Demcizumab Plus Standard of Care Yields Median Overall Survival of 12.7 Months

REDWOOD CITY, Calif., Jan. 22, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updated survival data from the company's Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) at the Gastrointestinal Cancers Symposium.

The Phase 1b dose-escalation and expansion study assessed the safety, biomarker, and anti-tumor activity of demcizumab and gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in 32 previously untreated patients with advanced pancreatic cancer.  Demcizumab in combination with chemotherapy had an acceptable safety profile.  The updated Kaplan-Meier estimated median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received the demcizumab-gemcitabine-Abraxane combination.  Current standard-of-care treatment for advanced pancreatic cancer with gemcitabine and Abraxane, based on Phase 3 data, has median progression-free survival of 5.5 months and median overall survival of 8.5 months.1

"Pancreatic cancer remains a difficult-to-treat tumor and patients with this disease are in need of new and improved treatment options.  We are very encouraged by the safety and early efficacy results observed in our Phase 1b clinical trial of demcizumab in pancreatic cancer," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer.  "In this updated data set from our Phase 1b study of demcizumab plus standard of care in thirty-two patients with pancreatic cancer, we are pleased to see the median overall survival extend beyond 12.5 months.  Overall, the safety, response, progression-free and overall survival data observed in our single-arm Phase 1b clinical study support our ongoing Phase 2 randomized YOSEMITE clinical trial for the treatment of first-line metastatic pancreatic cancer."
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A randomized Phase 2 "YOSEMITE" trial in first-line pancreatic cancer patients with metastatic disease is currently being conducted at more than 50 centers in the U.S., Canada, Europe and Australia.  Approximately 200 patients will be randomized into one of three study arms.  Patients in Arm 1 will receive standard-of-care gemcitabine plus Abraxane plus placebo.  Patients in Arm 2 patients will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for six doses (70 days).  Patients in Arm 3 will receive standard of care with demcizumab for two courses.  OncoMed expects to complete enrollment of the Phase 2 trial in 2016 and data from this trial is anticipated in early 2017. 

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=951326

​​Demcizumab Plus Standard of Care Yields Median Overall Survival of 12.7 Months

REDWOOD CITY, Calif., Jan. 22, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updated survival data from the company's Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) at the Gastrointestinal Cancers Symposium.

The Phase 1b dose-escalation and expansion study assessed the safety, biomarker, and anti-tumor activity of demcizumab and gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in 32 previously untreated patients with advanced pancreatic cancer.  Demcizumab in combination with chemotherapy had an acceptable safety profile.  The updated Kaplan-Meier estimated median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received the demcizumab-gemcitabine-Abraxane combination.  Current standard-of-care treatment for advanced pancreatic cancer with gemcitabine and Abraxane, based on Phase 3 data, has median progression-free survival of 5.5 months and median overall survival of 8.5 months.1

"Pancreatic cancer remains a difficult-to-treat tumor and patients with this disease are in need of new and improved treatment options.  We are very encouraged by the safety and early efficacy results observed in our Phase 1b clinical trial of demcizumab in pancreatic cancer," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer.  "In this updated data set from our Phase 1b study of demcizumab plus standard of care in thirty-two patients with pancreatic cancer, we are pleased to see the median overall survival extend beyond 12.5 months.  Overall, the safety, response, progression-free and overall survival data observed in our single-arm Phase 1b clinical study support our ongoing Phase 2 randomized YOSEMITE clinical trial for the treatment of first-line metastatic pancreatic cancer."

​A randomized Phase 2 "YOSEMITE" trial in first-line pancreatic cancer patients with metastatic disease is currently being conducted at more than 50 centers in the U.S., Canada, Europe and Australia.  Approximately 200 patients will be randomized into one of three study arms.  Patients in Arm 1 will receive standard-of-care gemcitabine plus Abraxane plus placebo.  Patients in Arm 2 patients will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for six doses (70 days).  Patients in Arm 3 will receive standard of care with demcizumab for two courses.  OncoMed expects to complete enrollment of the Phase 2 trial in 2016 and data from this trial is anticipated in early 2017. 

