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Mesothelioma Vaccine Receives Orphan Drug Approval

168295_injection1Mesothelioma patients who are not candidates for surgery may soon have another treatment option. The FDA has granted orphan drug approval to a new cancer vaccine called CRS-207.

CRS-207 is manufactured by Aduro Biotech, Inc. and is made from an attenuated (less potent) version of the bacteria Listeria monocytogenes. CRS-207 triggers a powerful immune response against cells that produce mesothelin, a tumor-associated antigen produced by several types of cancer, including mesothelioma. Because it works in conjunction with the body’s natural immune responses, CRS-207 is classified as a type of immunotherapy.

Aduro Biotech is currently enrolling mesothelioma patients in a Phase 1b clinical trial of CRS-207. They are looking for 40 mesothelioma patients who have inoperable cancer and have not yet received any other therapy. Trial participants will get CRS-207 along with standard mesothelioma chemotherapy in an effort to make chemotherapy more effective.

“We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma,” Aduro Senior Vice President of Research and Development, Dr. Dirk Brockstedt said in a statement earlier this month.

Preliminary tests of CRS-207 have been promising. According to data presented at the Mesothelioma Interest Group Conference last October, 94 percent of the 16 evaluable mesothelioma patients who got the vaccine experienced either a stabilization of their mesothelioma or some tumor shrinkage. At the time of the presentation,the  estimated progression-free survival rate for these mesothelioma patients was 7.5 months but one patient had been on the study for 19 months, received CRS-207 as a maintenance therapy.

Orphan drug designation was designed to help encourage and support the development of drugs to treat very rare diseases like mesothelioma. The approval means that Aduro Biotech will get grant funding and tax credits to offset the cost of clinical testing and licensing fees. CRS-207 has already been granted orphan drug status for the treatment of pancreatic cancer.


“Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma”, March 26, 2015, New Release, Aduro Biotech website, accessed March 30, 2015.

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