Replies to post #201231 on Biotech Values

[jdc]

http://insidertrading.org/?sort_by=acceptance_datetime&asc=&symbol=mnta&date_from=2014-10-05&date_to=2016-05-03&submit=+GO+

,,nothing but sales for a long time by insiders..albeit in very small numbers..

donc

[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.

[DewDiligence]

MNTA starts phase-1 trial of M281 anti-FcRn mAb:

http://finance.yahoo.com/news/momenta-pharmaceuticals-initiates-phase-1-120000781.html

Momenta Pharmaceuticals…today announced the dosing of the first healthy volunteers in a Phase 1 randomized, double-blind, placebo-controlled, ascending-dose cohort study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281, an anti-FcRn monoclonal antibody, for the treatment of autoimmune diseases.

… “The initiation of this trial advances our initiative to develop a best-in-class monoclonal antibody for the treatment of antibody-mediated diseases with high unmet medical needs. We anticipate presenting the data from this trial in the second half of 2017.”

M281 is a fully human IgG1 monoclonal antibody that targets the IgG-binding site of FcRn. In preclinical models, M281 potently antagonizes FcRn binding of IgGs and rapidly diminishes circulating levels of IgG antibodies, the primary pathogenic agent in a number of autoimmune diseases.

This study will enroll up to approximately 72 healthy volunteers depending on the number of cohorts enrolled. Part 1 of the study will assess ascending doses of M281 administered as a single dose. Part 2 will assess ascending doses of M281 administered as repeated weekly or twice-weekly doses over 28 days.