​Read More: ​http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=951326

On Jan. 8, a team of UNC vascular surgeons were the first physicians in North Carolina to utilize the ENROUTE Transcarotid Stent, a new carotid stent system developed by Silk Road Medical, Inc.

Implanted by Mark Farber, MD, professor of surgery, and Raghuveer Vallabhaneni, MD, assistant professor of surgery, the new stent system is the first device designed specifically for a new procedure called TransCarotid Artery Revascularization (TCAR). This procedure combines surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery.

"This procedure is the best of both worlds, giving direct surgical access to the carotid artery without the risks of nerve damage of open revascularization. It also decreases the stroke risk when compared to transfemoral carotid stenting.  It is a minimally invasive and safer way of revascularizing appropriate patients,” said Vallabhaneni.

Read More: ​http://news.unchealthcare.org/som-vital-signs/2016/jan-14/unc-vascular-surgeons-are-first-in-north-carolina-to-utilize-new-carotid-stent-system

Minneapolis Heart Institute Foundation® selected to test less invasive procedure for carotid artery stenosis

Minneapolis, MN - January 14, 2016 - The carotid arteries supply oxygenated blood to the brain. Every year, more than 300,000 people in the United States are diagnosed with blockages, or plaques, in their carotid artery. When these arteries become blocked due to plaque build-up, an individual is at high risk for a stroke if the plaque ruptures and flows to the brain. Many individuals can manage carotid artery disease with medications and lifestyle changes. However, many may require carotid artery revascularization surgery to repair the blockage in the artery. Carotid endarterectomy has been the gold standard of treatment with carotid stenting reserved for those who are high risk for open surgery. While largely effective in some patients, carotid stenting from the transfemoral route has been found to carry a higher risk of stroke, with a significant amount of this risk felt to be related to the approach.

The FDA recently approved a new Transcarotid Artery Revascularization (TCAR) procedure that utilizes the ENROUTE® Transcarotid Neuroprotection and Stent System from Silk Road Medical. The TCAR procedure offers patients a potentially safer method of carotid stenting through a small cut down at the base of the neck and direct carotid artery access along with neuro-protective flow reversal during delivery of the stent. The Minneapolis Heart Institute Foundation® (MHIF) was selected as the only center in the four state area to participate in the ROADSTER 2 Study. Jessica Titus, MD, and Timothy Sullivan, MD, vascular surgeons at the Minneapolis Heart Institute® at Abbott Northwestern Hospital, will serve as Principal Investigator and Co-Investigator, respectively, for the trial. "We are excited to be able to bring this carotid artery revascularization option to our patients. It combines the advantages of a minimally invasive approach for high risk patients with a lower stroke risk than the standard method for carotid stent placement." said Dr. Titus.

Read More: ​http://www.eurekalert.org/pub_releases/2016-01/mhif-vsr011516.php

StartUp Health last month released its annual health insights report for 2015 and if there's one overarching theme, it's that the digital health industry is maturing. What's interesting to StartUp Health co-founder and CEO Unity Stoakes is how quickly the landscape has changed over the past five years. In 2010, the digital health sector generated about $1 billion in investment. The sector is expected to bring in a total of $6 billion in funding in 2015.

Here are seven takeaways from the 2015 report:  

4. Digital solutions will be scaled for millions.
Over the next year, Stoakes predicts more technologies will focus on improving  outcomes and will be used by large populations.
“You have companies like Omada Health, which has an interesting business model with a risk involved in it,” said Stoakes. “There's a lot of metrics and data that prove what's working.”

Read More: http://www.mmm-online.com/agency/7-takeaways-from-startup-healths-annual-report/article/463533/

REDWOOD CITY, Calif., Jan. 08, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced the publication of a manuscript in Cancer Research describing OncoMed's efforts to develop novel therapeutics against R-spondin (RSPO) targets and elucidating the link between expression of the RSPO cancer stem cell pathway and tumor growth.  OncoMed is currently conducting a Phase 1a/b clinical trial of its anti-RSPO3 (OMP-131R10) antibody.

