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Momenta Pharmaceuticals, Inc.

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Craig A. Wheeler, President and CEO, gave guidance for data from the Necuparanib phase-II trial in pancreatic cancer. He stated, "Moving on to novel drug candidates, I will start with Necuparanib Our phase-II trial of Necuparanib in pancreatic cancer continues to progress after a brief halt in enrollment. In November our Data Safety Monitoring Board or DSMB asked us to amend the protocol for diagnosing and managing thrombocytopenia. Based on a limited number of specific toxicities observed in the study. Our team was able to amend the protocol and gain DSMB support in short order and in December we announced the trial had resumed enrollment. I am now happy to report that almost all of the sites are back up and running. While the enrollment pause was brief, when you halt enrollment in a protocol you do lose the current patients in the queue and have to have the amendment approved by institutional review boards. Because of the delay, we now expect to have top-line data in the second half of 2017. Importantly though there has been no evidence of safety issues that would warn stopping the study or changing the dosing and we remain optimistic about the opportunity for Necuparanib. We also continue to collect data from patients on our phase-I study and plan to publish and or present updated results at a medical meeting in 2016."
Source: Q4 2015 earnings conference call, 2/18/16.

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Momenta Resumes Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study

CAMBRIDGE, Mass., Dec. 21, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that it has resumed patient enrollment in its ongoing Phase 2 portion of the trial "A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer." Study enrollment was paused last month following Momenta's acceptance of recommendations from its Data Safety Monitoring Board (DSMB) to develop guidelines for diagnosing and managing thrombocytopenia, based on a limited number of specific toxicities observed in the study.

"We are pleased that following their review of the protocol amendment, the DSMB is supportive of resuming patient enrollment in our necuparanib study," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "Given the projected timelines to obtain Institutional Review Board approval of the protocol amendment across study sites, we now anticipate that the top-line data should be available in the second half of 2017."
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Source: press release, 12/21/15. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=947753

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Momenta Announces Temporary Pause of Patient Enrollment in the Necuparanib (MOM-M402-103) Phase 2 Study

CAMBRIDGE, Mass., Nov. 13, 2015 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that it has put a temporary hold on patient enrollment in its ongoing Phase 2 portion of the trial, "A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer," pending the institution of a protocol amendment following receipt of recommendations from its independent Data Safety Monitoring Board (DSMB).

The DSMB met to discuss a limited number of specific toxicities, including thrombocytopenia, risk of bleeding, and thromboembolic events. After thorough review, the DSMB found no safety signals to suggest the need to unblind results, close the study, or discontinue dosing in patients already enrolled in the trial. The DSMB did recommend that the company amend its protocol to standardize the approach to diagnosing and managing thrombocytopenia and consider holding new patient accrual until the amendment is instituted. The DSMB also noted that the causes of thrombocytopenia and subsequent bleeding in these patients can be multifactorial. The Company is assessing whether its protocol amendment and enrollment pause will delay release of top-line data beyond the first half of 2017.

"We support the DSMB's recommendations regarding the most appropriate path forward for the Phase 2 portion of the trial. As always, patient safety is our primary concern, and we will work diligently to institute their recommendations and resume enrollment in this study," stated Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals.
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Source: press release, 11/13/15. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=942645

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October 9, 2014
Momenta Pharmaceuticals Announces Top-Line Part A Results From Phase 1/2 Trial of Necuparanib in Patients With Pancreatic Cancer

Novel Oncology Candidate Necuparanib Well Tolerated in Part A; Dose Selected for Part B Proof-of-Concept Trial and Trial Initiation Underway
CAMBRIDGE, Mass., Oct. 9, 2014 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, announced top-line results from the dose-escalation component (Part A) of the Phase 1/2 trial evaluating necuparanib in combination with Abraxane® (ABX; nab-paclitaxel) and gemcitabine (GEM) in patients with advanced metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243). A dose was established to take forward into Part B (Phase 2) of the trial, which is a randomized, controlled, proof-of-concept study to evaluate the antitumor activity of necuparanib in combination with ABX and GEM, compared with ABX and GEM alone.

Part A is a Phase 1 study of escalating daily necuparanib doses in combination with 125 mg/m2 ABX and 1000 mg/m2 GEM (Days 1, 8, and 15 of each 28-day cycle) in patients with metastatic pancreatic cancer. The necuparanib starting dose was 0.5 mg/kg, which was increased via a modified 3+3 design until a maximum tolerated dose was determined. ABX was added to the treatment regimen starting with Cohort 3 following release of the Phase 3 ABX + GEM data last year. Thirty-seven patients (12 patients in the first two cohorts and 25 patients in the five subsequent cohorts) received necuparanib as of data cutoff and were included in the analyses. Top-line results included:

The most common (≥30% of patients) AEs included anemia, fatigue, nausea, diarrhea, and vomiting - comparable to what has been observed for ABX and GEM alone.
Twelve patients were treated with the combination regimen of necuparanib, ABX, and GEM and have completed the first 28-day cycle as of data cutoff. All 12 of these patients also had at least one follow up CT scan and were considered evaluable for radiographic response. Seven (58%) achieved a RECIST partial response (PR) and an additional 4 (33%) achieved stable disease (SD). Disease Control (the # of patients with Complete Response + PR + SD / total # of evaluable patients) was achieved in 11/12 (92%).
All twelve evaluable patients also had > 20%; and 11/12 had > 50% decreases from baseline in CA19.9 levels (a predictive biomarker for long-term outcome and treatment response in pancreatic cancer).
Data have been submitted to the 2015 Gastrointestinal Cancers Symposium for consideration.

