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Enrollment Begins for Mesothelioma Vaccine Clinical Trial

Illustration of lungs (Mikael Häggström/Wikimedia Commons)

(Mikael Häggström/Wikimedia Commons)

Aduro BioTech Inc. in Berkeley, California enrolled the first patient in a clinical trial of a therapeutic cancer vaccine to treat malignant pleural mesothelioma. The trial will test the safety and immune response of Aduro BioTech’s CRS-207 vaccine combined with chemotherapy on patients recently diagnosed with the disease.

The phase 1B trial is expect to enroll 16 patients at H. Lee Moffitt Cancer Center in Tampa, Florida and National Cancer Institute in Bethesda, Maryland. Patients will receive two vaccinations with CRS-207, followed by standard-of-care chemotherapy with the drugs pemetrexed and cisplatin, followed by at least two booster vaccinations after chemotherapy.

The vaccine is based on Aduro BioTech’s technology that develops immunotherapies from genetically altered Listeria bacteria. The Listeria are engineered to induce an immune response for the mesothelin tumor-associated antigen expressed on some types of tumors, including mesothelioma. While Listeria is often considered a dangerous food-borne pathogen, the bacteria used to generate the Aduro BioTech vaccine have been attenuated (altered) to remove their dangerous properties.

The company tested the safety of CRS-207 and its ANZ-100 vaccine, also made from attenuated Listeria bacteria, in an earlier phase 1 trial, with results published in the journal Clinical Cancer Research (paid subscription required). CRS-207 was evaluated in a multiple-dose study in 17 subjects with cancers known to over-express mesothelin, including mesothelioma, as well as non-small-cell lung, ovarian, and pancreatic cancers. The doses used in the CRS-207 and ANZ-100 studies were found to be safe and induce an immune response.

Pleural mesothelioma is a rare form of cancer diagnosed in people who have been exposed to high levels of asbestos, affecting the pleura, a thin membrane of lubricating cells that lines the lungs and chest wall. The disease can take up to 10 years to develop including for symptoms to appear. Thickening or calcification of the pleural lining is often serves as a precursor to mesothelioma.

Aduro BioTech is testing CRS-207 in a phase 2 trial in combination with the GVAX Pancreas vaccine and the drug cyclophosphamide. That trial is recruiting some 90 patients at 10 sites in the U.S.

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