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Celldex reports tumor-specific immune response in Phase II glioblastoma trial

Celldex Therapeutics, a wholly-owned subsidiary of Avant Immunotherapeutics, has announced that new data from the Phase II ACT II study in glioblastoma multiforme suggest that temozolomide, may potentiate the effect of Avant's vaccine candidate CDX-110.

All patients vaccinated with CDX-110 in the Phase IIa ACT II extension study showed a tumor-specific immune response, a significant improvement over previous vaccines and over CDX-110 alone. Patients vaccinated in conjunction with the daily temozolomide (TMZ) dose had a statistically significant increase in anti-EGFRvIII antibody titers (P=0.028) compared to patients that received the standard 200mg/m2 dose of TMZ.

In addition, the delayed type hypersensitivity response (DTH) following vaccination was also greater in the patients receiving the continuous 21 day TMZ dose (P=0.05). Early time to progression and overall survival data also look very promising. These data suggest that chemotherapy enhances the induction of a vaccine specific immune response, and that daily chemotherapy may further enhance the vaccine’s effect.

Tom Davis, Avant’s chief medical officer, said: “We expect to present survival data from this study at ASCO in June, 2008. We also eagerly await the data from Avant’s currently enrolling randomized Phase IIb/III study, ACT III, which is designed to confirm the Phase IIa results.”