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Mesothelioma Vaccine Enters Phase 2 Testing

ByAlex Strauss

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The makers of a new cancer vaccine say they have enrolled the first mesothelioma patients in a study that will combine their drug with chemotherapy against this virulent cancer.

The drug, currently known as CRS-207, is manufactured by Aduro Bio Tech, Inc. According to a company press release, CRS-207 is based on an attenuated (made less potent) version of Listeria monocytogenes, bacteria found in soil and water than can cause the food borne illness, Listeriosis.

To make CRS-207, scientists at Aduro genetically modified the Listeria monocytogenes in order to produce a powerful immune response against cells that produce mesothelin. Mesothelin is a tumor-associated antigen produced by several types of cancer cells, including mesothelioma cells. Because it works in conjunction with the body’s natural immune responses, the CRS-207 vaccine is classified as a type of immunotherapy.

CRS-207 has already been evaluated in a Phase 1 trial of 17 patients with mesothelioma and several other end-stage cancers. Although most ‘end stage’ cancer patients have just a few months to live, six of the 17 patients treated with CRS-207 lived 15 months or longer. Based on those promising results, two new Phase 2 clinical trials of CRS-207 have been launched – one for patients with metastatic pancreatic cancer and one for patients with malignant pleural mesothelioma.

The CRS-207 trial of mesothelioma is being conducted at the National Cancer Institute in Bethesda, Maryland under the direction of noted mesothelioma researcher Dr. Raffit Hassan and at the H. Lee Moffitt Cancer Center in Tampa, Florida where Dr. Scott Antonia is the lead researcher.

“We are excited to be expanding our Listeria-based platform into a new indication and extending our collaborations with leading mesothelioma translational researchers, “ says Aduro Senior Vice President of Research and Development, Dr. Dirk Brockstedt. “This trial will evaluate our vaccine treatment for the first time in front-line cancer patients and we predict a synergistic benefit to their standard chemotherapy.”

In the new Phase 2 mesothelioma trial, newly-diagnosed mesothelioma patients will start their therapy by receiving two prime vaccinations with CRS-207. They will then receive the standard mesothelioma chemotherapy regimen of cisplatin with pemetrexed.  When their chemotherapy round concludes, these mesothelioma patients will receive at least 2 additional ‘booster’ shots of CRS-207. The aim of Phase 2 drug trials is to study a drug’s safety and efficacy profile and to determine the best dosing strategy. The CRS-207 trial is currently recruiting newly-diagnosed mesothelioma patients and is set to conclude in December 2013.

Sources:

“Aduro Announces First Patient Enrolled in Mesothelioma Clinical Trial”, October 2, 2012, Press Release, Wall Street Journal, MarketWatch online.
CRS-207 Cancer Vaccine in Combination with Chemotherapy as a Front-line Treat for Malignant Pleural Mesothelioma, CDC Clinical Trial website.

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