"Necuparanib continues to be a promising compound with several potential and relevant mechanisms of action in pancreatic cancer, a field with limited treatment options. Based on the favorable tolerability and encouraging early signals of potential efficacy observed to date, I look forward to further exploring necuparanib in the Part B portion of the Phase 1/2 study," said David Ryan, M.D., Chief of Hematology and Oncology and Clinical Director of the Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Hospital, and Lead Investigator in the trial.

"We are pleased to have achieved a dose of necuparanib in Part A that is significantly higher than the doses of low molecular weight heparins historically tested in studies conducted to evaluate the effect of heparins on survival in patients with cancer," said Jim Roach, M.D., Chief Medical Officer of Momenta Pharmaceuticals. "We are eager to begin dosing patients in the next few weeks in the Part B portion of the study. Furthermore, we look forward to presenting and publishing data from the Part A study regarding safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy over the next several months."
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Source: press release, 10/13/14. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=875538

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June 5, 2014
Momenta Pharmaceuticals Receives Orphan Drug Designation for Necuparanib (Formerly M402) in Pancreatic Cancer

CAMBRIDGE, Mass., June 5, 2014 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that its novel oncology candidate, necuparanib (formerly M402), has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

"We are pleased to receive Orphan Drug Designation for necuparanib, which highlights the great need for new medications for patients suffering from pancreatic cancer," said Jim Roach MD, Chief Medical Officer of Momenta Pharmaceuticals. "We are encouraged by the progress of the program to date, and in the next several months, we anticipate completing Part A of our ongoing Phase 1/2 study of necuparanib in combination with Abraxane® and gemcitabine. We look forward to sharing the results from Part A and advancing the product into the Phase 2 part of the study in the second half of 2014."

The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics intended to treat, diagnose or prevent rare diseases/disorders, defined as affecting fewer than 200,000 people in the U.S. This designation provides certain incentives, including federal grants, tax credits, waiver of PDUFA filing fees and a seven-year marketing exclusivity period against competition once the product is approved.
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Source: press release, 6/05/14. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=852647

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Craig A. Wheeler, President and CEO, commented on the progress being made with the M-402 compound for Pancreatic cancer. He stated, "In the clinic, we are testing M-402 in a two part phase-I/II proof-of-concept trial in patients with advanced metastatic pancreatic cancer. Part A is an open label multiple ascending dose escalation study of M-402 dosed in conjunction with the standard-of-care regimen of Abraxane plus Gemcitabine. To date, we have completed several dose escalation cohorts and based on encouraging signs of tolerability, we are continuing to add cohorts at a higher dose of M-402. The progress we have made so far is giving us increasing confidence that we will be able to advance this program to Part B of the study. We expect to complete Part A this year, which will allow us to determine the dose that we will take forward into Part B. It is our hope that we will have this data and time to start Part B by the end of this year. This will be a randomized controlled study investigating the safety and anti-tumor activity of M-402 administered in combination with Abraxane and Gemcitabine compared with Abraxane and Gemcitabine alone in patients with metastatic pancreatic cancer."
Source: Q4 2013 earnings conference call, 2/10/14.

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The primary objectives of Part A are to evaluate safety and tolerability of M402 in combination with Abraxane and gemcitabine and to establish the dose of M402 to take forward into Part B. Part B will be a randomized, controlled study to evaluate the antitumor activity of M402 in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. As a result of the amendment and the lead time required to implement the protocol changes, Momenta now expects to have data from Part A during the first half of 2014.
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Source: press release, 4/30/13. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=760381

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Craig A. Wheeler, President and CEO, commented on the progress being made with the M402 for pancreatic cancer program. He stated, "I’ll now move to our novel drug programs. In our M402 oncology program, we continue to enroll patients in Part A of a two-part Phase 1/2 to proof-of-concept study in advanced metastatic pancreatic cancer. Part A is an open label multiple ascending dose study. We expect dose escalation data from Part A this year."
Source: Q4 2012 earnings conference call, 2/15/13.

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A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer
Estimated Enrollment: 180
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01621243?term=M402+MOMENTA&rank=1

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
M402OncologyPancreatic cancerTumor angiogenesis inhibitorGrowth factors, adhesion molecules, and chemokines

Mechanism of action: M402 is a novel heparan sulfate mimetic that binds to multiple growth factors, adhesion molecules, and chemokines to inhibit tumor angiogenesis, progression, and metastasis. 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. M402, which is derived from unfractionated heparin, has been engineered to have significantly reduced anticoagulant activity while preserving the relevant antitumor properties of heparin.

Phase of Development: I/II

Event Type: Data: Phase I/II trial results

Dates: 2016-06-01 - 2016-12-31

Results:

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Momenta Pharmaceuticals Announces Presentation of Final Data from Phase 1 Trial of Necuparanib in Patients with Pancreatic Cancer at ASCO

Novel oncology candidate necuparanib had favorable tolerability and encouraging signals of activity in Phase 1 study

CAMBRIDGE, Mass., June 04, 2016 (GLOBE NEWSWIRE) -- 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."
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Source: press release, 6/04/16. http://ir.momentapharma.com/releasedetail.cfm?ReleaseID=974293

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