Celldex discontinues phase 3 study of Rintega after DSMB recommendation

Rintega (rindopepimut) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII, a functional and permanently activated mutation of the epidermal growth factor receptor (EGFR) which has been well validated as a target for cancer therapy.

The board recommended to discontinue the study of Rintega in newly diagnosed glioblastoma as it is unlikely to meet primary overall survival endpoint in patients with minimal residual disease.

The company said it does not anticipate incurring substantial additional costs associated to the study at present.

It will provide ongoing access to Rintega on a compassionate use basis for all patients on the Rintega arm of the ACT IV study, prior phase 2 studies and the current compassionate use recipients.

Celldex Therapeutics co-founder, president and CEO Anthony Marucci said: "We are extremely disappointed for patients that the ACT IV study was not successful.

"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 is currently leading seven clinical trials across five product candidates.

The company expects to report data from several of these studies in the next three to 18 months, including a registration study in triple negative breast cancer and various phase 1 and 2 cancer immunotherapy combination trials.

Celldex’s pipeline is built from a portfolio of antibodies and immunomodulators to create novel, disease-specific therapies that induce, improve or suppress the body’s immune response.