Vaccine: Rindopepimut
Company: Celldex Therapeutics
Target: Brain cancer

Celldex Therapeutics' ($CLDX) brain cancer vaccine, rindopepimut, also known as CDX-110, targets EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR). This mutation is found in about 31% of cases of glioblastoma multiforme, a form of fast-growing brain cancer and the most common type of primary brain tumor. It can contribute to tumor growth, and is linked with poor long-term survival. It is not seen in normal tissue.

In the ACT III Phase II trial, which involved people with newly diagnosed EGFRvIII-positive glioblastoma, 65 patients were given rindopepimut in combination with standard-of-care treatment (temozolomide), after having undergone surgery and standard chemotherapy and radiation therapy.

Rindopepimut improved survival, with a median survival of 24.6 months, compared with 15.2 months for matched patients receiving standard treatment in published studies. Overall survival at 24 months was 52%, compared with 6% in the historical group. The vaccine was well-tolerated and the patients had robust immune responses.

In September 2010, Pfizer ($PFE) returned its rights to the vaccine because it was not a strategic priority. Rindopepimut is in a Phase III registration trial called ACT IV for the first-line treatment of glioblastoma, with trials under way in the U.S. and planned in additional centers elsewhere. The vaccine is also under assessment in a Phase II trial in the U.S. in patients with recurrent glioblastoma (the ReACT trial).


Suggested Articles

Ad Environment Matters for Message Receptivity

After the U.K.'s nod for Pfizer's vaccine, NIAID director Anthony Fauci argues the country’s regulators acted too quickly. 

Implementing data integration strategy in your commercialization breaks down traditional healthcare silos and improves patient outcomes.