OncoMed's OMP-54F28 on Partial Clinical Hold

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Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

OncoMed Pharmaceuticals Inc. (OMED) recently suffered another setback when the FDA  placed a partial clinical hold on phase I clinical trials of another pipeline candidate, FZD8-Fc (OMP-54F28).

Last week, the FDA placed a partial clinical hold on phase I trials of oncology candidate, OMP-18R5 (vantictumab).

The FDA’s decision to put the trials on clinical hold follows OncoMed's decision to voluntary halt the trials after the company observed mild-to-moderate bone adverse events in patients enrolled for the phase I trials on OMP-18R5  and OMP-54F28.

The partial clinical hold will be effective until OncoMed provides additional data as required by the FDA's Division of Oncology Products 1 (DOP1) along with compliance of proposed protocol amendments.

Meanwhile, the FDA agreed to OncoMed's plan to continue dosing of a patient in the single-agent phase Ia trial on OMP-54F28 who has remained on treatment for more than 390 days showing progression free survival without significant drug-related adverse effects.

Consequently, OncoMed plans to submit amended protocols to the FDA and subsequently to clinical sites for both the OMP-18R5 and OMP-54F28 programs. The amendments are expected to incorporate modified dosing regiments, updated risk mitigation measures and revised enrollment criteria.

We note that OncoMed has initiated three separate phase Ib combination trials on OMP-54F28- one trial each in patients suffering from ovarian cancer, pancreatic cancer, and hepatocellular carcinoma.

Both the candidates are being developed in collaboration with Bayer (BAYRY).

Since OncoMed does not have any approved product in its portfolio, the news of partial clinical hold on both the candidates was disappointing. We expect investor focus to remain 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 the stocks carry a Zacks Rank #1 (Strong Buy).
 

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