OncoMed Pharmaceuticals, Inc. (OMED) announced that it has enrolled the first biomarker-selected patient in the expansion stage of a phase I study on its cancer candidate, OMP-52M51.
OMP-52M51, an anti-Notch1 antibody, is being evaluated for the treatment of solid tumor by OncoMed in partnership with GlaxoSmithKline (GSK). The candidate is currently in two phase Ia studies – one for the treatment of select advanced solid tumors (including HER2-negative breast, esophageal, colorectal, gastric, pancreatic and small cell lung cancers, adenoid cystic carcinoma and cholangiocarcinoma) and the other for certain types of hematologic malignancy. The study aims to determine the maximum tolerated dose and assess the safety, pharmacokinetics, immunogenicity and preliminary efficacy of OMP-52M51.
Currently, patients with tumors over-expressing the activated form of Notch1 are being enrolled in the expansion stage of the phase I study. They will be treated with 1.5 mg/kg dose of OMP-52M51 (recommended phase II dose) every three weeks. This stage aims at assessing the safety profile of the phase II single-agent dose of OMP-52M51 while evaluating activity of the candidate in the patients. Data from the expansion cohort should be out in 2015.
We remind investors that in Dec 2007, OncoMed and Glaxo had inked a deal for the development of cancer stem cell antibody therapeutics targeting the Notch signaling pathway. Initiation of the expansion study has triggered a $5 million milestone payment from Glaxo.
As part of the agreement, both companies are now focused on the development of two candidates, OMP-52M51 and tarextumab. Glaxo retains an early option to obtain an exclusive license to OMP-52M51 through the end of certain phase I studies or a standard option through the end of certain phase II studies. Additionally, it retains an option to obtain an exclusive license to tarextumab through the completion of select randomized, proof-of-concept phase II studies. If the company chooses to opt for both the programs, OncoMed will be eligible to receive aggregate payments of more than $600 million from Glaxo (including milestones and upfront payments already received and double-digit royalties on net product sales).
We are encouraged with OncoMed’s efforts to develop its pipeline and expect investor focus to remain on further updates from the company.
OncoMed carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Alexion Pharmaceuticals, Inc. (ALXN) and Auxilium Pharmaceuticals Inc. (AUXL). While Alexion carries a Zacks Rank #1 (Strong Buy), Auxilium carries a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment