Celldex Announces Clinical Trial Collaboration with Roche
News Mar 20, 2015
Celldex Therapeutics, Inc. has announced that it has entered into a clinical trial collaboration with Roche to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A (anti-PDL1), 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 (11.0+ months) that has continued to decrease in tumor volume over time and prolonged stable disease (4 patients with a range of 5.3 to 30.7+ months).
"This collaboration with Roche furthers our ongoing initiative to investigate varlilumab's potential in combination with a broad range of mechanisms and across multiple tumor types," said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics. "Varlilumab is currently being studied in two Phase 1/2 combination studies and we expect it will enter at least another four combination studies this year. This latest trial is supported by promising signs of single-agent activity observed in our Phase 1 study in patients with renal cell carcinoma. We believe combining an immune activator with a checkpoint inhibitor in this disease setting may augment this activity and the synergy demonstrated in our preclinical varlilumab/anti-PDL1 combination models provide further support for this approach."
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.
Study Reveals How MRSA Infection Compromises Lymphatic FunctionNews
Infections of the skin or other soft tissues with the hard-to-treat MRSA bacteria appear to permanently compromise the lymphatic system, which is crucial to immune system function. Investigators describe how MRSA infection impairs the ability of lymphatic vessels to pump lymphatic fluid to lymph nodes in mouse models, which may contribute to the frequent recurrences of MRSA infection experienced by patients.
Possible Biomarker to Identify Who Would Benefit from ImmunotherapyNews
While immunotherapy has made a big impact on cancer treatment, the fact remains that only about a quarter of patients respond to these treatments. In a new study, researchers examined tissue samples from melanoma and ovarian cancer patients treated with immunotherapies and found a link between the percentage of antigen-presenting cells expressing PD-L1 and an objective clinical response to treatment.READ MORE