The article "Therapeutic Targeting of Tumor-Derived R-Spondin Attenuates beta-Catenin Signaling and Tumorigenesis in Multiple Cancer Types" (released online December 30, 2015) describes the generation of neutralizing monoclonal antibodies against RSPO-1, -2 or -3 and the successful use of these antibodies to treat diverse types of patient-derived xenografts, including colon, ovarian, pancreas and lung tumors.  Of note, these anti-RSPO antibodies were effective in the tumor models regardless of whether the tumors overexpressed RSPO because of gene translocations or because of other tumor-intrinsic pathways.  OncoMed is utilizing biomarker assays to prospectively screen patients for RSPO gene expression as part of its Phase 1a/b clinical program.

Mechanistically, the paper establishes a functional link between RSPO expression and tumor growth.  Tumor-derived RSPO can activate beta-catenin, and antibody-mediated blocking of RSPO binding to its receptor potently inhibits tumor growth.  This anti-tumor activity is associated with the modulation of beta-catenin and cancer stem cell pathways.
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"R-spondins are emerging as an important cancer target.  As key stimulators of beta-catenin activity in a variety of human tumor types, targeting the RSPO pathway may prove to be an effective approach to modulating this fundamental signaling axis," said John Lewicki, Ph.D., OncoMed's Chief Scientific Officer.  "Our first anti-RSPO candidate is being studied in Phase 1a/b clinical trials with a strong biomarker hypothesis and we expect to establish a single-agent dose and treat biomarker-positive patients this year."

Read More: ​http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=949522

$70 Million Safety and $2.5 Million Clinical Candidate Designation Milestones Achieved
Enters 2016 with $227 Million in Pro-Forma Cash

REDWOOD CITY, Calif., Jan. 05, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), today announced the achievement of two milestones from Celgene Corporation and pre-announced its 2015 year-end pro-forma cash balance and key anticipated events for 2016.

OncoMed achieved the $70 million safety milestone from Celgene based on an analysis of available Phase 1b and blinded interim Phase 2 clinical trial safety data associated with the demcizumab (anti-DLL4, OMP-21M18) program.  The data from the pancreatic, non-small cell lung and ovarian cancer clinical trials showed no demcizumab-related Grade 3 or higher cardio-pulmonary toxicities among 155 patients treated with truncated dosing.  Of those, 68 patients have received at least two cycles of demcizumab at the Phase 2 dose or higher and have been followed for at least 100 days.  OncoMed also achieved a $2.5 million milestone for clinical candidate designation of an undisclosed preclinical immuno-oncology program, "IO#2".  This is OncoMed's second immuno-oncology program to reach clinical candidate designation, and both programs are advancing in IND-enabling studies. 

Including the Celgene milestones, OncoMed ended 2015 with approximately $227.2 million in pro-forma cash, representing approximately 1.5 years of cash, without taking into account future potential milestone payments from partners, and exceeding its 2015 guidance predicting a year-end cash balance of greater than $120 million.  Full-year operating expenses for 2015 are anticipated to be approximately $110 million, in accordance with previous guidance.  OncoMed plans to provide full-year 2016 guidance during its 2015 fourth quarter earnings call in the first quarter of 2016.
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"The achievement of the demcizumab $70 million safety milestone is based on extensive Phase 1b and blinded Phase 2 data, and positions OncoMed to rapidly enroll its Phase 2 randomized YOSEMITE and DENALI clinical trials, as well as the Phase 1b demcizumab plus pembrolizumab (anti-PD1) trial, and also to explore the potential of demcizumab in ovarian cancer," said Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer.  "We enter 2016 in a strong cash position to support all seven internally discovered programs through clinical trials, including four randomized Phase 2 clinical studies, and to advance two immuno-oncology candidates toward IND filings while maintaining ongoing discovery efforts.  Over the course of this year, we anticipate completing and reporting on our first randomized Phase 2 clinical trial, the tarextumab ALPINE study in pancreatic cancer, presenting additional data from our ongoing clinical- and discovery-stage programs, filing at least one new IND and achieving additional milestones related to our collaborations."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=948770