The clinical trial will be designed to bring together CRS-207, Aduro's LADD, a live attenuated double-deleted immunotherapy with Keytruda, the anti-PD-1 therapy to treat patients with malignant pleural mesothelioma that has not responded to previous treatment.
Aduro, the Berkeley, Calif.-based immunotherapy company is developing therapies to harness the body's immune system to fight cancer as well as autoimmune and infectious diseases.
LADD is Aduro's platform of listeria monocytogenes engineered to bring an innate immune response and express tumor-related antigens and induce tumor specific T-cell immunity.
Keytruda, approved by the Food and Drug Administration in October, can treat certain cases of advanced non-small cell lung cancer, advanced melanoma, head and neck squamous cell cancer and classical Hodgkin lymphoma.
Mesothelioma affects the smooth layer of mesothelial cells of the lungs, heart, chest and abdomen. Malignant pleural mesothelioma is the most common form of the disease, with about 13,000 cases in the U.S., Europe and Japan a year. The disease does not lend itself to surgical intervention and there currently is no FDA approved therapy for patients who have failed prior treatments.
After closing at $10 on May 16, shares of Aduro slid to an open $9.65 May 17 after the announcement. Shares began to trade back up at $9.78 in early afternoon trading.
The planned trial will take place in multiple locations and will be an open-label study to evaluate safety and efficacy of CRS-207 with Ketruda in adults. Enrollment in the trial is expected to be as high as 35 patients and the patients must have failed one or two prior treatments.