Biotech Values

[DewDiligence]

MNTA presents final Necuparanib data from phase-1 portion of phase-1/2 trial in pancreatic cancer at ASCO:

http://finance.yahoo.com/news/momenta-pharmaceuticals-announces-presentation-final-130000484.html

Necuparanib was administered daily in combination with 125 mg/m2 nabP [Abraxane] and 1000 mg/m2 gem [gemcitabine] (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.

o …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.

o 24-month survival rates for patients treated with >=1 cycle and >=1 dose of necuparanib + nabP + gem were 25% and 21%, respectively.

o Of 15 CA19.9 [biomarker] evaluable patients, 15 (100%) had >=20%, 14 (93%) had >=50%, and 7 (47%) had >=90% decreases from baseline.

The phase-2 randomized portion of this trial, which tests Abraxane/gemcitabine ± Necuparanib, is listed at https://clinicaltrials.gov/ct2/show/NCT01621243 . Results are expected in 2H17.