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news.Celldex Therapeutics has received FDA's orphan drug designation for CDX-110, an immunotherapy that targets the tumor-specific growth promoter EGFRvIII, for the treatment of Glioblastoma Multiforme.
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In the Activate Phase IIa study, CDX-110 treated Glioblastoma Multiforme (GBM) patients showed a median survival time of 30 months, more than a 100% increase in survival, versus the historical control’s median of 14.5 months. The study has demonstrated a median time-to-progression of 13 months (p=0.0001) versus the historical control’s median of 6.4 months.
In September, Celldex randomized its first patient into ACT III, a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly-diagnosed GBM. The clinical trial is investigating the anticancer activity, impact on survival, and safety of the addition of CDX-110 vaccine to standard of care, versus standard of care alone. Celldex has currently enlisted 18 clinical centers throughout the US and also recently received approval from Health Canada to open enrolment in Canada. The National Cancer Institute has also agreed to collaborate with Celldex in expanded clinical development of CDX-110 under a clinical trials agreement.
Thomas Davis, chief medical officer of Celldex Therapeutics, said: “Approval to expand clinical research into Canada and the scientific and clinical collaboration from the National Cancer Institute all promote our ability to fully explore the promise of CDX-110.”