February 23, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
New Jersey biotech Celldex Therapeutics is riding a rocket Monday, shooting up as much as 20 percent in morning trading after the company announced the U.S. Food and Drug Administration (FDA) had granted breakthrough therapy designation for its experimental drug rindopepimut (Rintega).
The FDA made the decision after reviewing Phase III clinical trial data that showed an improvement in care for patients with EGFRvIII-positive glioblastoma, a type of brain cancer with high fatality rates and few treatments. Hampton, N.J.-based Celldex said the new designation will allow physicians to get the drug to patients much more quickly, which hopefully will help them with both palliative care and life expectancy.
"These patients have extremely limited treatment options, with only three new drugs approved in more than 20 years," says CEO Anthony Marucci. "Emerging clinical data suggests that rindopepimut may offer an improvement over existing standard of care for EGFRvIII-positive patients."
The FDA the Breakthrough Therapy Designation in the hopes of building a process for drug companies to expedite the development and review of drugs for serious or life-threatening conditions. Drugs seeking the coveted designation (and patent protection that comes with it) must meet strict preliminary clinical trial evidence criteria that demonstrate the drug may have “substantial improvement on at least one clinically significant endpoint over available therapy.”
Celldex’s rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII, which is a patient population with a worse prognosis than the overall glioblastoma population, including lower chances of survival. The presence of EGFRvIII has shown to indicate more and worse tumors in mice, as well as 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,” said Celldex. “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.”
BioSpace Temperature Poll
Analyst Mark Schoenebaum, a biotech and pharmaceuticals analyst and medical doctor for ISI Group Evercore, has been running a Best Hair in Biopharma contest for several months now. So far, the candidates are Bristol-Myers Squibb Company's John Elicker, Receptos’ Chief Executive Officer Faheem Hasnain, Celgene's Vice President of Investor Relations Patrick Flanigan and Acorda Therapeutics' Ron Cohen.
We want to know what our BioSpace community thinks: Who do you believe actually has the Best Hair in BioPharma?
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