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FDA Breakthrough Therapy Designation: Celldex Therapeutics And Glioblastoma Vaccine

February 24, 2015

Celldex Therapeutics, a New Jersey-headquartered biotechnology company, announces February 23rd that the FDA grants the Breakthrough Therapy Designation (BTD) to the company’s investigational immunotherapy Rindopepimut (Rintega) vaccine, for adult patients with EGFRvIII-positive Glioblastoma (GBM). Only 3 drugs have been approved in more than 20 years for GBM. Rindopepimut receives Orphan Drug Designation (ODD) in Europe in 2011.

The FDA BTD is based on data from the Phase II ReACT clinical trial in relapsed EGFRvIII-Positive GBM, Phase II ACT III clinical trial in newly diagnosed GBM, and additional Phase II clinical trials. An international Phase III study, ACT IV, in newly diagnosed GBM completes enrollment in December 2014 with 745 participants.

Rindopepimut is an experimental cancer drug that is administered via intradermal injection. It acts to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein. Per the company’s Press Release:

Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “White Pocket Reflection” by John Fowler (Flickr: White Pocket Reflection) [CC BY 2.0] | Wikimedia Commons.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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