- A mid-stage clinical failure and a licensing deal with Bayer that didn't work out dealt OncoMed Pharmaceuticals and its stock a one-two punch on Monday.
- Topline results from the Phase 2 YOSEMITE study of patients with metastatic pancreatic cancer who hadn't received prior treatment showed there wasn't a significant difference in progression free survival between those receiving OncoMed's demcizumab in combination with Celgene's Abraxane (paclitaxel) and the chemotherapy medication gemcitabine versus placebo plus Abraxane and gemcitabine.
- Furthering OncoMed's woes, Bayer decided against licensing two of the California-based biotech's anti-tumor candidates: OMP-54F28 (ipafricept) and OMP-18R5 (vantictumab), citing "strategic reasons." As of June, Oncomed will hold worldwide rights to those drugs, as well as any others targeting what's called the Wnt pathway, a transduction process that helps regulate stem cell activity.
Individually, a trial failure or a less than perfect end to a deal can shake investor confidence in a clinical-stage drug developer. Together, they're like an earthquake. OncoMed's stock fell nearly 43% to $5 apiece in premarket trading on Monday. Shares were back up to around $5.50, however, later that morning.
The news is especially damaging given demcizumab is one of just two drugs in Phase 2 testing. The remainder of OncoMed's candidates are in Phase 1 and pre-clinical investigations.
The YOSEMITE trial evaluated 207 metastatic pancreatic cancer patients, dividing them into three arms. All patients received Abraxane and gemcitabine. One arm received demcizumab, another received placebo and the third arm received both. Pooled interim data from patients taking demcizumab demonstrated a median overall survival (OS) of 13.2 months, but median OS had not been reached for those in the placebo arm, indicating a lack of clinical benefit to demcizumab over standard of care.
Correspondingly, OncoMed is terminating the trial as well as enrollment for other studies of demcizumab.
On the Bayer end of things, OncoMed now has one less partner that could have helped shepherd the company's medications to market. The Germany-based drugmaker has so far fully funded development of ipafricept and vantictumab, paying $90 million in upfront and milestone payments, according to an April 10 statement from OncoMed.
In 2010, Bayer inked a deal with OncoMed for the option to hold exclusive rights to any Wnt pathway treatments, but had to exercise that option by the time the candidates wrapped up Phase 1 testing. Both ipafricept and vantictumab are in early-stage testing.
"While we had looked forward to collaborating with the Bayer team on the late-stage development of these biotherapeutics, we are very pleased to have worldwide rights to two promising Phase 2-ready assets," OncoMed CEO Paul Hastings said in the statement. "We will be conducting an internal portfolio review and prioritization as we determine next steps for all our programs, including vantictumab and ipafricept."