Momenta Pharmaceuticals Announces Presentation of Final Data from Phase 1 Trial of Necuparanib in Patients with Pancreatic Ca...
June 04 2016 - 9:00AM
Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology
company specializing in the characterization and engineering of
complex drugs, today presented final data from the Phase 1 trial
evaluating necuparanib in combination with nab-paclitaxel (nabP;
Abraxane®) and gemcitabine (gem) in patients with advanced
metastatic pancreatic cancer (ClinicalTrials.gov Identifier
NCT01621243) at the 2016 ASCO Annual Meeting, from 8:00 to 11:30 am
CDT (Abstract #4117 / Poster #109) in Chicago, IL.
“The final data read out from the Phase 1 study
continues to show favorable tolerability and promising antitumor
activity as assessed by survival and response data,” said Eileen
O’Reilly, MD of David M. Rubenstein Center for Pancreatic Cancer
Research, Memorial Sloan Kettering Cancer Center and lead author on
the poster. “We also continued to see a clinically meaningful
reduction in levels of CA19.9, a predictive biomarker that often
correlates with the long-term outcome and response to treatment in
pancreatic cancer patients.”
Necuparanib was administered daily in
combination with 125 mg/m2 nabP and 1000 mg/m2 gem (Days 1, 8, and
15 of each 28-day cycle). The necuparanib starting dose was
0.5 mg/kg, which was increased until the maximum tolerated
dose of 5 mg/kg was determined. nabP was added to the
treatment regimen starting with the third cohort. Thirty-nine
patients (12 patients in the first two cohorts and 27 patients in
the five subsequent cohorts) received necuparanib and were included
in the analyses. Top-line results included:
- Necuparanib was well tolerated when added to standard of care;
no increases in incidence, severity, or duration for known adverse
events of gem or nabP + gem were observed when combined with
necuparanib.
- Measurable levels of necuparanib were seen starting at the 2
mg/kg dose group. Release of heparin-binding protein (a
pharmacodynamic marker) increased with increasing doses and
plateaued at 4-5 mg/kg.
- Encouraging signals of activity were observed:
- 16 patients treated with necuparanib + nabP + gem completed
Cycle 1 and had ≥1 scan on treatment; 9 (56%) achieved RECIST
partial response (PR) and 5 (31%) achieved stable disease, for a
disease control rate (DCR) of 14/16 (88%); median OS in this subset
was 15.6 months. Median OS of patients treated with ≥1 dose of
necuparanib + nabP + gem (n=24) was 13.1 months.
- 24-month survival rates for patients treated with ≥1 cycle and
≥1 dose of necuparanib + nabP + gem were 25% and 21%,
respectively.
- Of 15 CA19.9 evaluable patients, 15 (100%) had ≥20%, 14 (93%)
had ≥50%, and 7 (47%) had ≥90% decreases from baseline.
“We continue to be encouraged by these data from
our lead novel drug candidate, and look forward to completing
enrollment of the Phase 2 study over the next several months,” said
Jim Roach, M.D., Senior Vice President of Development and Chief
Medical Officer of Momenta Pharmaceuticals. “We expect to report
key results from the Phase 2 study in the second half of 2017.”
About NecuparanibNecuparanib
(M402) is a novel oncology drug candidate engineered to have a
broad range of effects on tumor cells. The use of heparins to treat
venous thrombosis in cancer patients has generated numerous reports
of antitumor activity; however, the dose of these products has been
limited by their anticoagulant activity. Leveraging its experience
in deciphering the structure-function relationships of complex
therapeutics, Momenta engineered necuparanib from unfractionated
heparin to have significantly reduced anticoagulant activity while
preserving relevant antitumor properties associated with heparins.
A Phase 2, randomized, double-blind, controlled study in pancreatic
cancer is ongoing, which will evaluate the antitumor activity of
necuparanib in combination with nab-paclitaxel (Abraxane®) plus
gemcitabine, versus nab-paclitaxel plus gemcitabine alone.
Necuparanib has received Orphan Drug and Fast Track designations
from the U.S. Food and Drug Administration (FDA) for the treatment
of pancreatic cancer.
About MomentaMomenta
Pharmaceuticals is a biotechnology company specializing in the
detailed structural analysis of complex drugs and is headquartered
in Cambridge, MA. Momenta is applying its technology to the
development of generic versions of complex drugs, biosimilar and
potentially interchangeable biologics, and to the discovery and
development of novel therapeutics for oncology and autoimmune
indications.
To receive additional information about Momenta,
please visit the website at www.momentapharma.com, which does not
form a part of this press release. The company’s logo, trademarks,
and service marks are the property of Momenta Pharmaceuticals, Inc.
All other trade names, trademarks, or service marks are property of
their respective owners.
Forward-Looking
StatementsStatements in this press release regarding
management's future expectations, beliefs, intentions, goals,
strategies, plans or prospects, including without limitation
statements regarding future evaluation and development of
necuparanib, its potential safety profile and activity, the timing
of completion of enrollment of clinical trials, and the timing of
availability of data from clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements can be
identified by terminology such as "continue," "expect," "look
forward," or similar terms, variations of such terms or the
negative of those terms. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
referred to in the Company's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2016 filed with
the Securities and Exchange Commission under the section
"Risk Factors," as well as other documents that may be filed by
Momenta from time to time with the Securities and Exchange
Commission. As a result of such risks, uncertainties and
factors, the Company's actual results may differ materially from
any future results, performance or achievements discussed in or
implied by the forward-looking statements contained
herein. Momenta is providing the information in this press
release as of this date and assumes no obligations to update the
information included in this press release or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor Relations:
Sarah Carmody
Momenta Pharmaceuticals
1-617-395-5189
IR@momentapharma.com
Media Relations:
Karen Sharma
MacDougall Biomedical Communications
1-781-235-3060
Momenta@macbiocom.com
Business Development:
Momenta Pharmaceuticals
1-617-491-9700
businessdevelopment@momentapharma.com
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Momenta Pharmaceuticals (NASDAQ:MNTA)
Historical Stock Chart
From Apr 2023 to Apr 2024