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News Breaks
May 14, 2014
08:07 EDTCLDX, BMYCelldex to collaborate with Bristol-Myers on varlilumab/nivolumab combo therapy
Bristol-Myers Squibb (BMY) and Celldex Therapeutics (CLDX) announced that they have entered into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers' investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex’s CD27 targeting investigational antibody in a Phase 1/2 study. Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer, metastatic melanoma, ovarian, colorectal and squamous cell head and neck cancers. Under the terms of this agreement, Bristol-Myers Squibb will make a one-time payment of $5M to Celldex and the parties will share development costs. Celldex will be responsible for conducting the Ph 1/2 study, which is expected to begin in the fourth quarter of 2014. Additionally, the parties have re-structured an existing agreement between Celldex and Medarex related to Celldex’s CD27 program, and waived certain future milestone payments and reduced future royalty rates that would have been due from Celldex to Medarex. Medarex was acquired by Bristol-Myers Squibb in September of 2009. The companies will work exclusively with each other to explore anti-PD-1 antagonist antibody and anti-CD27 agonist antibody combination regimens. Bristol-Myers Squibb will have a time-limited right of first negotiation if Celldex wishes to out-license varlilumab.
News For CLDX;BMY From The Last 14 Days
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March 26, 2015
07:30 EDTBMYDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
March 24, 2015
08:02 EDTBMYBristol-Myers acquires exclusive license from Novo Nordisk for research program
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March 20, 2015
07:55 EDTBMYAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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March 17, 2015
09:25 EDTCLDXOn The Fly: Pre-market Movers
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08:13 EDTCLDXCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.

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