OncoMed (OMED) presented updated results from two phase 1b trials of
demcizumab (anti-DLL4) at the ESMO 2014 Congress over the weekend. Both
studies demonstrated encouraging tumor response rates. In the pancreatic cancer
study, demcizumab + gemcitabine + ABRAXANE demonstrated a 41% partial 
response (PR) rate and a 45% stable disease (SD) rate, resulting in an overall
clinical benefit rate of 86%. In the non-squamous NSCLC study, demcizumab +
ALIMTA + carboplatin demonstrated 3% CR, 45% PR, and 39% SD, resulting
in an overall clinical benefit rate of 88%. Demcizumab was described as
generally well tolerated in both studies. The truncated dosing schedule for
demcizumab appeared to prevent the onset of late cardiopulmonary toxicity, as
none of the 64 patients in the two studies who received the truncated dosing 
experienced any moderate-to-severe cardiopulmonary toxicities. Phase 2 studies
in these two cancer indications are expected to commence by the end of 2014. 

Read More: http://research-ca.bmocapitalmarkets.com/documents/c70fa216-f89c-471b-b35e-2b0b16304167.pdf

Data Supports Phase 2 ALPINE Study of Tarextumab in Pancreatic Cancer and Phase 2 PINNACLE Trial in Small Cell Lung Cancer

MADRID and REDWOOD CITY, Calif., Sept. 29, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented promising data on safety and anti-tumor activity from the ALPINE and PINNACLE Phase 1b clinical studies of tarextumab (anti-Notch2/3, OMP-59R5) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

"The Phase 1b tarextumab data presented at ESMO 2014 support our randomized Phase 2 clinical programs with this novel antibody targeting the Notch pathway," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In the ALPINE study of patients with pancreatic cancer, we are seeing promising anti-tumor activity and tolerability in combination with standard of care. Notably, we now have pharmacodynamic evidence of Notch pathway inhibition, which provides clinical validation that tarextumab is hitting its desired target. In our PINNACLE trial of small cell lung cancer patients, we have seen a number of partial responses and tarextumab has been well tolerated in combination with standard platinum and etoposide chemotherapy."

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873389

MADRID and REDWOOD CITY, Calif, Sept. 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, presented safety and efficacy data from two Phase 1b clinical trials of demcizumab (anti-DLL4, OMP-21M18) in pancreatic cancer and non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.

Results from the Phase 1b studies demonstrate that demcizumab, in combination with standard-of-care chemotherapy, is well tolerated, especially in patients where the company's risk mitigation, monitoring and truncated dosing strategies have been employed. Encouraging tumor response rates were presented at ESMO from a study of demcizumab with gemcitabine or gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectible suspension) (albumin bound) in patients with first-line pancreatic cancer, and from the study of demcizumab plus pemetrexed and carboplatin for the first-line treatment of Stage III/IV NSCLC. OncoMed's Phase 1b studies identified the demcizumab dosing schedules for the company's planned randomized Phase 2 proof-of-concept trials.

"As we advance to Phase 2 clinical trials of demcizumab, we have successfully identified strategies that result in both favorable tolerability and compelling response rates," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "To date, sixty-four patients have been enrolled and treated on the demcizumab truncated dosing schedule that will be used in our randomized Phase 2 studies. The majority of these patients have now been followed for greater than 100 days without any moderate-to-severe cardiopulmonary toxicities and a number of patients remain on treatment."  

"Based on the data generated from our Phase 1b studies in pancreatic and non-small cell lung cancer we have identified a dosing regimen with impressive anti-tumor activity and an acceptable safety profile. We have confidence that these data enable the advancement of both programs into planned randomized Phase 2 studies in pancreatic cancer and NSCLC.  Results from our Phase 1b demcizumab program not only signal the potential safety and anti-tumor activity for this drug, but also provide encouragement for the potential of an anti-cancer stem cell hypothesis," said Paul J. Hastings, Chairman and Chief Executive Officer. 


Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=873324