Shares of OncoMed Pharmaceuticals, Inc. (OMED) were down 8.80% after the FDA placed a clinical hold on phase I trials of oncology candidate, OMP-18R5 (vantictumab).
The partial clinical hold was placed following OncoMed's decision to voluntarily halt enrollment and dosing in the ongoing phase I trials on OMP-18R5.
However, the FDA agreed to OncoMed's plan to continue dosing a patient in the phase Ia trial on OMP-18R5, who has remained on treatment for more than 700 days with progression free survival without significant drug-related adverse effects.
Consequently, OncoMed plans to analyze the data from the trial with the investigators and academic bone expert advisors to assess the adverse events in these trials as well as develop revised clinical trial protocols. The FDA will decide on the trial after submission of revised protocols.
OMP–18R5 targets the Wnt pathway. We note that OncoMed recently initiated three separate phase Ib combination trials on OMP-18R5 – one trial each in patients suffering from breast cancer, pancreatic cancer and non-small-cell lung cancer.
Meanwhile, the FDA has also agreed to OncoMed's plan to continue dosing a patient in the single-agent phase Ia trial on another candidate, OMP-54F28 (Fzd8-Fc), who has remained on treatment for more than 390 days without significant drug-related adverse effects.
We note that OncoMed is developing the candidate in collaboration with Bayer (BAYRY).
Since OncoMed does not have any approved product in its portfolio, the news of partial clinical hold on OMP-18R5 was disappointing. We expect investor focus on further updates on the pipeline.
OncoMed currently carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the healthcare sector may consider companies like Gilead Sciences (GILD) and Allergan (AGN). Both stocks carry a Zacks Rank #1 (Strong Buy).