Catastrophic Year for Bay Area's OncoMed Continues as Lead Drug Comes Crashing Down in Phase II Study

May 8, 2017
By Alex Keown, BioSpace.com Breaking News Staff

REDWOOD CITY, Calif. – Bay Area-based OncoMed is drowning in a flood of bad news. Share prices dropped 17 percent in pre-market trading this morning and continued to fall after the markets opened following reports of a third clinical trial fail this year.

OncoMed said its Phase II front-line cancer drug demcizumab failed to meet its efficacy endpoints when compared to placebo in treating patients with non-squamous non-small cell lung cancer. OncoMed and Celgene had partnered for this trial. This morning, the company said the drug actually performed worse than placebo. No statistically significant differences in efficacy were observed between patients receiving one course or two courses of demcizumab, the company said.

Following OncoMed’s announcement this morning, the company said it was discontinuing the dosing of all patients on the demcizumab trials, including the demcizumab plus Keytruda Phase Ib study it was conducting with Merck . OncoMed said it will conduct a complete program review in the near term with its partner Celgene regarding the most recent failure.

This is the second time in about a month that demcizumab has failed. In April, demcizumab failed to meet endpoints in a phase II trial with pancreatic cancer.

Also, on April 17 the company announced its mid-stage trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide and a chemotherapy drug to treat patients with extensive-stage small cell lung cancer showed results that were “undifferentiated from those of chemotherapy plus placebo.” That trial testing demcizumab in combination with Abraxane as a first-line treatment in metastic pancreatic cancer was terminated.

Also in April, Bayer Pharma announced that it opted to terminate its option to license two OncoMed drugs, vantictumab and ipafricept, both first-in-class Wnt pathway inhibitors. Phase 1a and Phase 1b clinical trials, vantictumab and ipafricept have each demonstrated safety and tolerability alone and in combination with standard-of-care chemotherapies in several solid tumors.

In April, OncoMed slashed half its workforce in an effort to focus its finances on three clinical-stage programs. The terminations left the company with 54 employees. With another failed trial, pink slips may be handed out again at the beleaguered company. This morning the company said that as of March 31, cash and short-term investments totaled $156.9 million. Paul Hastings, OncoMed’s chairman and chief executive officer, said the company has about two years-worth of financing to continue development of its pipeline.

“We continue to drive forward our strong immuno-oncology R&D pipeline, including anti-TIGIT, wholly-owned GITRL-Fc trimer, and our novel undisclosed immuno-oncology discovery programs–as well as advancing programs in our Celgene collaboration to $98 million in potential opt-in payments within the next two years,” Hastings said in a statement.

Earlier this year, the company began enrollment of patients in two Phase 1b clinical trials of anti-DLL4/VEGF bispecific antibody (OMP-305B83), now known as navicixizumab, plus standard-of-care chemotherapy for the treatment of second-line colorectal and platinum-resistant ovarian cancers. The company also enrolled patients in a Phase Ia single-agent study of OncoMed’s anti-TIGIT antibody (OMP-313M32).

Shares of OncoMed are currently trading at $3.64 as of 10:15 a.m. Share prices had hit a low of $3.25 this morning.