Celldex brain cancer vaccine increases survival in Phase II

Celldex Therapeutics ($CLDX) has unveiled overall survival data from a 65-person Phase II trial of the company's brain cancer vaccine rindopepimut. In the single-arm trial, the Needham, MA-based developer said subjects who received the therapeutic vaccine had a median overall survival of 24.6 months from diagnosis; historical data on patients with the same eligibility of those in the trial had a median survival of just 15.2 months.

Rindopepimut targets the epidermal growth factor receptor variant III (EGFRvIII). The vaccine was given to newly-diagnosed EGFRvIII-expressing patients whose cancer had been surgically removed. Three months after diagnosis and after standard chemo treatments, the patients were given the vaccine along with temozolomide therapy, which is a standard treatment for glioblastoma.

Two year overall survival rates in the rindopepimut group were 52%, compared with 6% for the matched EGFRvIII positive cohort. The company noted the survival data were consistent with two previous smaller studies with rindopepimut.

Celldex's stock price was hit hard in August after sluggish sales of Dendreon's prostate cancer vaccine Provenge dragged the entire cancer vaccine sector down. In 2010, Pfizer pulled out of a pact to develop rindopepimut, saying the programs was no longer a "strategic priority."

"The consistency of data from three separate studies, including a large multicenter trial, is very encouraging and clearly supports our plan to advance clinical development of rindopepimut with ACT IV, a pivotal, randomized, blinded international Phase III study," said Celldex CMO Thomas Davis. Before the end of the year, Celldex will kick off a Phase III trial of rindopepimut as a frontline treatment for glioblastoma, and a second trial for recurrent glioblastoma in combination with Avastin, a company spokesperson said in an email to FierceVaccines. The data were presented at the 16th Annual Meeting of The Society for Neuro-Oncology.

- here's Celldex's release