Merrimack Pharmaceuticals Inc (NASDAQ:MACK) and Baxalta Incorporated (NYSE:BXLT) jointly announced the enrollment of the first patient in an exploratory Phase 2 clinical study of ONIVYDE™ (irinotecan liposome injection), also known as MM-398 or “nal-IRI,” in previously untreated, metastatic pancreatic adenocarcinoma.
The Phase 2 clinical study of ONIVYDE in patients with previously untreated, metastatic pancreatic adenocarcinoma will assess the safety and efficacy of the combination of ONIVYDE plus fluorouracil (5-FU) and leucovorin (LV), with or without the addition of oxaliplatin, versus nab-paclitaxel and gemcitabine. The start-up of this study resulted in $62.5M of milestone payments to Merrimack from Baxalta.
“The initiation of this Phase 2 study is an important step in evaluating ONIVYDE’s effectiveness as a front-line treatment option for patients diagnosed with metastatic pancreatic cancer. This design allows us to quickly and efficiently learn about the safety and efficacy of these potential new regimens prior to entering into a large, confirmatory Phase 3 study,” said Eliel Bayever, M.D., Vice President at Merrimack and medical director for ONIVYDE.
“Our team is extremely excited to be the first center in the world to open this trial of ONIVYDE in front-line metastatic pancreatic cancer given the results of the NAPOLI trial in the post-gemcitabine setting,” said Dr. Andrew Dean, one of the principal investigators on the study and an Oncologist at St John of God Hospital Subiaco in Australia.
In addition to pancreatic cancer, there are ongoing Phase 1 studies of ONIVYDE in glioma, breast cancer, gastric cancer and pediatric solid tumors.
“This trial is part of our broad development plan for ONIVYDE in solid tumors that have high unmet medical need,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “By expanding our research of ONIVYDE into patients who have not been previously treated for metastatic pancreatic cancer, our hope is that we learn more about its potential to meet the needs of people who currently have few approved treatment options.”
Merrimack and Baxalta have entered into an exclusive licensing agreement to develop and commercialize ONIVYDE outside of the United States.A Marketing Authorization Application is under review in the European Union for the treatment of adult patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize ONIVYDE in Taiwan.
Clinical Study of ONIVYDE in Previously Untreated, Metastatic Pancreatic Adenocarcinoma
The study will be conducted in two parts, first assessing the safety of ONIVYDE in combination with 5-FU/LV and oxaliplatin, and then expanding into a three arm randomized study assessing the safety and efficacy of the combination of ONIVYDE and 5-FU/LV with or without oxaliplatin versus nab-paclitaxel and gemcitabine. Eligible patients for the study must have received no prior systemic treatment.
In the first part of the study, approximately 6-18 patients will be enrolled. The primary outcome for Part 1 of the study is to evaluate the safety and tolerability of ONIVYDE in combination with 5-FU/LV and oxaliplatin. In the second part of the study, an additional 150 patients (50 patients per arm) with previously untreated, metastatic pancreatic adenocarcinoma will be enrolled and randomized to receive either ONIVYDE in combination with 5-FU/LV and oxaliplatin, ONIVYDE in combination with 5-FU/LV, or nab-paclitaxel and gemcitabine. In Part 2, efficacy of the ONIVYDE containing regimens will be compared to the nab-paclitaxel and gemcitabine regimen, evaluating progression free survival (PFS) rate at 24 weeks, as well as overall survival, PFS, objective response rate, tumor marker CA19-9 response, safety and tolerability. (Original Source)
Shares of Merrimack Pharmaceuticals Inc. closed yesterday at $9.59 . MACK has a 1-year high of $13.84 and a 1-year low of $7.21. The stock’s 50-day moving average is $9.63 and its 200-day moving average is $10.95.
On the ratings front, Merrimack Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on October 23, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on MACK, with a price target of $16, which implies an upside of 66.8% from current levels. Separately, on October 22, Mizuho’s Eric Criscuoloare maintained a Buy rating on the stock and has a price target of $16.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Eric Criscuoloare have a total average return of -5.0% and -1.2% respectively. Aschoff has a success rate of 35.8% and is ranked #3674 out of 3802 analysts, while Criscuoloare has a success rate of 75.0% and is ranked #2643.
Merrimack Pharmaceuticals Inc is engaged in discovering, developing and preparing to commercialize medicines consisting of novel therapeutics paired with companion diagnostics for the treatment of cancer.