Celldex cancer vaccine meets goal in midstage trial

Sat Nov 20, 2010 7:00am EST

* Vaccine extends survival time without disease progression

* Vaccine was well-tolerated

By Esha Dey

NEW YORK, Nov 20 (Reuters) - Celldex Therapeutics Inc (CLDX.O) said its experimental vaccine for the the most common type of brain cancer met the main goal of extending survival time for patients without a progression of the disease in a mid-stage trial.

The vaccine rindopepimut or CDX-110 is Celldex's lead product candidate. The Needham, Massachusetts-based company had faced a setback on it earlier this year when partner Pfizer (PFE.N) pulled out from a co-development deal, saying it was no longer a priority for them. [ID:nSGE6820ET]

The trial, named ACT III, showed 66 percent of patients had no disease progression at 5.5 months from the start of vaccination, a statistically significant increase over a predetermined progression-free rate estimate of 53 percent, with standard of care.

The study had 65 patients suffering from newly diagnosed glioblastoma multiforme (GBM) tumors who started vaccination with rindopepimut at about three months post-diagnosis.

The vaccine was well-tolerated, with local reactions at the injection site being the most common adverse event.

Rindopepimut targets a specific molecule that is only expressed in cancer cells and can directly lead to cancer cell growth.

The molecule targeted by the vaccine is usually present in 25-30 percent of GBM tumors, the company said.

Celldex's vaccine is similar to Dendreon's DNDN.O Provenge, the only FDA-approved cancer vaccine, which treats advanced prostate cancer.

Antigenics (AGEN.O) is also developing a cancer vaccine, called Oncophage, for kidney cancer and melanoma.

Celldex shares, which tumbled 26 percent to $3.53 on the day Pfizer ended its partnership, have recovered since then and closed at $4.62 on Friday on the Nasdaq, up 5.7 percent. (Reporting by Esha Dey, editing by Matthew Lewis)