DSMB recommends Celldex's Phase III study of Rintega (rindopepimut) in newly diagnosed glioblastoma be discontinued

Study unlikely to meet primary overall survival endpoint in patients with minimal residual disease.

In the ACT IV study, Rintega has performed consistently with prior Phase II studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: Rintega 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to Rintega at this time. All patients on the Rintega arm of the ACT IV study, prior Phase II studies and existing compassionate use recipients will be offered ongoing access to Rintega on a compassionate use basis. Celldex first received the data after market close on Friday, 4 March and is in the process of reviewing the results.

"We are extremely disappointed for patients that the ACT IV study was not successful," said Anthony Marucci, Co-founder, President and CEO of Celldex Therapeutics. "On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment."

Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase I and II cancer immunotherapy combination trials.