Rindopepimut (CDX-110) is an injectable
peptide
Peptides (, ) are short chains of amino acids linked by peptide bonds. Long chains of amino acids are called proteins. Chains of fewer than twenty amino acids are called oligopeptides, and include dipeptides, tripeptides, and tetrapeptides.
A ...
cancer vaccine[ which targets a mutant protein called EGFRvIII present in about 25% to 30% of ]glioblastoma
Glioblastoma, previously known as glioblastoma multiforme (GBM), is one of the most aggressive types of cancer that begin within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality ch ...
cases.[
The vaccine consists of the EGFRv3-specific peptide (a 13-]amino acid
Amino acids are organic compounds that contain both amino and carboxylic acid functional groups. Although hundreds of amino acids exist in nature, by far the most important are the alpha-amino acids, which comprise proteins. Only 22 alpha am ...
mutant vIII epitope
An epitope, also known as antigenic determinant, is the part of an antigen that is recognized by the immune system, specifically by antibodies, B cells, or T cells. The epitope is the specific piece of the antigen to which an antibody binds. The p ...
) conjugated to the non-specific immunomodulator
Immunotherapy or biological therapy is the treatment of disease by activating or suppressing the immune system. Immunotherapies designed to elicit or amplify an immune response are classified as ''activation immunotherapies,'' while immunotherap ...
keyhole limpet hemocyanin
Keyhole limpet hemocyanin (KLH) is a large, multisubunit, oxygen-carrying, metalloprotein that is found in the hemolymph of the giant keyhole limpet, ''Megathura crenulata'', a species of keyhole limpet that lives off the coast of California, fro ...
(KLH).
The US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
granted it Breakthrough Therapy
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "br ...
designation for glioblastoma
Glioblastoma, previously known as glioblastoma multiforme (GBM), is one of the most aggressive types of cancer that begin within the brain. Initially, signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality ch ...
in Feb 2015 meaning that it might be able to get approval sooner if it is effective.
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Clinical trials
Glioblastoma
The phase II ACT III study reported encouraging results in June 2015.
The ReACT clinical trial for glioblastoma reported encouraging results in 2015.[Celldex Vaccine Rindopepimut Cuts Death Risk From Brain Cancer, Study Shows. WSJ Nov 2015]
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In March 2016 the phase III ACT IV trial was terminated because it did not increase overall survival
Survival rate is a part of survival analysis. It is the proportion of people in a study or treatment group still alive at a given period of time after diagnosis. It is a method of describing prognosis in certain disease conditions, and can be use ...
.
References
{{pharma-stub
Vaccines
Breakthrough therapy
Experimental cancer drugs