Novel oncology candidate necuparanib had favorable tolerability and encouraging signals of activity in Phase 1 study
CAMBRIDGE, MA, USA I June 04, 2016 I 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 Necuparanib
Necuparanib (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 Momenta
Momenta 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.
SOURCE: Momenta Pharmaceuticals
Post Views: 366
Novel oncology candidate necuparanib had favorable tolerability and encouraging signals of activity in Phase 1 study
CAMBRIDGE, MA, USA I June 04, 2016 I 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 Necuparanib
Necuparanib (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 Momenta
Momenta 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.
SOURCE: Momenta Pharmaceuticals
Post Views: 366
