Celldex, Roche to evaluate varlilumab and MPDL3280A combination in renal cell carcinoma

As part of the deal, Roche will provide study drug and Celldex will be responsible for conducting and funding the trial, which is scheduled to be initiated later this year.

Varlilumab, Celldex’s fully human monoclonal antibody that targets CD27, and MPDL3280A (anti-PDL1), Roche’s investigational cancer immunotherapy, are part of a new class of investigational medicines known as cancer immunotherapies.

CD27 is a critical molecule in the activation pathway of lymphocytes and it can be effectively manipulated with activating antibodies to induce potent anti-tumor responses and may result in fewer toxicities due to its restricted expression and regulation.

Celldex Therapeutics executive vice-president and chief medical officer Dr Thomas Davis said: "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.

"Varlilumab is currently being studied in two Phase I/II combination studies and we expect it will enter at least another four combination studies this year."

The immunotherapies are designed to harness the body’s own immune system to fight cancer through separate yet complementary mechanisms of action that may allow the activation of T cells, restoring their ability to effectively detect and attack tumor cells.

According to preclinical data, the combination of these two mechanisms is expected to improve anti-tumor immune response compared to either agent alone.

Positive signs of clinical activity in patients with refractory renal cell carcinoma were observed in Celldex’s Phase I trial of varlilumab conducted in multiple solid tumors.