or success of ongoing
or later preclinical or clinical trials and that the development of
the Company’s product candidates will take longer and/or cost more
than planned, as well as those listed in the Company’s Quarterly
Report on Form 10-Q filed on November 13, 2017 with the Securities
and Exchange Commission (“SEC”). Except as required by law, the
Company assumes no obligation to update these forward-looking
statements publicly, or to update the reasons actual results could
differ materially from those anticipated in the forward-looking
statements, even if new information becomes available in the
future.
Copies of the Company’s our Quarterly Report on Form 10-Q and
our other SEC filings are available by visiting EDGAR on the
SEC website at http://www.sec.gov.
Contacts:
Media Contact Paul Kidwell, 617-680-1088
paulkidwell@mersana.com or Investors Contact Stern Investor
Relations, Inc. Christina Tartaglia, 212-362-1200
christina@sternir.com
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